ISO 15759:200Amd1

ISO/TC 76 Secretariat: DIN

Voting begins on: Voting terminates on:

2003-04-17 2003-09-17
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION • МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ • ORGANISATION INTERNATIONALE DE NORMALISATION

Medical infusion equipment — Plastics caps with inserted

elastomeric liner for containers manufactured by the Blow-Fill-
Seal (BFS) process
AMENDEMENT 1
Matériel de perfusion à usage médical — Capsules plastiques avec un joint à base d'élastomère pour récipients
(flacons plastiques) produits par le procédé simultané d'extrusion/soufflage/remplissage (ESR)
AMENDEMENT 1

ICS 11.040.20

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THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS THEREFORE SUBJECT TO CHANGE AND MAY NOT BE
REFERRED TO AS AN INTERNATIONAL STANDARD UNTIL PUBLISHED AS SUCH.
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INTERNATIONAL STANDARDS MAY ON OCCASION HAVE TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN NATIONAL REGULATIONS.

© International Organization for Standardization, 2003

ISO 15759:2002/DAmd 1

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ii © ISO 2003 – All rights reserved

 ISO 15759:2002/DAM 1:200. (E)

Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO
member bodies). The work of preparing International Standards is normally carried out through ISO technical
committees. Each member body interested in a subject for which a technical committee has been established has
the right to be represented on that committee. International organizations, governmental and non-governmental, in
liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical
Commission (IEC) on all matters of electrotechnical standardization.

International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.

The main task of technical committees is to prepare International Standards. Draft International Standards adopted
by the technical committees are circulated to the member bodies for voting. Publication as an International
Standard requires approval by at least 75 % of the member bodies casting a vote.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights.
ISO shall not be held responsible for identifying any or all such patent rights.

ISO 15759 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment for
medical and pharmaceutical use.

The following version of Draft Amendment 1 to ISO 15759:2002 is now submitted to a new ISO enquiry.

© ISO 2003 — All rights reserved iii

DRAFT AMENDMENT ISO 15759:2002/DAM 1:200. (E)

Medical infusion equipment — Plastics caps with inserted

elastomeric liner for containers manufactured by the Blow-Fill-Seal
(BFS) process
DRAFT AMENDMENT 1

General

Replace in the overall text "marked area" by "target area".

Page 1

Delete ISO 8536-4:1998.

Add ISO 2230:1973 from Bibliography to clause 2 Normative references.

Page 4

Insert new Figure 3:

Key
1 Trimming edge max. Ø 30,2
a
Target area
Figure 3

© ISO 2003 — All rights reserved 1

ISO 15759:2002/DAM 1:200. (E)

Page 4

Clause 4.3: Replace text by "Compatibility of the drug with the liner shall be assessed by the user."

Page 5

Clause 5.1: Replace title by "Resistance to liquid penetrant".

Replace text by "When performing the leak test of the covered piercing area in accordance with annex H, no
leakage shall be observed."

Clause 6.3: Replace "two" by "seven".

Clause 6.5: Replace "20" by "15".

Clause 6.6: Replace title by "Static spike-retention capability of the liner and leaktightness of the piercing area".

After "4 h" insert "and the spike shall not fall out."

Clause 6.7: Replace text by "When doing the test in accordance with annex E no air shall escape."

Page 6

Clause 8: Replace text by "The liners shall fulfil the minimum requirements for type II materials in accordance with
ISO 8871-1."

Delete Table 1.

Clause 11: Replace text by "The plastics caps and liners shall be stored according to ISO 2230 and shall not be
exposed to UV radiation. Under these conditions they shall maintain compliance with the requirements of this
International Standard throughout a storage period agreed on between manufacturer and customer."

Page 7

Clause A.3.1: Replace text by "Autoclave ten liners at sterilization conditions agred on between manufacturer and
customer (typically 106 °C for 50 min or 121 °C for 30 min) and cool down to ambient temperature".
nd
Delete 2 paragraph.

Clauses A.4.4 and A. 4.5: Interchange clauses; in A.4.4. replace "A.4.4" by "A.4.3".

Page 8

Clause B.1: Delete "or ISO 8536-4".

Clause B.2.2: Delete "or ISO 8536-4".

Clause B.3: Replace text by "Autoclave ten liners at sterilization conditions agred on between manufacturer and
customer (typically 106 °C for 50 min or 121 °C for 30 min) and cool down to ambient temperature".
nd
Delete 2 paragraph.

Clause B.4.1: Replace text by "Degrease the spike with acetone, fix the spike to the fixture of the tensile testing
machine and place the liner in the holding device."

Clause B.4.3: Replace text by "Pierce the liner in the target area at a speed of 200 mm/min until the conical part of
the spike has gone through the liner."

2 © ISO 2003 — All rights reserved

 ISO 15759:2002/DAM 1:200. (E)

Clause B.4.4: Replace text by "Measure the maximum force, with a tolerance of ± 2 N as indicated in Figure B.1".

Insert new Figure B.1:

Key
1 Maximum force
2 Piercing force
Figure B.1 – Force penetration diagram

Insert new Clause B.4.5: "Repeat B.4.1 to B.4.4 with the remaining liners."

Clause B.5.1: Replace "tests" by "measurements".

Clause B.5.2: Delete "State the type of spike used".

Page 9

Clause C.1: Delete "or ISO 8536-4".

Clause C.3: Replace text by "Autoclave ten liners at sterilization conditions agreed on between manufacturer and
customer (typically 106 °C for 50 min or 121 °C for 30 min) and cool down to ambient temperature".
nd
Delete 2 paragraph.

Clause C.4.1: Replace "Fix the spike to the piercing device" by "Degrease the spike with acetone and".

Clause C.4.2: Insert "all the way through" after "liner".

Clause C.4.4: Replace "minimum" by "maximum".

Clause C.4.5: Replace "C.4.3" by "C.4.4".

© ISO 2003 — All rights reserved 3

ISO 15759:2002/DAM 1:200. (E)

Clause C.5.1: Replace "tests" by "measurements".

Clause C.5.2: Delete "State the type of spike used."

Page 10

Clause D.1: Delete "or ISO 8536-4".

Clause D.2.2: Delete "or ISO 8536-4".

Clause D.3: Replace text by "Autoclave ten liners at sterilization conditions agreed on between manufacturer and
customer (typically 106 °C for 50 min or 121 °C for 30 min) and cool down to ambient temperature".
nd
Delete 2 paragraph.

Clause D.4.1: Replace text by "Degrease the spike with acetone, fill the liner holding device with water and place
the liner in the holding device". Delete "If a spike is ... to testing".

Clause D.4.2: Insert "all the way through" after "liner".

Clause D.5.2: Delete "State the type of the spike used".

Page 11

Clause E.3: Replace text by "Autoclave ten liners at sterilization conditions agreed on between manufacturer and
customer (typically 106 °C for 50 min or 121 °C for 30 min) and cool down to ambient temperature".
nd
Delete 2 paragraph.

Clause E.4.2: Replace text by "Holding the hypodermic needle perpendicular to the liner, pierce the liner target
area in three different locations using the same needle."

Clause E.4.5: Replace text by "Repeat E.4.1 to E4.4 with the remaining liners using a new hypodermic needle for
each liner."

Page 13

NOTE: Delete "or ISO 8536-4."

Page 14

Annex H, title: Replace by "Resistance to liquid penetration"

Clause H.3: Replace text by "Autoclave ten liners at sterilization conditions agreed on between manufacturer and
customer (typically 106 °C for 50 min or 121 °C for 30 min) and cool down to ambient temperature".
nd
Delete 2 paragraph.

Clause H.4.1: Replace text by "Carefully remove the liners from the ten caps and cover the piercing with area with
penetrant."

Clause H.4.4: Delete

Clause H.5: Delete "from ten tests."

4 © ISO 2003 — All rights reserved

 ISO 15759:2002/DAM 1:200. (E)

Page 15

Clause I.1: Insert "the lid of" after "remove".

Clause I.3: Replace text by "Autoclave ten liners at sterilization conditions agreed on between manufacturer and
customer (typically 106 °C for 50 min or 121 °C for 30 min) and cool down to ambient temperature".
nd
Delete 2 paragraph.

Clause I.4.2: Replace "cap" by "lid".

Clause I.5: Replace "tests" by "measurements".

Page 16

Delete clause "Bibliography".

© ISO 2003 — All rights reserved 5