ASME PTB-11-2017-Guide For ASME BPVC Section I Stamp Holders

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AS M E P TB - 1 1 - 2 0 1 7

G u i d e fo r AS M E B P VC
S e c ti o n I S ta m p H o l d e rs
PTB-1 1 -201 7

GUIDE FOR
ASME BPVC SECTION I
STAMP HOLDERS
USE OF ASME SECTION I TO MEET THE EC PRESSURE
EQUIPMENT DIRECTIVE (201 4/68/EU)

Prepared by:
Elmar Upitis
Ambitech Engineering Corporation
Date of Issuance: June 9, 201 7

by ASME Standards Technology, LLC (“ASME ST - LLC”) and sponsored by


This report was prepared

the American Society of Mechanical Engineers (“ASME”) Pressure Technology Codes & S tandards.

Neither AS ME, AS ME S T-LLC, the authors, nor others involved in the preparation or review of this

report, nor any of their respective employees, members or persons acting on their behalf, makes any

warranty, express or implied, or assumes any legal liability or responsibility for the accuracy, completeness

or usefulness of any information, apparatus, product or process disclosed, or represents that its use would

not infringe upon privately owned rights.

Reference herein to any specific commercial product, process or service by trade name, trademark,

manufacturer or otherwise does not necessarily constitute or imply its endorsement, recommendation o r

favoring by AS ME S T-LLC or others involved in the preparation or review of this report, or any agency

thereof. The views and opinions of the authors, contributors and reviewers of the report expressed herein

do not necessarily reflect those of AS ME S T-LLC or others involved in the preparation or review of this

report, or any agency thereof.

AS ME S T-LLC does not take any position with respect to the validity of any patent rights asserted in

connection with any items mentioned in this document, and does not undertake to insure anyone utilizing

a publication against liability for infringement of any applicable Letters Patent, nor assumes any such

liability. Users of a publication are expressly advised that determination of the validity of any such patent

rights, and the risk of infringement of such rights, is entirely their own responsibility.

Participation by federal agency representative(s) or person(s) affiliated with industry is not to be

interpreted as government or industry endorsement of this publication.

AS ME is the registered trademark of the American S ociety of Mechanical Engineers.

No part of this document may be reproduced in any form,

in an electronic retrieval system or otherwise,

without the prior written permission of the publisher.

The American S ociety of Mechanical Engineers

Two Park Avenue, New York, NY 1 001 6-5 990

IS B N No. 978 -0-791 8 -71 5 4-6

Copyright © 201 7 by

THE AMERICAN S OCIETY OF MECHANICAL ENGINEERS

All Rights Reserved

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PTB -1 1 -201 7: Guide for AS ME B PVC S ection I S tamp Holders

TABLE OF CONTENTS
Foreword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

1 INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

2 THE EUROPEAN CONTEXT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

2. 1 Main Concepts of New Directives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

2. 2 Terms Used in European Directives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

3 PED OVERVIEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

3 . 1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

3.1 .1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

3.1 .2 Intent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

3.1 .3 Manufacturers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

3.1 .4 Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

3 . 2 General Concepts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

3 . 2. 1 S cope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

3 . 2. 2 Hazard Categories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

3 . 2. 3 Conformity Assessment (CA) Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

3 . 2. 4 Notified B ody . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

3 . 2. 5 Conformité Européene (CE) Marking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

3 . 2. 6 Essential S afety Requirements (ES R) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

3 . 2. 7 Material S pecifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

3 . 2. 8 Use of Non-Harmonized S tandards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

3 . 3 S tructure of the PED . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

4 S COPE (ARTICLES 1 , 2, AND 4 OF THE PED) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

4. 1 S cope (Article 1 -§ 1 of the PED) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

4. 2 Types of Equipment Covered (Article 2 and Article 4 of the PED) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

4. 3 PED Exclusions (Article 1 -§ 2 of the PED) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

5 CLAS S IFICATION OF PRES S URE EQUIPMENT (ARTICLE 4, ARTICLE 1 3 , ANNEX 1 , AND

ANNEX II OF THE PED) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 0

5 . 1 Level of Hazards in Pressure Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 0

5 . 2 S ound Engineering Practice (S EP) (Article 4-§ 3 of the PED) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 0

5 . 3 Equipment in Categories I to IV (Article 4-§ 1 of the PED) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 0

5 . 4 Vessels Not S ubj ect to Fire or Heat (Article 4-§ 1 (a) of the PED) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 2

5 . 5 Vessels S ubj ect to Fire or Heat (Article 4-§ 1 (b) of the PED) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 2

5 . 6 Piping (Article 4-§ 1 (c)) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 2

5 . 7 S afety Accessories (Article 4-§ 1 (d), Annex ll-§ 2 of the PED) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 2

5 . 8 Pressure Accessories (Article 4-§ 1 (d), Annex ll-§ 3 of the PED) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 2

5 . 9 S ummary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 3

6 CONFORMITY ASSESSMENT (CA) PROCEDURES (ARTICLE 1 4, ANNEX III OF THE PED)1 4

6. 1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 4

6. 2 General Concept . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 4

6. 3 Structure of the Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 7

6. 4 Review of CA Modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 8

6. 4. 1 CA Modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 8

6. 4. 2 Module A: Internal Production Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 8

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6. 4. 3 Module A2: Internal Production Control plus S upervised Pressure Equipment Checks at

Random Intervals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 8

6. 4. 4 Module B : EU Type Examination – Production Type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 9


6. 4. 5 Module B : EU Type Examination – Design Type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

6. 4. 6 Module C2: Conformity to Type B ased on Internal Production Control plus S upervised

Pressure Equipment Checks at Random Intervals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

6. 4. 7 Module D: Conformity to Type B ased on QA of the Production Process . . . . . . . . . . . . . . . . . . 21

6. 4. 8 Module D1 : Quality Assurance of the Production Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

6. 4. 9 Module E: Conformity to Type B ased on Pressure Equipment Quality Assurance . . . 22

6. 4. 1 0 Module E1 : Quality Assurance of Final Pressure Equipment Inspection and Testing23

6. 4. 1 1 Module F: Conformity to Type B ased on Pressure Equipment Verification . . . . . . . . . . . . . . 23

6. 4. 1 2 Module G: Conformity B ased on Unit Verification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

6. 4. 1 3 Module H: Conformity B ased on Full QA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

6. 4. 1 4 Module H1 : Conformity B ased on Full QA Plus Design Examination . . . . . . . . . . . . . . . . . . . . . . 25

6. 5 S ummary of Activities of Manufacturers and NB s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

7 ES S ENTIAL S AFETY REQUIREMENTS (ES R) (ARTICLES 4 AND 6, ANNEX I OF THE PED)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

7. 1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

7. 2 General Discussion of ES R (Annex I of the PED) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

7. 2. 1 Preliminary Remarks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

7. 3 Hazard Analysis (Annex I of the PED) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 1

7. 3 . 1 Identify the Hazard Due to Pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 1

7. 3 . 2 Evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 2

7. 3 . 3 Reduction of Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 2

7. 3 . 4 Informing Users . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 2

7. 3 . 5 Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 2

8 MATERIALS (ARTICLE 1 5 , ANNEX I, S ection 4 OF THE PED) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 3

8 . 1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 3

8 . 2 Materials that Comply with Harmonized Materials S tandards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 3

8 . 3 European Approval of Pressure Equipment Materials (Article 1 5 of the PED) . . . . . . . . . . . . . . . . . . . . . . 3 3

8.3. 1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 3

8.3. 2 General Requirements for Obtaining EAMs of Pressure Equipment Materials . . . . . . . . . 3 4

8 . 4 PMA (Annex I-§ 4. 2c of the PED) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 5

8 . 5 Material Certificates (Annex I-§ 4. 3 of the PED) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 5

8 . 6 Material Manufacturers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 5

9 NOTIFIED B ODIES (article 24 OF THE PED) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 6

10 CE MARKING (ARTICLE 1 8 , ARTICLE 1 9, OF THE PED) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 7

11 S PECIFIC IS S UES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 8

1 1 . 1 Assemblies (Article 6, Article 1 2 of the PED) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 8

1 1 . 2 User Inspectorates (Article 25 of the PED) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 8

1 1 . 3 S pecific Cases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 8

1 1 .4 Manufacturer’s Responsibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 9
1 1 . 5 Operating Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

12 COMPARIS ON OF AS ME AND PED REQUIREMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

13 ADDITIONAL CONS IDERATIONS FOR APPLICATION OF AS ME B PVC S ECTION I, POWER

B OILERS WITHIN THE S COPE OF PED 201 4/68 /EU, ANNEX I . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 1

14 GUIDELINES related TO PED 201 4/68 /EU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 04

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1 4. 1 Purpose of the Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 04

1 4. 2 S tatus of the Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 04

1 4. 3 Classification of the Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 04

1 4. 4 Inquiries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 04

REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 05

APPENDIX A: Glossary of Terms Used in The Directives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 06

APPENDIX B : Contents of the PED . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 08

APPENDIX C: Flowchart for Pressure Equipment Directive (201 4/68 /EU) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 1 0

APPENDIX D: PED Exclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 1 1

APPENDIX E: Graphs for Hazard Categories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 1 2

APPENDIX F: Manufacturers and Notified B odies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 21

APPENDIX G: Declaration of Conformity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 25

APPENDIX H: Responsibilities of the Manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 26

APPENDIX I: S imultaneous Application of European Directives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 3 0

LIST OF FIGURES
Figure 5 -1 : Category for Vessel Containing a Dangerous Gas . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 1

Figure 6-1 : Relation of Conformity Assessment Procedures to Categories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 4

Figure 6-2: Conformity Assessment Modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 5

Figure 6-3 : Conformity Assessment Procedures in the PED . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 6

Figure 6-4: Conformity Assessment Procedure to B e Applied In Each Category . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 7

Figure 7-1 : Allowable General Membrane S tress Values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Figure 7-2: Joint Efficiency Values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Figure 7-3 : Welding Procedure Qualifications and Welder Qualifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Figure 1 2-1 : Comparison of AS ME S ection I Requirements with PED 201 4/68 /EU, Annex I . . . . . . . . . . 41

Figure 1 2-2: Q1 S afety Factors for Allowable S tresses Given in Annex I, § 7. 1 . 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79

Figure 1 2-3 : Q2 Joint Efficiencies Given in Annex I, § 7. 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79

Figure 1 2-4: Q3 Formula for Calculating Hydrostatic Test Pressure Given in Annex I, § 7. 4 . . . . . . . . . . . . . 79

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FOREWORD
This Guide is a comprehensive review of the Pressure Equipment Directive (PED) and AS ME B oiler and

Pressure Vessel Code (B PVC), S ection I. AS ME has received requests from all over the world to provide

guidance to manufacturers who have been or will be impacted by the European PED. This document

provides that guidance. Manufacturers of AS ME B PVC, S ection I Power B oilers will find this document

to be a useful tool when working with a notified body toward compliance with the PED and applying the

Conformité Européene (CE) mark to their products.

This document begins with an explanation of the European New Approach and continues with the goals of

the PED and a description of its scope of coverage. Then, the document offers an in-depth analysis of the

PED concept of hazard categories and the various combinations of Conformity Assessment (CA) modules

that can be used for each hazard category. Each of the PED Essential S afety Requirements (ES R) are then

covered, including materials, use of Notified B odies, and requirements for CE marking.

The reader is presented next with a detailed comparison of the PED with AS ME S ection I, followed by a

modified version of Annex Z for AS ME S ection I. This Annex Z provides instructions regarding what

additional tasks must be completed to meet the administrative requirements of the PED.

The author and AS ME S T-LLC acknowledges, with deep appreciation, the contributions of

S tuart Cameron, Alan Nywening, Anne Chaudouet of CETIM, France, the comments provided by

Peter Hanmore, Consultant in the United Kingdom, Matteo Convento, the PED Notified B ody in the UK,

the AS ME Pressure Technology B ook (PTB ) peer review group, and Luis Pulgarin of the AS ME S T-LLC

staff in preparing this PED Guide.

Established in 1 8 8 0, AS ME is a professional not-for-profit organization with more than 1 3 5 , 000 members

and volunteers promoting the art, science, and practice of mechanical and multidisciplinary engineering

and allied sciences. AS ME develops codes and standards that enhance public safety, and provides lifelong

learning and technical exchange opportunities benefiting the engineering and technology community. Visit

www. asme. org for more information.

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1 INTRODUCTION
When the European Commission (EC) PED 97/23 /CE was adopted in May 1 997, it became clear that

pressure equipment designed and built to standards other than European standards could carry the “ CE”
marking. This was made possible by the European approach, in which Essential S afety Requirements

(ES R) are established in the Directives, and standards are used to support them. The PED 97/23 /CE has

now been aligned with the new legislative framework and replaced by Directive 201 4/68 /EU, issued 1 5

May 201 4. The new PED shall be applied no later than July 1 9, 201 6, except that Article 1 3 shall be applied

from June 1 , 201 5 .

The purpose of this AS ME PED Guide is to provide analysis of the PED and compare its ES R with the

design, construction, and administrative requirements of AS ME B PVC S ection I. The first portion of the

PED Guide consists of Chapters I through XI, which gives an overview of the PED, provides important

basic information on the entire Directive, and identifies specific issues of higher importance. T he next

maj or portion is Chapters XII and XIII, which provide a comparison of the PED and AS ME B PVC S ection

I requirements, including commentary on both the PED ES Rs (Annex I) and AS ME B PVC S ection I.

Chapter XIII provides AS ME B PVC S ection I Code users with additional considerations on how to augment

their current practices to meet all ES Rs of the PED.

It is the intent that this Guide will form the basis for an understanding between manufacturers and Notified

B odies (NB ) regarding the use of AS ME B PVC S ection I as the basis for compliance with the PED. Having

such a uniform approach will benefit not only manufacturers and NB s, but also users of pressure equipment.

S everal PED Information Resource Center websites provide the latest information on the status of European

approval of materials, names, contact information for all NB s, and other valuable news and developments.

These are:

 http: //ec. europa. eu/enterprise/sectors/pressure-and-gas /documents/ped/index_en. htm

 http: //ec. europa. eu/growth/single-market/european-standards/harmonised-standards/pressure-

equipment/index_en. htm

 http: //ec. europa. eu/enterprise/newapproach/nando/index. cfm? fuseaction=directive. notifiedbody&

dir_id=1 9

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2 THE EUROPEAN CONTEXT


2.1 Main Concepts of New Directives
(a) B efore 1 98 5 , there were very few European Directives. They had to contain all technical requirements

and had to be applied unanimously.

(b) In 1 98 5 , a New Approach to Technical Harmonization and Standards was established. The main

obj ectives were to:

(1) Remove technical barriers to trade to permit free movement of goods throughout the

European Union (EU).

(2) Implement common regulations and common standards throughout the EU.

(c) The fundamental principles of the New Directives are as follows.

(1) Directives are fully mandatory throughout the EU and supersede national regulations.

(2) Directives contain only ES R B PVC, which are defined in terms of general safety obj ectives to

enforce a common high level of protection in the EU regarding the hazards inherent to the product.

Only harmonized standards provide the presumption of conformity. There are numerous European

standards that do not.

(3) EN-S tandards will be explicit and quantify ES R to achieve these safety obj ectives. Use of these

EN-S tandards is not mandatory, but products complying with these standards are presumed to

comply with the ES R of the Directive.

(4) Each Directive sets out CA Procedures to ensure that the product complies with all the requirements

of the Directive. These procedures are selected from the European Council Decision No.

768 /2008 /EC of July 9, 2008 and are adapted to the products covered by each Directive.

(5) Each product covered by a Directive must be in full conformity with its specifications and must be

CE marked, which will ensure free movement throughout the EU.

(6) A product may be subj ect to several Directives. The placing on the market and putting into service

can only take place when the product complies with the provisions of all applicable directives.

Additional comments on S imultaneous Application of European Directives are provided in

Appendix I of this Guide.

2.2 Terms Used in European Directives


Appendix A in this Guide gives a definition of the main terms used in the Directives, and especially in the

PED. These terms are identified in this Guide by an initial capital letter (Notified B ody, Marking, etc. ).

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3 PED OVERVIEW
3.1 Introduction
3.1 .1 General
Pressure components present inherent hazards due to the potential energy of their content, especially for

gas. As a consequence, most industrial countries have regulated these products for many decades.

This is the case with the European countries that have developed national regulations, which often vary

significantly. S ome are very detailed (as in France), others contain only very general requirements (as in

the UK), and some others have developed very detailed CA Procedures for Pressure Equipment (as in

Germany). This profusion of different regulations leads to technical barriers to trade. In 1 98 9 the EU

decided to establish a PED to eliminate these problems.

3.1 .2 Intent
The PED has three intents:

(a) Adopt a common regulation for Pressure Equipment throughout EU.

(b) Eliminate the technical barriers to trade for this industrial sector and permit free movement of

products throughout the EU.

(c) Ensure a high level of safety for Pressure Equipment throughout the EU.

The third intent is the most important in that the PED has been built on this concept of safety level with the

implementation of four Hazard Categories. Therefore, the PED is more a hazard-oriented than a product-

oriented Directive. As a consequence, the PED covers only the pressure hazard. Other Directives may
be applicable to cover other hazards.

Manufacturers must not forget that when they affix the CE Marking they implicitly declare that their

equipment fully complies with all the Directives that apply to it.

3.1 .3 Manufacturers
The liberal principles of the New Approach applied to the PED will lead to more freedom than before. The

Manufacturers will be free to select:

(a) Their Notified B ody: anywhere in the EU.

(b) The CA Procedure: adapted to their fabrication.

(c) How they will comply with the ES R: use of the European Harmonized S tandard or a National Code.

3.1 .4 Requirements
PED, like any European Directive, includes three types of requirements, which are:

(a) Legislative, as contained in Articles 1 to 5 2 of the PED.

(b) Devoted to CA Procedures (detailed in Annex III of the PED), which concern the responsibilities

of Manufacturers and Notified B odies.

(c) Devoted to the equipment itself and are called ES R (detailed in Annex I of the PED).

3.2 General Concepts


The PED was adopted on May 29, 1 997 and published in the Official Journal of the European Union

(OJEU) on July 9, 1 997 under the reference 97/23 /CE. This Directive came into force in November 1 999

and became fully mandatory in May 2002. The PED 97/23 /CE has now been substantially amended and

replaced by Directive 201 4/68 /EU, issued 1 5 May 201 4.

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The two main purposes of the PED are as follows :

(a) S et up in all countries of the EU a common regulation for all Pressure Equipment to ensure a high

level of safety throughout the EU.

(b) Allow the free movement of Equipment in the EU to remove the technical barriers to trade.

The purpose of this AS ME Guide is to make the users familiar with the key elements of the PED .

3.2.1 Scope
The PED applies to all Equipment (pressure vessels, piping, and boilers) subj ect to a pressure greater than

0. 5 bar.

(a) The application of the PED is fully mandatory in all countries of EU and has superseded the National

Regulations.

(b) Any Pressure Equipment within the scope of the PED has to comply with it and b ear the CE

Marking.

(c) The PED applies only to new Equipment going into service in the EU for the first time. Equipment

already in service is not subj ect to the PED, but will continue to meet the National Regulations.

Despite several exclusions, such as the nuclear field, this scope is very wide as it covers small products (such

as pressure-cookers) as well as large industrial Equipment (such as chemical reactors or liquefied gas

vessels). The PED applies only to new Equipment.

3.2.2 Hazard Categories


Equipment that is above the thresholds specified by the PED is classified in four categories (I, II, III, and

IV) according to their hazards, based on the:

(a) Nature of the fluid contained (more or less hazardous). The fluid is gas or liquid. They are classified

as more dangerous or less dangerous.

(b) Internal pressure (higher or lower).

(c) Internal volume (larger or smaller) .

Equipment below these thresholds is not subj ect to the requirements in paragraphs 3 . 2. 3 through 3 . 2. 6,

below.

3.2.3 Conformity Assessment (CA) Procedures


Each pressure equipment must be subj ect to a CA Procedure to verify that it complies with the specifications

of the Directive. For each Hazard Category, one or several procedures are proposed to the Manufacturer.

These procedures are more stringent for the higher categories. A reduction of stringency is provided for the

Manufacturers who operate a Quality Assurance (QA) system. The QA route does not reduce the

stringency. It is j ust an alternative.

3.2.4 Notified Body


The CA is performed by an independent inspection organization, notified by each of the Member S tates to

the EC, who publishes the list in the OJEU. The Manufacturer may select any of the NB from this list for

the CA of the Equipment. The inspecting criteria of each Notified B ody will differ and although that these

guidelines are not mandatory, they serve as the recommended best practice.

3.2.5 Conformité Européene (CE) Marking


The CE Marking must be affixed on each piece of pressure equipment, which complies with the

specifications of the PED, ensuring the equipment the benefit of free movement in the EU.

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3.2.6 Essential Safety Requirements (ESR)


Each piece of equipment classified in one of the four Hazard Categories must fulfill all the ES R specified in

Annex I of the PED that apply to it. These technical requirements cover the design, material, fabrication,

testing, and inspection aspects for the equipment.

3.2.7 Material Specifications


In May 2002, AS ME was committed to working with manufacturers submitting proposals for European

Approval of Materials (EAM) to the EC to gain approval of AS ME material specifications for repeated use

under the PED. Other notified bodies also submitted proposed EAMs covering AS ME materials. However,

the EC determined that Article 1 1 , paragraph 5 of the PED 97/23 /EC (the previous edition of the PED)

prohibits the issuance of EAMs for grades of materials for which there exist an equivalent European

harmonized standard. All of the submittals for EAMs for AS ME materials were subsequently rej ected.

This means that the only method for using AS ME materials under the PED is the Particular Material

Appraisal (PMA) route. AS ME has spent the last two years working with notified bodies to bring some

uniformity to the PMA process, which is not clearly defined in the PED. The result has reduced the amount

of redundancy of the process because it has been clarified that PMAs can be used repeatedly (by the same

manufacturer using the same NB ) for similar applications.

3.2.8 Use of Non-Harmonized Standards


When using a non-harmonized standard, many of the criteria for demonstrating compliance with the ES R

of the PED revolve around the concept of equivalent overall level of safety (EOLS ). The EOLS is

applicable to using values other than those specified in Annex I. For that reason, it is valuable to select an

NB that is familiar with the requirements and design/fabrication philosophies of the AS ME B PVC. There

are several AS ME accredited Authorized Inspection Agencies that have established affiliations with

European inspection bodies that are notified under the PED. These organizations bring knowledge of the

AS ME B PVC and the PED and can advise manufacturers as to what needs to be done in addition to AS ME

requirements to meet the PED. S ection 1 2, Figure 1 2-1 , and S ection 1 3 , Annex Z, of this document provides

manufacturers additional information on compliance with the PED.

3.3 Structure of the PED


The PED has 5 2 Articles, which are listed in Appendix B of this Guide.

The following articles form the cornerstone of the PED.

Article 1 : S cope.

Article 2: Definitions of the terms used in the PED.

Article 4: Technical Requirements. It defines the thresholds (pressure and volume) for the Pressure

Equipment (vessels, piping, safety accessories, and assemblies) above which the Pressure

Equipment will have to be classified in Hazard Categories in Annex II and will be subj ect

to ES R, listed in Annex I of the PED.

Article 6: defines the obligations of the manufacturers. The manufacturers shall assure that they have

designed and manufactured the pressure equipment or assemblies in accordance with the

ES R in Annex I.

Article 1 2: The pressure equipment or assemblies which are in conformity with the harmonized

standards and materials used for the manufacture of pressure equipment which are in

conformity with EAM shall be presumed to be in conformity with the ES R in Annex 1 .

Article 1 3 : Pressure equipment referred to in Article 4(1 ) shall be class ified by category in accordance

with Annex II, according to level of hazard. Article 1 3 groups fluids into two groups.

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Group 1 includes substances and mixtures listed for that group. Group 2 includes those

substances and mixtures not specifically assigned to Group 1 .

Article 1 4: defines the four Hazard Categories (I, II, III, and IV) that are obtained from graphs given

in Annex II of the PED and lists the various CA Procedures to be applied to the four

Hazards Categories detailed in Annex III of the PED. Article 1 5 lists the procedures for

obtaining EAM.

Article 1 5 : lists the procedures for EAM.

Article 1 9: lists the rules and conditions for affixing the CE marking.

Article 24: defines requirements relating to the NB s and Recognized Third-Party Organizations

(RTPO).

The remaining Articles are devoted to Member S tates (Article 2) , Free Movement (Article 5 ), Importers

and Distributors (Articles 8 , 9, and 1 0), User Inspectorates (Article 1 6), Notification of Conformity and

NB s Articles 20 –3 8 ), Market S urveillance, Control of Pressure Equipment and Assemblies Entering the

EU, and S afeguard Procedures (Articles 3 9 –43 ), and Articles of Administrative Nature (Articles 44 –5 2).

These Articles are complemented by four Annexes of technical nature (Annexes I, II, III, and IV) or

administrative nature (Annex V); the last Annex (Annex VI) lists the correlation between the articles in

Directives 97/23 /EC and 201 4/68 /EU.

The listing of all Articles and Annexes in PED 201 4/68 /EU is provided in Appendix B of this Guide.

Appendix C presents a flowchart of the PED.

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4 SCOPE (ARTICLES 1 , 2, AND 4 OF THE PED)


4.1 Scope (Article 1 -§1 of the PED)
The PED embraces all Pressure Equipment subj ect to an internal pressure of gas or liquid above 0. 5 bar. It

applies to new Equipment fabricated in the EU (and to new or used Equipment imported from countries

outside the EU).

In-service inspection of operating equipment is covered in the national regulations of each EU country. (It

is not intended to develop an EU Directive covering in-service inspection. )

All materials, metallic and nonmetallic, are considered.

This scope is very wide as it covers any pressure containment above 0. 5 bar from simple pressure- cookers

to large water-tube boilers.

4.2 Types of Equipment Covered (Article 2 and Article 4 of the PED)


In the PED, the term Pressure Equipment covers the four following types:

Vessel: a component intended to contain a fluid (gas or liquid) above 0. 5 bar. This covers what was formerly

called pressure vessels (unfired or fired).

Piping: a component intended for the transport of fluids.

Safety accessories: devices designed to protect the Equipment.

Pressure accessories: devices with an operational function and subj ect to pressure (such as valves, pressure

regulators, pressure gauges, filters, expansion j oints, etc. ).

Components (such as covers, collars, gaskets, flanges, bolts, and nozzles) are not considered as pressure

accessories and cannot bear the CE Marking.

PED covers also Assemblies made of several parts of Pressure Equipment, assembled by the Manufacturer

to constitute an integrated and functional whole, such as boilers.

These Assemblies are mentioned several times throughout the PED and are covered in Appendix H of this

Guide.

Only the above four types of Pressure Equipment (plus Assemblies) can bear the CE Marking and have the

free movement throughout EU.

Equipment subj ect to 0. 5 bar or less are not regulated by the PED, as they do not present a significant

hazard.

4.3 PED Exclusions (Article 1 -§2 of the PED)


B ecause the scope is very wide, many exclusions are listed in the PED. They are of three types:

(a) S pecific Equipment (e. g. , pipelines, water networks, and nuclear sector), which are too difficult to

regulate and is more properly addressed by the member S tate concerned.

(b) Equipment already covered by other Directives (e. g. , S imple Pressure Vessels, Aerosol Dispensers,

and Transportation of Dangerous Goods)

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(c) Equipment that does not present significant hazards due to pressure (e. g. , motor vehicles, tires, and

gaseous bottles). These are covered by Type approval directives.

A list of these exclusions is provided in Appendix D of this Guide.

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5 CLASSIFICATION OF PRESSURE EQUIPMENT (ARTICLE 4, ARTICLE 1 3,


ANNEX 1 , AND ANNEX II OF THE PED)
5.1 Level of Hazards in Pressure Equipment
The primary goal of the Directive is to prevent potential hazards due to internal pressure in pressure

equipment. The pressure equipment referred to in Article 4 of the PED is classified by Category in accordance

with Annex II, according to an ascending level of hazard.

S everal levels of hazards are considered in the PED, which have practical consequences for the Equipment

both for the stringency of the ES R and CA Procedures to be car ried out. “Levels” are not used in the PED,
but are used in the Guide to help explain the various Categories and those areas outside the numbered

Categories.

Level 1 The pressure is 0. 5 bar or lower: There is no significant hazard, and the equipment is outside the

scope of the PED.

Level 2 The pressure is above 0. 5 bar, which does not require a CA. This is generally referred to as " S ound

Engineering Practice (S EP) of the Member S tate, " which defines the threshold above which the

Equipment is classified in Hazard Categories I, II, III, or IV.

Level 3 The pressure hazard level is low: The equipment is classified in Hazard Category I. There is no

intervention of the NB .

Level 4 The pressure hazard level is moderate: The equipment is classified in Hazard Category II. The NB

will check the Fabrication.

Level 5 The pressure hazard level is high: The equipment is classified in Hazard Category III. The NB will

check the Design and the Fabrication.

Level 6 The pressure hazard level is very high: The equipment is classified in Hazard Category IV. The

NB will perform increased checks of the Design and Fabrication.

Therefore, there are two main cases for Pressure Equipment:

(a) Equipment categorized as Levels 1 and 2.

(b) Equipment categorized as Levels 3 to 6.

5.2 Sound Engineering Practice (SEP) (Article 4-§3 of the PED)


This concerns all the equipment that is at or below the thresholds defined in Article 4 -§ 3 of the PED (see

Fig. 5 -1 in this Guide). These thresholds depend on the type of the Equipment, the dangerousness of the

fluid, and the pressure (PS ) and volume (V) of the Equipment. Pressure equipment and assemblies below

or equal to the limits set out in Article 4, paragraph 3 shall be designed and manufactured in accordance

with S EP of a Member S tate in order to ensure a safe life.

S uch equipment:

(a) Is not subj ect to the ES R: it must be constructed in accordance with S EP.

(b) Is not subj ect to the CA Procedures.

(c) Is not subj ect to the Declaration of Conformity: it must only bear the identification of the

manufacturer and be accompanied by instructions for use.

(d) Must not bear the CE Marking; however, it has the benefit of the free movement throughout the

EU.

5.3 Equipment in Categories I to IV (Article 4-§1 of the PED)


Equipment that is above the thresholds defined in Article 4-§ 3 of the PED is classified in Category I to IV,

depending on their level of hazard. This Equipment:

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(a) is subj ect to ES R

(b) is subj ect to the CA Procedure

(c) is subj ect to the Declaration of Conformity

(d) must bear the CE Marking

(e) has free movement throughout the EU

Hazard categories depend on the following factors.

(a) Type of Equipment: Vessel (fired on unfired), Piping, S afety Accessory, Pressure Accessory.

(b) Nature of Fluid:

(1) Gas in the sense of the PED (Article 4-§ l. l(a) of the PED): gas (vapor pressure greater than 0. 5

bar), liquefied gas (vapor pressure equal to or less than 0. 5 bar) , gas dissolved under pressure,

vapors, etc.

(2) Liquid in the sense of the PED (Article 4-§ l. l(b) of the PED): liquids having a vapor pressure 0. 5

bar.

Figure 5-1 : Category for Vessel Containing a Dangerous Gas

Note: Refer To Table 1 of the PED

(c) Dangerousness of the fluid, which is classified into two groups (Article 1 3 -§ 1 (a) of the PED):

(1) Group 1 : Most dangerous fluids (explosives, flammable, toxic, oxidizing, pyrophoric).

(2) Group 2: Less dangerous fluids (all others).

(d) Operations conditions characterized by the maximum allowable pressure, PS , and the internal volume,

V (for Vessels), or the nominal diameter, DN (for Piping).

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The hazard categories are defined in the PED by graphs (Tables 1 through 9 of Annex II of the PED).

How to determine the hazard category is explained as follows for each type of Equipment.

5.4 Vessels Not Subject to Fire or Heat (Article 4-§1 (a) of the PED)
Figure 4- 1 enables the determination of the Hazard Category of a vessel “not fired, nor heated with a risk

of overheating” containing a dangerous (Group 1 ) gas, as a function of internal volume, V, and maximum
allowable pressure, PS .

NOTE: If the vessel is composed of several chambers, the determination of the Hazard Category must be

performed for each chamber and the higher hazard category is to be used.

The volume, V, to be used is the total internal volume of the vessel or the chamber (not the volume occupied

by the fluid).

Each demarcation line pertains to the lower hazard category.

Three additional graphs, given by Tables 2, 3 , and 4 of the PED (Annex II), cover vessels containing a

(a) Non-dangerous (Group 2) gas (Table 2)

(b) Dangerous (Group 1 ) liquid (Table 3 )

(c) Non-dangerous (Group 2) liquid (Table 4).

5.5 Vessels Subject to Fire or Heat (Article 4-§1 (b) of the PED)
This covers vessels subj ect to fire (e. g. , boilers) and vessels subj ect to heat with the risk of overheating

(e. g. , pressure-cookers) intended for generation of steam or superheated water (at T <1 1 0° C, or 23 0° F).

This is a non-dangerous liquid (Group 2), and only one graph (Table 5 of the PED) is sufficient to determine

the Category.

5.6 Piping (Article 4-§1 (c))


As for unfired vessels, four graphs are also necessary to determine the Category of piping given by Tables

6, 7, 8 , and 9 of the PED.

5.7 Safety Accessories (Article 4-§1 (d), Annex ll-§2 of the PED)
According to the Category of the Equipment on which the safety accessory is fitted, the following two cases

are possible.

(a) The pressure equipment and assemblies are below or equal to the limits in paragraphs 1 (a) , 1 (b), or

1 (c) and in paragraph 2. (Article 4-§ 3 of the PED). The safety accessories shall be designed and

manufactured in accordance with S EP instead of ES R. No CA and no CE Marking is required.

(b) The Equipment is in Category I, II, III, or IV (Annex II-§ 2 of the PED). Two cases are possible:

(1 ) The accessory is fabricated specifically for the Pressure Equipment: The safety accessory is in the

same Category as the Equipment,

(2) The accessory is not fabricated specifically for the Pressure Equipment: The accessory is

classified in Category IV.

5.8 Pressure Accessories (Article 4-§1 (d), Annex ll-§3 of the PED)
According to the Hazard Category of the Pressure Equipment on which the Pressure Accessory is fitted, the

following two cases are possible.

(a) S EP (Article 4-§ 3 of the PED). The pressure accessories on equipment and assemblies that are

below or equal to the limits in paragraphs 1 (a), 1 (b), or 1 (c) and in paragraph 2. The accessories

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shall be designed and manufactured in accordance with S EP instead of ES R. No CA and no CE

Marking is required. S EP equipment must not bear CE marking.

(b) The Equipment is in Hazard Category I, II, III, or IV. The Accessory is classified using its pressure,

PS , and its volume, V (using Table 1 , 2, 3 , 4, or 5 of the PED, as appropriate), or its nominal diameter,

DN, (using Table 6, 7, 8 , or 9 of the PED, as appropriate).

NOTE: If both V and DN are considered appropriate to define the Accessory, it is classified in the higher

Hazard Category.

5.9 Summary
The Hazard Category system forms the cornerstone of the PED both on technical and legal aspects. The

Hazard Category has a significant impact on:

(a) The severity level of the ES R applicable to the Equipment.

(b) The stringency level of the CA Procedure to be performed by the NB and the Manufacturer.

(c) Tables 1 –9 of the PED are provided in Appendix E of this Guide.

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6 CONFORMITY ASSESSMENT (CA) PROCEDURES (ARTICLE 1 4, ANNEX III OF


THE PED)
6.1 Introduction
(a) Any product regulated by a European Directive is subj ect to a CA to ensure that it complies with

all the requirements of the PED, generally under the responsibility of a NB (Article 1 4 of the

PED).

(b) Thirteen CA Procedures that are proposed conform to the following principles (see Figure 5 -1 of

this Guide).

Figure 6-1 : Relation of CA Procedures to Categories


CATEGORY CA PROCEDURES

I Module A

II Modules A2, D1 , E1

III Modules B (design type) + D, B (design type) + F, B (production type) + E,

B (production type) + C2, H

IV Module B (production type) + D, B (production type) + F, G, H1

(1 ) The procedures are divided into a design phase and a production phase.

(2) In each phase, the roles and responsibilities of the Manufacturer and the NB are detailed.

(3) S ome procedures are better adapted to single production (procedures G, H). Others are better

adapted to production type (procedures B +C, B +E, B +F, B +D). In this case the procedure is

divided in two modules covering separately the design phase and the production phase.

(4) The Manufacturer always has the choice between

(i) CA Procedure without a QA system: the NB will check the product itself.

(ii) CA Procedure requiring a QA system: the NB will check the QA system more than the product

itself.

(5) The seven CA Procedures of Figure 5 -1 of this Guide imply an increasing involvement of the NB

from procedure A to procedure H, depending on the level of hazard presented by the Equipment

covered by the Directive.

(6) Each Manufacturer must select a CA Procedure among these seven procedures. Their application

is mandatory for affixing the CE Marking (Article 1 4 of the PED).

6.2 General Concept


(a) The PED uses these seven CA procedures (A to H) plus six additional ones (which are identified

in Figure 5 -3 of this Guide), making a total of 1 3 procedures. The multiplicity of these procedures

results from the consensus between 1 5 countries and is j ustified by:

(1 ) diversity of types of Pressure Equipment,

(2) diversity of means of production (unit production, series production, with or without QA system),

(3) diversity of hazard levels presented by these Equipment, which has led to four Hazard Categories

in the PED.

Figure 5 -3 of this Guide shows a general overview of these CA Procedures.

(b) In each Hazard Category one or several CA Procedures, of equivalent stringency, are proposed to

the Manufacturer, depending on production (single or series) and if there is a QA system (see Figure

5 -2).

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When the Hazard Category increases, the requirements of the procedures become more severe and there is

more involvement of the NB :

Category I No intervention by the NB (Module A).

Category II No intervention by the NB at Design phase, but surveillance by the NB during production

phase (A2), or surveillance by the NB of QA system (D1 , E1 ).

Category III Design examination by the NB and final assessment of the equipment: B (production type)

+ C2, B (design type) + F.

S urveillance of the QA system: B (production type) + E, B (design type) + D, H.

Category IV Increased intervention of the NB : B (production type) + D, B (production type) +F, G, H1 .

The Manufacturer may always use a CA Procedure of a higher category level.

Figure 6-2: CA Modules


A. (Internal G. (Unit H. (Full Quality
Control of B. (Type Examination) Verification) Assurance
Production) (QA))

Manufacturer:
Manufacturer: Manufacturer S ubmits to NB : Manufacturer: Operates an
Keeps technical (a) Technical documentation S ubmits approved quality
documentation (b) Type technical system (QS ) for
at the disposal documentation design
of national NB :

authorities (a) Ascertains conformity with essential requirements Notified body:


DES IGN

(b) Carries out tests, if necessary (a) Carries out


(c) Issues EU type-examination certificate surveillance of

the QS

(b) Verifies

conformity of the

design (H1 )

(c) Issues EC

design

examination

certificate (H1 )

C2 E. (Product F. (Product D.
(Conformity QA) Verification) (Production
to Type) QA)

Manufacturer:
A. (a) Operates Manufacturer: Manufacturer:

Manufacturer: an approved (a)Operates an Manufacturer: (a)Operates an


Manufacturer:
(a) Declares Manufacturer: QS for approved QS (a)S ubmits approved QS for
(a)Declares
conformity (a) Declares inspection and for production product production and
conformity
with essential conformity testing and testing (b)Declares testing
with approved
requirements with approved (b)Declares (b)Declares conformity (b)Declares
type, or with
PRODUCTION

(b) Affixes the type conformity conformity (c)Affixes the conformity


essential
CE mark (b) Affixes the with approved with approved CE mark (c)Affixes the
requirements
CE mark type, or to type CE mark
(b)Affixes the
essential (c)Affixes the
CE marking
requirements CE mark

(c)Affixes the

CE mark

A2. NB : NB : NB : NB : NB : NB :

NB : (a)Tests on (a)Approves (a)Verifies (a)Approves (a)Verifies Carries out

(a)Tests on specific the QS conformity the QS conformity surveillance of

specific aspects aspects of the (b)Carries out (b)Issues (b)Carries out with essential the QS

of the product product surveillance of certificate at surveillance of requirements

(b)Product (b)Product the QS conformity the QS (b)Issues

checks at checks at certificate of

random random conformity

intervals intervals

1 2 3 4

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Figure 6-3: CA Procedures in the PED


Module Category Design Production

A I Technical documentation Internal production control

Internal production control

A2 II Technical documentation with surveillance of the

final assessment

Type without QA: C2 or F


B – Production Type III
examination with QA: E or D

Design without QA: F


B – Design Type IV
examination with QA: D

(Module B – Production Conformity of the


C2 III
Type) production to the type

(Module B – Production
D III & IV QA for production
Type or B - Design Type)

D1 II Technical documentation QA for production

(Module B – Production QA for final testing on


E III
Type) products

QA for final testing on


E1 II Technical documentation
products

(Module B – Production
F III & IV
Type or B - Design Type) Product verification

G IV Unit verification
Unit verification

H III QA for design QA for production

QA for production with


QA for design, with
H1 IV specific surveillance of
design examination
final assessment

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Figure 6-4: CA Procedure to Be Applied In Each Category


Without QA With QA

Category Series Unit Series Unit

I A A A A

II A2 A2 D1 or E1 D1 or E1

B + C2 B + E H
B 1 B -Design
III B 1 B -Design B 1 B -Design B 1 B -Design
Type + F
Type + F Type + D Type + D

B -Production B -Production
IV G H1
Type + F Type + D

NOTE: S ee Table 5 for Categories applicable to boilers. Power boilers typically are Category IV pressure

equipment.

6.3 Structure of the Procedures


(a) Each CA Procedure is described in detail in Annex III of the PED and specifies the respective tasks

and responsibilities of the Manufacturer and of the NB for the Design and Production phases. For

all Equipment:

(1 ) The Manufacturer must

(i) draw up the Technical Documentation

(ii) ensure conformity to the ES R by drawing up a Declaration of Conformity (Annex IV of the

PED)

(iii) affix the CE Marking,

(iv) affix the identification number of the NB .

(2) The NB must check the conformity of the Equipment with the ES R by applying the

specifications of the Procedure. This check will differ according to whether the manufacturer

uses a QA procedure.

(b) For the six CA Procedures without QA (A, A2, B -Production Type +C, B -Production Type +F, B 2-

Design Type+F, G), the NB must examine the Design and the Fabrication of each Equipment, and

perform appropriate tests, so as to check its conformity to the ES R, except for the following

procedures.

(1 ) Procedure A. S elf-certification by the Manufacturer.

(2) Procedure A2. S elf-certification by the Manufacturer and surveillance by an NB that takes the

form of unexpected visits.

(c) For the seven CA Procedures with QA (D1 , E1 , B -Production Type +E, B -Production Type +D,

B 1 B -Design Type+D, H, H1 ), the involvement of the NB on the Equipment itself is reduced, and

the NB concentrates on the QA system. The NB :

(1 ) assesses the adequacy of the QA system to the production

(2) carries out periodic audits to ensure that the Manufacturer applies the QA system

(3) applies the surveillance by unexpected visits to check that the QA systems works correctly.

(d) S ix procedures are devoted to unit production (A, A2, D1 , E1 , G, H, H1 ).

(e) S even procedures are devoted to series production (B -Production Type +C2, B -Production Type

+D, B -Production Type +E, B -Production Type +F, B -Production Type +D, B -Production Type

+F). They consist of a design module covering the design phase (modules B ) and a production

module covering the production phase (modules C2, D, E, and F).

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6.4 Review of CA Modules


6.4.1 CA Modules
Module A Internal Production Control

Module A2 Internal Production Control Plus S upervised Pressure Equipment Checks at Random

Intervals

Module B EC type examination - Production Type

Module B EU type examinations, B - Production Type, and B -Design Type

Module C2 Conformity to Type B ased on Internal Production Control plus S upervised Pressure

Equipment Checks at Random Intervals

Module D Conformity to Type B ased on Quality Assurance of the Production Process

Module D1 Quality Assurance of the Production Process

Module E Conformity to Type B ased on Pressure Equipment Quality Assurance

Module E1 Quality Assurance of Final Pressure Equipment Inspection and Testing

Module F Conformity to Type B ased on Pressure Equipment

Module G Conformity B ased on Unit Verification

Module H Conformity B ased on Full Quality Assurance

Module H1 Conformity B ased on Full Quality Assurance Plus Design Examination

Appendix F Declaration of Conformity

Appendix G Activities of Manufacturers and Notified B odies in Accordance with CA Procedures

6.4.2 Module A: Internal Production Control


This module describes procedures by which Manufacturers, or their authorized representatives established

in the European Community, ensure and declare that pressure equipment satisfy the requirements of the

PED to which they apply. This module is applicable for Category I, for a production by series or unit, with

or without a QA system.

6.4.2.1 Characteristics of the Module

(a) Internal Production Control by the Manufacturer

(b) No intervention of the NB

6.4.2.2 Role of the Manufacturer

(a) The Manufacturer must draw up the technical documentation (see Module A2) and must keep it at

the disposal of the relevant national authorities for inspection purposes for 1 0 years after the last of

the pressure equipment has been manufactured.

(b) The Manufacturer must affix the CE marking to each item of pressure equipment.

(c) The Manufacturer must draw up a written declaration of conformity.

(d) The Manufacturer must keep a copy of the declaration of conformity with the technical

documentation.

6.4.3 Module A2: Internal Production Control plus Supervised Pressure Equipment
Checks at Random Intervals
This module describes procedure by which the Manufacturer, or its authorized representative established

in the Community, ensures and declares that pressure equipment of Category II satisfies the requirements

of the PED.

This module is applied for a production in series or by unit, without a QA system.

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6.4.3.1 Tasks of the Manufacturer

(a) The Manufacturer chooses an NB .

(b) The Manufacturer draws up technical documentation, as far as is relevant to such assessment, and

covers the design, manufacture, and operation of the pressure equipment. The basic document is

the general design drawing of the equipment completed if necessary by more detailed

manufacturing drawings or diagrams of the subas semblies or circuits and commented if necessary

by a written description. The technical documentation will contain:

(1 ) name of the Manufacturer and site of production

(2) conceptual design and manufacturing drawings

(3) a list of harmonized standards applied and des cription of the solutions adopted

(4) results of design calculation made and/or test reports

(c) The Manufacturer ensures that the manufacturing process complies with technical documentation.

(d) The Manufacturer affixes the CE marking and NB identification number to each item.

(e) The Manufacturer draws up written declaration of conformity.

(f) Retain declaration of conformity and technical documentation for ten years.

6.4.3.2 Tasks of the Notified Body

(a) Monitoring of final assessment by unexpected visits. The final assessment must include

(1 ) visual examination of the equipment

(2) hydrostatic pressure test

(3) examination of safety devices.

(b) Take samples of pressure equipment at manufacturing or storage premises to conduct checks.

(c) Take appropriate action if items do not conform.

(d) Monitor the state of art and revert to the manufacturer if type of approval does not keep up.

6.4.4 Module B: EU Type Examination – Production Type


This module describes the part of the procedure by which an NB ascertains and attests that a representative

example of the production meets the provisions of the PED to which they apply. This module is applied

for risk category III and IV, for a production in series, with or without QA.

6.4.4.1 Characteristics of the Module

This module is only applicable for the design examination. It is always associated with another module

concerning the manufacturing of the pressure equipment (C2, E, F, or D).

6.4.4.2 Tasks of the Manufacturer

(a) The Manufacturer draws up the technical documentation that covers the design, manufacture, and

operation of the pressure equipment. The documents to be given to the NB for a design examination

are:

(1 ) general description of the pressure equipment

(2) list of codes or harmonized standards applied and solution adopted where harmonized

standards are not used

(3) design drawings, manufacturing drawings, diagram of components

(4) identification marking drawings (identity plate)

(5) list of materials used

(6) results of design calculation made and/or test reports

(7) forming procedures

(8) heat treatment procedures

(9) Non Destructive Testing (NDT) procedures

(1 0) certification of Non Destructive Examination (NDE) personnel

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(1 1 ) qualification of permanent assembly procedures: welding, braze-welding, brazing, expanding,

and gluing

(1 2) operating instructions

For calculation design, the results of the design calculation shall be given; for experimental design, the test

reports shall be given; and, for calculation design completed by experimental design, the results of the

calculation shall be supplemented by the test reports.

These documents shall be given to the NB for this module, but also for EU Type examination - Design

Type (modules B and H1 ). They shall also be available in complement of the documents for the final

assessment in modules A, A2, D1 , E1 , and H.

(a) The Manufacturer provides representative example of production (a “type”) to the NB.
(b) The Manufacturer retains documentation and copies of EU type-examination during ten years.

6.4.4.3 Tasks of the NB

(a) Examines the technical documentation

(b) Verify that the “type” is manufactured in conformity with the technical documentation
(c) Assess materials when they are not in conformity with harmonized standard or EAM, and check

material certificates

(d) Approve procedures for permanent j oining or check they have been previously approved

(e) Verify staff are qualified or approved for permanent j oining and NDE

(f) Issues EU type-examination certificate with a validity of ten years

(g) Retain copy of documentation and EU type - examination certificate

6.4.5 Module B: EU Type Examination – Design Type


This module describes the part of the procedure where an NB ascertains and attests that the design of an

item of pressure equipment meets the provisions of the PED to which they apply. This module is applied

for risk category III, for production in series or by unit, with or without QA.

6.4.5.1 Characteristics of the Module

This module is only applicable for design examination (e. g. , Module D) ; it is always associated with another

module concerning the manufacturing of a pressure equipment (F or D).

6.4.5.2 Tasks of the Manufacturer

The Manufacturer draws up the technical documentation as described in module B .

6.4.5.3 Tasks of the Notified Body

S ee module B (para. 4. 4).

(a) Examine the technical documentation

(b) Issue EC design-examination certificate

6.4.6 Module C2: Conformity to Type Based on Internal Production Control plus
Supervised Pressure Equipment Checks at Random Intervals
This module describes that part of procedure whereby the Manufacturer ensures and declares that pressure

equipment is in conformity with the type as described in the EU type-examination certificates – Design Type
and satisfies the requirements of the PED to which they apply.

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The Manufacturer must affix the EC marking to each item of pressure equipment and draw up a written

declaration of conformity.

6.4.6.1 Characteristics of the Module

This module is only applicable for the manufacturing of the pressure equipment in series without QA. It is

always associated with the module B (EU type-examination – Production Type).

6.4.6.2 Tasks of the Manufacturer

(a) Ensure that the manufacturing process produces pressure equipment that complies with the type as

described in the EU type-examination certificate. (The PED does not restrict the use of Modules;

the manufacturer may choose the most appropriate Module).

(b) Choose an NB

(c) Affix CE marking and NB identification number.

6.4.6.3 Tasks of the Notified Body

(a) Monitor the final assessment by unexpected visits

(a) Ensure that the Manufacturer performs the final assessment according to the PED

(b) Take samples of pressure equipment at manufacturing and storage premises to conduct chec ks.

6.4.7 Module D: Conformity to Type Based on QA of the Production Process


This module describes procedures where the Manufacturer ensures and declares that the pressure equipment

concerned is in conformity with the type described in the EU design-examination certificate and satisfies

the requirements of the PED to which they apply.

6.4.7.1 Characteristics of this Module

This module is only applicable for the manufacturing of the pressure equipment in series or by unit, with

QA for risk categories III or IV. It is always associated with the module B (EU type examination,

production type or design type).

6.4.7.2 Tasks of the Manufacturer

(a) S et up and operate quality system for production, final inspection, and testing, which ensures

compliance of the pressure equipment with the type described in the EU type examination –
Production Type certificate, or the EU type examination – Design Type certificate.
(b) Lodge application for assessment of quality system with an NB as described in module D1

(c) Affix CE marking and NB identification number

(d) Draw up written declaration of conformity.

6.4.7.3 Tasks of the Notified Body

(a) Assess quality system including an inspection visit to the Manufacturer’s premises.
(b) Carry out surveillance visits to ensure that the Manufacturer fulfills the obligation arising from the

approved quality system.

(c) Carry out periodic audits such that a full reassessment is carried out.

(d) Carry out unexpected visits to verify that the quality system is functioning correctly.

(e) Notify the Manufacturer of assessment decision.

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6.4.8 Module D1 : Quality Assurance of the Production Process


This module is applicable for conception and for the manufacturing of pressure equipment. It is not

associated with another module.

6.4.8.1 Characteristics of the Module

This module is applicable for risk category II with QA for production in series or by unit.

6.4.8.2 Tasks of the Manufacturer

(a) Draw up technical documentation covering design, manufacture, and final inspection. The

documents given to the NB for final inspection shall contain

(1 ) certificates of qualification of NDT personnel, welders, brazing personnel

(2) data dealing with heat treatment (diagram of temperatures)

(3) inspection documents for the base materials and the consumables

(4) procedures for ensuring materials traceability

(5) test reports of NDT, including radiographic films

(6) test reports of destructive tests

(7) forming conformity certificate.

(b) S et up and operate quality system for production, final inspection and testing (e. g. , International

Organization for S tandardization (IS O) 9002), which ensures compliance of the pressure equipment

with the PED.

(c) Give to the NB the documentation on the quality system including a description of quality

obj ectives and organization structure.

(d) Affix EC marking and draw up written declaration of conformity.

6.4.8.3 Tasks of the Notified Body

(a) Assess quality s ystem including an inspection visit to the manufacturer’s premises.
(b) Carry out periodic audits such that a full reassessment is conducted.

(c) Carry out unexpected visits to verify that the quality system is functioning correctly.

(d) Notify the Manufacturer of assessment decision.

6.4.9 Module E: Conformity to Type Based on Pressure Equipment Quality Assurance


This module is applicable only for the manufacturing of pressure equipment. It is associated with module

B (conception).

6.4.9.1 Characteristics of the Module

This module is applicable for risk category III with QA for production in series.

6.4.9.2 Tasks of the Manufacturer

(a) S et up and operate quality system for products, which ensures compliance of the pressure

equipment with the type described in the EU type examination certificate.

(b) Lodge application for assessment of quality system with an NB as described in module E1 (para.

4. 1 0).

(c) Affix EC marking and notified body identification number.

(d) Draw up written declaration of conformity.

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6.4.9.3 Tasks of the Notified Body

(a) Assess quality system, including technical aspect, with an inspection visit to the Manufacturer’s
premises.

(b) Carry out periodic audits such that a full reassessment is carried out.

(c) Carry out unexpected visits to verify that the quality system is func tioning correctly.

(d) Notify the Manufacturer of assessment decision.

6.4.1 0 Module E1 : Quality Assurance of Final Pressure Equipment Inspection and Testing
This module is applicable for conception and for manufacturing of pressure equipment. It is not associated

with another module.

6.4.10.1 Characteristics o f th e M o d u l e

Th is module is applicable for risk category II with QA for production in series and by unit.

6.4.10.2 Tasks of the Manufacturer

(a) Draw up technical documentation covering design, manufacture, and final inspection.

(b) S et up a quality system for products, and operate this QA for final assessment and testing.

(c) Affix EC marking and notified body identification number.

(d) Draw up written declaration of conformity.

6.4.10.3 Tasks of the Notified Body

(a) Assess quality system, including tec hnical aspect, with an inspection visit to the Manufacturer’s
premises.

(b) Carry out periodic audits such that a full reassessment is conducted.

(c) Carry out unexpected visits to verify that the quality system is functioning correctly.

(d) Notify the Manufacturer of assessment decision.

6.4.1 1 Module F: Conformity to Type Based on Pressure Equipment Verification


This module is applicable only for the manufacturing of pressure equipment, including power boilers. It is

associated with modules B .

6.4.11.1 Characteristics o f th e M o d u l e

Th is module is applicable for category III or IV without QA for production in series or by unit.

6.4.11.2 Tasks of the Manufacturer

(a) Ensure that the manufacturing process produces pressure equipment that is in conformity with the

type described in the EU type-examination certificate (B ), Production Type or Design Type.

(b) Choose an NB .

(c) Affix EC marking and notified body identification number.

(d) Draw up written declaration of conformity.

6.4.11.3 Tasks of the Notified Body

(a) Examine and test each item of pressure equipment, to verify that every item conforms to the type.

(b) Verify qualification of personnel responsible for permanent j oining and NDT examination,

(c) Carry out final inspection and proof test.

(d) Draw up written certificate of conformity relating to the test.

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6.4.1 2 Module G: Conformity Based on Unit Verification


This module is applicable for design and manufacturing pressure equipment, including power boilers. It is

not associated with another module.

6.4.12.1 Characteristics o f the Mo du le

Th is module is applicable for category IV, without QA and for production by unit.

6.4.12.2 Tasks of the Manufacturer

(a) Lodge application for unit verification with an NB that must include

(1 ) The technical documentation as described under module A2 and additional modules, as

appropriate.

(2) Information relating to the approval of the manufacturing and test procedures .

(3) Information of the qualifications or approvals of staff carrying out permanent j oining and non-

destructive tests.

(b) Affix EC marking.

(c) Draw up written declaration of conformity.

6.4.12.3 Tasks of the Notified Body

(a) Examine design and construction of each item.

(b) Examine technical documentation with respect to design and manufacturing procedures.

(c) Perform additional examinations of materials from material Manufacturers, as appropriate.

(d) Approve procedures for permanent j oining of parts or check previous approval.

(e) Verify personnel responsible for permanent j oining of parts and non-destructive testing.

(f) Perform during manufacture appropriate tests set out in relevant harmonized standards or

equivalent to ensure the conformity to the PED.

(g) Carry out final inspection and perform, or have performed, the proof test.

(h) Examine the safety devices, if applicable.

(i) Affix identification number or have it affixed to the pressure equipment.

(j) Draw up certificate of conformity for the tests carried out.

6.4.1 3 Module H: Conformity Based on Full QA


This module is applicable for conception and for the manufacturing of pressure equipment. It is not

associated with another module.

6.4.13.1 Characteristics o f th e M o d u l e

Th is module is applicable for risk category III with QA for production by unit.

6.4.13.2 Tasks of the Manufacturer

(a) Implement an approved quality system for design, manufacture, and final inspection and testing

(e. g. , IS O 9001 ), which must ensure compliance of the pressure equipment with the requirements

of the PED that apply to it.

(b) Lodge application for assessment of the quality system with an NB , which includes

(1 ) relevant information on the pressure equipment concerned

(2) documentation on the quality system including a description of quality obj ectives and

organizational structure

(3) technical design specifications, including standards, that will be applied

(4) design control and technical verifications, process and systematic measures, particularly the

procedures for permanent j oining

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(5) examinations and tests to be carried out

(6) quality records, such as inspection reports, test data, and the qualifications or approvals of the

personnel concerned particularly with permanent j oining

(7) means of monitoring quality and quality system.

(c) Undertake the fulfilment of obligations arising out of the quality system.

(d) Affix EC marking and identification number of the NB responsible for surveillance.

(e) Draw up declaration of conformity.

6.4.13.3 Tasks of the Notified Body

(a) Assess quality system including an inspection visit to the Manufacturer’s premises.
(b) Presume conformity with respect to the elements of the quality system that implements a relevant

harmonized standard (e. g. , IS O 9001 ).

(c) Notify the Manufacturer of assessment decision.

(d) Carry out surveillance visits to ensure that the Manufacturer fulfils the obligations arising from the

approved quality system.

(e) Carry out periodic audits such that a full reassessment is carried out every three years.

(f) Carry out unexpected visits to verify that the quality system is functioning correctly.

(g) Assess proposed changes to the quality system. For category III and IV vessels for group 1 and

group 2 gases and group 1 liquids and steam generators, the NB , when performing unexpected

visits, must take a sample of equipment and perform, or have performed, the proof test.

For one-off production of category III steam generators, the NB must perform, or have performed, the proof

test for each unit.

6.4.1 4 Module H1 : Conformity Based on Full QA Plus Design Examination


This module is applicable to Category IV pressure equipment, including power boilers.

6.4.14.1 Tasks of the Manufacturer

(a) Lodge application for examination of the design with an NB . The application must enable the

design, manufacture, and operation of the pressure equipment to be understood and enable

conformity with the relevant requirements of the PED to be assessed. It must include

(1 ) technical design specifications, including standards

(2) necessary supporting evidence for their adequacy, in particular where harmonized standards

have not been applied in full

(b) Inform the NB of all modifications to the approved design.

6.4.14.2 Tasks of the Notified Body

(a) Examine the application and, if satisfied, issue an EC design examination certificate.

(b) Carry out surveillance of the final assessment in the form of unexpected visits, which must include

examinations on the pressure equipment.

(c) Assess any modifications to the approved design and give additional approval.

6.5 Summary of Activities of Manufacturers and NBs


A summary of the activities of Manufacturers and NB s in accordance with the CA Procedures is provided

in Appendix F of this Guide.

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7 ESSENTIAL SAFETY REQUIREMENTS (ESR) (ARTICLES 4 AND 6, ANNEX I


OF THE PED)
7.1 Introduction
The technical requirements concerning the Pressure Equipment itself are included in Annex I of the PED

under the designation ES R. The following principles apply.

(a) All pressure equipment above the thresholds mentioned in Article 4 of the PED (i. e. , classified in

Hazard Category I, II, III, or IV) shall comply with all these ES R. They concern the various steps

of the construction: design, material selection, fabrication, inspection, and safety devices.

(b) These ESR are generally formulated in general terms of safety objectives, such as, “Pressure
Equipment shall be constructed in such a way to ensure its safety in reasonable foreseeable

conditions.”

The PED does not provide the means to achieve these requirements; this is the role of the Harmonized

Standards. Some quantitative requirements are provided by PED §7 of Annex I, which “apply as a general
rule.” Manufacturers can depart from these quantitative requirements, but they shall convince the NB that
“they have taken appropriate measures to achieve an equivalent overall level of safety.”
(c) It is the role of European Committee for S tandardization (CEN) Harmonized S tandards

(harmonized to the PED), such as EN1 3 445 for Unfired Pressure Vessel developed by CEN/TC5 4),

to quantify each of these requirements. As a consequence, this gives them a presumption of

conformity to the PED (see PED Article 1 2-§ 1 ).

However, use of these Harmonized S tandards is not compulsory. The Manufacturer may construct its

pressure vessel using any Code or S tandard but must be able to demonstrate to the NB that the vessel

complies with each of the ES R of PED Annex I. Or, the Manufacturer shall sho w that it has used a

quantitative requirement different from the Harmonized S tandards, provided an equivalent level of safety

is achieved.

(d) The Manufacturer is free to use one of the following three options to prove that this Equipment

complies with the ES R.

(1 ) use of the EN Harmonized S tandard, which will give presumption of conformity to the ES R

(2) use of a recognized Code like AS ME B PVC, French Code for Construction of Unfired Pressure

Vessel (CODAP), etc. (supplemented by additional requirements to ensure comp liance with

the PED)

(3) by applying directly the ES R and providing calculation sheets carrying out tests, etc.

In options 2 and 3 , the Manufacturer will have to convince the NB of its compliance with the ES R.

(e) The stringency of some of these ES R depend on the Hazard Category of the Equipment, especially:

(1 ) approval of welding operating permanent j oining procedures (Annex I-§ 3 . 1 . 2 of the PED)

(2) approval of welders (Annex I-§ 3 . 1 . 2 of the PED)

(3) approval of non-destructive test personnel (Annex I-§ 3 . 1 . 3 of the PED)

(4) types of material certificate (Annex I-§ 4. 3 of the PED).

7.2 General Discussion of ESR (Annex I of the PED)


7.2.1 Preliminary Remarks
(a) All equipment above the thresholds specified in PED Article 4 -§ 1 (i. e. , Equipment classified in

Categories I, II, III, and IV) shall meet each of the ES R of Annex I of the PED. This applies to

assemblies (Article 4-§ 2 of the PED), taking into account the derogation specified in clause Article

4-§ 2. 3 (see Annex I-§ 2. 8 of the PED).

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(b) The ES R are mandatory. These are expressed qualitatively in terms of general purposes. Only

some numerical values are given in Annex I-§ 7 of the PED (j oint efficiency, proof tes t pressure,

etc. ). The Manufacturer is not obliged to use these values provided an equivalent overall level

safety has been achieved (Annex I-§ 7 of the PED).

7.2.1.1 General (Annex I-§1 of the PED)

Equipment shall be constructed in such a way that their safety is ensured (Annex I-§ 1 . 1 of the PED). The

Manufacturer shall carry out an analysis of hazards and risks , which shall be used as indicated in Annex I-

§ 1 . 2 and Annex I-§ 1 . 3 of the PED.

7.2.1.2 Design (Annex I-§2 of the PED)

7.2.1.2.1 General (Annex I-§2.1 of the PED)

Pressure e quipment shall be “properly designed” to ensure that the equipment will be safe throughout its
intended life, taking into account

(a) suitable safety margins against the different failure modes

(b) loads corresponding to the intended use (pressure, temperature, wind, earthquake, etc. )

(c) expected working conditions (corrosion, erosion, fatigue, etc. ), (Annex I-§ 2. 2. 1 of the PED).

7.2.1.2.2 Design Method

Two methods for design are proposed (Annex I-§ 2. 2. 2 of the PED):

(a) Calculation Method. This method is applicable to all cases (Annex I-§ 2. 2. 3 of the PED).

(1 ) This method shall specify the maximal allowable stresses to prevent possible failure modes

including creep, corrosion, fatigue, and instability (Annex I-§ 2. 2. 3 a of the PED).

(2) The allowable general membrane stress, S a, is defined below, for each type of material (Annex

I-§ 7. 1 . 2 of the PED).

Figure 7-1 : Allowable General Membrane Stress Values


Material Allowable General Membrane S tress, Sa
Ferritic steel, including normalized steel and Lesser of Re/t /1 . 5 and Rm/20 /2. 4
excluding fine-grain steel and specially heat treated

steel

Austenitic steel if A > 3 0% Re/t /1 . 5


Austenitic steel if A > 3 5 % Lesser of Re/t /1 . 2 and Rm /t /3
Cast steel Lesser of Re/t /1 . 9 and Rm/20 /3

Aluminium Re/t /1 . 5
Aluminium alloys (excluding precipitation hardened Lesser of Re/t /1 . 5 and Rm/20 /2. 4
alloys)

A = elongation, %

Re/t = specified minimum yield strength at calculation (design) temperature


Rm/20 = specified minimum ultimate tensile strength at 20 ⁰ C (room temperature)
Rm/t = ultimate tensile strength at calculation (design) temperature
NOTE: These stress values apply as a general rule. Other values may be used if an equivalent overall

level of safety is achieved (PED Annex I-§ 7).

(3) The method shall take into account the following (PED Annex I-§ 2. 2. 3 . b):

(i) the calculation pressure (greater than or equal to PS ), the calculation temperature, and the

possible combinations

(ii) the maximal stresses and stress concentrations

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(iii) the j oint efficiency according to the level of testing of welded j oints (Annex I-§ 7. 2 of the

PED).

Figure 7-2: Joint Efficiency Values


Extent of Examination Joint Efficiency

1 00% Radiographic Testing (RT) or Ultrasonic Testing (UT) 1 .0

Random NDE by RT or UT (spot RT or UT) 0. 8 5

Visual examination only 0. 70

NOTE: These j oint efficiency values apply as a general rule. Greater values may be used if an equivalent

overall level of safety has been achieved (Annex I-§ 7 of the PED). Joint efficiency of 1 may be used for

equipment subj ect to destructive and non-destructive tests which confirm that the whole series of j oints

show no significant defects.

(a) Experimental Method. When no calculations are performed, this method is applicable only for

(Annex I-§ 2. 2. 4 of the PED):


3
(1 ) vessels that have a PS x V less than 6, 000 bar L (3 ,072 psi x ft )

(2) piping that has a PS x DN less than 3 , 000 bar mm (1 , 71 3 psi x in. ).

This method does not apply when CA is carried out according to Module B , EU Type Examination – Design
Type. The Manufacturer shall draw up a test program on a representative sample, subj ected to the

agreement of the Notified B ody in charge of the design assessment module.

7.2.1.2.3 Other Requirements for Design

Other requirements regarding design shall cover the following, if relevant (PED references are noted in

parentheses).

(a) safety of handling and operation (Annex I-§ 2. 3 )

(b) means of inspection (Annex I-§ 2. 4)

(c) means of draining and venting (Annex I-§ 2. 5 )

(d) corrosion and chemical attack (Annex I-§ 2. 6)

(e) wear (Annex I-§ 2. 7)

(f) reliability of assemblies (Annex I-§ 2. 8 )

(g) provisions for filling and discharge (Annex I-§ 2. 9)

(h) protection against exceeding the allowable limits (Annex I-§ 2. 1 0)

(i) safety accessories (Annex I-§ 2. 1 1 )

(j) external fire (Annex I-§ 2. 1 2).

7.2.1.3 Fabrication (Annex I-§3 of the PED)

7.2.1.3.1 Manufacturing Procedures

(a) The Manufacturer shall ensure that design specifications are effectively applied at fabrication stage

(Annex I-§ 3 . 1 of the PED), especially regarding the following aspects (PED references are noted

in parentheses).

(1 ) preparation of the component parts (Annex I-§ 3 . 1 . 1 )

(2) permanent j oining (Annex I-§ 3 . 1 . 2)

(3) heat treatments (Annex I-§ 3 . 1 . 4)

(4) traceability (Annex I-§ 3 . 1 . 5 ).

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(b) Permanent j oining (Annex I-§ 3 . 1 . 2 of the PED) by welding, brazing, etc. , shall be performed using

qualified personnel and in accordance with qualified operating procedures. For pressure equipment

in Categories II, III, and IV, the operating procedures and personnel shall be approved by a

competent third party which, at the Manufacturer’ s discretion, may be a Notified Body, or a third
party organization recognized by a Member S tate, as provided for in Article 20.

Figure 7-3: Welding Procedure Qualifications and Welder Qualifications


Category of Equipment Approval of Welding Procedure Qualification and Welder Qualification

By

Category I Manufacturer

Category II Notified B ody (PED Article 3 0) Chosen by

Category III or the

Category IV Third-party organization Manufacturer

recognized by a Member S tate

7.2.1.3.2 Non - Destructive Testing (NDT) (Annex I-§3.1 .3of the PED)

This shall be performed by qualified personnel. B ody in charge of the approval of these qualifications

depends on the Category in which the Pressure Equipment is classified is as follows.

Equipment Category Approval of NDE Personnel B y

Category I Manufacturer

Category II

Category III Third-party organization recognized by

Category IV a Member S tate (PED Article 20)

7.2.1.3.3 Final Assessment (Annex I-§3.2 of the PED)

Pressure Equipment shall undergo a final assessment to ensure the compliance with the ES R. This final

assessment must include a final examination and a proof test performed by the Manufacturer or the Notified

B ody according to the assessment module that applies.

(a) Final examination (Annex I-§ 3 . 2. 1 of the PED) comprises

(1 ) internal and external visual examination of the Equipment

(2) examination of the accompanying documents of the Equipment.

(b) Proof test (Annex I-§ 3 . 2. 2 of the PED), generally hydrostatic, carried out at a pressure Pt defined
in Annex I-§ 7. 4 of the PED. The test pressure shall be the larger of the following.

where,

Ps = allowable maximum operating pressure

fa = nominal design stress at test temperature

ft = nominal design stress at operating temperature.

NOTE: Lower values may be used if an equivalent overall level of safety has been achieved (Annex I-§ 7

of the PED).

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(a) Exceptionally, where the hydrostatic pressure test is impractical, an “equivalent test” (e. g. , a

pneumatic test) may be performed.

(b) The test shall be performed for each equipment, unless the equipment is classified in Category I

(where the test may be carried out on a statistical basis).

(c) For assemblies, an examination of the safety accessories shall be performed additionally.

7.2.1.3.4 Marking and Operating Instructions

(a) In addition to CE Marking, information specified in PED Annex I-§ 3 . 3 shall be affixed on the

Equipment.

(b) Pressure Equipment shall be accompanied with instructions covering all information necessary for

the user (mounting, start-up, use, maintenance). (S ee Annex I-§ 3 . 4 of the PED. )

7.2.1.4 Materials (Annex I-§4 of the PED)

The word Material includes the parent materials (i. e. , base metals, such as steel, aluminum, etc. ) as well as

j oining materials (for welding, brazing, etc. ). Welding consumables and other j oining materials are subj ect

only to some of the parent material requirements.

7.2.1.4.1 Materials Intended for Pressure Parts (Annex I-§4.1 of the PED)

Materials must have appropriate properties for all operating conditions reasonably foreseeable and for test

conditions, especially regarding (Annex I-§ 7. 5 of the PED) . Materials shall be sufficiently ductile and

tough, which can be demonstrated by the following properties:

(a) ductility: for steel, elongation after rupture, A % not less than 1 4%

(b) toughness: for steel, impact test energy not less than 27J (20 ft-lb).

NOTE: Other means of achieving sufficiently ductile and tough material may be adopted as long as an

equivalent overall level of safety can be as sured.

The materials shall be sufficiently chemically resistant and not be affected by aging, etc.

7.2.1.4.2 Material Characteristics (Ann ex I-§4.2 of the PED)

(a) The Manufacturer shall define material characteristics required by equipment design and material

use (Annex I-§ 4. 2a of the PED).

(b) The Manufacturer shall record in the technical documentation the j ustification for compliance with

one of the following forms :

(1 ) Material that complies with Harmonized S tandards. Thus, the material is presumed to comply

with the ES R

(2) Material subj ect to a EAM (Article 1 5 of the PED)

(3) Material subj ect to a PMA, which shall be carried out by a body depending on the Risk

Category in which the equipment is classified. (S ee below)

Equipment Category PMA Carried Out by

Category I Manufacturer

Category II

Category III NB in charge of evaluation and approval of the Pressure

Category IV Equipment

(c) Materials shall be accompanied by an inspection document established by the material producer.

For pressure parts the type of inspection document depends on the Equipment Risk Category

(Annex I-§ 4. 3 of the PED), as follows.

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Equipment Category Type of Inspection Document (According to EN1 0204)

Category I Test report Type 2. 2 (Certificate of Compliance)

Inspection certificate

Category II Type 3 . 1 or Type 3 . 2 (if the material manufacturer does

Category III not have an approved quality system)

Category IV

NOTE: S ee S ection VII of this Guide for more details regarding PED requirements for materials.

7.2.1.5 Specific Requirements Applicable to Fired Equipment (Annex I-§5 of the PED)

This pressure equipment shall be constructed so as to avoid or minimize risks of a significant loss of

containment from overheating.

7.2.1.6 Specific Requirements Applicable to Piping (Annex I-§6 of the PED)

This equipment shall be constructed so as to ensure that the risks listed in sub -clauses (a) to (g) in PED

Annex I-§ 6 are taken into account or minimized.

7.2.1.7 Specific Quantitative Requirements for All Equipment (Annex I-§7 of the PED)

(a) The quantitative requirements specified in this clause of Annex I may be superseded by other

requirements (or other values) provided that these values result in an equivalent overall level of

safety.

(b) These requirements have been included in Annex I-§ 7, sub-clauses 2, 3 , and 4 of the PED. They

deal with the following items.

(1 ) allowable stresses (Annex I-§ 7. 1 )

(2) j oint coefficients (Annex I-§ 7. 2)

(3) means of pressure limitation (Annex-§ 7. 3 )

(4) hydrostatic test pressure (Annex I-§ 7. 4)

(5) material characteristics (Annex I-§ 7. 5 ).

7.3 Hazard Analysis (Annex I of the PED)


Annex I of the PED (Preliminary Observations -§ 3 ) requires the Manufacturer to perform an assessment of

hazards and risks and design and build the equipment taking account this analysis.

NOTE: S uch a hazard analysis has no relationship with the Category concept, defined in PED Article 1 3 ,

whose purpose is to determine the level of hazard presented by Pressure Equipment.

The hazard and risk analysis should be performed as follows.

7.3.1 Identify the Hazard Due to Pressure


All potential failure mechanisms or dangers that can be anticipated during operation of the Pressure

Equipment should be considered, such as:

(a) effect of operating parameters (pressure, temperature, fluid, etc. )

(b) effect of static stresses

(c) effect of fluctuating stresses

(d) corrosion, erosion, abrasion

(e) creep

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(f) modification of mechanical properties due to temperature, manufacturing process (forming, etc. ),

aging, etc.

(g) potential misuse of the Pressure Equipment during operation.

NOTE: Only hazards due to pressure need to be considered for the PED. Other hazards (such as electrical

hazards, electromagnetic hazards, and transportation hazards) may be covered by other Directives.

7.3.2 Evaluation
Evaluate the hazards and risks to determine if the hazards and risks can be eliminated (using adequate safety

margins in design, adequate materials, adequate testing and inspection, etc. ) or reduced to an acceptable

level (PED Annex 1 , § 1 . 2, first indent).

NOTE: This is not a risk evaluation. The severity and probability of risk is not in the scope of the PED,

which does not account for the consequences of a failure of the Pressure Equipment. This appears clearly

in the determination of the Hazard Category of the Equipment.

7.3.3 Reduction of Hazards


Reduce hazards and risks that cannot be eliminated by applying protective measures during operation of

the Equipment.

7.3.4 Informing Users


Inform Users of residual hazards so that they can take adequate measures (PED Annex I-§ 1 . 2, third indent).

This also covers potential misuse of the Equipment by the User during operation (PED Annex I-§ 1 . 3 ).

7.3.5 Documentation
The results of the hazard analysis shall be included in the Technical Documentation.

The ES R contained in Annex I apply only when the corresponding hazards due to the pressure existing on

the Pressure Equipment under operating conditions that are “reasonably foreseeable by the Manufacturer”
(PED Annex I —Preliminary Observations, § 2).

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8 MATERIALS (ARTICLE 1 5, ANNEX I, SECTION 4 OF THE PED)


8.1 General
(a) B efore a material can be used in Pressure Equipment, it must comply with the applicable ES R

specified in PED Annex I-§ 4 (also see paragraph 7. 2. 1 . 4 of this Guide):

(1 ) The material shall have appropriate properties for all foreseeable operating and test conditions.

(2) It shall be sufficiently ductile: e. g. , 1 4% minimum elongation for steel.

(3) It shall have sufficient notch toughness: 27J at 20° C (or 20 ft-lb at 68 ° F) for steel but not higher

than the lowest scheduled operating temperature.

(4) It shall be sufficiently chemically resistant to the fluid contained in the pressure equipment.

(5) It shall not be significantly affected by aging.

(6) It shall be suitable for the intended processing procedures during manufacture of the pressure

equipment.

(7) It shall be selected to avoid undesirable (e. g. , galvanic) effects when different materials are

j oined.

(8) It shall be suitable for such application during the scheduled lifetime unless replacement is

foreseen.

(b) For selecting a material for Pressure Equipment, the Manufacturer has three options (Annex I-§ 4. 2b

of the PED):

(1 ) Use material specification taken from an EN Material Harmonized S tandard. Materials taken

from these S tandards are presumed to conform to the ES R and there will be no requirement to

demonstrate compliance with the essential requirements for materials .

(2) Use material covered by EAM as explained below. This procedure is only applicable for

materials intended for repeated use.

(3) Use of material covered by a PMA. Any material may be used in pressure equipment if it can

be demonstrated that it complies with the ES R for the material.

8.2 Materials that Comply with Harmonized Materials Standards


A European standard may be adopted as a “Harmonized Standard” if the following conditions are fulfilled.
(a) Conforms to the addressed essential requirements

(b) Has an annex ZA

(c) Has been evaluated by the CEN consultant

(d) Is sent to the EC for publication in the OJEU. Harmonized S tandards for materials devoted to

pressure equipment are issued by CEN. Examples are as follows.

(1 ) EN 1 0028 S eries: Flat products made of steels for pressure purposes.

(2) EN 1 021 6 S eries: S eamless tubes for pressure purposes.

8.3 European Approval of Pressure Equipment Materials (Article 1 5 of the PED)


8.3.1 General
When the Pressure Equipment material is not covered by a Harmonized S tandard, the Manufacturer of

Pressure Equipment can request an EAM to the NB .

The general procedure is as follows.

(a) The Manufacturer prepares a Data S heet containing all the technical information relevant to the

material specification.

(b) The NB performs appropriate inspections and tests to certify the conformity of the material to the

applicable ES R. If the material was recognized as being safe before the implementation of the

PED, the NB takes into account the existing data.

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(c) The NB must comment on the material Data S heet to the Member S tates and the European

Commission who can disapprove the EAM within three months.

(d) If there is no disapproval during these three months the NB issues an EAM specification that will

be published in the OJEU.

(e) This material specification is presumed to conform to the applicable ES R and can be used at any

time. It has therefore the same status as a Harmonized S tandard material.

An EAM is a technical document defining the characteristics of materials intended for repeated use in the

manufacture of pressure equipment that are not covered by any harmonized standard.

An EAM will be issued, at the request of one or more Manufacturers of materials or equipment, by an NB

specifically designated for the task.

8.3.2 General Requirements for Obtaining EAMs of Pressure Equipment Materials


8.3.2.1 European Approvals of Nationally Approved Specifications of EU Member Countries for
Pressure Equipment Materials.

EAMs are established by transforming the material specifications for pressure equipment originally covered

in national standards of CEN member countries or in national technical material datasheets approved by

the body competent for such approvals. The following requirements shall apply.

(a) The national material specification existed before the work on the relevant European S tandard

commenced.

(b) The material represents a real alternative to the materials covered in the relevant European Material

S tandard or an already existing European Approval for pressure equipment materials.

(c) The sampling and testing conditions are equivalent to, or more stringent than, those specified in the

relevant European Material S tandard.

(d) The requirements specified in the national specification shall in general be backed by statistical

data.

8.3.2.2 EAM Covered in Non-EU Member Specifications

An EAM may be issued for a special or novel material grade not included in a European material standard

harmonized under the PED. S uch a material grade shall have a particular chemistry or specific mechanical

properties or characteristics, such as corrosion resistance.

An EAM will not be issued for a grade of material listed in the current of former national material standard

that has a specification covered by a harmonized European material standard.

NOTE: Guideline 7/26 includes additional information on European Approval of Materials. Note 2 to the

Guideline further states the EAM shall be withdrawn by the NB if the type of material is covered by a

harmonized standard.

8.3.2.3 Procedure for Incorporation of Existing National Material Specifications into European
Material Data Sheets (EMDS)

8.3.2.3.1 Applications

Applications shall be made in writing to an NB for incorporation of the material specification.

8.3.2.3.2 The NB Shall Verify the Requirements of Annex I in the PED

Where appropriate, the NB shall complete a questionnaire with the assistance of the applicant. After

consideration, the NB shall prepare a draft EMDS . The draft EMDS may contain restrictions or

34
PTB -1 1 -201 7: Guide for AS ME B PVC S ection I S tamp Holders

supplementary requirements to ensure compliance of the specified material with the requirements of the

main part.

The draft EMDS shall be submitted to the EU Member S tates and the European Commission.

8.4 PMA (Annex I-§4.2c of the PED)


This approach is intended for a material that is not listed in a Harmonized S tandard or for which an EAM

has not been issued. It shall be in the following form:

(a) The pressure equipment manufacturer shall always provide in his technical documentation for

compliance with the material specifications of the Directive. It shall be in the form of PMA if the

material is not listed in a Harmonized S tandard.

(b) Where the pressure equipment is Category III or Category IV, a specific assessment of the PMA

shall be performed by the NB in charge of CA procedures for the pressure equipment.

The material specification shall be reviewed for compliance with the ES R and, if necessary, additional tests

must be carried out.

A PMA indicates that the Material complies with the applicable ES R, but is limited to its application to the

conditions specified. If the vessel manufacturer wants to use the material outside that range, it must reapply

to the NB for extension of the approval.

To grant approval, the NB may require additional tests to be carried out. S ubj ect to these results, the NB

may approve the use of the material for those particular conditions . Decisions made concerning the

suitability of a material within a specified range of conditions do not need to be repeated.

8.5 Material Certificates (Annex I-§4.3 of the PED)


All materials shall have documentation, issued by the Material Manufacturer, which confirms compliance

with an appropriate material specification. Where the component is a main pressure part of equipment in

Category II, III, or IV, this documentation shall be a Certificate of specific product control, e. g. , EN 1 0204,

Type 3 . 1 . Certificates of Conformity (e. g. , Type 2. 2) are acceptable only for pressure equipment in

Category I.

8.6 Material Manufacturers


Material certificates issued by Material Manufacturers that hold certification, issued by a European

Accredited Certification B ody, can be presumed by the Pressure Equipment Manufacturer to comply with

the relevant material ES R.

Where the Material Manufacturer does not have such certification, its certificates are not presumed to

comply with the relevant requirements and, therefore, it is up to the Pressure Equipment Manufacturer to

determine if the certificate is acceptable or if independent inspection is required.

convince the NB that the Material Manufacturer’s certificates are


The Pressure Equipment

Manufacturer may also need to

acceptable. Direct inspection by a Competent B ody, appointed by the Pressure Equipment Manufacturer,

is an appropriate route. An alternative to the quality system certification of the manufacturer is Type 3 . 2

certification of conformance.

There are two options for Manufacturers with IS O 9001 Certification without a Legal Entity in the EU:

(a) Annex I, paragraph 4. 3 assessment by Notified B ody

(b) Type 3 . 2 certification.

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9 NOTIFIED BODIES (ARTICLE 24 OF THE PED)


(a) The PED provides for the involvement of an NB to assess the conformity of the Equipment to the

requirements of the PED.

(b) These NB s shall comply with various requirements in terms of technical competence, organization,

independence, etc. (S ee PED, Article 24).

They are designated by the official authorities of each Member S tate, who notify the references of these

bodies to the Commission of the EC. The Commission publishes the list of the NB in the OJEU.

(a) The Manufacturer may select any of the NB from this list.

(b) According to the PED, the approval of permanent j oining procedures, j oint operators (particularly

welders) and NDT operators may also be performed by RTPOs (PED Article 24); however, an

NDT examiner may only be qualified by the RTPOs.

These entities shall comply with criteria similar to those of the NB .

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10 CE MARKING (ARTICLE 1 8, ARTICLE 1 9, OF THE PED)


(a) The CE Marking is the visual symbol affixed on an Equipment placed on the EU market. It attests

that the Equipment complies with all the provisions of the PED (Article 1 2). This marking allows

the free movement of the Equipment in the territory of the EU.

(b) The CE Marking is affixed by the Manufacturer, who takes in this way the responsibility to declare

that the Equipment complies with the requirements of the Directive.

(c) A product may be subj ect simultaneously to various New Approach Directives. Thus, a piece of

Equipment might be subj ect to the Machinery Directive if it is made of mobile parts, to the Low

Voltage Directive if electrical energy is involved, etc.

In such cases, a single CE Marking must be affixed, which attests the compliance with all applicable

Directives. It is therefore the responsibility of the Manufacturer to verify the list of Directives to which the

equipment may be subj ected.

The size of the CE Marking shall meet certain rules (see Article 3 0 of EC Regulation no. 765 / 2008 ).

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11 SPECIFIC ISSUES
1 1 .1 Assemblies (Article 6, Article 1 2 of the PED)
(a) PED covers also Assemblies, which are defined in the PED (Article 2- §6) as “several pieces of
Pressure Equipment assembled by a Manufacturer to constitute an integrated and functional

whole.” Typical examples are pressure-cookers and boilers. Two cases are possible:

(1 ) If the Manufacturer of an assembly intends to place it on the European Market and put it into

service as an assembly (and not in the form of its constituent non-assembled elements), that

assembly shall comply with the PED.

(2) If the assembly of Pressure Equipment is performed by the user on its site and under its

responsibility (as in the case of industrial installations), that assembling operation is outside

the scope of the PED.

(b) The following requirements apply:

(1 ) Assemblies including at least a Pressure Equipment above the thresholds shall comply with the

ES R (Article 4-§ 2 of the PED).

(2) Assessment of the integration of the various Equipment of the assembly is determined by the

highest Category of its Equipment, ignoring S afety Accessories. Design shall be conducted as

stated in Annex I-§ 2. 8 of the PED.

(c) Clauses of PED dealing with assemblies:

(1 ) Article 2-§ 6: Definition

(2) Article 4-§ 2(a): B oilers

(3) Article 1 4-§ 6: CA

(4) Article 1 9-§ 3 : CE Marking

(5) Annex I-§ 2. 8 : Design

(6) Annex I-§ 3 . 2. 3 : Inspection of S afety Devices.

1 1 .2 User Inspectorates (Article 25 of the PED)


(a) Member S tates may authorize in their territory the placing on the market, and the putting into

service by Users, of Pressure Equipment whose conformity with the essential requirements has

been assessed by a User Inspectorate (Article 1 6-§ 1 of the PED).

(b) Tasks and responsibilities of an NB may be transferred to a User Inspectorate under the following

conditions.

(1 ) the User Inspectorate has been designated by one of the Member S tates (Article 1 6-§ 6 and 7 of

the PED)

(2) the Equipment must be assessed according to one of the following modules: A2, C2, F, or G

(Article 1 6-§ 5 of the PED)

(3) the User Inspectorate shall act exclusively for the organization of which he or she is part

(c) The consequences are as follows.

(1 ) the Equipment so assessed shall not bear the CE Marking (Article 1 6 -§ 2 of the PED)

(2) the Equipment may be used only in establishments operated by the group of which the User

Inspectorate is part (Article 1 6-§ 3 of the PED)

1 1 .3 Specific Cases
The following specific cases do not follow the general rules of the PED and the User should refer to the

concerned Articles of the PED.

(a) Heat exchangers consisting of pipes for the purpose of cooling or heating air. (S ee Article 1 -§ 2(f)

of the PED)

(b) Unfired Pressure Vessels and B oilers containing dangerous fluids (Group1 ), classified in Hazard

Category III or IV and assessed by QA procedures. (S ee Article 1 4-§ 4 of the PED)

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(c) B oilers of one-off production in Hazard Category III and module H. (S ee Article 1 4-§ 5 of the

PED)

(d) Vessels containing a dangerous unstable gas in Hazard Category I or II. (S ee Annex II, Table 2 of

the PED)

(e) Piping containing a dangerous unstable gas in Hazard Category I or II. (S ee Annex II, Table 6 of

the PED)

(f) Portable extinguishers and bottles for B reathing Equipment. (S ee Annex II, Table 2 of the PED)

(g) Pressure- cookers. (S ee Annex II, Table 5 of the PED)

(h) Piping containing gas at T <3 5 0° C, in Hazard Category II. (S ee Annex II, Table 7 of the PED)

1 1 .4 Manufacturer’s Responsibility
(a) The PED lays down definitions and responsibilities for the Manufacturer, the Authorized Inspector

(AI), the NB , the Importer, and the Distributor.

In the New Legislative Framework (the New Approach) , “the Manufacturer is the person who is responsible
for designing and manufacturing a product with a view of placing it on the European Market o n his behalf.”
This definition, means that the Manufacturer is fully responsible for the design of the Pressure Equipment.

There is no allowance made for sharing the responsibility with the User or an engineering contractor or

designer.

The Manufacturer can subcontract the Design but will remain fully responsible for the Pressure Equipment

when placed on the market or put into service in Europe.

(b) The responsibility of the Manufacturer appears explicitly in the PED at the following clauses:

(1 ) Article 6, Obligations of Manufacturers : “the CA Procedures of Annex III, at its choice. ”


(2) Annex I, Preliminary Observations, §3 : “The Manufacturer is under an obligation to analyze
the hazards and risks in order to identify those which apply to his Equipment on account of

pressure; he shall then design and construct it taking account of his analysis.”
(3) Annex I-§1 (General) : shows the responsibility of the Manufacturer pertaining to design and

manufacture the construction of his Equipment.

(4) Annex I-§2 (Design) : shows the responsibility of the Manufacture pertaining to the Design of

his Equipment.

(5) Annex I-§3 (Manufacturing): The manufacturer is responsible for selecting the appropriate

conformity procedure and the documentation.

(6) Annex I-§4 (Materials) : “Materials used for the manufacture for the Equipment shall be suitable
for such application during the scheduled lifetime.”
(7) Annex III (CA Procedures) : Whatever are the CA Procedures selected by the Manufacturer, its

responsibilities are as follows:

(8) More details on the Manufacturer’ s responsibility is given in Appendix H of this Guide, which
covers the following items.

(i) responsibility of the Manufacturer

(ii) p l ac i n g o n th e marke t an d p u tti n g i n to service

(c) The Manufacturer is also responsible to ensure its product complies with the obligations of all

Directives which apply to it. The Manufacturer shall affix the CE Marking to each Pressure

Equipment. B y affixing the CE Marking, the Manufacturer officially declares that its product

complies with all relevant Directives.

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1 1 .5 Operating Instructions
When pressure equipment is placed on the market, it shall be accompanied, as far as relevant, by instructions

for the user, containing all the necessary safety information relating to:

(a) information as affixed to the equipment and required by Annex I, § 3 . 3 of the PED (Marking and

Labeling) with the exception of serial identification

(b) necessary safety information (see Annex I, § 3 . 4 of the PED) relating to

(1 ) mounting, including assembling of different pieces of pressure equipment

(2) putting into service

(3) use

(4) maintenance, including checks by the user

(5) drawings necessary for a full understanding of the information, if applicable

(c) In particular, this information shall include the elements of the design files used for the in -service

verification or for eventual modifications or repairs, such as materials nature, minimal design

thicknesses, corrosion allowance, j oints coefficients.

Where appropriate, this information shall be accompanied by the technical documents for a full

understanding of this information and instructions.

Furthermore, for all the modules, a Declaration of Conformity (see Annex VII of the PED) is established

by the Manufacturer and for modules F and G, a Certificate of Conformity is established by the NB .

The Directive does not specify that these two documents shall be given with the equipment but they can

be furnished on request.

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12 COMPARISON OF ASME AND PED REQUIREMENTS


Figure 1 2-1 : Comparison of ASME Section I Requirements with PED 201 4/68/EU, Annex I

PED REQUIREMENTS RELATED ASME SECTION I REQUIREMENTS

ANNEX I YES, ADDITIONAL


PED ESSENTIAL SAFETY REQUIREMENTS COMMENTS NONE, CODE REF. COMMENTS CONSIDERATION
PAR. (ESR) PARTIAL S FOR PED,
ANNEX 1
1 2 4 5 6 7 8
1

PRELIMINARY OB S ERVATIONS

1. The obligations arising from the essential S ee Art. 2, Point 6 for Yes PG-1 1 S ect. I covers the

requirements listed in this annex for pressure definition of “assemblies” PG-5 8 complete boiler

equipment also apply to assemblies where the PG-5 9 assembly,

corresponding hazard exists. PG-60 including piping,

PG-67 appurtenances,

PG-68 and safety relief

PG-71 devices

2. The essential requirements laid down in the Informative statement

directive are compulsory. The obligations laid

down in these essential requirements apply only

if the corresponding hazard exists for the pressure

equipment in question when it is used under the

conditions that are reasonably foreseeable by the

manufacturer.

3. The manufacturer is under an obligation to None S ect. I does not Note 1

analyze the hazards and risks in order to identify require hazard

those which apply to his equipment on account of analysis.

pressure;

He shall then design and construct it taking None Note 2

account of his analysis.

4. The general requirements are to be interpreted

and applied in such a way as to take account of Informative statement Yes Foreword, Note A

the state of the art and current practice at the time Preamble

of design and manufacture as well as of technical

and economic considerations that are consistent

with a high degree of health and safety

protection.

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PTB -1 1 -201 7: Guide for AS ME B PVC S ection I S tamp Holders

PED REQUIREMENTS RELATED ASME SECTION I REQUIREMENTS

ANNEX I YES, ADDITIONAL


PED ESSENTIAL SAFETY REQUIREMENTS COMMENTS NONE, CODE REF. COMMENTS CONSIDERATION
PAR. (ESR) PARTIAL S FOR PED,
ANNEX 1
1. GENERAL

1 .1 Pressure equipment must be designed, Partial S ect. I, Note B Note 3 ,

manufactured, and checked and, if applicable, Foreword Note 4

equipped and installed in such a way as to ensure

its safety when put into service in accordance

with the manufacturer’ s instructions, or in

reasonably foreseeable conditions.

1 .2 In choosing the most appropriate solutions, the Partial

manufacturer shall comply with the principles set

out below in the following order:

a) Eliminate or reduce hazards as far as is Hazards during operation of Yes Note 5

reasonably practicable the vessel

b) Apply appropriate protection measures against Pressure relief devices, Yes PG-67

hazards that cannot be eliminated temperature controls, low- through PG-

water cutoffs, etc. 73 , PMB -1 7

& PEB -1 6

c) Where appropriate, inform users of residual None

hazards and indicate whether it is necessary to

take appropriate special measures to reduce

risks at the time of installation and/or use.

1 .3 Where the potential for misuse is known or can Yes PG-60, Note 6

be clearly foreseen, the pressure equipment shall PG-61

be designed to prevent danger from such misuse

or,

If that is not possible, adequate warning (must be) Partial Note B

given that the pressure equipment must not be

used in that way.

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PTB -1 1 -201 7: Guide for AS ME B PVC S ection I S tamp Holders

PED REQUIREMENTS RELATED ASME SECTION I REQUIREMENTS

ANNEX I YES, ADDITIONAL


PED ESSENTIAL SAFETY REQUIREMENTS COMMENTS NONE, CODE REF. COMMENTS CONSIDERATION
PAR. (ESR) PARTIAL S FOR PED,
ANNEX 1
2 DESIGN REQUIREMENTS
2. DES IGN

2. 1 General

The pressure equipment shall be properly Partial PG-1 6, PG- Note C Note 4

designed taking all relevant factors into account 23 through

in order to ensure that the equipment will be safe PG-3 8 , PG-

throughout its intended life. 43 , PG-46,

PG-5 2, PG-

5 3 and PW-9

The design shall incorporate appropriate safety (The PED does not define Yes S ee above Note D

coefficients using comprehensive methods such how this is to be

as are known to incorporate adequate safety accomplished in a

margins against all relevant failure modes in a “consistent manner. ”)

consistent manner.

2. 2 Design for Adequate S trength

2. 2. 1 The pressure equipment shall be designed for Partial PG-22

loadings appropriate to its intended use and other

reasonably foreseeable operating conditions. In

particular, the following factors shall be taken

into account:

a) Internal/external pressure, Yes PG-27

b) Ambient and operational temperatures, Yes PG-21 and

PG-27

c) S tatic pressure and mass of contents in Yes PG-22. 1

operating and in test conditions,

d) Traffic, wind, earthquake loading, Partial PG-22. 1 Except traffic.

e) Reaction forces and moments that result from Yes PG-22. 2,

the supports, attachments, piping, etc. B 3 1 . 1 S ect.

119

f) Corrosion and erosion, fatigue, etc. Partial PG-27. 4, S ect. I addresses

Note 3 , B 3 1 . 1 need, not how to

§ 1 02. 4 analyze

g) Decomposition of unstable fluids. None Note E Note 7

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PTB -1 1 -201 7: Guide for AS ME B PVC S ection I S tamp Holders

PED REQUIREMENTS RELATED ASME SECTION I REQUIREMENTS

ANNEX I YES, ADDITIONAL


PED ESSENTIAL SAFETY REQUIREMENTS COMMENTS NONE, CODE REF. COMMENTS CONSIDERATION
PAR. (ESR) PARTIAL S FOR PED,
ANNEX 1
h) Various loadings that can occur at the same Yes PG-22, B 3 1 . 1

time shall be considered, taking into account § 1 01 . 5

the probability of their simultaneous

occurrence.

2. 2. 2 Design for adequate strength shall be based on:

1 . as a general rule, a calculation method, as Yes PG-27

described in 2. 2. 3 , and through PG

53,

2. supplemented if necessary by an experimental Partial PG 1 00 Note 8

design method as described in 2. 2. 4, or

3 . an experimental design method without Partial There is no limit

calculation, as described in 2. 2. 4, when the on pressure and

product of the maximum allowable pressure volume in PG

PS and the volume V is less than 6000 bar x 1 00

L, or the product PS x DN less than 3 , 000 bar

2. 2. 3 Calculation method

(a) Pressure containment and other loading

aspects.

The allowable stresses for pressure equipment Yes PG-23

shall be limited having regard to reasonably

foreseeable failure modes under operating

conditions.

To this end, safety factors must be applied to (It is not possible to fully Yes PG-23

eliminate fully any uncertainty arising out of eliminate any uncertainty).

manufacture, actual operational conditions,

stresses, calculation models and the properties

and behavior of the material.

These calculations methods shall provide S ee Fig. 1 2-2: Q1 of this Yes S ect. II, Part

sufficient safety margins consistent, where Guide D, App. 1

applicable, with the requirements of S ect. 7.

The requirements set out above may be met by

applying one of the following methods, as

appropriate, if necessary as a supplement to or

in combination with another method:

(1 ) design by formula Yes PG-27 to PG-

53

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PED REQUIREMENTS RELATED ASME SECTION I REQUIREMENTS

ANNEX I YES, ADDITIONAL


PED ESSENTIAL SAFETY REQUIREMENTS COMMENTS NONE, CODE REF. COMMENTS CONSIDERATION
PAR. (ESR) PARTIAL S FOR PED,
ANNEX 1
(2) design by analysis Partial

(3) design by fracture mechanics Not applicable

(b) Resistance Yes

Appropriate design calculations shall be used

to establish the resistance of the pressure

equipment concerned.

In particular:

(1 ) the calculation pressures shall not be less Yes PG-21

than the maximum allowable pressures

and take into account static head, and Yes PG-22. 1

dynamic fluid pressures; and Yes

the decomposition of unstable fluids. None Note E Note 7

Where a vessel is separated into individual Yes PG-1 6. 2

pressure-containing chambers, the partition

wall shall be designed on the basis of the

highest possible chamber pressure relative

to the lowest pressure possible in the

adj oining chamber.

(2) the calculation temperatures shall allow for Yes PG-21 ,

appropriate safety margins, Note 9

(3) the design shall take appropriate account Yes PG-21 , Note

of all possible combinations of temperature 9, PG 27-4,

and pressure which might arise under Note 2

reasonably foreseeable operating

conditions for the equipment

(4) the maximum stress and peak stress Yes PG-22,

combinations must be kept within safe PG-23

limits.

(5) the calculation for pressure containment Yes PG-23 and

shall utilize the values appropriate to the S ect. II, Part

properties of the material, based on the D, App. 1

documented data, having regard to the S ee Fig 7-1 of this Guide Yes

provisions set out in Point 4 together with for the PED design factors

the appropriate safety factors.

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PED REQUIREMENTS RELATED ASME SECTION I REQUIREMENTS

ANNEX I YES, ADDITIONAL


PED ESSENTIAL SAFETY REQUIREMENTS COMMENTS NONE, CODE REF. COMMENTS CONSIDERATION
PAR. (ESR) PARTIAL S FOR PED,
ANNEX 1
Materials characteristics to be considered, Partial

where applicable, include:

(a) yield strength, 0. 2% or 1 . 0% proof Yes PG-5 , PG-23

strength as appropriate at the calculation

temperature,

(b) tensile strength, Yes PG-23 and

S ect. II, Part

D, App. 1

(c) time-dependent strength, i. e. creep Partial PG-23 and Note I

strength, S ect. II, Part

D, App. 5

(d) fatigue data, Partial PG-22 Note F

(e) Young’s modulus (modulus of Yes S ect. II, Part

elasticity), D, App. 5

(f) appropriate amount of plastic Partial Note G Note 9

strain,

(g) impact strength, None Note 3 3

(h) fracture toughness, None Note 3 3

(6) appropriate j oint facts shall be applied to S ee 7. 2. 1 . 4 of this Guide Partial PG-27. 4, Note H

the materials properties depending, for Note 1 , PW-

example, on the type of NDT, the materials 1 1 and PW-

j oined an the operating conditions 41

envisaged,

(7) the design shall take appropriate account Yes PG-22, PG- Note I

of all reasonably foreseeable degradation 23 , PG-27

mechanisms (e. g. corrosion, creep, fatigue) Note 3 and

commensurate with the intended use of the S ect. II, Part

equipment. D, App. 6

Attention shall be drawn, in the instructions Note 3

referred to in Point 3 . 4, to particular features

of the design which is relevant to the life of

the equipment, for example:

(a) for creep; design hours of operation at Partial Note I Note 1 0

specified temperatures,

(b) for fatigue: design number of cycles at Partial Note J Note 1 0

the specified stress levels,

46
PTB -1 1 -201 7: Guide for AS ME B PVC S ection I S tamp Holders

PED REQUIREMENTS RELATED ASME SECTION I REQUIREMENTS

ANNEX I YES, ADDITIONAL


PED ESSENTIAL SAFETY REQUIREMENTS COMMENTS NONE, CODE REF. COMMENTS CONSIDERATION
PAR. (ESR) PARTIAL S FOR PED,
ANNEX 1
(c) for corrosion: design corrosion None Note K

allowance;

(d) S tability Aspects

Where the calculated thickness does not allow Yes PG-22

for adequate structural stability,

the necessary measures shall be taken to Including transport of Partial PG-5 5 Note L Note 1 1

remedy the situation taking into account the original vessel

risks from transport and handling.

2. 2. 4 Experimental design method

The design of the equipment may be validated, in Yes App. A-22

all or in part, by an appropriate test program

carried out on a sample representative of the

equipment or the category of equipment.

The test program shall be clearly defined prior to None Note M Note 1 2

testing and accepted by the notified body

responsible for the design CA module, where it

exists.

This program shall define test conditions and Yes App. A-22. 1 0

criteria for acceptance or refusal. and PG

91 . 1 . 5

The actual values of the essential dimensions and Yes App. A-

characteristics of the materials, which constitute 22. 1 1 . 3

the equipment tested, shall be measured before

the test.

Where appropriate, during tests, it shall be Yes App. A-

possible to observe the critical zones of the 22. 1 1 . 1

pressure equipment with adequate

instrumentation capable of registering strains and

stresses with sufficient precision.

47
PTB -1 1 -201 7: Guide for AS ME B PVC S ection I S tamp Holders

PED REQUIREMENTS RELATED ASME SECTION I REQUIREMENTS

ANNEX I YES, ADDITIONAL


PED ESSENTIAL SAFETY REQUIREMENTS COMMENTS NONE, CODE REF. COMMENTS CONSIDERATION
PAR. (ESR) PARTIAL S FOR PED,
ANNEX 1
The test program shall include:

(a) A pressure strength test, the purpose of which Yes App. A-22 Notes N, O

is to check that, at a pressure with a defined

safety margin in relation to the maximum

allowable pressure, the equipment does not

exhibit sufficient leaks or deterioration

exceeding a determined threshold.

The test pressure shall be determined on the Yes App. A-22

basis of the differences between the values of

the geometrical and material characteristics

measures under test conditions and the values

used for design purposes;

it shall take into account the differences Yes App. A-22 Note P

between the test and design temperatures;

(b) Where the risk of creep or fatigue exists, None Note J Note 8

appropriate tests determined on the basis of

the service conditions laid down for the

equipment, for instance, hold time at specified

temperatures, number of cycles at specified

stress-levels, etc. ;

(c) Where necessary, additional tests concerning None Note 8

other factors referred to in 2. 2. 1 such as

corrosion, external damage, etc.

2. 3 Provisions to ensure safe handling and operation

The method of operation specified for pressure None Note Q Note 1 3

equipment shall be such as to preclude any

reasonable foreseeable risk in operation of the

equipment. Particular attention shall be paid,

where appropriate, to:

a) closures and opening; Partial PG-3 2

through PG-

44, PFT-43 ,

PWT-1 4

48
PTB -1 1 -201 7: Guide for AS ME B PVC S ection I S tamp Holders

PED REQUIREMENTS RELATED ASME SECTION I REQUIREMENTS

ANNEX I YES, ADDITIONAL


PED ESSENTIAL SAFETY REQUIREMENTS COMMENTS NONE, CODE REF. COMMENTS CONSIDERATION
PAR. (ESR) PARTIAL S FOR PED,
ANNEX 1
b) dangerous discharge of pressure relief blow- Partial B 3 1 . 1 , App.

off II

c) devices to prevent physical access while None

pressure or vacuum exists,

d) surface temperature taking into consideration None

the intended use

e) decomposition of unstable fluids. None

In particular, pressure equipment fitted with an Partial PWT-1 4 Note R Note 1 4

access door shall be equipped with an automatic

or manual device enabling the user easily “to


ascertain that the opening will not present any

risk”.

Furthermore, where the opening can be operated N/A B oilers are

quickly, the pressure equipment shall be fitted typically not

with a device to prevent it being opened fitted with quick-

whenever the pressure or temperature of the fluid actuating

presents a risk. closures

2. 4 Means of examination

Implied, but rules

(a) Pressure equipment shall be designed and Partial Part PG, Part are not given for

constructed so that all necessary examinations PW inspection stubs,

to ensure safety can be carried out; etc.

(b) Means of determining the internal condition Yes PG-44, PWT- Note S

of the equipment shall be available, where it is 1 4, and PFT-

necessary to ensure the continued safety of the 43

equipment, such as access openings allowing

physical access to the inside of the pressure

equipment so that appropriate examinations

can be carried out safely and ergonomically;

(c) Other means of ensuring the safe condition of Yes PG-44 Handholes are

the pressure equipment may be applied in any required

of the following situations :

(1 ) where it is too small for physical Yes

internal access, or

49
PTB -1 1 -201 7: Guide for AS ME B PVC S ection I S tamp Holders

PED REQUIREMENTS RELATED ASME SECTION I REQUIREMENTS

ANNEX I YES, ADDITIONAL


PED ESSENTIAL SAFETY REQUIREMENTS COMMENTS NONE, CODE REF. COMMENTS CONSIDERATION
PAR. (ESR) PARTIAL S FOR PED,
ANNEX 1
(2) where opening the pressure equipment N/A Does not apply to Note 1 5

would adversely affect the inside, or boilers

(3) where the substance contained has been N/A S ect. I requires

shown not to be harmful to the material all boilers to have

from which the pressure equipment is inspection

made and no other internal degradation openings

mechanisms are reasonably foreseeable.

2. 5 Means of draining and venting

Adequate means shall be provided for draining Yes PG-5 9. 4 and Note T Note 1 6

and venting of pressure equipment where B31 .1

necessary: § 1 22. 1 . 5

a) to avoid harmful effects such as water Yes PG-5 9. 1 Note U

hammer, vacuum collapse, corrosion and Note V

uncontrolled chemical reactions.

b) All stages of operations and testing, Yes PG-5 9. 4 Ample drains are

particularly pressure testing, shall be required for all

considered, boiler

components

c) to permit cleaning, inspection, and Yes PG-5 9. 3 and B lowoff

maintenance in a safe manner. PG-5 9. 4 connections are

required

2. 6 Corrosion or other chemical attack

Where necessary, adequate allowance or Partial PG-5 . 5 , Note Note 1 7

protection against corrosion or other chemical 1 , PG-27. 4,

attack shall be provided, taking due account of Note 3

the intended and reasonably foreseeable use.

2. 7 Wear

Where severe conditions of erosion or abrasion Partial B 3 1 . 1 § 1 02. 4 Note W Note 1 8

may arise, adequate measures shall be taken to:

a) minimize the effect by appropriate design, e. g. Partial B 3 1 . 1 § 1 02. 4

additional material thickness, or by the use of

liners or cladding materials,

50
PTB -1 1 -201 7: Guide for AS ME B PVC S ection I S tamp Holders

PED REQUIREMENTS RELATED ASME SECTION I REQUIREMENTS

ANNEX I YES, ADDITIONAL


PED ESSENTIAL SAFETY REQUIREMENTS COMMENTS NONE, CODE REF. COMMENTS CONSIDERATION
PAR. (ESR) PARTIAL S FOR PED,
ANNEX 1
b) permit replacement of parts which are most Partial B oiler

affected, components such

as piping and

tubing are

accessible for

replacement

c) draw attention, in the instructions referred to None Note B Note 3

in Point 3 . 4, to measures necessary for

continued safe use.

2. 8 Assemblies

Assemblies shall be so designed that: Note X Note 1 9

a) the components to be assembled together are Yes Part PG and

suitable and reliable for their duty, Part PW

b) all the components are properly integrated and Yes

assembled in an appropriate manner.

2. 9 Provisions for filling and discharge

Where appropriate, the pressure equipment shall N/A Note Y

be so designed and provided with accessories, or

provisions made for their fitting, as to ensure safe

filling and discharge in particular with respect to

hazards such as:

(a) on filling:

1. overfilling or over pressurization having N/A Note Y

regard in particular to the filling ratio and

to vapor pressure at the reference

temperature

2. instability of the pressure equipment N/A

(b) on discharge: the uncontrolled release of the N/A

pressurized fluid;

(c) on filling or discharge: unsafe connection and N/A

disconnection.

SAFETY DEVICES REQUIREMENTS

51
PTB -1 1 -201 7: Guide for AS ME B PVC S ection I S tamp Holders

PED REQUIREMENTS RELATED ASME SECTION I REQUIREMENTS

ANNEX I YES, ADDITIONAL


PED ESSENTIAL SAFETY REQUIREMENTS COMMENTS NONE, CODE REF. COMMENTS CONSIDERATION
PAR. (ESR) PARTIAL S FOR PED,
ANNEX 1
2. 1 0 Protection against exceeding the allowable limits

of pressure equipment

Where under reasonably foreseeable conditions, Yes PG-67

the allowable limits could be exceeded, the through PG-

pressure equipment shall be fitted with, or 73

provisions made for the fitting of, suitable

protective devices, within an assembly.

The suitable device or combination of such Yes PG-67

devices shall be determined on the basis of the through PG-

particular characteristics of the equipment or 73

assembly.

S uitable protective devices and combinations

thereof comprise:

(a) safety accessories as defined in Article 2, Yes PG-67

Point 4; through PG-

73

(b) where appropriate, adequate monitoring Yes PG-60. 1 , PG- Note Z Note 20

devices such as indicators and/or alarms 60. 2, PG

which enable adequate action to be taken 60. 6, PFT-47,

either automatically or manually to keep the PMB -1 3 ,

pressure equipment within the allowable PMB -1 7,

limits. PEB -1 3 , and

PEB -1 6

2. 1 1 S afety accessories

2. 1 1 . 1 S afety accessories shall:

a) be so designed and constructed as to be Yes PG-67

reliable and suitable for their intended duty through PG-

and take into account the maintenance and 73

testing requirements of the devices, where

applicable,

52
PTB -1 1 -201 7: Guide for AS ME B PVC S ection I S tamp Holders

PED REQUIREMENTS RELATED ASME SECTION I REQUIREMENTS

ANNEX I YES, ADDITIONAL


PED ESSENTIAL SAFETY REQUIREMENTS COMMENTS NONE, CODE REF. COMMENTS CONSIDERATION
PAR. (ESR) PARTIAL S FOR PED,
ANNEX 1
b) be independent of other functions, unless their Yes PG-71 and

safety function cannot be affected by such PVG-1 2. 3 . 4

other functions,

c) comply with the appropriate design principles Yes PG-60. 3 , PG- Note AA Note 21

in order to obtain suitable and reliable 61

protection. These principles include, in

particular, fail-safe modes, redundancy,

diversity, and self-diagnosis.

2. 1 1 . 2 Pressure limiting devices

The devices shall be so designed that the pressure Pressure surge is limited to Yes PG-67

will not permanently exceed the maximum 1 0% by in 7. 3 of the PED.

allowable pressure PS ;

however, a short duration pressure surge in

keeping with the specifications laid down in Point

7. 3 is allowable, where appropriate.

2. 1 1 . 3 Temperature monitoring devices

These devices shall have an adequate response Partial PEB -1 6 Note B B Note 22

time on safety grounds, consistent with the

measurement function.

2. 1 2 External fire

Where necessary, pressure equipment shall be so N/A Intended for

designed and, where appropriate, fitted with pressure vessels

suitable accessories, or provision made for their

fitting, to meet damage-limitation requirements in

the event of external fire, having particular regard

to the intended use.

FABRICATION REQUIREMENTS
3 MANUFACTURING

53
PTB -1 1 -201 7: Guide for AS ME B PVC S ection I S tamp Holders

PED REQUIREMENTS RELATED ASME SECTION I REQUIREMENTS

ANNEX I YES, ADDITIONAL


PED ESSENTIAL SAFETY REQUIREMENTS COMMENTS NONE, CODE REF. COMMENTS CONSIDERATION
PAR. (ESR) PARTIAL S FOR PED,
ANNEX 1
3.1 Manufacturing procedures

The manufacturer shall ensure the competent Yes PG-75

execution of the provisions set out at the design through PG-

stage by applying the appropriate techniques and 82

relevant procedures, especially with the view to

the aspects set out below.

3.1 .1 Preparation of the component parts

Preparation of the component parts (e. g. , forming Yes PG-1 1 , PG-

and chamfering) shall not give rise to defects or 75 through

cracks or changes in the mechanical PG-8 2, PW-

characteristics likely to be detrimental to the 29, and PW-

safety of the pressure equipment. 33

3.1 .2 Permanent j oining

Permanent j oints and adj acent zones shall be free Yes PW-29 and

of any surface or internal defects detrimental to PW-3 3

the safety of the equipment.

The properties of permanent j oints shall meet the Yes PW-5 . 4 and Note CC

minimum properties specified for the materials to PW-28

be j oined unless other relevant property values

are specifically taken into account in the design.

For pressure equipment, permanent j oining of PW-28

components which contribute to the pressure

resistance of the equipment and

components which are directly attached to them

shall be carried out by suitably qualified

personnel according to suitable operating

procedures.

54
PTB -1 1 -201 7: Guide for AS ME B PVC S ection I S tamp Holders

PED REQUIREMENTS RELATED ASME SECTION I REQUIREMENTS

ANNEX I YES, ADDITIONAL


PED ESSENTIAL SAFETY REQUIREMENTS COMMENTS NONE, CODE REF. COMMENTS CONSIDERATION
PAR. (ESR) PARTIAL S FOR PED,
ANNEX 1
For pressure equipment in categories II, III, and

IV, operating procedures and personnel shall be

approved by a competent third party which, at the

manufacturer’s discretion, may be:


(a) a notified body, S ee harmonized standard None Note 23

EN IS O 1 5 607 for welding

procedure qualifications

(b) A third party organization recognized None

by a Member S tate as provided in Article 20.

To carry out these approvals the third party shall None Note 24

perform examinations and tests as set out in the

appropriate harmonized standards or

equivalent examinations and tests or Partial PW-28

must have them performed. Partial PW-28

3.1 .3 Non-destructive tests

For pressure equipment, non-destructive tests of Yes PW-5 1 and Note 25

permanent j oints shall be carried out by suitable PW-5 2

qualified personnel.

For pressure equipment in categories III and IV Partial

the personnel shall be approved by a third party

organization recognized by a Member S tate

pursuant to Article 20.

3.1 .4 Heat treatment

Where there is a risk that the manufacturing Yes PW-3 8 and

process will change the material properties to an PW-3 9

extent which would impair the safety of the

pressure equipment, suitable heat treatment shall

be applied at the appropriate stage of

manufacture.

55
PTB -1 1 -201 7: Guide for AS ME B PVC S ection I S tamp Holders

PED REQUIREMENTS RELATED ASME SECTION I REQUIREMENTS

ANNEX I YES, ADDITIONAL


PED ESSENTIAL SAFETY REQUIREMENTS COMMENTS NONE, CODE REF. COMMENTS CONSIDERATION
PAR. (ESR) PARTIAL S FOR PED,
ANNEX 1
3.1 .5 Traceability

S uitable procedures shall be established and Yes PG-77, PG-

maintained for identifying the material making up 90. 1 . 6, PG-

the components of the equipment which 90. 1 . 7, and

contribute to pressure resistance by suitable App. 3 02. 4

means from receipt, through production, up to the

final test of the manufactured pressure

equipment.

INSPECTION REQUIREMENTS

3.2 Final assessment

Pressure equipment shall be subj ected to final Final inspection plus proof

assessment as described below: test

3 . 2. 1 Final inspection

Pressure equipment shall undergo a final Yes PG-90. 1 . 1 3 , Note 26

inspection to assess visually and PG-99. 2

by examination of the accompanying documents Partial PG-90, PG-

compliance with the requirements of the 1 1 21 and

Directive. Tests carried out during manufacture App. A-3 5 0

may be taken into account through A-

357

As far as is necessary on safety grounds, the final Yes PG-90, PG-

inspection shall be carried out internally and 93

externally on every part of the equipment, where

appropriate in the course of manufacture (e. g.

where examination during the final inspection is

no longer possible).

3 . 2. 2 Proof test

56
PTB -1 1 -201 7: Guide for AS ME B PVC S ection I S tamp Holders

PED REQUIREMENTS RELATED ASME SECTION I REQUIREMENTS

ANNEX I YES, ADDITIONAL


PED ESSENTIAL SAFETY REQUIREMENTS COMMENTS NONE, CODE REF. COMMENTS CONSIDERATION
PAR. (ESR) PARTIAL S FOR PED,
ANNEX 1
Final assessment of pressure equipment shall Yes PG-99 Note DD

include a test for the pressure containment aspect,

which will normally take the form hydrostatic

pressure test at a pressure at least equal, where

appropriate, to the value laid down in Point 7. 4.

For category I series produced equipment, this N/A S ect. I has no

test may be performed on a statistical basis. provisions for

series produced

boilers

Where the hydrostatic pressure test is harmful or Yes B 3 1 . 1 S ect. B 3 1 . 1 allows for

impractical, other tests of a recognized value may 1 37 alternatives to

be carried out. For test other than the hydrostatic hydro testing,

pressure test, additional measures, such as non- S ect. I does not.

destructive tests or other methods of equivalent

validity, shall be applied before those tests are

carried out.

3 . 2. 3 Inspection of safety devices Yes PG-90. 1 . 1 4, Note Z

PG-90. 1 . 1 5 ,

For assemblies, the final assessment shall also and PG-

include a check of the safety devices intended to 1 1 2. 2. 8

check full compliance with the requirements

referred to in Point 2. 1 0.

3.3 Marking and labeling

In addition to the CE marking referred to in This can be on

Articles 1 8 & 1 9 and the information to be one or more

provided in accordance with Article 6(6) and nameplates.

Article 8 (3 ) of the PED, the following

information shall be provided:

(a) For all pressure equipment: Yes PG-1 06 Note EE Note 27

1 . the name and address or other means of through PG-

identification of the manufacturer and, where 111

appropriate, of his authorized representative

established within the European Community;

57
PTB -1 1 -201 7: Guide for AS ME B PVC S ection I S tamp Holders

PED REQUIREMENTS RELATED ASME SECTION I REQUIREMENTS

ANNEX I YES, ADDITIONAL


PED ESSENTIAL SAFETY REQUIREMENTS COMMENTS NONE, CODE REF. COMMENTS CONSIDERATION
PAR. (ESR) PARTIAL S FOR PED,
ANNEX 1
2. The year of manufacture, Yes PG-1 06

through PG-

111

3 . Identification of the pressure equipment Yes PG-1 06. 4. 1 S erial number on

according to its nature, such as type, series or stamping plate.

batch identification and serial number,

4. Essential maximum/minimum allowable Yes PG-1 06. 4. 1

limits;

(b) Depending on the type of pressure equipment, None Generally not Note 27

further information necessary for safe required in S ect.

installation, operation or use and, where I.

applicable, maintenance and periodic

inspection, such as:

1 . the volume V of the pressure equipment in

L,

2. the nominal size for piping DN,

3 . the test pressure PT applied in bar and date,

4. safety device set pressure in bar,

5 . output of the pressure equipment in kW,

6. supply voltage in V (volts),

7. intended use,

8 . filling ration kg/L,

9. maximum filling mass in kg,

1 0. tare mass in kg,

11. the fluid group;

(c) where necessary, warnings fixed to the None Not included in Note 28

pressure equipment drawing attention to S ect. I

misuse which experience has shown might requirements.

occur.

58
PTB -1 1 -201 7: Guide for AS ME B PVC S ection I S tamp Holders

PED REQUIREMENTS RELATED ASME SECTION I REQUIREMENTS

ANNEX I YES, ADDITIONAL


PED ESSENTIAL SAFETY REQUIREMENTS COMMENTS NONE, CODE REF. COMMENTS CONSIDERATION
PAR. (ESR) PARTIAL S FOR PED,
ANNEX 1
The information referred to in Points a, b, and c Partial PG-1 06 S ect. I does not Note 29

of Annex I shall be given on the pressure cover CE

equipment or on a data plate firmly attached to it, marking.

with the following exceptions:

1 . where applicable, appropriate documents may Yes PG-1 06. 8 . 2

be used to avoid repetitive marking of and PG-1 09

individual parts such as piping components,

intended for the same assembly. This applies

to CE marking and other marking and labeling

referred to in this Annex;

2. where the pressure equipment is too small, Yes PG-1 06. 8 . 2

e. g. , accessories, the information referred to in

(b) may be given on a label attached to that

pressure equipment;

3 . labeling or other adequate means may be used None Refers to the

for the mass to be filled and the warnings permanence of

referred to in (c), provided it remains legible warnings affixed

for the appropriate period of time. to the boiler

3.4 Operating instructions None Note B Note 3

(a) When pressure equipment is placed on the

market, it shall be accompanied, as far as

relevant, with instructions for the user,

containing all the necessary safety information

relating to:

1 . mounting including assembling of different

pieces of pressure equipment,

2. putting into service,

3 . use,

4. maintenance including checks by the user.

(b) Instructions shall cover information affixed to

the pressure equipment in accordance with

Point 3 . 3 , with the exception of serial

identification, and

59
PTB -1 1 -201 7: Guide for AS ME B PVC S ection I S tamp Holders

PED REQUIREMENTS RELATED ASME SECTION I REQUIREMENTS

ANNEX I YES, ADDITIONAL


PED ESSENTIAL SAFETY REQUIREMENTS COMMENTS NONE, CODE REF. COMMENTS CONSIDERATION
PAR. (ESR) PARTIAL S FOR PED,
ANNEX 1
shall be accompanied, where appropriate,

B y the technical documents,

drawings, and diagrams necessary for a full

understanding of these instructions;

(c) If appropriate, these instructions must also

refer to hazards

arising from misuse in accordance with Point

1 . 3 and particular features of the design in

accordance with Point 2. 2. 3 .

MATERIAL REQUIREMENTS
4. MATERIALS

Materials used for the manufacture of pressure Yes PG-5 , PG-1 2,

equipment must be suitable for such application S ect. II, App. Note 3 0

during the scheduled lifetime unless replacement 6.

is foreseen.

Welding consumables and other j oining materials Yes PW-5 . 4, S ect. Note 3 1

need fulfill only the relevant requirements of II, Part C.

Points 4. 1 and 4. 2(a), and the first paragraph of

Point 4. 3 , in an appropriate way, both

individually and in a j oined structure.

4. 1 Materials for pressurized parts must: Partial

(a) Have appropriate properties for all operating As general rules, with the Partial PG-5 through Note 3 2

conditions which option of providing an PG-1 2, S ect.

are reasonably foreseeable and for all test equivalent overall level of Partial II, Parts A, B ,

conditions, and in particular they should be safety. C, D.

sufficiently ductile

and tough. Partial Note 3 3

Where appropriate, the characteristics of the S ee PED S ect. 7. 5 Partial PG-5 through For S ect. I Note 3 4

materials shall comply with the requirements PG-1 2 applications,

of Point 7. 5 . brittle-type

fracture is not a

60
PTB -1 1 -201 7: Guide for AS ME B PVC S ection I S tamp Holders

PED REQUIREMENTS RELATED ASME SECTION I REQUIREMENTS

ANNEX I YES, ADDITIONAL


PED ESSENTIAL SAFETY REQUIREMENTS COMMENTS NONE, CODE REF. COMMENTS CONSIDERATION
PAR. (ESR) PARTIAL S FOR PED,
ANNEX 1
Moreover, due care should be exercised in Partial S ect. II, Parts significant failure

particular in selecting materials in order to A, B , C, D. mode.

prevent brittle-type fracture where necessary;

where for specific reasons brittle material has Yes PG-8 , PG-1 1

to be used appropriate measures must be

taken;

(b) B e sufficiently chemically resistant to the Partial PG-5 , Note 1 , Note FF Note 3 2

fluid contained in the pressure equipment; PG-6, PG-7,

PG-8 and PG-

the chemical and physical properties necessary Partial S ect. II, Part Note FF

for operational safety shall not be significantly D, App. 5 , 6.

affected within the scheduled lifetime of the

equipment;

(c) Not be significantly affected by aging; Partial S ect. II, Part Note 3 2

D, App. 5 , 6.

(d) B e suitable for the intended processing (Fabrication) Yes PG-6, PG-7,

procedures; PG-8 , PG-9

(e) B e selected in order to avoid significant Yes PW-5 , PW-28

undesirable effects when the various materials and PW-3 9

are put together.

4. 2 The pressure equipment manufacturer shall: Yes S ect. II Part Note 3 2 and 3 4

(a) define in an appropriate manner the values D, App. 1

necessary for the design calculations referred

to in Point 2. 2. 3 and

the essential characteristics of the materials Partial

and

their treatment referred to in Point 4. 1 ; Partial

(b) provide in his technical documentation Note 3 5

elements relating to compliance with the

material specification of the Directive in one

of the following forms:

1 . by using materials which comply with None

harmonized standards

61
PTB -1 1 -201 7: Guide for AS ME B PVC S ection I S tamp Holders

PED REQUIREMENTS RELATED ASME SECTION I REQUIREMENTS

ANNEX I YES, ADDITIONAL


PED ESSENTIAL SAFETY REQUIREMENTS COMMENTS NONE, CODE REF. COMMENTS CONSIDERATION
PAR. (ESR) PARTIAL S FOR PED,
ANNEX 1
2. by using materials covered by a European None

approval of pressure equipment materials in

accordance with Article 1 5 ,

3 . by a PMA, Performed by the NB for None

category III and IV vessels

(c) For pressure equipment in categories III and None Note 3 6

IV, particular appraisal as referred to in the

third indent of (b) shall be performed by the

notified body in charge of the CA procedures

for the pressure equipment.

4. 3 The equipment manufacturer shall take Yes PG-77, App.

appropriate measures to ensure that the material A-3 02. 4

used conforms to the required specification.

In particular, documentation prepared by the Yes PG-77, App.

material manufacturer affirming compliance with A-3 02. 4

the specification shall be obtained for all

materials.

For the main pressure bearing parts of equipment Partial PG-77, App. Note 3 7

in categories II, III, and IV, this shall take the A-3 02. 4

form of certificate of specific product control.

Where a material manufacturer has an appropriate None Note 3 8

quality-assurance system, certified by a

competent body established within the

Community and having undergone a specific

assessment for materials, certificates issued by

the manufacturer are presumed to certify

conformity with relevant requirements of this

section.

SPECIFIC REQUIREMENTS FOR HEATED


PRESSURE VESSELS
S PECIFIC PRES S URE EQUIPMENT

REQUIREMENTS

62
PTB -1 1 -201 7: Guide for AS ME B PVC S ection I S tamp Holders

PED REQUIREMENTS RELATED ASME SECTION I REQUIREMENTS

ANNEX I YES, ADDITIONAL


PED ESSENTIAL SAFETY REQUIREMENTS COMMENTS NONE, CODE REF. COMMENTS CONSIDERATION
PAR. (ESR) PARTIAL S FOR PED,
ANNEX 1
In addition to the applicable requirements of

Points 1 to 4, the following requirements apply to

the pressure equipment covered by Points 5 and

6.

5 FIRED OR OTHERWIS E HEATED PRES S URE Note HH

EQUIPMENT WITH RIS K OF

OVERHEATING AS REFERRED TO IN

ARTICLE 4(1 )

This pressure equipment includes: S cope statement

a) S team and hot water generators as referred to Partial Preamble S ect. I does not

in Article 4(1 )(b), such as fired steam and cover vessels in

hot-water boilers, superheaters and which steam is

reheaters, waste-heat boilers, waste generated for

incineration boilers, electrode or immersion- internal use such

type electrically heated boilers, pressure as pressure

cookers, together with their accessories and cookers.

b) Process heating equipment for other than Partial Preamble Unfired steam

steam and hot water generation falling under boilers can be

Art. 4(1 )(a), such as heaters for chemical and built to either

other similar processes and pressurized food- S ect. I or S ect.

processing equipment. VIII.

This pressure equipment shall be calculated, Yes Part PG

designed, and constructed so as to avoid or to

minimize risks of a significant loss of

containment from overheating.

In particular it must be ensured, where applicable,

that:

(a) appropriate means of protection are provided Yes PG6-60 and

to restrict operating parameters such as heat PG-61

input, heat take-off and, where applicable,

fluid level so as to avoid any risk of local and

general overheating,

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PED REQUIREMENTS RELATED ASME SECTION I REQUIREMENTS

ANNEX I YES, ADDITIONAL


PED ESSENTIAL SAFETY REQUIREMENTS COMMENTS NONE, CODE REF. COMMENTS CONSIDERATION
PAR. (ESR) PARTIAL S FOR PED,
ANNEX 1
(b) sampling points are provided where required Yes PG-5 9. 3 and

to allow evaluation of the properties of the PG-5 9. 4

fluid so as to avoid risks related to deposits

and/or corrosion.

(c) adequate provisions are made to eliminate Yes PG-5 9. 3

risks of damage from deposits,

(d) safe removal of residual heat after shutdown None Normally provided

are provided, for by boiler

designers

(e) steps are taken to avoid a dangerous None Normally provided

accumulation of ignitable mixtures and for by boiler

combustible substances and air, or flame designers

flowback.

6. PIPING AS REFERRED TO IN ARTICLES Internal and external piping Note II Note 3 9

4. 1 (c) of the PED comprising the complete

boiler system

Design and construction must ensure: Yes PG-27. 2. 2,

PG-5 8

(a) that the risk of overstressing from Yes PG-5 9. 1 . 2;

inadmissible free movement or excessive B 3 1 . 1 § 1 1 9,

forces being produced, e. g. , on flanges, 1 20, 1 21 and

connections, bellows, or hoses, is adequately 1 22. 1 . 1

controlled by means such as support,

constraint, anchoring, alignment, and pre-

tension;

(b) that where there is a possibility of Yes PG-5 8 . 3 . 7

condensation occurring inside pipes for and PG-5 9. 4;

gaseous fluids, means are provided for B31 .1

drainage and removal of deposits from low § ’ s 1 01 . 5. 1


areas to avoid damage from water hammer or and 1 22. 1 . 5

corrosion.

(c) that due consideration is given to the potential Yes PG-5 9. 2;

damage from turbulence and formation of B 3 1 . 1 § 1 02. 4

vortices; the relevant parts of 2. 7 are

applicable;

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PTB -1 1 -201 7: Guide for AS ME B PVC S ection I S tamp Holders

PED REQUIREMENTS RELATED ASME SECTION I REQUIREMENTS

ANNEX I YES, ADDITIONAL


PED ESSENTIAL SAFETY REQUIREMENTS COMMENTS NONE, CODE REF. COMMENTS CONSIDERATION
PAR. (ESR) PARTIAL S FOR PED,
ANNEX 1
(d) that due consideration is given to the risk of Yes PG-5 9. 1 . 2; Note 40

fatigue due to vibrations in pipes; B31 .1

§ 1 01 . 5 . 4 and

App. D

(e) that, where fluids of Group 1 are contained in N/A

the piping, appropriate means are provided to

isolate “take - off” pipes the size of which

represents a significant risk;

(f) that the risk of inadvertent discharge is N/A

minimized; the take-off points must be clearly

marked on the permanent side, indicating the

fluid contained;

(g) that the position and route of underground None Note 41

piping is at least recorded in the technical

documentation to facilitate safe maintenance,

inspection, or repair.

QUANTITATIVE REQUIREMENTS
7. S PECIFIC QUANTITATIVE REQUIREMENTS

FOR CERTAIN PRES S URE EQUIPMENT

The following provisions apply as a general rule. Manufacturer can depart Note 42

However, where they are not applied, including from these quantitative

in cases where materials are not specifically requirements, but it will

referred to and no harmonized standards are have to prove to the NB that

applied, the manufacturer must demonstrate that an equivalent level of safety

appropriate measures have been taken to achieve is achieved.

an equivalent overall level of safety.

This section is an integral part of Annex I. The

provisions laid down in this section supplement

the essential requirements of S ect. 1 to 6 for the

pressure equipment to which they apply.

7. 1 Allowable stresses Note 43

7. 1 . 1 S ymbols

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PED REQUIREMENTS RELATED ASME SECTION I REQUIREMENTS

ANNEX I YES, ADDITIONAL


PED ESSENTIAL SAFETY REQUIREMENTS COMMENTS NONE, CODE REF. COMMENTS CONSIDERATION
PAR. (ESR) PARTIAL S FOR PED,
ANNEX 1
Re /t, yield limit, indicates the value at the These quantitative

calculation temperature of: requirements have been

reincorporated in the

a) upper flow limit for a material presenting previous sections.

upper and lower flow limits,

b) the 1 . 0% proof strength of austenitic steel and

non-alloyed aluminum

c) the 0. 2% proof strength in other cases.

Rm /20 indicates the minimum value of the ultimate

strength at 20  C

Rm /t designates the ultimate strength at the

calculation temperature.

7. 1 . 2 The permissible general membrane stress for Included in Fig. 1 2-2: Q1 of Yes S ect. II, Part Note GG Note 44

predominantly static loads and for temperatures this Guide D, Table 1 A

outside the range in which creep is significant and App. 1 .

must not exceed the smaller of the following

values, according to the material used:

a) in the case of ferritic steel including

normalized (normalized rolled) steel and

excluding fine grain steel and specially heat-

treated steel, 2/3 of Re /t and 5 /1 2 of Rm /20 ;

b) in the case of austenitic steel:

1. if its elongation after rupture Note 45

exceeds 3 0%, 2/3 of Re /t

2. or, alternatively, and if its

elongation after rupture exceeds

3 5 %, 5 /6 of R e/t, and 1 /3 of Rm /20;

c) in the case of non-alloy or low alloy cast steel,

1 0/1 9 of Re /t and 1 /3 of Rm /20 ;

d) in the case of aluminum, 2/3 of Re /t;

e) in the case of aluminum alloys, excluding

precipitation hardening alloys, 2/3 of R e /t and

5 /1 2 of Rm /20 .

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PED REQUIREMENTS RELATED ASME SECTION I REQUIREMENTS

ANNEX I YES, ADDITIONAL


PED ESSENTIAL SAFETY REQUIREMENTS COMMENTS NONE, CODE REF. COMMENTS CONSIDERATION
PAR. (ESR) PARTIAL S FOR PED,
ANNEX 1
7. 2 Joint coefficients To be applied as a general Yes PG-27. 4,

rule. Demonstration of an Note 1 , PW-

equivalent overall level of 1 1 and PW-

safety required by Annex I, 41

§ 2. 2. 3 (b).

For welded j oints, the j oint coefficient must not Also included in Fig. 1 2-3 :

exceed the following values: Q2 of this Guide

a) for equipment subj ect to destructive and

nondestructive tests which confirm that the

whole series of j oints show no significant

defects: 1 ,

b) for equipment subj ect to random NDT: 0. 8 5 ,

c) for equipment not subj ect to NDT other than

visual inspection: 0. 7.

If necessary, the type of stress and the mechanical Yes PG-3 9. 6,

and technological properties of the j oint must also PFT-1 2. 2,

be taken into account. and PWT-1 1

7. 3 Pressure limiting devices, particularly for

pressure vessels

The momentary pressure surge referred to in Yes PG-67. 2 PG-67. 2 limits

2. 1 1 . 2 must be kept to 1 0% of the maximum this to 6%.

allowable pressure.

7. 4 Hydrostatic test pressure

For pressure vessels, the hydrostatic test pressure Included in Fig. 1 2-4: Q3 of

referred to in 3 . 2. 2 must be no less than: this Guide.

a) that corresponding to the maximum loading to S ee 7. 2. 1 . 3 . 3 of this Guide. Yes PG-99

which the pressure equipment may be

subj ect in service, taking into account its

maximum allowable pressure and its

maximum allowable temperature, multiplied

by the coefficient 1 . 25, or

b) the maximum allowable pressure multiplied Yes Note DD

by the coefficient 1 . 43 , whichever is the

greater.

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PED REQUIREMENTS RELATED ASME SECTION I REQUIREMENTS

ANNEX I YES, ADDITIONAL


PED ESSENTIAL SAFETY REQUIREMENTS COMMENTS NONE, CODE REF. COMMENTS CONSIDERATION
PAR. (ESR) PARTIAL S FOR PED,
ANNEX 1
7. 5 Material characteristics

Unless other values are required in accordance Yes Note 3 4

with other criteria that must be taken into

account, a steel is considered as sufficiently

ductile to satisfy 4. 1 (a) if, in a tensile test carried

out by a standard procedure, its elongation after

rupture is no less than 1 4% and

its bending rupture energy measured on an IS O V Partial 27 J is not Note 3 3

test-piece is no less than 27 J, at a temperature no specified in

greater than 20  C but not higher than the lowest AS ME S ection I.

scheduled operating temperature

Note: Any reference to the Code in this table or its notes means AS ME B oiler and Pressure Vessel Code, S ection I.

N/A = not applicable.

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Notes in Fig. 1 2-1 of this Guide on ASME Section I Requirements


A. AS ME B PVC S ection I (the Code [3 ] ) is based on “design by rule.” It requires the use of the design

rules provided in the Code. Other methods may be used only if no rules are provided in the Code.

B. AS ME B PVC S ection I does not require manufacturers to issue operating instructions or warnings

regarding potential hazards or misuse of pressure equipment. The PED requires the manufacturers to

provide such instructions; see Notes 3 and 4.

C. AS ME B PVC S ection I includes requirements for new construction and therefore only includes

considerations for in-service degradation that can be anticipated by the designer. The user is generally

responsible for operating the equipment within the limits of those considerations, which, although not

a requirement of AS ME B PVC S ection I, are commonly provided to the user by the boiler

manufacturer.

D. S afety factors are built into the AS ME B PVC S ection I allowable design stresses, ligament efficiencies,

j oint efficiencies/NDE requirements, etc. The Code does not include margins for in-service

degradation.

E. AS ME B PVC S ection I does not specifically address decomposition of unstable fluids.

F. AS ME B PVC S ection I recognizes the need for fatigue analysis in cyclic service, but does not have

rules on how to perform fatigue analysis. AS ME B PVC S ection I does require consideration of cyclic

and dynamic loading in design of pressure equipment, if appropriate (PG-22). In base load cases, such

loadings do not exceed the limits given in PG-22 and are not a significant failure mode in power boilers

covered by AS ME B PVC S ection I. For two shift or load following operation, then detailed fatigue

analysis of critical components may be necessary. In these cases, established documented methods

should be used to determine fatigue degradation.

G. AS ME B PVC S ection I does not have a direct limit on plastic strain, but other limits indirectly control

this, such as those defining establishment of allowable stresses in the creep range.

H. AS ME B PVC S ection I requirements take into account experience demonstrating that welded j oints

exempted from NDE by AS ME B PVC S ection I have given safe and reliable service. (PW-1 1 . 1 ). Note

that the j oint factor applied by AS ME B PVC S ection I does not apply to tube welds, where no

volumetric NDE is required by AS ME B PVC S ection I. B ecause the practice in Europe is to perform

1 0% RT on tube welds, some notified bodies may require some percentage of NDE to be performed.

I. Corrosion must be taken into account in AS ME B PVC S ection I by the Code design requirements for

a particular boiler or component (PG-27, 4. 3 ). Creep is taken into account by the Code design basis

for establishing the allowable stresses in the creep range. The Code design in the creep range is based

on average stress to cause rupture in 1 00, 000 hours. That number is intended as a base criterion for

design, and does not imply that the equipment is only intended for use up to 1 0 0, 000 hours, because

AS ME B PVC Section I’ s use of conservative design margins provides for a much longer service life.
This is demonstrated by the successful service history of AS ME B PVC S ection I equipment. Design

hours of operation at specified temperat ures should be based on the manufacturer’ s experience and
calculations.

J. AS ME B PVC S ection I does not require design for specific hours in the creep range, nor specific

number of cycles at specified stress levels. PG-22, requires consideration of cyclic loads in the design

but, because of their low impact on boiler failure modes, only when their magnitude exceeds 1 0% of

the allowable working stress on the component.

K. AS ME B PVC S ection I does not require the design corrosion allowance to be shown on the Data Report

for in-service use. To comply with Annex I, § 2. 6, this information must be provided to the end user in

the operating instructions.

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PTB -1 1 -201 7: Guide for AS ME B PVC S ection I S tamp Holders

L. AS ME B PVC S ection I does not address design for transport or handling loads. However, provisions

are given in PG-5 5 for attachment of supports and attachment lugs to the pressure-retaining boundary.

M. PG-90. 1 . 5 of AS ME B PVC S ection I requires witnessing the tests and approval of the test results by

the AI, but not necessarily acceptance of the test program by the AI prior to testing. All of these

functions would be the responsibility of the NB .

N. AS ME B PVC S ection I Appendix A-22 is written to consider leakage to be failure by rupture. The

threshold for sufficient leaks in the context of the PED is therefore zero.

O. In the context of AS ME B PVC S ection I Appendix A-22, deterioration is defined as excessive strain.

The thresholds for such are defined in Appendix 22.

P. These requirements are included in AS ME B PVC S ection I Appendix A-22. Appendix 22 is

conservative in that the proof test pressures are based on test temperature rather than design

temperature, requiring the application of a higher level of stress.

Q. AS ME B PVC S ection I provides partial coverage of the items listed in Annex I, § 2. 3 . S ee Note 1 3 .

R. AS ME B PVC S ection I only addresses this aspect for firing doors in water tube boilers (PWT-1 4). The

requirements for access doors to be fitted with devices “to ascertain that the opening will not present a
hazard” or to prevent from opening quick opening closures when the pressure or temperature of the
fluid may present a hazard is something that boiler manufacturers already prov ide for. The PED

requires that this practice be documented.

S. AS ME B PVC S ection I provides for inspection openings large enough for physical access to the interior

of the boiler, as well as for handholes when such access is not practical.

T. AS ME B PVC S ection I and B 3 1 . 1 [6] address drains and venting of all boiler and piping components.

U. Water hammer and piping system reactions such as thermal expansion and contraction are addressed in

AS ME B PVC S ection I and B 3 1 . 1 . Uncontrolled chemical reactions are partially addressed in AS ME

B PVC S ection I.

V. AS ME B PVC S ection I does not specifically address vacuum vents as vacuum conditions do not

normally exist in boilers.

W. Erosion is addressed in B 3 1 . 1 , S ect. 1 04.

X. AS ME B PVC S ection I is a system code, so it does address assemblies in its inherent requirements for

various boiler components and how they are connected.

Y. This requirement is primarily aimed at pressure vessels and how they are filled and emptied. AS ME

B PVC Section I does not require accessories “to assure safe filling and discharge” with respect to the
hazards listed in Annex I, § 2. 9, and for the most part, these requirements do not apply to boilers.

Z. AS ME B PVC S ection I has specific requirements for monitoring devices, such as gage glasses, water

level indicators, and low water cutoffs referred to in Annex I § 2. 1 0(b). PG-90. 1 . 1 5 requires the AI to

verify that all required safety accessories are installed in compliance with the requirements of AS ME

B PVC S ection I. Each boiler constructed to AS ME B PVC S ection I must be provided with a copy of

Data Report Form P-7 which records all required safety valves, or for boilers provided with a single

safety valve, this must be documented in the remarks section of Data Report Forms P-2 or P- 3 . S ee

PG-1 1 2. 2. 8 .

AA. Fail-safe modes, redundancy, diversity, and self-diagnosis are addressed in AS ME B PVC S ection

I. S ee Note 21 .

BB. The response time of temperature monitory devices is not specifically addressed in AS ME B PVC

S ection I.

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PTB -1 1 -201 7: Guide for AS ME B PVC S ection I S tamp Holders

CC. AS ME B PVC S ection I requires the minimum tensile properties of the weld metal to meet the

specified minimum tensile properties of the base metal. S ee AS ME B PVC S ection II, Part D, Table

1 A[4] .

DD. AS ME B PVC S ection I, PG-99 requires a hydrotest pressure of 1 . 5 times Maximum Allowable

Working Pressure (MAWP), which exceeds the value given in Annex I, § 7. 4. PG-99. S ection I

also limits the amount of stress on any component in the boiler system.

EE. The AS ME B PVC S ection I requirements for marking of boilers, components , and safety valves

are included in PG-1 06 through PG-1 1 1 . The requirements for Data Reports are included PG-1 1 2,

PG-1 1 3 , and in Appendices A-3 5 0 through A-3 5 7. The name and address of the vessel

manufacturer shall be listed in the Data Reports.

FF. Chemical and physical properties for operational safety are implied in AS ME B PVC S ection I.

S pecific guidance is given in PG-5 .

GG. AS ME B PVC S ection I permits the use of higher design stresses when components are contained

within the boiler setting.

HH. The scope of AS ME B PVC S ection I includes most of the equipment listed, except pressure cookers

where steam is generated for use internal to itself, and some process heating equipment, which may

be built to either AS ME B PVC S ection I or S ection VIII, Division 1 .

II. The PED Annex I, § 6 addresses all types of piping. S ome requirements are not applicable to what

AS ME B PVC S ection I refers to as boiler proper piping. For AS ME B PVC S ection I boilers, the

requirements of AS ME B 3 1 . 1 must also be used for external piping, and the appropriate paragraph

references in B 3 1 . 1 are shown in the Code Reference column of section 1 2 of this Guide.

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PTB -1 1 -201 7: Guide for AS ME B PVC S ection I S tamp Holders

Additional Notes in Fig. 1 2-1 of this Guide on Considerations for Annex I ESR:
GENERAL

Many of the recommendations contained in the following notes address requirements of the PED that are

not specifically covered in AS ME S ection I [3 ] . For the maj ority of these situations, the manufacturer

would be performing these activities in the normal course of equipment design. Included in the guidance

given in the following notes is information on which of those common activities need to be documented for

PED compliance.

1. The manufacturer must perform a hazard analysis in accordance with Article 6, Annex I, Preliminary
Observations 3, and Annex II of the PED [1 ] . Manufacturers of power boilers have always taken the

hazards due to pressure into consideration, but demonstration of compliance with a standard such as

AS ME S ection I has, in the past, been sufficient to demonstrate consideration of such hazards. The

PED requires documentation that all hazards described in Annex II of the PED have been addressed,

regardless of the standard used for design and construction. Typical hazards for pressure containment

that may have to be considered are:

(a) B rittle fracture,

(b) S tress corrosion cracking,

(c) Creep,

(d) Damage during transport or installation,

(e) Rapid release of high pressure fluid,

(f) S pecial operational hazards.

It should be noted that it is a hazard assessment that is specified not a Hazard and Operability (HAZOP),

which is generally associated with a Piping and Instrumentation Diagram (P&ID).

2. The manufacturer is required to design and construct the pressure equipment to comply with all the

ES R in Annex I. Annex I of the PED does not assign any responsibil ity to “User.” That makes it the

duty of the manufacturer to achieve safety and comply with the ES Rs, or, document that the purchaser

has stipulated certain design considerations or fabrication requirements. For a boiler plant, the

manufacturer is normally the designer and therefore is responsible for all aspects of complying with the

PED. In cases where the design is performed by a separate organization or the utility is carrying out a

maj or modification to existing equipment using a supplier who was no t the original equipment

manufacturer, there is an onus on the utility to ensure that the manufacturer of equipment is given

sufficient information on the operation of the plant to carry out a hazard analysis.

3. The manufacturer shall prepare, as far as relevant, instructions for the User, containing the necessary

safety information listed in PED, Annex I, § 3 . 4. The instructions shall include the following:

(a) Marking and labeling as required by § 3 . 3 of Annex I of the PED,

(b) Installation instructions, including assembling different pieces of pressure equipment,

(c) Putting into service,

(d) Use,

(e) Maintenance, including checks by the User,

(f) Drawings necessary for full understanding of the information, if applicable,

(g) Design information for in-service verification, modification, or repairs,

(h) Warnings to prevent the danger of misuse of the equipment,

(i) Declaration of Conformity.

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PTB -1 1 -201 7: Guide for AS ME B PVC S ection I S tamp Holders

Most manufacturers of pressure equipment provide their customers with some degree of instructions

and service information. On boilers the operation and maintenance manuals normally cover this. The

PED requires that this practice be documented in the language of the country to which the product is

destined, or that which is specified by the purchaser, and that it includes all of the aspects contained in

Annex I , § 3 . 4.

4. The manufacturer must also consider the following specific aspects (not specifically addressed in

AS ME S ection I):

(a) Inform users of residual hazards,

(b) Prevent dangers from foreseeable misuse,

(c) Take into account foreseeable degradation mechanisms,

(d) Ensure safety throughout the intended life of the pressure equipment.

A checklist on the hazard assessment is beneficial. It should be noted that this is not a full hazard

analysis that includes the likelihood and consequences of failure. Again, most manufacturers who

construct to AS ME B PVC S ection I provide their customers with this type of information. The PED

requires that this practice be documented in the language of the country to which the product is destined,

or that which is specified by the purchaser.

5. The manufacturer must:

(a) Eliminate or reduce hazards as far as it is reasonably possible,

(b) Apply appropriate protection measures against hazards that cannot be eliminated,

(c) Where appropriate, inform users of any residual hazards and any additional meas ures to be taken

to reduce risks during installation and/or use.

Consultation with the NB , considering the provisions of AS ME S ection I and its long -standing history

of providing for safe operation throughout the boiler’ s intended life, will provide for th e first two

aspects. The third aspect is not covered by AS ME S ection I, but is something that manufacturers may

already be providing to their customers and which will become routine whenever their product is

destined for Europe.

6. The manufacturer must provide the necessary safeguards (e. g. , temperature measuring devices, water

level gages and other sensors, etc. ) where there is potential for misuse or improper use of the pressure

equipment. AS ME S ection I contains requirements for many such safeguards, but the manufacturer

may have to supply additional information, such as wall clearances to allow access, that are not covered

by AS ME B PVC S ection I. The potential for rapid startup and shutdown rates may have to be

considered as being reasonably foreseeable.

7. Annex I of the PED requires consideration of decomposition of unstable fluids in the design. This

could affect manufacturers of organic vapor generators under Part PVG of AS ME B PVC S ection I.

AS ME B PVC S ection I provides some guidance on handling these fluids, but the manufacturer may

have to document any additional considerations made.

8. AS ME B PVC S ection I Appendix A-22 provides for establishment of MAWP by proof testing. In

order to verify a design under the PED using an experimental design method, Annex I, § 2. 2. 4, may

require additional test for fatigue, creep, corrosion rates, and impose additional limitations consistent

with those in the PED (e. g. , hold time at temperature, number of fatigue cycles at a given stress level,

corrosion rates, etc. ).

9. Manufacturers using AS ME B PVC S ection I can generally demonstrate that plastic strain is not a

consideration beyond that which is limited in the criteria for establishing allowable stresses in the creep

range.

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PTB -1 1 -201 7: Guide for AS ME B PVC S ection I S tamp Holders

1 0. Any limitations on design life from operation at the design temperature in creep range, fatigue cycles,

and corrosion allowance must be specified in operating instructions.

1 1 . The design calculations must take into account supporting structures, including during transport and

handling, as appropriate. These must be documented, as appropriate. PG-5 5 addresses attachment of

lugs and supports, and this can be referenced in such documentation.

1 2. The manufacturer must obtain approval from the notified body (NB ) responsible for the CA module, if

one exists, for the experimental test program. AS ME B PVC S ection I (Appendix A-22) gives guidance

on a comprehensive test program, including witnessing of tests by the AI (PG-90. 1 . 5 ). The difference

for PED compliance would be the presence of the NB in place of the AI.

1 3 . The experimental method must take into account leakage and deterioration of pressure equipment (e. g.

corrosion) . The manufacturer must consider the following aspects to ensure safe handling and preclude

risk operation from:

(a) closures and openings,

(b) discharge of pressure relief blowoff,

(c) access while pressure or vacuum exists in the pressure equipment,

(d) surface temperature, taking into account the intended use of the equipment,

(e) decomposition of unstable fluids.

Most of these items are directed toward pressure vessels in various applications. AS ME B PVC S ection

I contains design requirements for inspection openings, but not their operation, except for firing doors

in watertube boilers, whose operation is covered in PWT-1 4. B 3 1 . 1 Appendix I addresses design of

safety valve discharge piping, and although Part PVG of AS ME B PVC S ection I addresses boilers

using organic fluids as a working medium, it does not address the decomposition of the fluid in the

boiler. For PED compliance, the manufacturer can demonstrate that some of the above pose no hazard

due to pressure, while others can be addressed in the operation manual or with signage on the boiler

itself.

1 4. B oilers fitted with access doors must be equipped with automatic or manual devices enabling the user

“to ascertain that the opening will not present any hazards.”
1 5 . Provisions for safe condition inside the boiler, where applicable, must be included in operating

instructions.

1 6. The boiler manufacturer must provide adequate means for venting and draining (including vacuum

vents), as required by PED, Annex 1 , § 2. 5 for all stages of operation and testing to avoid harmful

effects, such as water hammer, corrosion, uncontrolled chemical reaction, etc. Any drains, vents, or

blowoff connections provided in addition to that required by AS ME B PVC S ection I and B 3 1 . 1 should

be documented.

1 7. AS ME B PVC S ection I provides for consideration of other forms of chemical attack besides corrosion,

such as stress induced cracking in the presence of chlorides, as required by PED Annex I, § 2. 6. The

manufacturer needs to allow for and/or protect against any other types of chemical attack.

1 8 . Erosion must be considered in the design, where appropriate, to meet the requirements of PED, Annex

I, § 2. 7. Design of boiler piping systems generally takes this into account, although it is not specifically

addressed in AS ME B PVC S ection I.

1 9. AS ME B PVC S ection I is essentially a system code taking into account the assembly of various types

of equipment and piping into a completed boiler unit. The manufacturer must make certain that all

assemblies comply with the requirements of Annex I, § 2. 8 . (The PED defines assemblies as several

pieces of pressure equipment assembled by the manufacturer to constitute an integral and functional

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PTB -1 1 -201 7: Guide for AS ME B PVC S ection I S tamp Holders

whole. ) The rules of AS ME B PVC S ection I taken as a whole fulfill these requirements and the

manufacturer will benefit from working with a NB that is experienced in the application of AS ME

B PVC S ection I to demonstrate compliance.

20. The manufacturer may need to consult with its NB to demonstrate that the indicators, cutoffs, and

alarms required by AS ME B PVC S ection I meet the requirements of PED, Annex I, § 2. 1 0.

21 . The design of safety accessories shall comply with the requirements of PED, Annex I, § 2. 1 1 , including

fail-safe modes, redundancies, diversity, and self-diagnosis. AS ME B PVC S ection I accomplishes this

in several ways such as gage glass connections, backup feed pumps, duplicate water level indicators,

and consideration that components such as tubing within the boiler setting will not pose a hazard due

to pressure should they fail. Consultation with an NB familiar with the application of AS ME B PVC

S ection I will confirm that the intent of this requirement has been met.

22. Temperature monitoring devices must have adequate response time, consistent with the measurement

function. AS ME B PVC S ection I only requires temperature controls for electric boilers in Part PEB .

Manufacturers who use temperature controls consider the device’s performance characte ristics when

choosing the appropriate device. When they are used, the requirement of PED Annex I, § 2. 1 1 . 3 applies

and must be documented based on the control manufacturer’s specifications.


23 . S ee PED Article 24 for requirements related to notified bodies and Article 1 3 for RTPOs.

24. For pressure equipment in Categories II, III, and IV, welders and welding operators shall meet the

requirements of EN IS O 9606 and qualification of welding procedures the requirements of EN IS O

1 5 607 (European Harmonized S tandards). The welder, welding operator, and welding procedure

qualification shall be approved by a Notified B ody or by an approved third party organization. To carry

out these approvals, the third party shall perform (or have performed) examinations and test as s et out

in the approved European Harmonized S tandards or equivalent examinations and tests. Consultation

with a NB familiar with the application of AS ME B PVC S ection I is necessary in this case. S ee also

Guidelines 6/1 , 6/6, and 6/1 2. This also applies to ongoing certification of welders.

NOTE: For welders, the IS O 9606 qualification for butt welds does not cover fillet welding without

an additional test piece.

25 . For pressure equipment in Categories III and IV, the NDE personnel shall be approved by an approved

third party organization recognized by a member state in the European Community. (S ee PED, Article

24 for RTPOs. ) Manufacturers that utilize the AS NT Central Certification Program (ACCP) to meet

their AS ME S ection I NDE personnel qualification requirements may be able to benefit from an

arrangement between American S ociety for Nondestructive Testing (AS NT) and RW-TUV to

recognize each other’s testing programs.


NOTE: The PED does not provide any specific requirements for qualification of NDE personnel;

therefore, the qualification in accordance with Recommended Practice No. S NT-TC-1 A should be

acceptable for radiographic examination of Category I and II pressure equipment and for Categories III

and IV if issued by an RTPO.

26. The manufacturer must provide the additional documentation to demonstrate compliance with the PED.

The following list should be reviewed to determine what information is covered by the manufacturer’s
ASME Quality Control (QC) manual and the AI’s duties for inspection in PG-90. Any information not
fully covered needs to be documented for PED compliance.

(a) Qualifications of NDT personnel

(b) Qualifications of welders and welding operators

(c) Welding procedure qualifications

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PTB -1 1 -201 7: Guide for AS ME B PVC S ection I S tamp Holders

(d) Heat treat procedures and data

(e) Material approvals, certifications. and inspection documents for base metal and welding

consumables

(f) Procedures for ensuring material traceability

(g) NDT reports, including radiographic films

(h) Test reports of mechanical tests (e. g. , on test coupons)

(i) Reports on defects and deviations during manufacture

(j) Forming and other manufacturing procedures

(k) Other technical documentation in accordance with the applicable CA Module

27. In addition to the CE marking, the vessel manufacturer must provide the additional information

provided in PED, Annex I, § 3 . 3 (a) and § 3 . 3 (b), as applicable. The name and address of manufacturer’s
representative in the European Community is not covered by AS ME S ect. I, and if the information for

the manufacturer is insufficient, the information for the representative must be supplied for PED

compliance. The information required by Annex I, § 3 . 3 (b) generally does not apply to boilers, or is

covered by marking and Data Report requirements of AS ME B PVC S ection I. If a boiler has an “S”
stamp nameplate, a separate nameplate will be necessary to supply the extra information required by

the PED.

28 . B ased on the type of boiler and intended service, and only where necessary, the PED requires that

warning labels be attached to the boiler giving warnings about its potential misuse, based on past

experience. (Examples of such misuse could be bypassing safety devices, lack of maintenance of water

level indicators, etc. )

29. The manufacturer needs to provide the necessary CE marking and labels (where applicable) in

accordance with the requirements in PED, Annex I, § 3 . 3 .

3 0. The PED requires the manufacturer to select material, which is suitable for the scheduled lifetime of

the vessel, therefore specific consideration must be given to various degradation mechanisms, such as

creep, fatigue, embrittlement, etc. , some of which are not addressed in AS ME S ection I. S ee Annex I,

§’ s 3.1 .4, 4.1 , 4.2, 4.3, 7.1 , and 7.5 for additional requirements. B oiler manufacturers choose their

materials for construction based on these considerations, even though they are not specifically stated in

AS ME B PVC S ection I. This practice may need to be documented for PED compliance, or consultation

with a NB familiar with the application of AS ME B PVC S ection I may suffice.

3 1 . The properties of permanent welded j oints (weld metal and heat affected zones) must meet the required

minimum properties for the materials (including elongation and impact test requirements) to be j oined

unless other relevant property values are specifically taken into account in the design. The general

principles in AS ME B PVC S ection I regarding selection of materials, P- numbers, and welding

procedure qualifications all contribute to meeting these requirements. This is another case where

consultation with an NB that is familiar with the application of AS ME B PVC S ection I will contribute

to determination of having achieved an overall equivalent level of safety.

3 2. Although it is implied by the considerations in AS ME B PVC S ection I when taken as a whole, some

of the materials requirements in § 4. 1 of Annex I are not specifically addressed in the Code, such as

aging and the materials being sufficiently resistant of fluids contained in the boiler. The PED requires

the manufacturer to be responsible for material selec tion for the intended service that meet the

requirements of Annex I, § 4. 1 (a) through § 4. 1 (e). B oiler manufacturers choose their materials for

construction based on these considerations, even though they are not spelled out in AS ME B PVC

S ection I. This practice may need to be documented for PED compliance.

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3 3 . Annex I, § 7. 5 requires materials to have minimum average impact test value of 27 J (20 ft-lb) at 20  C

(68  F) but no higher than the lowest scheduled operating temperature. For AS ME B PVC S ection I

boilers, the operating range is not near the transition temperature. Note: The previous EC’s Working

Group “Pressure” (WGP) Guideline 7/1 7 states that specified impact properties are not required for


steel grades: When selecting ductile materials that are not subj ect to ductile/brittle transition at the

foreseeable conditions the equipment will be exposed to . ” The Guideline also states ,“ Where the

application of these rules indicate that the material will not behave in a brittle manner and all aspects

of the chosen design code have been followed, sufficient confidence is gained in the behavior of the

material not to require specific impact properties. When these codes are applied, also other items need

to be taken into account. ” The Guideline 7/1 7 then goes on to list additional considerations, such as

full range of the chemical analysis, the extreme mechanical properties, etc.

3 4. Materials will only be approved if they have the following properties, or if an equivalent level of safety

can be demonstrated:

It may be necessary to demonstrate that the hydrotest temperature is above the brittle transition

temperature to support decisions described in this note.

(a) Have appropriate properties for all foreseeable operating and test conditions

(b) Are sufficiently ductile (1 4% minimum elongation for steel)

(c) Are sufficiently tough (27 J minimum average for steel) at 20  C (68  F), or at the lowest operating

temperature.

In the case of AS ME B PVC S ection I, its long history of boilers with safe service life can be

demonstrated through consultation with an NB that is familiar with the application of AS ME B PVC

S ection I.

3 5 . Materials must conform to one of the following:

(a) Materials that are specified in a European harmonized product standard.

(b) Pressure equipment materials that are covered by an EAM.

(c) Materials that are issued with a PMA, for equipment in Category III and IV.

NOTE: In 2001 , the European Commission determined that on the basis of Article 1 1 of Directive

97/23 /EC (now 201 4/68 /EU), § 5 , no EAMs would be issued covering materials for which there exists

(or is under development) a harmonized European material specification. ASME’s attempts to process
EAMs for S A materials were all rej ected on this basis. Therefore, the only way to use AS ME S A

materials in AS ME B PVC S ection I boiler construction intended for CE marking is to perform PMAs

for each material. Notified bodies are issuing PMAs to manufacturers of AS ME equipment based on

their long history of safe service when used in compliance with the appropriate AS ME B PVC section.

Repeated use of the same material grade in subsequent j obs can be achieved with PMAs based on

previous approvals, easing the process.

3 6. If the boiler is classified in Category III or Category IV, the PMA of the material must be approved by

the NB in charge of the CA procedure for that boiler.

3 7. The manufacturer must ensure that the material conforms to one of the appropriate specifications and

is supported by appropriate certification:

(a) For main pressure parts in Categories II, III, and IV the test certificates shall be in accordance with

EN 1 0204, Types 3 . 1 or 3 . 2. Type 3 . 2 certificate is alternative if the materials manufacturer does

not have an appropriate quality system. (NOTE: Certificates of Compliance required by AS ME

material specifications may not be completely acceptable and may need to be augmented. )

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PTB -1 1 -201 7: Guide for AS ME B PVC S ection I S tamp Holders

(b) Certificates of Type 2. 2 are acceptable for Category I equipment.

(c) Certificates of Type 2. 2 are acceptable for welding consumables for pressure equipment in all

categories.

(NOTE: S ee S ection 8 . 5 of this Guide for the types of EN 1 0204 material certificates required for

material used in boilers, depending on hazard category. )

3 8 . If the material manufacturer holds accredited certification from a certification body established within

the European community, a material certificate of the EN 1 0204, 3 . 1 is acceptable. Where the material

manufacturer does not hold such a certification, the boiler manufacturer is responsible for determining

the certification requirements.

NOTE: IS O is not referenced in the PED; it j ust states " competent body, " therefore IS O or another

quality system is acceptable. The Materials Manufacturer must have undergone a specific assessment

for materials, not j ust systems.

3 9. AS ME B PVC S ection I contains requirements for piping within the b oiler proper as defined in Fig. PG-

5 8 . 3 . 1 and Fig. PG-5 8 . 3 . 2. Those figures also define the limits of B oiler External Piping, the design

and construction rules for which are contained in AS ME B 3 1 . 1 , Power Piping. PED compliance for

the completed boiler will be demonstrated by using the combination of AS ME S ection I and AS ME

B 3 1 . 1 to meet the ES Rs for piping.

40. Note 3 to AS ME B 3 1 . 1 § 1 1 9. 7 describes how fatigue is considered in the stress intensification factors

of Appendix D. Manufacturers may have to describe this in the context of a proven history of safe

operation of B 3 1 . 1 piping systems to demonstrate compliance with this requirement.

41 . Neither AS ME B PVC S ection I nor B 3 1 . 1 contain requirements for mapping of underground piping.

S uch documentation would have to be furnished and can easily be derived from plans and blueprints

for the buried piping system.

42. The specified quantitative requirements apply as a general rule. Other values may be used, but the

manufacturer must be able to demonstrate to the NB that the appropriate measures have been taken to

demonstrate that equivalent overall levels of safety have been achieved.

43 . For the materials listed in Annex I § 7. 1 , the allowable stresses are left to the manufacturer, who shall

demonstrate that an overall safety has been achieved. For this obj ective, the manufacturer may refer to

Harmonized S tandards, codes, and specifications approved by the CEN Technical Committee (e. g. , EN

1 3 3 45 , ), or may use the criteria used in AS ME B PVC S ection I, combined with all other aspects of that

Code that contribute to the overall level of safety.

44. The permissible general membrane stresses used in the calculations shall conform to the criteria listed

in Annex I, para. 7. 1 of the PED. Also, see Fig. 1 2-2 of this Guide. In case of the ferritic steel, including

normalized steel and excluding fine grain steel and specially heat-treated steel, the lesser of:

(a) 2/3 of the specified minimum yield strength (R e /t), and

(b) 5 /1 2 of the specified minimum ambient temperature tensile strength (R m /20 ).

In general, the allowable design stresses in AS ME B PVC S ection II, Part D, are acceptable. However,

the Code allows the design stresses to be 90% of the specified minimum yield strength for certain

materials (stainless steel and some strain hardening materials). The manufacturer shall verify that the

AS ME B PVC allowable design stresses meet the PED criteria in each particular case.

Note: Although not stated in Annex 1 , the allowable stresses for ferritic steels also apply to fine grain

steels. (S ee Fig. 1 2-2 of this PED Guide. )

45 . AS ME S ection I permits allowable stress, S ≤ 0. 9 S Y, for certain austenitic stainless steels. This

exceeds the allowable stresses permitted in Annex I, § 7. 1 .

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QUANTITATIVE REQUIREMENTS IN PED, ANNEX I TO BE APPLIED AS A GENERAL


RULE

Figure 1 2-2: Q1 Safety Factors for Allowable Stresses Given in Annex I, §7.1 .2
Material Allowable Stress, S a
Ferritic steel and low-alloy steel Lesser of Re /1 . 5 and Rm /2. 4

Fine grain steel Allowable stresses are not given in the PED

Austenitic steel with A  3 0% Re /1 . 5

Austenitic steel with A  35% Lesser of Re /1 . 2 and Rm /3

Cast steel Lesser of Re /1 . 9 and Rm /3

Aluminum Re /1 . 5

Aluminum alloys (not quenched) Lesser of Re /1 . 5 and Rm /2. 4

A = elongation, %

Re = specified minimum yield strength at design temperature

Rm = specified minimum tensile strength at room temperature

Figure 1 2-3: Q2 Joint Efficiencies Given in Annex I, §7.2


Extent of Examination Joint Efficiency
1 00% RT or UT 1 .0

Partial examination by RT or UT and destructive testing 0. 8 5

Visual examination only 0. 70

RT = radiographic testing

UT = ultrasonic testing

Note: examination requirements of AS ME S ection I may differ from other pressure vessel codes (i. e. , EN

1 3 445 ).

Figure 1 2-4: Q3 Formula for Calculating Hydrostatic Test Pressure Given in


Annex I, §7.4
Test pressure, Pt shall be the larger of:

 St 
Pt = 1 . 25 Ps   and

S
Pt = 1 . 43 Ps

Ps = maximum allowable operating pressure

S t = allowable nominal design stress at test temperature

S = allowable nominal design stress at design temperature

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ADDITIONAL CONSIDERATIONS
FOR APPLICATION OF
ASME BPVC SECTION I, POWER
BOILERS WITHIN THE SCOPE OF
PED 201 4/68/EU

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13 ADDITIONAL CONSIDERATIONS FOR APPLICATION OF ASME BPVC


SECTION I, POWER BOILERS WITHIN THE SCOPE OF PED 201 4/68/EU,
ANNEX I

ANNEX I ANNEX I ESSENTIAL SAFETY SECT. VIII, ADDITIONAL


PARAGRAPH REQUIREMENTS (ESR) DIV. 1 CONSIDERATIONS
REFERENCE
PRELIMINARY OBSERVATIONS
1. The obligations arising from the essential PG-1 1 , PG-5 8 ,

requirements listed in this annex for pressure PG-5 9, PG-60,

equipment also apply to assemblies where the PG-67, PG-68 ,

corresponding hazard exists. PG-71

2. The essential requirements laid down in the Informative

directive are compulsory. The obligations laid

down in these essential requirements apply

only if the corresponding hazard exists for the

pressure equipment in question when it is used

under the conditions that are reasonably

foreseeable by the manufacturer.

3. The manufacturer is under an obligation to (None) The manufacturer must perform

analyze the hazards and risks in order to hazards and risks analysis in

identify those that apply to his equipment on accordance with Article 4, Article

account of pressure; 1 3 and Annex II of the PED,

documenting many of their common

analyses.

They must then design and construct it taking (Partial) The manufacturer is required to

account of his analysis. design and construct the pressure

equipment to comply with all the

Essential S afety Requirements

(ES R) in Annex I.

4. The general requirements are to be interpreted Foreword,

and applied in such a way as to take account of Preamble

the state of the art and current practice at the

time of design and manufacture as well as of

technical and economical considerations which

are consistent with a high degree of health and

safety protection.

1. GENERAL
1 .1 Pressure equipment shall be designed, Preamble, S ect. The manufacturer must prepare

manufactured, and checked and, if applicable, II, Part D, instructions for the user containing

equipped and installed in such a way as to App. 6 the necessary safety information in

insure its safety when put into service in accordance with Point. 3 . 4 of

accordance with the manufacturer’ s Annex I.

instructions, or in reasonably foreseeable The manufacturer must also

conditions. consider the following aspects:

a) Inform users of residual hazards,

b) Prevent dangers from

foreseeable misuse,

c) Take into account foreseeable

degradation mechanisms,

d) Ensure safety throughout the

intended life of the pressure

equipment.

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ANNEX I ANNEX I ESSENTIAL SAFETY SECT. VIII, ADDITIONAL


PARAGRAPH REQUIREMENTS (ESR) DIV. 1 CONSIDERATIONS
REFERENCE
1 .2 In choosing the most appropriate solutions, the The manufacturer must:

manufacturer shall comply with the principles

set out below in the following order:

a) Eliminate or reduce hazards as far as is Parts PG and a) Eliminate or reduce hazards as

reasonably practicable. PW far as it is reasonably practical

through adequate design and

construction,

b) Apply appropriate protection measures PG-67 through c) Apply appropriate protection

against hazards which cannot be eliminated. PG-73 , PMB -1 7 measures against hazards that

and PEB -1 6 cannot be eliminated, such as

(partial) controls and pressure relief

devices, and

d) Where appropriate, inform users of residual (None) e) Where appropriate, inform users

hazards and indicate whether it is necessary of any residual hazards and any

to take appropriate special measures to additional measures to be taken

reduce risks at the time of installation to reduce risks during

and/or use. installation and/or use.

1 .3 Where the potential for misuse is known or can PG-60, PG-61 The manufacturer must provide the

be clearly foreseen, the pressure equipment (partial) necessary safeguards (e. g. ,

shall be designed to prevent danger from such temperature measuring devices,

misuse or, water level gages and other sensors,

etc. ) where there is potential for

misuse of the pressure equipment.

if that is not possible, adequate warning (shall (None) Where necessary, the manufacturer

be) given that the pressure equipment must not must provide appropriate warnings

be used in that way. in operating instructions regarding

improper use of the equipment.

(S ee Point 3 . 4 of Annex I. )

2. DESIGN
2. 1 The pressure equipment shall be properly Preamble, PG- The manufacturer must also

designed taking all relevant factors into 1 6, PG-23 consider the following factors in the

account in order to ensure that the equipment through PG-3 8 , design of the equipment:

will be safe throughout its intended life. PG-43 , PG-46, a) Take into account foreseeable

PG-5 2, PG- 5 3 degradation mechanisms,

and PW-9 b) Ensure safety throughout the

(Partial) intended life of the pressure

equipment.

The design shall incorporate appropriate safety S ect. II, Part D,

coefficients using comprehensive methods App. 1

which are known to incorporate adequate

safety margins against all relevant failure

modes in a consistent manner.

2. 2 Design for adequate strength

2. 2. 1 The pressure equipment shall be designed for PG-22

loadings appropriate to its intended use and

other reasonably foreseeable operating

conditions. In particular, the following factors

must be taken into account:

(a) internal/external pressure, PG-27,

(b) ambient and operational temperatures, PG-21 , and

PG-27

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ANNEX I ANNEX I ESSENTIAL SAFETY SECT. VIII, ADDITIONAL


PARAGRAPH REQUIREMENTS (ESR) DIV. 1 CONSIDERATIONS
REFERENCE
(c) static pressure and mass of contents in PG-22. 1 (partial) (Note: Traffic loads are not

operating and test conditions, generally considered to be

(d) traffic, wind, earthquake loading applicable to boilers. )

(e) reaction forces and moments which result PG-22. 2, B 3 1 . 1

from the supports, attachments, piping, §1 1 9

etc. ,

(f) Corrosion, erosion, fatigue, etc. PG-27. 4, Note 3 , S ect. I addresses need, not how to

B 3 1 . 1 § 1 02. 4 analyze.

(g) decomposition of unstable fluids (None) S ect. I does not specifically address

decomposition of unstable fluids.

Manufacturers of organic vapor

generators under Part PVG of S ect.

I may have to document any

additional considerations made.

(h) Various loadings which can occur at the PG-22, B 3 1 . 1

same time must be considered, taking into § 1 01 . 5

account the probability of their

simultaneous occurrence.

2. 2. 2 Design for adequate strength shall be based on: PG-27 through S ect. I App. 22 provides for

(a) as a general rule a calculation method, PG-5 3 , PG-1 00 establishment of MAWP by proof

described in 2. 2. 3 , and supplemented, if (partial) testing. An experimental design

necessary, by an experimental design method, as described in § 2. 2. 4 of

method as described in 2. 2. 4, or Annex I may require additional tests

for fatigue, creep, corrosion rates,

and may have to impose additional

limitations consistent with those in

the PED.

(b) an experimental design method without The manufacturer must ensure that

calculation, as described in 2. 2. 4, when the the limitations on the allowable

product of the maximum allowable pressure pressure PS and on volume V are

PS and the volume V is less than 6, 000 bar not exceeded.

x L, or the product PS x DN (is) less than

3 , 000 bar.

2. 2. 3 Calculation Method

(a) Pressure containment and other loading

aspects.

The allowable stresses for pressure PG-23

equipment shall be limited having regard to

reasonably foreseeable failure modes under

operating conditions. To this end, safety

factors shall be applied to eliminate fully

any uncertainty arising out of manufacture,

actual operational conditions, stresses,

calculation models, and the properties and

behavior of the material.

These calculation methods shall provide S ect. II, Part D,

sufficient safety margins consistent, where App. 1

applicable, with the requirements of

S ection 7.

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ANNEX I ANNEX I ESSENTIAL SAFETY SECT. VIII, ADDITIONAL


PARAGRAPH REQUIREMENTS (ESR) DIV. 1 CONSIDERATIONS
REFERENCE
The requirements set out above may be met

by applying one of the following methods,

as appropriate, if necessary as a supplement

to or in combination with another method:

1. design by formula, PG-27 to PG-5 3

2. design by analysis, Preamble

(partial)

3. design by fracture analysis. N/A

(b) Resistance

Appropriate design calculations must be

used to establish the resistance of the

pressure equipment concerned.

In particular:

(1 ) The calculation pressures shall not be less PG-21 , S ect. I does not specifically address

than the maximum allowable pressures decomposition of unstable fluids.

and Manufacturers of organic vapor

(a) take into account static head and dynamic PG-22. 1 generators under Part PVG of

fluid pressures and S ect. I may have to document any

(b) the decomposition of unstable fluids. (None) additional considerations made.

(c) Where a vessel is separated into PG-1 6. 2

individual pressure containing chambers,

the partition wall shall be designed on the

basis of the highest possible chamber

pressure relative to the lowest pressure

possible in the adj oining chamber.

(2) The calculation temperatures shall allow PG-21 , Note 9

for appropriate safety margins.

(3) The design shall take appropriate account PG-21 , Note 9,

of all possible combinations of temperature PG-27. 4, Note 2

and pressure which might arise under

reasonably foreseeable operating conditions

for the equipment.

(4) The maximum stresses and peak stress PG-22, PG-23

combinations must be kept within safe

limits.

(5) The calculation for pressure equipment PG-23 and

shall utilize the values appropriate to the S ect. II, Part D,

properties of the material, based on the App. 1

documented data, having regard to the

provisions set out in Point 4 together with

the appropriate safety factors. Material

characteristics to be considered, where

applicable, include:

(a) Yield strength, 0. 2% or 1 . 0% PG-5 , PG-23

proof strength, as appropriate, at

calculation temperature,

(b) Tensile strength, PG-23 and S ect.

II. Part D,

App. 1

(c) Time-dependent strength, i. e. , PG-23 and

creep strength, S ect. II, Part D,

App. 5 (Partial)

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ANNEX I ANNEX I ESSENTIAL SAFETY SECT. VIII, ADDITIONAL


PARAGRAPH REQUIREMENTS (ESR) DIV. 1 CONSIDERATIONS
REFERENCE
(d) Fatigue data, PG-22 (Partial) Cyclic and dynamic loadings

generally do not exceed the limits

given in PG-22 and are not a

significant failure mode in power

boilers covered by S ect. I. S ect. I

does not provide guidance on how a

fatigue analysis should be

performed.

(e) Young’s modulus (modulus of S ect. II, Part D,

elasticity), App. 5

(f) Appropriate amount of plastic (Partial) S ect. I does not have a direct limit

strain, on plastic strain, but other limits

indirectly control this. Plastic strain

is generally not a consideration

beyond that which is limited in the

criteria for establishing allowable

stresses in the creep range.

(g) Impact strength, None S ee EC WG Pressure

Guideline 7/1 7

(h) Fracture toughness, None S ee EC WG Pressure

Guideline 7/1 7

(6) Appropriate j oint factors shall be applied PG-27. 4, S ome partial percentage of

to the materials properties, depending, for Note 1 , PW-1 1 volumetric NDE may need to be

example, on the type of NDT, the materials and PW-41 carried out on such j oints as tube

j oined, and the operating conditions (Partial) butts, where there is no j oint factor.

envisioned.

(7) The design shall take appropriate account PG-22, PG-23 , Corrosion must be taken into

of all reasonably foreseeable degradation PG-27 Note 3 account in S ect. I by the Code

mechanisms (e. g. , corrosion, creep, fatigue) and S ect. II, design requirements for a particular

commensurate with the intended use of the Part D, App. 6 boiler or component (PG-27,

equipment. Note 3 ).

Attention shall be drawn, in the instructions

referred to in 3 . 4, to the particular features

of the design which is relevant to the life of

the equipment, for example:

(a) for creep: design hours of S ect. II, Part D, Any limitations on design life from

operation at specified App. 5 (partial) operation at design temperature in

temperatures, creep range, fatigue cycles, and

corrosion allowance must be

specified in operating instructions.

(b) for fatigue: design number of PG-22 (partial) PG-22 requires consideration of

cycles at the specified stress cyclic loads in the design but only

levels, when their magnitude exceeds 1 0%

of the allowable working stress on

the component.

(c) for corrosion: design corrosion PG-27, Note 3 S ect. I does not provide guidance on

allowance. (partial) how to arrive at the design

corrosion allowance.

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ANNEX I ANNEX I ESSENTIAL SAFETY SECT. VIII, ADDITIONAL


PARAGRAPH REQUIREMENTS (ESR) DIV. 1 CONSIDERATIONS
REFERENCE
(c) S tability Aspects

Where the calculated thickness does not allow PG-22 and The design calculations must take

for adequate structural stability, the necessary PG-5 5 into account structural stability,

measures must be taken to remedy the situation including transport and handling of

taking into account the risks from transport and vessels and assemblies. S ect. I does

handling. not address design for transport or

handling loads. PG-5 5 addresses

attachment of supports and

attachment lugs to the pressure-

retaining boundary.

2. 2. 4 Experimental Design Method

App. A-22

The design of the equipment must be validated,

in all or in part, by an appropriate test program

carried out on a sample representative of the

equipment or the category of the equipment.

The test program must be clearly defined prior (None) The manufacturer must obtain

to testing and accepted by the notified body approval from the notified body

responsible for the CA module, where it exists. responsible for the CA module, if

one exists, for the experimental test

program.

The program must define test conditions and App. A-22. 1 0

criteria for acceptance and refusal. and PG-91 . 1 . 5

The actual values of the essential dimensions App. A-22. 1 1 . 3

and characteristics of the materials which

constitute the equipment tested shall be

measured before the test.

App. A-22. 1 1 . 1

Where appropriate, during tests, it must be

possible to observe the critical zones of the

pressure equipment with adequate

instrumentation capable of registering strains

and stresses with sufficient precision.

The test program must include:

(a) A pressure strength test, the purpose of App. A-22 When using the program in A-22,

which is to check that, at a pressure with a the threshold for sufficient leaks in

defined safety margin in relation to the the context of the PED is zero. In

maximum allowable pressure, the the context of S ect. I, App. A-22,

equipment does not exhibit sufficient leaks the thresholds for deterioration by

or deterioration exceeding a determined excessive strain are defined in

threshold. App. 22.

The test pressure must be determined on the App. A-22

basis of the differences between the values

of the geometrical and material

characteristics measures under test

conditions and the values used for design

purposes;

it must take into account the differences App. A-22 A-22 is conservative in basing the

between the test and design temperatures. test pressures on test temperature.

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ANNEX I ANNEX I ESSENTIAL SAFETY SECT. VIII, ADDITIONAL


PARAGRAPH REQUIREMENTS (ESR) DIV. 1 CONSIDERATIONS
REFERENCE
(b) Where the risk of creep or fatigue exists, (None) An experimental design method, as

appropriate tests determined on the basis of described in § 2. 2. 4 of Annex I may

the service conditions laid down for the require additional tests and impose

equipment, for instance, hold time at additional limitations consistent

specified temperatures, number of cycles at with those in the PED (hold time at

specified stress-levels, etc. ; specified temperatures, number of

fatigue cycles at a given stress level,

corrosion rates, external damage,

etc. )

(c) Where necessary, additional tests (None)

concerning other factors referred in 2. 2. 1 ,

such as corrosion, external damage, etc.

2. 3 Provisions to Insure S afe Handling and

Operation

The method of operation specified for pressure (None) For PED compliance, the

equipment must be such as to preclude any manufacturer can demonstrate that

reasonable foreseeable risk in operation of the some of these pose no hazard due to

equipment. Particular attention must be paid, pressure, while others can be

where appropriate, to: addressed in the operation manual

or with warnings on the boiler itself.

a) Closures and openings PG-3 2 through Pressure equipment fitted with

PG-44, PFT-43 , access doors must be equipped with

PWT-1 4 automatic or manual devices to

(partial) enable the user to ascertain that the

opening will not present any

hazards.

Dangerous discharge of pressure relief B 3 1 . 1 , App. II

blowoff, (Partial)

c) Access while pressure or vacuum exists in (None)

the pressure equipment,

d) S urface temperature, taking into account (None)

the intended use of the equipment,

e) Decomposition of unstable fluids. (None)

In particular, the pressure equipment fitted with PWT-1 4

an access door must be equipped with an

automatic or manual device enabling the user

easily “to ascertain that the opening will not


present any hazard.”

Furthermore, where the opening can be N/A B oilers are typically not fitted with

operated quickly, the pressure equipment must quick actuating closures

be fitted with a device to prevent it being

opened whenever the pressure or temperature

of the fluid presents a hazard.

2. 4 Means of examination

(a) Pressure equipment must be designed and Part PG,

constructed so that all necessary Part PW (partial)

examinations to ensure safety can be carried

out.

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REFERENCE
(b) Means of determining the internal condition PG-44,

of the equipment shall be available, where PWT-1 4, and

it is necessary to ensure the continued PFT-43

safety of the equipment, such as access

openings allowing physical access to the

inside of the pressure equipment so that

appropriate examinations can be carried out

safely and ergonomically.

(c) Other means of ensuring the safe condition PG-44 S ect. I requires all boilers to have

of the pressure equipment may be applied: inspection openings.

1 ) Where it is too small for physical internal Handholes are required.

access, or

2) Where the opening of the pressure N/A Does not apply to boilers

equipment would adversely affect the

inside,

3 ) Where the substance contained has been N/A

shown not to be harmful to the material

from which the pressure equipment is

made and no other internal degradation

mechanisms are reasonably foreseeable.

2. 5 Means of venting and draining

Adequate means shall be provided for draining PG-5 9. 4 and Any drains, vents, or blowoff

and venting of pressure equipment, where B 3 1 . 1 § 1 22. 1 . 5 connections provided in addition to

necessary: that required by S ect. I and B 3 1 . 1

should be documented.

a) to avoid harmful effects, such as water PG-5 9. 1 and

hammer, vacuum collapse, corrosion, and B 3 1 . 1 § 1 22

uncontrolled chemical reactions.

b) All stages of operations and testing, PG-5 9. 4 Ample drains are required for all

particularly pressure testing, must be boiler components.

considered.

c) To permit cleaning, inspection and PG-5 9. 3 and B lowoff connections are required

maintenance in a safe manner. PG-5 9. 4

2. 6 Corrosion or other chemical attack

Where necessary, adequate allowance or PG-5 . 5 , Note 1 , The manufacturer must document

protection against corrosion or other chemical PG-27. 4, Note 3 S ect. I considerations for other

attack must be provided, taking due account of (partial) forms of chemical attack besides

the intended and reasonably foreseeable use. corrosion, where appropriate, as

required by PED Annex I, Point 2. 6.

2. 7 Wear

Where severe conditions of erosion or abrasion B 3 1 . 1 § 1 02. 4 Erosion and abrasion are generally

may arise, adequate measures must be taken to: (partial) considered in the design of boiler

and piping systems and the results

must be documented.

a) minimize the effect by appropriate design, B 3 1 . 1 § 1 02. 4

e. g. , additional material thickness, or by (partial)

the use of liners or cladding materials,

b) permit replacement of parts which are most (Partial) B oiler components such as piping

affected, and tubing are accessible for

replacement

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PARAGRAPH REQUIREMENTS (ESR) DIV. 1 CONSIDERATIONS
REFERENCE
c) draw attention, in the instructions referred (None) The manufacturer usually prepares

to in § 3 . 4, to measures necessary for instructions for the user regarding

continued safe use. the use of pressure equipment

containing the necessary safety

information in accordance with

Point 3 . 4 of Annex I and including

considerations for wear, where

applicable, in accordance with Point

2. 7.

2. 8 Assemblies

Assemblies must be so designed that: Part PG and S ect. I is a system code, so it does

Part PW address assemblies in its inherent

requirements for various boiler

components and how they are

connected.

a) The assemblies to be assembled together are The manufacturer must make

suitable and reliable for their duty, certain that all assemblies are so

designed that they comply with the

applicable PED requirements.

b) All the components are properly integrated

and assembled in an appropriate manner.

2. 9 Provisions for filling and discharge

Where appropriate, the pressure equipment N/A AS ME S ect. I does not require

must be so designed and provided with accessories “to assure safe filling

accessories, or provisions made for their and discharge” with respect to the

fitting, as to ensure safe filling and discharge in hazards listed in Annex I, Point 2. 9,

particular with respect to hazards such as: and for the most part, these

requirements do not apply to

boilers.

(a) on filling: N/A

(1 ) Overfilling or over

pressurization having regard in

particular to the filling ratio and

to the vapor pressure at the

reference temperature,

(2) Instability of pressure

equipment

(b) on discharge: the uncontrolled release of N/A

the pressurized fluid;

(c) on filling or discharge: unsafe connection N/A

and disconnection.

2. 1 0 Protection against exceeding the allowable

limits of pressure equipment

Where under reasonably foreseeable PG-67 through Each boiler constructed to S ect. I

conditions, the allowable limits could be PG-73 must be provided with a copy of

exceeded, the pressure equipment must be Data Report Form P-7 which

fitted with, or provisions made for the fitting records all required safety valves, or

of, suitable protective devices, within an for boilers provided with a single

assembly. safety valve, this must be

documented in the remarks section

of Data Report Forms P-2 or P-3 .

The suitable device or combination of such PG-67 through

devices must be determined on the basis of the PG-73

particular characteristics of the equipment or

assembly.

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PARAGRAPH REQUIREMENTS (ESR) DIV. 1 CONSIDERATIONS
REFERENCE
S uitable protective devices and combination

thereof comprise:

(a) S afety accessories as defined in Point 4 of PG-67 through

Article 2. PG-73

(b) Where appropriate, adequate monitoring PG-60. 1 , S ect. I has specific requirements for

devices such as indicators and/or alarms which PG-60. 2, monitoring devices, such as gage

enable adequate action to be taken either PG-60. 6, glasses, water level indicators, and

automatically or manually to keep the pressure PFT-47, low water cutoffs referred to in

equipment within the allowable limits. PMB -1 3 , Annex I, Point 2. 1 0(b).

PMB -1 7,

PEB -1 3 , and

PEB -1 6

2. 1 1 S afety Accessories

2. 1 1 . 1 S afety accessories shall: The design of safety accessories

must comply with the requirements

of PED Annex I, Point 2. 4.

a) B e so designed and constructed as to be PG-67 through

reliable and suitable for their intended PG-73

duty and take into account the

maintenance and testing requirements of

the devices, where applicable;

b) B e independent of other functions, unless PG-71 and PVG-

their safety function cannot be affected by 1 2. 3 . 4

such other functions;

c) Comply with the appropriate design PG-60. 3 , PG-61 Fail-safe modes, redundancy,

principles in order to obtain suitable and diversity, and self-diagnosis are

reliable protection. These principles addressed in S ect. I. Consultation

include, in particular, fail-safe modes, with a notified body familiar with

redundancy, diversity, and self-diagnosis. the application of S ect. I will

confirm that the intent of this

requirement has been met.

2. 1 1 . 2 Pressure limiting devices

The devices must be so designed that the PG-67 (Note: Allowable pressures above
pressure will not permanently exceed the MAWP in PG-67 should be
maximum allowable pressure PS ; however, a reviewed to ensure they do not
short duration pressure surge in keeping with exceed the PED maximum
the specifications laid down in Point 7. 3 is limitation of 1 0% in Annex I, § 7. 3 . )
allowable, where appropriate.

2. 1 1 . 3 Temperature monitoring devices

PEB -1 6 The response time of temperature

These devices must have an adequate response (Partial) monitoring devices is not

time on safety grounds, consistent with the specifically addressed in S ect. I,

measurement function. except for electric boilers in Part

PEB . The manufacturer must

provide temperature monitoring

devices that have adequate response

time, consistent with the

measurement function.

2. 1 2 External fire

Where necessary, pressure equipment must be N/A (Intended for pressure vessels)

so designed and, where appropriate, fitted with

suitable accessories, or provision made for

their fitting, to meet damage-limitation

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PARAGRAPH REQUIREMENTS (ESR) DIV. 1 CONSIDERATIONS
REFERENCE
requirements in the event of external fire,

having particular regard to the intended use.

3. MANUFACTURING
3.1 Manufacturing procedures

The manufacturer shall ensure the competent PG-75 through

execution of the provisions set out in the PG-8 2

design stage by applying the appropriate

techniques and relevant procedures especially

in view of the aspects set out below.

3.1 .1 Preparation of the component parts

Preparation of the component parts (e. g. , PG-1 1 ,


forming and chamfering) shall not give rise to PG-75 through
defects or cracks or changes in the mechanical PG-8 2, PW-29,
characteristics likely to be detrimental to the and PW-3 3
safety of the pressure equipment.

3.1 .2 Permanent j oining

Permanent j oints and adj acent zones shall be PW-29 and

free of any surface or internal defects PW-3 3

detrimental to the safety of the equipment.

The properties of permanent j oints shall meet PW-5 . 4, PW-28

the minimum properties specified for the and S ect. II, Part

materials to be j oined unless other relevant D, Table 1 A

property values are specifically taken into

account in the design.

For pressure equipment, permanent j oining of PW-28

components which contribute to pressure

resistance of the equipment and components

which are directly attached to them must be

carried out by suitably qualified personnel

according to suitable operating procedures.

For pressure equipment in categories II, III, S ee PED, Article 6 for obligations

and IV, operating procedures and personnel of manufactures and Article 24 for

must be approved by a competent third party requirements related to notified

which, at the manufacturer’s discretion, may bodies and RTPOs for approval of

be: welding procedure and welder

qualifications for category II, III

and IV pressure equipment.

(Note: The manufacturer can use

AS ME welding procedure and

welder qualifications for Category I

vessels. )

a) A notified body, (None) For pressure equipment in

b) A third party organization recognized by a (None) Categories II, III, and IV,

Member S tate as provided in Article 1 3 . qualification of welders and

welding operators must meet the

requirements of EN IS O 9606 and

qualification of welding procedures

the requirements of EN IS O 1 5 607.

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PARAGRAPH REQUIREMENTS (ESR) DIV. 1 CONSIDERATIONS
REFERENCE
To carry out these approvals the third party (None) The welder, welding operator and

must perform examinations and tests as set out welding procedure qualifications

in the appropriate harmonized standards, or must be approved by a notified

body or an approved third party

organization. This includes the

ongoing certification of permanent

j oining personnel.

equivalent tests or PW-28 (partial)

must have them performed. PW-28 (partial)

3.1 .3 Nondestructive tests

For pressure equipment, non-destructive tests PW-5 1 and For pressure equipment in

of permanent j oints shall be carried out by PW-5 2 Categories III and IV, the NDE

suitable qualified personnel. personnel must be approved by an

approved third party organization

recognized by a Member S tate in

the European Community.

For pressure equipment in Categories III and PW-5 1 and (Note: The manufacturer may use

IV the personnel must be approved by a third PW-5 2 (partial) the certification required by AS ME,

party organization recognized by a Member S ect. I for pressure equipment in

S tate pursuant to Article 20. Categories I and II for radiographic

examination. )

3.1 .4 Heat treatment

Where there is a risk that the manufacturing PW-3 8 and

process will change the material properties to PW-3 9

the extent which would impair the safety of the

pressure equipment, suitable heat treatment

shall be applied at the appropriate stage of the

manufacture.

3.1 .5 Traceability

S uitable procedures shall be established and PG-77,

maintained for identifying the material making PG-90. 1 . 6,

up the components of the equipment which PG-90. 1 . 7, and

contribute to the pressure resistance by suitable App. 3 02. 4

means from receipt, through production, up to

the final test of the manufactured pressure

equipment.

3.2 Final assessment

Pressure equipment must be subj ected to the

final assessment as described below.

3 . 2. 1 Final Inspection

Pressure equipment shall undergo a final PG-90. 1 . 1 3 , The manufacturer must provide

inspection to access visually and PG-99. 2 documentation to demonstrate

by examination of the accompanying PG-90, PG-1 1 2 compliance with the directive. This

documents compliance with the requirements and App. A-3 5 0 may be covered by the

of the directive. Test carried out during through A-3 5 manufacturer’s ASME QC manual
manufacture may be taken into account. (Partial)

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PARAGRAPH REQUIREMENTS (ESR) DIV. 1 CONSIDERATIONS
REFERENCE
As far as necessary on safety grounds, the final PG-90, PG-93 and the AI’s duties for inspection in
inspection must be carried out internally and PG-90 and shall include:

externally on every part of the equipment, (1 ) Qualifications of the

where appropriate in the course of manufacture NDT personnel,

(e. g. , where examination during the final (2) Qualification of

inspection is no longer possible). welders and welding

operators,

(3 ) Welding procedure

qualifications,

(4) Heat treat procedures

and data,

(5 ) Material certification

and inspection

documents for base

metal and welding

consumables,

(6) Procedures for

insuring material

traceability,

(7) NDT reports,

including

radiographic films,

(8 ) Test reports of

mechanical tests

(e. g. , coupons)

(9) Reports on defects

and deviations

during manufacture,

(1 0) Forming and other

manufacturing

procedures,

(1 1 ) Other technical

documentation in

accordance with the

appropriate CA

module.

3 . 2. 2 Proof test

Final assessment of pressure equipment must PG-99 PG-99. 3 limits the amount of stress

include a test for the pressure containment on any component in the boiler

aspect, which will normally take the form of a system, which meets the intent of

hydrostatic pressure test at a pressure at least the EC’s WG Pressure


equal, where appropriate, to the value laid Guideline 8 /2

down in Point 7. 4.

For category I series produced equipment, this (N/A) S ect. I has no provisions for series

test may be performed on a statistical basis. produced boilers.

Where a hydrostatic test pressure is harmful or B 3 1 . 1 allows for alternatives to

impractical, other tests of a recognized value B31 .1 §1 37 hydrotesting, S ect. I does not.

may be carried out. For test other than the

hydrostatic pressure test, additional measures,

such as non-destructive tests or other methods

of equivalent validity, must be applied before

those tests are carried out.

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PARAGRAPH REQUIREMENTS (ESR) DIV. 1 CONSIDERATIONS
REFERENCE
3 . 2. 3 Inspection of safety devices

For assemblies, the final assessment must also PG-90. 1 . 1 4, PG-90. 1 . 1 5 requires the AI to verify

include a check of the safety devices intended PG-90. 1 . 1 5 and that all required safety accessories

to check full compliance with the requirements PG-1 1 2. 2. 8 are installed in compliance with the

referred to in Point 2. 1 0. requirements of S ect. I. Each boiler

must be provided with a copy of

Data Report Form P-7, or for

boilers provided with a single safety

valve, this must be documented in

the remarks section of Data Report

Forms P-2 or P- 3 .

3.3 Marking and Labeling

In addition to the CE marking referred to in In addition to the CE marking, the

Article 1 8 and 1 9 and the information to be vessel manufacturer must provide

provided in accordance with Article 6(6) and the additional information required

Article 8 (3 ), the following information must be by PED, Annex I, § 3 . 3 (a) and

provided: § 3 . 3 (b), as applicable. This can be

on one or more nameplates.

(a) For all pressure equipment:

(1 ) The name and address or other PG-1 06 through The name and address of

means of identification of the PG-1 1 1 manufacturer’ s representative in the

manufacturer and, where European Community is not

appropriate, of his authorized covered by S ect. I, and if the

representative established information for the manufacturer is

within the Community, insufficient, the information for the

representative must be supplied for

PED compliance.

(2) The year of manufacture, PG-1 06 through S erial number on stamping plate.

(3) Identification of the pressure PG-1 1 1

equipment according to its PG-1 06. 4. 1

nature, such as type, series or

batch identification, and serial

number,

(4) The essential PG-1 06. 4. 1

maximum/minimum allowable

limits.

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REFERENCE
(b) Depending on the type of pressure (None) The information required by

equipment, further information necessary Annex I, § 3 . 3 (b) generally does not

for safe installation, operation, or use and, apply to boilers, or is covered by

where applicable, maintenance and periodic marking and Data Report

inspection such as: requirements of S ect. I.

(1 ) The volume V of the pressure

equipment in L,

(2) The nominal size for piping,

DN,

(3) The test pressure PT applied in

bar and date,

(4) S afety device set pressure in

bar,

(5) Output of pressure equipment in

kW,

(6) S upply voltage in V (volts),

(7) Intended use,

(8) Filling ratio kg/L,

(9) Maximum filling mass in kg,

(1 0) Tare mass in kg,


(1 1 ) The product group;

(c) Where necessary, warnings fixed to the (None) B ased on the type of equipment and

pressure equipment drawing attention to intended service, warning labels

misuse which experience has shown might shall be attached to the pressure

occur. equipment giving warnings about

potential misuse of the pressure

equipment, based on past

experience. (Examples of such

misuse could be bypassing safety

devices, lack of maintenance of

water level indicators, etc. )

The information referred to in Points (a), (b), PG-1 06 (Partial) The manufacturer needs to provide

and (c) shall be given on the pressure the necessary CE marking and

equipment or on a data plate firmly attached to labels (where applicable) in

it, with the following exceptions: accordance with the requirements of

PED, Annex I, Point 3 . 3 .

(1 ) where applicable, appropriate documents PG-1 06. 8. 2


may be used to avoid repetitive marking and PG-1 09
of individual parts such as piping

components, intended for the same

assembly.

(2) where the pressure equipment is too small, PG-1 06. 8. 2


e. g. accessories, this information may be

given on a label attached to that pressure

equipment;

(3) labeling or other adequate means may be (None) Refers to the permanence of

used for the mass to be filled and the warnings affixed to the boiler.

warnings referred to in Point (c), provided

it remains legible for the appropriate period

of time.

3.4 Operating instructions

(a) When pressure equipment is placed on the (None) S ect. I does not require

market, it shall be accompanied, as far as manufacturers to issue operating

relevant, with instructions for the user, instructions or warnings regarding

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PARAGRAPH REQUIREMENTS (ESR) DIV. 1 CONSIDERATIONS
REFERENCE
containing all the necessary safety potential hazards or misuse of

information relating to: pressure equipment. Manufacturers

(1 ) mounting including assembling generally do provide such

of different pieces of pressure instructions; and for PED

equipment, compliance, they shall include the

(2) putting into service, information listed in Point 1 . 3 ,

(3) use, 2. 2. 3 , 2. 7 , and in Point 3 . 4 of Annex

(4) maintenance including checks I of the PED.

by user;

(b) Instructions must cover information affixed (None)

to the pressure equipment in accordance

with 3 . 3 , with the exception of serial

identification, and must be accompanied,

where appropriate, by the technical

documents, drawings and diagrams

necessary for a full understanding of these

instructions;

(c) If appropriate, these instructions shall also (None)

refer to hazards arising from misuse in

accordance with Point 1 . 3 and particular

features of the design in accordance with

Point 2. 2. 3 .

4. MATERIALS
Materials used for manufacturing of pressure PG-5 through The PED requires the manufacturer

equipment must be suitable for such PG-1 2, S ect. II, to select material (including bolting)

application during the scheduled lifetime App. 6 that is suitable for the scheduled

unless replacement is foreseen. lifetime of the vessel. B oiler

manufacturers choose their

materials for construction based on

these considerations, even though

they are not spelled out in S ect. I.

This practice may need to be

documented for PED compliance,

or consultation with a notified body

familiar with the application of

S ect. I may suffice.

Welding consumables and other j oining PW-5 . 4, The general principles in S ect. I

materials need fulfill only the relevant S ect. II, Part C regarding selection of materials, P-

requirements of Points 4. 1 , 4. 2(a) , and the first numbers and welding procedure

paragraph of Point 4. 3 , in an appropriate way, qualifications all contribute to

both individually and in a j oined structure. meeting these requirements. This is

another case where consultation

with a notified body that is familiar

with the application of S ect. I will

contribute to determination of

having achieved an overall

equivalent level of safety.

4. 1 Materials for pressurized parts shall:

(a) Have appropriate properties for all PG-5 through The manufacturer of pressure

operating conditions which are reasonably PG-1 2, S ect. II, equipment is responsible for

foreseeable and for all test conditions, and Parts A, B , C, D. material selection for the intended

(partial) service. The materials shall meet the

requirements of

Annex I, Points 4. 1 (a) through

4. 1 (e). B oiler manufacturers choose

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REFERENCE
their materials for construction

based on these considerations, even

though they are not spelled out in

S ect. I. This practice may need to be

documented for PED compliance.

in particular they should be sufficiently Point 7. 5 of Annex I requires

ductile and tough. materials to have 1 4% minimum

elongation and to meet a minimum

average value of 27 J (20 ft-lbs) at

20  C (68  F). Consultation with a

notified body that is familiar with

the application of S ect. I will

contribute to determination of

having achieved an overall

equivalent level of safety.

Where appropriate, the characteristics of PG-5 through For S ect. I applications, brittle-type

the materials shall comply with the PG-1 2, S ect. II, fracture is not a significant failure

requirements of Point 7. 5 . Moreover, due Parts A, B , C, mode. Materials will be approved if

care should be exercised in particular in and D. they have the following properties,

selecting materials in order to prevent (partial) or if an equivalent level of safety

brittle type fracture where necessary; where can be demonstrated. In the case of

for specific reasons brittle material has to S ect. I, its long history of boilers

be used, appropriate measures shall be with safe service life can be

taken; demonstrated through consultation

with a notified body that is familiar

with the application of S ect. I.

(b) B e sufficiently chemically resistant to the PG-5 , Note 1 , The PED requires the manufacturer

fluid contained in the pressure equipment; PG-6, PG-7, PG- to be responsible for material

the chemical and physical properties 8 and PG-9; selection for the intended service.

necessary for operational safety shall not be S ect. II, Part D, The materials must meet the

significantly affected within the scheduled App. 5 , 6 requirements of Points 4. 1 (a)

lifetime of the equipment; (partial) through 4. 1 (e) in Annex I. Chemical

and physical properties for

operational safety are implied in

S ect. I. S pecific guidance is given in

PG-5 , Note 1 , and may have to be

documented.

(c) Not be significantly affected by aging; S ect. II, Part D, (Note: S ect. I has no specific

App. 5 , 6 requirements for aging. )

(partial)

(d) B e suitable for the intended processing PG-6, PG-7, PG-

procedures; 8 and PG-9

(e) B e selected in order to avoid significant PW-5 , PW-28

undesirable effects when the various and PW-3 9

materials are put together.

4. 2 The pressure equipment manufacturer shall: PG-23 , S ect. II Materials will only be approved if

(a) Define in an appropriate manner the values Part D, App. 1 they have the specified properties or

necessary for the design calculations (partial) if an equivalent level of safety can

referred to in 2. 2. 3 and the essential be demonstrated. It may be

characteristics of the materials and their necessary to demonstrate that the

treatment referred to in 4. 1 . hydrotest temperature is above the

brittle transition temperature to

support decisions on selecting

materials.

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REFERENCE
(b) The manufacturer shall provide in his (None) In 2001 , the European Commission

technical documentation elements relating determined that on the basis of

to compliance with the material Art. 1 1 , § 5 , no EAMs would be

specification of the Directive in one of the issued covering materials for which

following forms: there exists (or is under

(1 ) by using materials which (None) development) an equivalent

comply with harmonized harmonized European material

standards, specification. Therefore, the only

(2) by using materials covered by a (None) way to use AS ME S A materials in

European approval of pressure S ect. I boiler construction intended

equipment materials in for CE marking is to perform PMAs

accordance with Article. 1 5 , for each material for equipment in

(3) by a particular appraisal. (None) Category III and IV.

(c) For pressure equipment in categories III and (None) This becomes a problem only when

IV, a specific assessment of the PMA shall the manufacturer utilizes multiple

be performed by the NB in charge of the notified bodies. PMAs performed

CA procedures for the pressure equipment. by a notified body other than that

being used for the equipment in

question shall be repeated.

4. 3 The equipment manufacturer shall take PG-77,

appropriate measures to ensure that the App. A-3 02. 4

material used conforms to the required

specification.

In particular, documentation prepared by the PG-77,

material manufacturer affirming compliance App. A-3 02. 4

with the specification shall be obtained for all

materials.

For the main pressure bearing parts of PG-77, The manufacturer must ensure that

equipment in categories II, III, and IV, this App. A-3 02. 4 the material conforms to one of the

shall take the form of certificate of specific (partial) appropriate specifications and is

product control. supported by appropriate

certification.

a) For main pressure parts of

pressure equipment in

Categories II, III, and IV the

test certificates shall comply

with EN 1 0204, Types 3 . 1 or

3 . 2.

b) Certificates of Type 2. 2 are

acceptable for Category I

equipment.

c) Certificates of Type 2. 2 are

acceptable for welding

consumables for pressure

equipment in all categories.

Where the material manufacturer has an (None) For example, if the material

appropriate QA system, certified by a manufacturer holds accredited

competent body established within the certification to IS O 9000 from a

Community and having undergone a specific certification body established within

assessment of materials, certificates issued by the European Community, a

the manufacturer are presumed to certify the material certificate of the EN

conformity with relevant requirements of this 1 0204, 3 . 1 is acceptable. Where the

section. material manufacturer does not hold

such a certification, the pressure

equipment manufacturer is

responsible for determining the

certification requirements.

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ANNEX I ANNEX I ESSENTIAL SAFETY SECT. VIII, ADDITIONAL


PARAGRAPH REQUIREMENTS (ESR) DIV. 1 CONSIDERATIONS
REFERENCE
5. SPECIFIC REQUIREMENTS FOR
HEATED PRESSURE VESSELS
S pecific Pressure Equipment Requirements

In addition to the applicable requirements of

Points 1 to 4, the following requirements apply

to the pressure equipment covered by Points 5

and 6.

5. FIRED OR OTHERWIS E HEATED

PRES S URE EQUIPMENT WITH RIS K OF

OVERHEATING AS REFERRED TO IN

ARTICLE 4 (1 )

This pressure equipment includes:

(a) S team and hot water generators as referred Preamble S ect. I does not cover vessels in

to in Article 4(1 )(b), such as fired steam and (partial) which steam is generated for

hot-water boilers, superheaters and reheaters, internal use such as pressure

waste-heat boilers, waste incineration boilers, cookers.

electrode or immersion-type electrically heated

boilers, pressure cookers, together with their

accessories and where applicable their systems

for treatment of feedwater and for fuel supply,

and

(b) Process heating equipment for other than Preamble Unfired steam boilers can be built to

steam and hot water generation falling under (Partial) either S ect. I or S ect. VIII.

Article 3 , section 1 . 1 , such as heaters for

chemical and other similar processes and

pressurized food-processing equipment.

This pressure equipment shall be calculated, Part PG

designed, and constructed so as to avoid or to

minimize risks of a significant loss of

containment from overheating. In particular it

shall be ensured, where applicable, that:

(a) appropriate means of protection are PG-60 and

provided to restrict operating parameters PG-61

such as heat input, heat take-off and, where

applicable, fluid level so as to avoid any

risk of local and general overheating,

(b) sampling points are provided where PG-5 9. 3 and

required to allow evaluation of the PG-5 9. 4

properties of the fluid so as to avoid risks

related to deposits and/or corrosion,

(c) adequate provisions are made to eliminate PG-5 9. 3

risks of damage from deposits,

(d) safe removal of residual heat after None Normally provided for by boiler

shutdown are provided, designers

(e) steps are taken to avoid a dangerous None Normally provided for by boiler

accumulation of ignitable mixtures and designers

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ANNEX I ANNEX I ESSENTIAL SAFETY SECT. VIII, ADDITIONAL


PARAGRAPH REQUIREMENTS (ESR) DIV. 1 CONSIDERATIONS
REFERENCE
combustible substances and air, or flame

flowback.

6. PIPING AS REFERRED TO IN ARTICLE S ect. I contains requirements for

4(1 )(c) piping within the boiler proper as

defined in Fig. PG-5 8 . 3 . 1 and Fig.

PG-5 8 . 3 . 2. Those figures also

define the limits of boiler external

piping, the design and construction

rules for which are contained in

AS ME B 3 1 . 1 , Power Piping. PED

compliance for the completed boiler

will be demonstrated by using the

combination of AS ME S ect. I and

AS ME B 3 1 . 1 to meet the ES Rs for

piping.

Design and construction shall ensure: PG-27. 2. 2,

PG-5 8

(a) that the risk of overstressing from PG-5 9. 1 . 2;

inadmissible free movement or excessive B 3 1 . 1 § ’ s 1 1 9,

forces being produced, e. g. , on flanges, 1 20, 1 21 , and

connections, bellows or hoses is adequately 1 22. 1 . 1

controlled by means such as support,

constraint, anchoring, alignment, and

pretension;

(b) that where there is a possibility of PG-5 8 . 3 . 7 and

condensation occurring inside pipes for PG-5 9. 4; B 3 1 . 1

gaseous fluids, means are provided for § ’ s 1 01 . 5 . 1 and

drainage and removal of deposits from low 1 22. 1 . 5

areas to avoid damage from water hammer

or corrosion.

(c) that due to consideration is given to the PG-5 9. 2; B 3 1 . 1

potential damage from turbulence and § 1 02. 4

formation of vortices; the relevant parts of

Point 2. 7 are applicable;

(d) that due consideration is given to the risk of PG-5 9. 1 . 2; Note 3 to AS ME B 3 1 . 1 § 1 1 9. 7

fatigue due to vibrations in pipes; B 3 1 . 1 § 1 01 . 5. 4 describes how fatigue is considered

and App. D in the stress intensification factors

of App. D. Manufacturers may have

to describe this in the context of a

proven history of safe operation of

B 3 1 . 1 piping systems to

demonstrate compliance with this

requirement.

(e) that, where fluids of Group 1 are contained N/A

in the piping, appropriate means are

provided to isolate “take - off” pipes the size

of which represents a significant risk;

(f) that the risk of inadvertent discharge is N/A

minimized; the take-off points must be

clearly marked on the permanent side,

indicating the fluid contained;

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ANNEX I ANNEX I ESSENTIAL SAFETY SECT. VIII, ADDITIONAL


PARAGRAPH REQUIREMENTS (ESR) DIV. 1 CONSIDERATIONS
REFERENCE
(g) that the position and route of underground None Neither S ect. I nor B 3 1 . 1 contain

piping is at least recorded in the technical requirements for mapping of

documentation to facilitate safe underground piping. S uch

maintenance, inspection, or repair. documentation would have to be

furnished and can easily be derived

from plans and blueprints for the

buried piping system.

7. SPECIFIC QUANTITIVE
REQUIREMENTS FOR CERTAIN
PRESSURE EQUIPMENT
The following provisions apply as a general The specified quantitative

rule. However, where they are not applied, requirements apply as a general

including in cases where materials are not rule. Other values may be used but

specifically referred to and no harmonized the manufacturer must be able to

standards are applied, the manufacturer shall demonstrate to the notified body

demonstrate that appropriate measures have that appropriate measures have been

been taken to achieve an equivalent overall taken to demonstrate that equivalent

level of safety. overall level of safety has been

achieved.

The provisions laid down in this section

supplement the essential requirements of

sections 1 to 6 for the pressure equipment to

which they apply.

7. 1 Allowable stresses

7. 1 . 1 S ymbols For the materials not listed in § 7. 1 ,

the allowable stresses are left to the

Re /t, yield limit, indicates the value at the manufacturer, who must

calculation temperature of: demonstrate that an equivalent

a) The upper flow limit for a material overall safety has been achieved.

presenting upper and lower flow limits, For this obj ective, the manufacturer

b) The 1 . 0% proof strength of austenitic steel may refer to harmonized ENs,

and non-alloyed aluminum, codes, and specifications approved

c) The 0. 2% proof strength in other cases. by the CEN Technical Committee

(e. g. , EN1 295 2, Water Tube

Rm /20 indicates the minimum value of the B oilers, and EN1 295 3 , S hell

ultimate strength at 20  C. B oilers) .

Rm /t designates the ultimate strength at the

calculation temperature.

7. 1 . 2 The permissible general membrane stress for S ect. II, Part D, (Note: In general, the allowable

predominantly static loads and for temperatures Table 1 A, and design stresses in AS ME S ect. II,

outside the range in which creep is significant App. 1 Part D, are acceptable. The

must not exceed the smaller of the following manufacturer must verify that the

values, according to the material used: AS ME B PVC allowable design

stresses meet the PED criteria in

each particular case. )

a) in the case of ferritic steel including (Partial)

normalized (normalized rolled) steel and

excluding fine grain steel and specially

heat-treated steel, 2/3 of Re /t and 5 /1 2 of

Rm /20 ;

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ANNEX I ANNEX I ESSENTIAL SAFETY SECT. VIII, ADDITIONAL


PARAGRAPH REQUIREMENTS (ESR) DIV. 1 CONSIDERATIONS
REFERENCE
b) in the case of austenitic steel (Partial) (Note: S ect. I permits allowable

(1 ) if its elongation after rupture stress, S ≤ 0.9 S Y for certain


exceeds 3 0%, 2/3 of Re /t austenitic stainless steels that do not

(2) or, alternatively, and if its meet the limitations in Point 7. 1 . 2

elongation after rupture exceeds of Annex I. )

3 5 %, 5 /6 of Re /t and 1 /3 of Rm

/20 ;

c) in the case of non-alloy or low alloy cast

steel, 1 0/1 9 of Re /t and 1 /3 of Rm /20 ;

d) in the case of aluminum, 2/3 of Re / t;

e) in the case of aluminum alloys, excluding

precipitation hardening alloys, 2/3 of R e /t

and 5 /1 2 of Rm /20 .

7. 2 Joint Coefficients

For welded j oints, the j oint coefficient must not PG-27. 4,

exceed the following values: Note 1 , PW-1 1

a) for equipment subj ect to destructive and and PW-41

non-destructive tests which confirm that

the whole series of j oints show no

significant defects: 1 ,

b) for equipment subj ect to random NDT:

0. 8 5 ,

c) for equipment not subj ect to NDT other

than visual inspection: 0. 7.

If necessary, the type of stress and the

mechanical and technological properties of the

j oint must also be taken into account,

7. 3 Pressure limiting devices, particularly for

pressure vessels

The momentary surge referred to in 2. 1 1 . 2 PG-67. 2 PG-67. 2 limits this to 6% of

must be kept to 1 0% of the maximum MAWP.

allowable pressure.

7. 4 Hydrostatic test pressure

For pressure vessels, the hydrostatic test

pressure referred to in Point 3 . 2. 2 shall be no

less than:

a) That corresponding to the maximum PG-99

loading to which the pressure equipment

may be subj ect to in service, taking into

account its maximum allowable pressure

and its maximum allowable temperature,

multiplied by a coefficient of 1 . 25 , or

b) The maximum allowable pressure PG-99 PG-99. 3 limits the amount of stress

multiplied by the coefficient 1 . 43 , on any component in the boiler

whichever is greater. system, which meets the intent of

the EC’s WG Pressure Guideline


8 /2.

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ANNEX I ANNEX I ESSENTIAL SAFETY SECT. VIII, ADDITIONAL


PARAGRAPH REQUIREMENTS (ESR) DIV. 1 CONSIDERATIONS
REFERENCE
7. 5 Material Characteristics

Unless other values are required in accordance PG-5 through Materials will be approved if they

with other criteria that must be taken into PG-1 2, S ect. II, have the listed properties, or if an

account, a steel is considered as sufficiently Parts A, B , C, D. equivalent level of safety can be

ductile to satisfy Point 4. 1 (a) if, in a tensile test (partial) demonstrated. In the case of S ect. I,

carried out by a standard procedure, its its long history of boilers with safe

elongation after rupture is no less than 1 4% service life can be demonstrated

and through consultation with a notified

body that is familiar with the

application of S ect. I.

its bending rupture energy measured on an IS O None For S ect. I boilers, the operating

V test-piece is no less than 27 J, at a range is not near the transition

temperature no greater than 20  C but not temperature and the WG Pressure

higher than the lowest scheduled operating Guideline 7/1 7 should apply. The

temperature. guidelines related to the PED are in

the process of being updated- see

S ection 1 4 of this document.

Consultation with a notified body

that is familiar with the application

of S ect. I will contribute to

determination of having achieved an

overall equivalent level of safety.

Note: Any reference to the Code in this table means AS ME S ection I.

N/A = not applicable.

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14 GUIDELINES RELATED TO PED 201 4/68/EU


1 4.1 Purpose of the Guidelines
To ensure a coherent application of the PED 201 4/68 /EU, the Commission WGP is developing Guidelines

for implementation of the Directive. The Working Group is compos ed of representatives of Member S tates,

European Federation, the Notified B odies Forum, and CEN and is chaired by a representative of the

Commission services. The PED Guidelines for Directive 97/23 /EC are being reviewed and are being

updated, and possibly will be issued as a PED Guideline under the new Directive 201 4/68 /EU. Also, new

guidelines may be issued to support the implementation of the Directive. The updated Guidelines will be

made available when they are endorsed by the WGP.

1 4.2 Status of the Guidelines


The PED Guidelines are a not a legally binding interpretation of the Directive. The legally binding text is

that of the Directive. The PED Guidelines provide a reference for ensuring consistent application of the

Directive. They represent, unless indicated differently in the respective guideline text, the unanimous

opinion of the Member S tates.

1 4.3 Classification of the Guidelines


The Guidelines have an x/yy type identification

 (x) relates to the subj ect (A, B , C, etc. ),

 (yy) is a sequential numbering

NOTE: The Guideline retains the sequential numbering as far as possible. For example, the new guideline

A-24 under the new PED 201 4/68 /EU corresponds to Guideline 1 -24 under PED 97/23 /EC.

The letter x refers to one of the following subj ects:

A. S COPE AND EXCLUS IONS OF THE DIRECTIVE

B. CLAS IFICATION AND CATEGORIES

C. AS S EMB LIES

D. EVALUATION AS S ES S EMENT PROCEDURES

E. INTERPRETATION OF THE ES S ENTIAL S AFETY REQUIREMENTS ON ON DES IGN

F. INTERPRETATION OF THE ES S ENTIAL S AFETY REQUIREMENTS ON

MANUFACTURING

G. INTERPRETATION OF THE ES S ENTIAL S AFETY REQUIREMENTS ON MATERIALS

H. INTERPRETATION OF OTHER ES S ENTIAL S AFETY REQUIREMENTS

I. MIS CELLANEOUS

J. GENERAL- HORIZONTAL QUES TIONS

1 4.4 Inquiries
Remarks or questions concerning the PED should be addressed via the e-mail to the unit in the European

Commission dealing with the PED:

GROW-PRES S URE-EQUIPMENT@ ec. europa. eu

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REFERENCES
[1] Directive 201 4/68 /EU of the European Parliament and of the Council of 1 5 May 201 4.

[2] AS ME PTB -1 0-201 5 - Guide for AS ME S ection VIII, Division 1 S tamp Holders , AS ME, (201 5 ).

[3] ASME BPVC Section I, “Power Boilers,” AS ME.

[4] ASME BPVC Section II Part D, “Materials Properties,” AS ME.

[5] ASME BPVC Section V, “Nondestructive Examination,” AS ME.

[6] ASME B31.1, “Power Piping,” AS ME.

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APPENDIX A: GLOSSARY OF TERMS USED IN THE DIRECTIVES


CE marking: products in compliance with all the provisions of the applicable Directives, which provide for

the CE marking, must bear this marking. Thus, the CE marking indicates, in particular, that the products

comply with the essential requirements of all applicable Directives and that the products have been subj ect

to a conformity assessment procedure provided for in the Directive. Furthermore, Member S tates are

obliged to take appropriate measures to protect the CE marking.

conformity assessment procedures: before placing a product on the Community market, the Manufacturer

must subj ect the product to a conformity assessment procedure provided for in the applicable Directive, with

the intent of affixing the CE marking.

coordination of implementation: where the Member State or the Commission considers that a harmonized

standard does not fully meet the essential requirements of a Directive, the matter will be brought to the

attention of the committee set up by Directive 98 /3 4/EC (i. e. , Committee on technical standards and

regulations). The Commission, taking into account the committee's opinion, shall notify the Member S tates

to whether or not the standard should be withdrawn from the list published in the OJEU.

Many New Approach Directives provide for a S tanding Committee, which may assist the Commission in

delivering its opinion on the draft measures proposed to implement the provisions of the relevant Directive

and to examine any matter relating to implementation and practical application of the Directive.

Furthermore, regular meetings to discuss implementation issues take place as working groups, which are

composed of representatives appointed by Member S tates and interest groups (e. g. , notified bodies,

standards organizations, manufacturers, distributors, and trade unions), chaired by the Commission.

essential safety requirements (ESR): essential requirements are set out in annexes to the Directives, and

include all that is necessary to achieve the obj ectives of the Directive. Products may be placed on the

market and put into service only if they are in compliance with the essential requirements.

New Approach Directives are generally designed to cover all typical risks related to public interest that the

Directive intends to protect. Thus compliance with Community legislation often requires simultaneous

application of several New Approach Directives and, possibly, other Community legislation. Furthermore,

some elements may have been left outside the scope of the applicable Community legislation. This allows

member states to draw up national legislation, in accordance with Articles 3 0 and 3 6 of the Treaty.

free movement: Member S tates must presume that products bearing CE marking comply with all provisions

of the applicable Directives providing for its affixing. Accordingly, Member S tates may not prohibit,

restrict, or impede the placing on the market and putting into service in their territory of products bearing

CE marking, unless the provisions relating to CE marking are incorrectly applied.

— —
As an exemption, Member S tates may prohibit, restrict, or impede the free movement of products bearing

CE marking in accordance with Articles 3 0 and 3 6 of the Treaty because of risk that is not covered

by the applicable Directives.

notified bodies (NB): third party conformity assessment is carried out by notified bodies, which have been

designated by the Member S tates from the bodies, established on their territory, that fulfill the requirements

specified in the Directive.

placing on the market and putting into service: Member S tates are obliged to take the necessary measures

to ensure that products are placed on the market and put into service only if they do not endanger the safety

and health of persons, or other public interests covered by the Directive, when properly installed,

maintained, and used for the intended purposes. This entails an obligation for market surveillance on the

part of the Member S tates.

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Member S tates are allowed to adopt, in Compliance with the Treaty (e. g. , Articles 3 0 and 3 6), additional

national provisions to protect, in particular, workers, consumers, or the environment. However, these provi-

sions may neither require modifications of the product nor influence the conditions for its pl acing on the

market.

presumption of conformity: products that comply with national standards, which have been incorporated

into harmonized standards and the reference numbers of which have been published in the OJEU, are

presumed to comply with the corresponding essential requirements. Where the Manufacturer has not

applied, or has only partially applied such a standard, it must document the measures taken and their

adequacy to comply with the essential requirements.

safeguard clause: Member S tates are obliged to take all appropriate measures to prohibit or restrict the

placing on the market of products bearing CE marking or to withdraw them from the market, if these

products may compromise the safety and health of individuals or other public interest covered by the

applicable Directives, when the products are used for their intended purpose. Furthermore, the Member

S tate must inform the Commission of such a measure. Where the Commission considers the national

measure j ustified, it informs all Member S tates who must take appropriate action.

scope: defines the range of products covered by the Directive, or nature of hazards the Directive is intended
to avert. It usually covers risks related to a product (i. e. , product approach) or risks related to a phenomena

(i. e. , risk approach). Accordingly, a product may be covered by several Directives.

transposition and transitional provisions: Member S tates are required to incorporate the provisions of the

Directives into their national legislation. They must inform the Commission of the measures taken.

Member S tates must permit the placing on the market products that are in compliance with regulations in

force in their territory at the date of application of the Directive in question, until the date established by the

Directive. Under certain restrictions, such products must also be permitted to be placed into service beyond

that date.

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APPENDIX B: CONTENTS OF THE PED


ARTICLES
CHAPTER 1 GENERAL PROVISIONS

Article 1 S cope

Article 2 Definitions

Article 3 Making available on the market and putting into service

Article 4 Technical requirements*

Article 5 Free movement

CHAPTER 2 OB LIGATIONS OF ECONOMICAL OPERTORS

Article 6 Obligations of manufacturers

Article 7 Authorized representatives

Article 8 Obligations of importers

Article 9 Obligations of distributors

Article 1 0 Cases in which obligations apply to importers and distributors

Article 1 1 Identification of economic operators

CHAPTER 3 CONFORMITY AND CLAS S IFICATION OF PRES S URE EQUIPMENT AND AS S EMB LIES

Article 1 2 Presumption of conformity

Article 1 3 Classification of Pressure Equipment*

Article 1 4 Conformity assessment procedures*

Article 1 5 European approval for materials*

Article 1 6 User inspectorates

Article 1 7 EU declaration of conformity

Article 1 8 General principles of the CE Marking*

Article 1 9 Rules and conditions for affixing the CE marking*

CHAPTER 4 NOTIFICATION OF CONFORMITY AS S ES S MENT B ODIES

Article 20 Notification

Article 21 Notifying authority

Article 22 Requirements relating to notifying authorities

Article 23 Information obligation on notifying authorities

Article 24 Requirements relating to notified bodies and recognized third party organizations

Article 25 Requirements relating to user inspectorates

Article 26 Presumptions of conformity of conformity assessment bodies

Article 27 S ubsidiaries of and subcontracting by conformity assessment bodies

Article 28 Application for notification

Article 29 Notification procedure

Article 3 0 Identification numbers and lists of notified bodies

Article 3 1 Lists of recognized third-party organizations and user inspectorates

Article 3 2 Changes to notification

Article 3 3 Challenge of the competence of notified bodies, recognized third party organizations, and user

inspectorates

Article 3 4 Operational obligations of notified bodies, user inspectorates, and recognized third party

organizations

Article 3 5 Appeal against decisions of notified bodies, recognized third party organizations, and user

inspectorates

Article 36 Information obligation of notified bodies, recognized third party organizations, and user

inspectorates

Article 3 7 Exchange of experience

Article 3 8 Coordination of notified bodies, recognized third party organizations, and user inspectorates

CHAPTER 5 UNION MARKET S URVEILLANCE, CONTROL OF PRES S URE EQUIPMENT AND AS S EMB LIES

ENTERING THE UNION MARKET, AND UNION S AFEGUARD PROCEDURES

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Article 3 9 Union market surveillance and control of pressure equipment and assemblies entering the Union

market

Article 40 Procedure for dealing with pressure equipment or assemblies presenting risk at national level

Article 41 Union safeguard procedure

Article 42 Compliant pressure equipment or assemblies which present a risk

Article 43 Formal non-compliance

CHAPTER 6 COMMITTEE PROCEDURE AND DELEGATED ACTS

Article 44 Committee procedure

Article 45 Delegated power

Article 46 Exercise of the delegation

CHAPTER 7 TRANS ITIONAL AND FINAL POS ITIONS

Article 47 Penalties

Article 48 Transitional provisions

Article 49 Transposition*

Article 5 0 Repeal

Article 5 1 Entry into force and application

Article 5 2 Addresses

ANNEXES
Annex I Essential S afety Requirements*

Annex II Conformity Assessment Tables*

Annex III Conformity Assessment Procedures*

Annex IV EU Declaration of Conformity

Annex V Part A: Repealed Directive with list of the successive amendments thereto

Part B : Time limits for transposition into national law and date of application

Annex VI Correlation (of this Directive and Directive 97/23 /EC)

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APPENDIX C: FLOWCHART FOR PRESSURE EQUIPMENT DIRECTIVE (201 4/68/EU)

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APPENDIX D: PED EXCLUSIONS


(ARTICLE 1-§2 OF THE PED)

(1) pipeline for conveyance of fluids

(2) water network

(3) simple pressure vessels (201 4/29/EU)

(4) aerosol dispenser (75 /3 24/EEC)

(5) equipment for functioning of vehicles

(6) equipment classified as no higher than Category I under Article 1 3 and covered by one of the

Directives listed in Article 1 - § 2(f) of Directive 201 4/68 /EU.

(7) equipment of Article 3 46 of the Treaty

(8) equipment designed for nuclear use

(9) equipment used in petroleum, gas, or geothermal exploration or extraction

(1 0) equipment comprising casings or machinery, where pressure is not a significant factor, including

engines, turbines, internal combustion engines, compressors, pumps, actuating devices, etc. )

(11) blast furnace

(12) enclosure for high-voltage electrical equipment

(13) pressurized pipe for electrical power and telephone cable

(14) ship, rocket, aircraft, off-shore

(15) tire, flexible casing

(16) exhaust and inlet silencer

(17) bottle or can for carbonated drinks

(18) vessel for drinks PS . V ≤ 5 00 bar L and P ≤ 7 bar


(19) equipment covered by Directive 2008 /68 /EC and Directive 201 0/3 5 /EU and equipment for carriage

of dangerous goods

(20) radiator and pipe in warm heating system

(21) vessel contained liquid with a gas pressure above the liquid ≤ 0. 5 bar

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APPENDIX E: GRAPHS FOR HAZARD CATEGORIES


The following graphs reproduce those given in the PED (Annex II, Tables 1 through 9), with correction of

the errors.

GENERAL NOTE: Exceptionally, vessels intended to contain an unstable gas and falling within categories I or II on the basis of PED Table

1 shall be classified in category III.

TABLE 1 VESSELS CONTAINING GROUP 1 GAS

(PED Table 1, Vessels referred to in Article 4(1)(a)(i), first indent)

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GENERAL NOTE: Exceptionally, portable extinguishers and bottles for breathing equipment shall be class ified

at leas t in category III.

TABLE 2 VESSELS CONTAINING A GROUP 2 GAS

(PED Table 2, Vessels referred to in Article 4(1)(a)(i), second indent)

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TABLE 3 VESSELS CONTAINING A GROUP 1 LIQUID

(PED Table 3, Vessels referred to in Article 4(1)(a)(ii), first indent)

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GENERAL NOTE: Exceptionally, ass emblies intended for generating warm water as referred to in the second indent of

Article 4(2), shall be subj ect either to an EU design examination (Module B - Design Type) with respect to their

conformity with the ess ential requirements referred to in Sections 2. 10, 2. 11 , 3 . 4, 5 (a), and 5 (d) of Annex I, or to full

quality ass urance ( Module H) .

TABLE 4 VESSELS CONTAINING A GROUP 2 LIQUID

(PED Table 4, Vessels referred to in Article 4(1)(a)(ii), Second indent)

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GENERAL NOTE: Exceptionally, the des ign of press ure- cookers s hall be subj ect to a conformity as ses s ment procedure

equivalent to at leas t one of the category III modules .

TABLE -5 BOILERS

(PED Table 5, Pressure Equipment referred to in Article 4(1)(b))

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GENERAL NOTE: Exceptionally, piping intended for unstable gases and falling within categories I or II on the bas is of PED Table

6 shall be class ified in category III.

TABLE 6 PIPING CONTAINING A GROUP 1 GAS

(PED Table 6, Piping referred to in Article 4(1)(c)(i), first indent)

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GENERAL NOTE: Exceptionally, all piping containing fluids at a temperature greater than 3 5 0° C and falling within category II on the basis

of PED Table 7 shall be classified in category III.

TABLE 7 PIPING CONTAINING A GROUP 2 GAS

(PED Table 7, Piping referred to in Article 4(1)(c)(i), second indent)

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TABLE 8 PIPING CONTAINING A GROUP 1 LIQUID

(PED Table 8, Piping referred to in Article 4(1 )(c)(ii), first indent)

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TABLE 9 PIPING CONTAINING A GROUP 2LIQUID

(PED Table 9, Piping referred to in Article 4(1 )(c)(ii), second indent)

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APPENDIX F: MANUFACTURERS AND NOTIFIED BODIES


ACTIVITIES OF MANUFACTURERS AND NOTIFIED BODIES IN ACCORDANCE
WITH CONFORMITY ASSESSMENT PROCEDURES
Manufacturer and Notified Body Activities in Relation to Hazard
Categories and Conformity Assessment Procedures
Hazard Categories

I II II II III III III IV IV

Procedures

Range of Activities Operation A A2 D1 E1 B +F H B 1 +D G H1

Design
Design Contractual documents M M M M M M M M M

Design review M M M M M M M M M

Design approval … … … … NB … NB NB NB
(a) purchase specifications M M M M M M M M M

(b) subcontracting specifications (including M M M M M M M M M

accessories)

Production technical Check

specifications

(a) forming procedures M M M M NB M NB NB NB

(b) welding procedures M M M M NB M NB NB NB

(c) testing procedures M M M M NB M NB NB NB

Issue of EC design-examination certificate … … … … NB … NB … NB


Materials and Subcontracting
Inspection at material Attendance when sampling intended to make NA NA NA(1 )

m anufacturer’s factory specimens.

Attendance during tests and destructive

testing.

Non-destructive Check the validity of operator approvals that M M M M NB M M NB M/NB

testing of materials at NDT reports are issued, and that results (2)

material conform to the purchase specifications.

m anufacturer’s factory
Acceptance Check that information and test results M M M M NB M M NB M/NB

certificates for base recorded in the inspection documents (2)

materials conform to the purchase specifications.

Acceptance Check that information and test results M M M M NB M M NB M/NB

certificates for welding recorded in the inspection documents (2)

consumables conform to the purchase specifications.

Check of products on (a) Check that M M M M NB M M NB M/NB

stock (1 ) satisfying inspection documents are (2)

issued

(2) information and test results, recorded in

the

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Manufacturer and Notified Body Activities in Relation to Hazard


Categories and Conformity Assessment Procedures
Hazard Categories

I II II II III III III IV IV

Procedures

Range of Activities Operation A A2 D1 E1 B +F H B 1 +D G H1

inspection documents, comply with the

requirements of the Code.

(b) When additional tests and testing are to M M M M NB M M NB M/NB

be conducted, the following items apply:

(1 ) attendance when sampling intended to

make

specimens

(2) attendance during tests and testing


(3 ) check of test and testing reports

Identification of (a) Check that the product identification and M M/NB M M M M NB M/NB

products marking conform to the specification and (3 ) (2)

(traceability) inspection documents in accordance with the


provisions of M1 . 9.

(b) Check the permanent identification M M/NB M M M M NB M/NB

procedure and transfer of marking during the (3 ) (2)

fabrication is in accordance with the

provisions of F1 . 2. 2.

Acceptance of S ame works as those performed for S ee activities related to corresponding works.

subcontracted components carried out by the

components Manufacturer.

Works Prior to Welding


Welding procedure Check M M/NB M M NB M NB NB M/NB

specifications (a) of the validity of the welding procedure (3 )(4) (4) (4) (4) (4) (4) (4)
(4)
specification approved for the j oint under

consideration

(b) that the welding procedure specification

is within the scope of the welding procedure

approval

Welding procedure Check that the welding procedures have M M/NB M M NB M NB NB M/NB

approvals been approved in accordance with the (3 )(4) (4) (4) (4) (4) (4) (4)
(4)
provisions of Annex FA2.

Welders and operators Check M M/NB M M NB M NB NB M/NB

approvals (a) that the welders and operators have been (3 )(4) (4) (4) (4) (4) (4) (2)(4)
(4)
approved in accordance with the provisions

of F1 . 4. 2

(b) the validity in time of approvals

(c) the validity of the approval for the j oint

under consideration

Supervision During Fabrication


Instructions Check that instructions for fabrication and M M M M M/NB M M M/NB M

testing applicable to the poste de travail are

issued.

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Manufacturer and Notified Body Activities in Relation to Hazard


Categories and Conformity Assessment Procedures
Hazard Categories

I II II II III III III IV IV

Procedures

Range of Activities Operation A A2 D1 E1 B +F H B 1 +D G H1

S upervision during Check that instructions for fabrication and M M M M M/NB M M M/NB M

fabrication testing are suitably applied. In particular,

visual examination of welds before back

welding and when completed.

Destructive Testing of Welded Joints on Specimens


Performance of (a) Attendance when sampling specimens M M M M NB M M NB M

specimens and stamping.

(b) Check of post-welding heat treatments M M M M NB M M NB M/NB

carried out independently of the vessel. (2)

Non-destructive Examination of radiographs or attendance to M M M M NB M M NB M/NB

testing of specimens ultrasonic examination. (3 )

Mechanical tests (a) S tamping of specimens intended to M M M M NB M M NB M

mechanical tests.

(b) Attendance to mechanical tests. M M M M NB M M NB M/NB

(3 )

Testing and test reports Examination of testing and test reports M M/NB M M NB M M NB M/NB

drawn up by the manufacturer. (3 )

Non-destructive Testing of Welded Joints


Instructions and Check that M M/NB M M NB M NB NB NB

procedures (a) instruction and NDT procedure drawn up (3 ) (2)

by the Manufacturer are issued and comply

with the Code requirements

(b) the drafter is competent M M/NB M M NB M NB NB NB

(3 ) (2)

Testing operators Check that the testing operators are M M/NB M M NB M NB NB NB

approved. (4) (4) (4) (4) (2)(4)

Non destructive testing (a) Examination of radiographs M M M M M/NB M M M/NB M

(b) Attendance to examination other than

radiographic

Examination

Testing reports Examination of testing and test reports M M/NB M M NB M M NB M/NB

drawn up by the Manufacturer. (3 ) (2)

Acceptance of the Vessel


Technical Examination of the technical documentation M M M M NB M M NB M

documentation

Calibration of Random examination of calibration reports M M M M NB M M NB M

measuring devices related to measuring devices used for

strength test, dimensional check, and other

testing and tests.

Examination of the Visual examination of all accessible parts of M M/NB M M NB M/NB M NB M/NB

completed vessel the vessel prior to strength test and possible (3 ) (3 ) (3 )

lining or painting.

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Manufacturer and Notified Body Activities in Relation to Hazard


Categories and Conformity Assessment Procedures
Hazard Categories

I II II II III III III IV IV

Procedures

Range of Activities Operation A A2 D1 E1 B +F H B 1 +D G H1

S trength test (a) Check that test instructions are issued. M M/NB M M NB M/NB M NB M/NB

(3 ) (3 ) (3 )

(b) Attendance to tests, visual examination M M/NB M M NB M/NB M NB M/NB

of the vessel during and after the tests. (3 ) (3 ) (3 )

(c) Check of nameplate marking M M/NB M M NB M/NB M NB M/NB

(3 ) (3 ) (3 )

Vessel acceptance (a) Issue inspection and strength test M M M M M M M M M

certificate.

(b) Certificates of conformity to Directive M M M M M M M M M

Documents to be Examination of construction and M M/NB M M NB M M NB M/NB

available manufacturer documentation, and check that (3 )(6) (3 )

they comply with the Code requirements.

CE marking (5 ) M M M M M M M M M

Certificate of conformity … … … … NB … NB …
Affixing of the Notified B ody identification … M/NB M M M/NB M/NB M M/NB M/NB

number (5 ) (3 ) (3 )

GENERAL NOTES :

NB : Notified B ody 1 00%,

M: Manufacturer 1 00%,

M/NB : Manufacturer 1 00%, Notified B ody: random ass ess ment on the basis of his knowledge of the Manufacturer quality system (if applicable), or of procedures in force.

The Conformity Assessment Procedure B 1 no longer exists in Directive 201 4/68 /EU. The following conformity assess ment procedures are used In Table V-2-1 :

B : Conformity Ass essment Procedure B – Production Type, and


B 1 : Conformity Assess ment Procedure B – Design Type.

NOTES :

(1 ) These are activities if the material Manufacturer does not apply a quality assurance system.

(2) This may performed during final assess ment.

(3 ) Performed by unexpected visits of the Notified B ody.

(4) Approvals are witnessed by a recognized Third Party or by a Notified B ody.

(5 ) For the user ins pectorate activity, there is no CE marking nor stamping of identification number.

(6) The Notified B ody must perform or must have performed the final assess ment for each equipment for the following:

(a) vessels and equipment of hazard category III fired or heated with the risk of overheating intended for generation of steam or super-heated water at temperatures

higher than 1 1 0 ⁰ C having a volume greater than 2L

(b) pressure cookers, serially constructed in accordance with the procedure of the module H, for unit production using confor mity assess ment procedure H

For this purpose, the Manufacturer must submit to the Notified B ody the proj ect of production program.

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APPENDIX G: DECLARATION OF CONFORMITY


The EU declaration of conformity shall contain the following:

1 . Pressure equipment or assembly (product, type, batch or serial number) .

2. Name and address of the manufacturer and, where applicable, his authorized representative.

3 . This declaration of conformity is issued under the sole responsibility of the manufacturer.

4. Obj ect of the declaration (identification of pressure equipment or assembly allowing traceability; it may, where

necessary for the identification of the pressure equipment or assembly, include an image):

— description of the pressure equipment or assembly,


— conformity assessment procedure followed,
— in the case of assemblies, description of the pressure equipment constituting the assembly, and the conformity

assessment procedures followed.

5 . The obj ect of the declaration described above is in conformity with the relevant Union harmonization legislation.

6. References to the relevant harmonized standards used or references to the other technical specifications in relation

to which conformity is declared.

7. Where appropriate, the name, address, and number of the notified body which carried out the conformity assessment

and the number of the certificate issued, and a reference to the EU-type examination certificate – production type, EU-
type examination certificate – design type, EU design examination certificate or certificate of conformity.

8 . Additional information:

S igned for and on behalf of

(place and date of issue)

(name, function) (signature)

(where appropriate, particulars of the signatory authorized to sign the legally binding declaration for the

manufacturer or his authorized representative).

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APPENDIX H: RESPONSIBILITIES OF THE MANUFACTURER


1.1 MANUFACTURER
(a) A manufacturer, in the meaning of New Approach, is the person who is responsible for designing and

manufacturing a product with a view of placing it on the Community market on his or her own behalf.

(b) The manufacturer has an obligation to ensure that a pro duct intended to be placed on the Community

market is designed and manufactured, and its conformity assessed, to the essential requirements in

accordance with the provisions of the applicable New Approach directive(s).

(c) The manufacturer may use finished products, ready-made parts or components or may subcontract tasks.

However, the manufacturer must always retain overall control and have the necessary competence to take

the responsibility for the product.

(d) The manufacturer is any natural or legal person who is responsible for designing or manufacturing a
*
product with a view of placing it on the Community market under his or her own name. The responsibilities

of the manufacturer apply also to any natural or legal person who assembles, packs, processes, and/or labels

readymade products with a view to their being placed on the Community market under his or her own name.

Furthermore, the responsibility of the manufacturer is placed on any person who changes the intended use

of a product in such a way that the different essential requirement will become applicable, or substantially

modify or rebuild a product, thus creating a new product, with a view of placing it on the Community

market.

(e) The manufacturer may design and manufacture the product. As an alternative, the manufacturer may

have it designed, manufactured, assembled, packed, processed, and/or labeled with a view of placing it on

the Community market under his or her own name, thus being presented as a manufacturer. Where

subcontracting takes place, the manufacturer must retain the overall control for the product and ensure

receipt of all the information that is necessary to fulfill the manufacturer’ s responsibilities according to New
Approach directives.

(f) The manufacturer who subcontracts some or all activities may in no circumstances discharge himself

from responsibilities (e. g. , to an authorized representative, a distributor, or retailer, a wholesaler, a user, or

a subcontractor).

(g) The manufacturer has sole and ultimate responsibility for conformity of the product to the applicable

directives. The manufacturer is responsible for

(1 ) designing and manufacturing the product in accordance with essential requirements laid down by the

directive(s)

(2) carrying out conformity assessment in accordance with the procedure(s) laid down by the

directive(s).

(h) The manufacturer is obliged to understand both the design and construction of the product to be able to

take the responsibility for the product [i. e. , for its being in compliance with all the provisions of the relevant

New Approach directive(s)] . Regarding conformity assessment, the manufacturer’ s responsibility depends
on the procedure applied. As a general rule, the manufacture must take all measures necessary to ensure

that the manufacturing process assures compliance of the products (e. g. , to operate a quality system), to

affix the CE marking to the product, to establish a technical documentation, and to draw up EC declaration

of conformity. Depending on the directive, the manufacturer may be required to submit the product to a

third party (usually a notified body) for product testing and certification, or to have the quality system

certified by a notified body. In addition, several directives set up complementary obligations (e. g. , the

requirement to accompany the product with specified information).

*
The manufacturer is not defined in the New Approach directives, with the exemption of the directives relating to medical devices

and in vitro diagnostic medical devices.



For responsibilities of manufacturers and notified bodies according to each conformity assessment procedure, see Chapter V, p ara.

4 and Appendix G of this Guide.

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(i) Directives usually require that the manufacturer is identified on the product. However, sometimes it is

not possible to identify the person who, in reality, was in charge of designing and manufacturing the

product.

In certain sectors this does not reduce the responsibilities of the person who placed the product on the

Community market (e. g. , any natural or legal person who imports a product from a third country with a view

of placing it on the Community market) . Accordingly, this person must ensure that the product complies

with the applicable directives, and that the appropriate conformity assessment procedure has been
§
conducted.

(j) A product may be put into service without prior placing on the market (e. g. , a product manufactured for

own use). In such a case the person who puts the product into service must assume the responsibility of the

manufacturer. Accordingly, this person must ensure that the product complies with the directive, and that

the appropriate conformity assessment has been conducted.

(k) New approach directives do not require the manufacturer to be established in the community. Thus, the

responsibilities of the manufacturer established outside the community are equal to those of the

manufacturer established in a Member S tate.


S ee the applicable directives.
§
This has explicitly been laid down in the directives relating to machinery and lifts. According to article 8 (6) of the lift directive,

regulations regarding the conformity assessment procedure fall to any person placing the product on the market in the Community,

where neither the manufacturer nor his authorized representative established in the Community or the installer of the lift fulfills

these obligations.

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1.2 PLACING ON THE MARKET AND PUTTING INTO SERVICE


(a) A product must comply with the applicable New Approach directives when it is placed on the Community

market for the first time or put into service.

(b) Placing on the market is the initial action of making a product available for the first time on the

Community market, with a view to distribution and/or use in the Community. Availability can be either for

payment or free of charge.

(c) Placing into service takes place at the moment of first use within the Community by the end user.

However, the need to ensure, in the framework of market surveillance, that products are in compliance with

the provisions of the directive when being put into service is limited to products, which are not directly

ready for use at the stage of placing on the market, whose compliance may be influenced by the distribution

conditions, and/or which are not placed on the market prior to putting into service.

1.2.1 Placing on the Market**

(a) New Approach directives are designed to ensure free movement of products that comply with the high

level of protection laid down in the applicable directives. Therefore, Member S tates may not prohibit,

release, or impede the placing on the market of such products. However, Member S tates are allowed to

adopt, in compliance with the Treaty (e. g. , articles 3 0 and 3 6), additional national provisions regarding the
††
use, and which are intended for the protection of workers or other users, or the environment. S uch

national provisions may neither require modifications or a product manufactured in accordance with the

provisions of the applicable directives, nor influence the conditions for its placing on the Community

market.

(b) A product is placed on the Community market when it is made available for the first time. This is

considered to take place when the product is transferred (or offered to be transferred) from the stage of

manufacture with the intention of distribution and/or use on the Community market. Moreover, the concept

of placing on the market refers to each individual product, not to a type of product, and whether it was

manufactured as an individual unit or in series.

(c) The transfer of the product takes place either from the manufacturer, or the authorized representative

in the Community, to the importer established in the Community, or to the person responsible for

distributing the product on the Community market. The transfer may also take place directly from the

manufacturer, or the authorized representative in the Community, to the final consumer or user.

1.2.2 Putting into Service


Putting into service takes place at the moment of the first use within the Community by the end user.

Products must comply with the provisions of the applicable New Approach directives and other

Community legislation when they are put into service.

1.3 USER
‡‡
(a) New Approach directives do not lay down obligations for users.

(b) Community legislation concerning the health and safety of the workplace has an impact on the

maintenance and use of products covered by New Approach directives that are used at the workplace.

**
Placing on the market has only been defined in very few sentences.
††
S ee references in the directives relating to simple pressure vessels, construction products, machinery, personal protective

equipment, potentially explosive atmospheres, recreational craft, lifts , and pressure equipment. This may also become applicable

in sectors covered by other directives.


‡‡
As an exemption, according to the directive on pressure equipment, Member S tates may, under certain conditions, authorize in

their territory, the placing on the market, and the putting into service by users.

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(c) Many products covered by New Approach directives are used at the workplace. Employers have

obligations regarding the use of work equipment in the workplace. An employer is considered any natural

or legal person who has an employment relationship with a worker (i. e. , any person employed by an

employer) and has responsibility for the undertaking and/or establishment.

(d) According to the directive concerning minimum safety and health requirements for the use of work

equipment by workers at work (2009/1 04/EC), the employer must take all measures necessary to ensure

that work equipment (e. g. , machinery and apparatus) is available to the workers suitable for the work

carried out, and may be used by the workers without impairment to their safety or health. The employer

may only obtain and/or use work equipment that complies with the provisions of the applicable directives,

or, if no other directive is applicable or is so only partially, the minimum requirements laid down in the

annex apply to the directive 8 9/65 5 /EEC. The employer must also take the necessary measures to ensure

that the work equipment is kept at such a level. Furthermore, the employer has an obligation to provide

information and training for workers as regards the use of work equipment.

(e) According to the directive concerning the minimum health and safety requirements for the use of

personal protective equipment by workers in the workplace (8 9/65 6/EEC), such equipment must comply

with the relevant Community provisions on design and manufacture with respect to safety and health (i. e. ,

the New Approach directive relating to personal protective equipment). Furthermore, the equipment must

be appropriate for the risk involved, correspond to existing conditions at the work place, take into account

ergonomic requirements and the worker’ s state of health, fit the wearer correctly, and be compatible where

more than one equipment must be used simultaneously. The employer is required, before choosing the

personal protective equipment, to assess that it satisfies the requirements.

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APPENDIX I: SIMULTANEOUS APPLICATION OF EUROPEAN DIRECTIVES


(a) Essential Requirements set up by New Approach directives may overlap and/or complement each other,

depending on the risks related to the product in question.

(b) The placing on the market and putting into service can only take place when the product complies with

the provisions of all applicable directives, and when the conformity assessment has been carried out in

accordance with all applicable directives.

(c) Where the same product or risk is carried by two or more directives, the application of other directives

can sometimes be excluded, for instance following a risk analysis of the product.

(d) New approach directives cover a wide range of products and/or risks, which both overlap and

complement each other. As a result several directives may have to be taken into consideration for one

product, since the placing on the market and putting into service can only take place when the product

complies with all applicable provisions.

(e) Risks covered by the essential requirements of the directives concern different aspects that in many

cases complement each other (e. g. , the directive relating to machinery covers in particular mechanical

hazards, the directive relating to low voltage electrical hazards, and the directive relating to electromagnetic

compatibility, electromagnetic disturbance and immunity), which calls for a j oint application of the

directives. Accordingly, the product has to be designed and manufactured in accordance with all applicable

directives, as well as undergo the conformity assessment procedures according to all applicable directives,

unless otherwise provided for.

(f) Certain directives make a direct reference to require the application of other directives (e. g. , the

directives relating to machinery, and the directive relating to telecommunications terminal equipment to

the directive relating to low voltage equipment). Although such a reference has not been included in a

number of directives, the general principle of simultaneous application still applies where the essential

requirements of the directives are complementary to each other.

(g) The same product or risk can be covered by two or more directives. In such a case, the application of

other directives is often limited by excluding certain products from the field of application of the other

directives, or by giving preference to the more specified directive. This usually requires a risk analysis of

the product, or sometimes an analysis of the intended purpose of the product, which then determines the

applicable directive.

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