BS EN 1865-3:2012+A1:2015

BS EN 1865-3:2012

BSI Standards Publication

Patient handling equipment

used in road ambulances
Part 3: Heavy duty stretcher
BS EN 1865-3:2012+A1:2015 BRITISH STANDARD

National foreword
This British Standard is the UK implementation of
EN 1865-3:2012+A1:2015. It supersedes BS EN 1865-3:2012, which is
withdrawn.
The start and finish of text introduced or altered by amendment is
indicated in the text by tags. Tags indicating changes to CEN text carry
the number of the CEN amendment. For example, text altered by CEN
amendment A1 is indicated by .
The UK participation in its preparation was entrusted to Technical
Committee CH/239, Rescue systems.
A list of organizations represented on this committee can be obtained
on request to its secretary.
This publication does not purport to include all the necessary provisions
of a contract. Users are responsible for its correct application.
© The British Standards Institution 2015.
Published by BSI Standards Limited 2015
ISBN 978 0 580 86228 1
ICS 11.160
Compliance with a British Standard cannot confer immunity from
legal obligations.
This British Standard was published under the authority of the Standards
Policy and Strategy Committee on 30 June 2012.
Amendments/corrigenda issued since publication
Date Text affected
31 March 2015 Implementation of CEN amendment A1:2015
EUROPEAN STANDARD EN 1865-3:2012+A1
NORME EUROPÉENNE
EUROPÄISCHE NORM March 2015

ICS 11.160 Supersedes EN 1865-3:2012

English Version

Patient handling equipment used in road ambulances - Part 3:

Heavy duty stretcher

Equipement d'ambulances pour le transport de patients - Krankentransportmittel im Krankenkraftwagen - Teil 3:

Partie 3 : Brancard bariatrique Schwerlastkrankentrage

This European Standard was approved by CEN on 10 May 2012 and includes Amendment 1 approved by CEN on 20 December 2014.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same
status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.

EUROPEAN COMMITTEE FOR STANDARDIZATION

COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels

© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 1865-3:2012+A1:2015 E
worldwide for CEN national Members.
BS EN 1865-3:2012+A1:2015
EN 1865-3:2012+A1:2015 (E)
EN 1865-3:2012+A1:2015 (E)

Contents Page

Foreword ..............................................................................................................................................................3
Introduction .........................................................................................................................................................5
1 Scope ......................................................................................................................................................6
2 Normative references ............................................................................................................................6
3 Terms and definitions ...........................................................................................................................6
4 Requirements .........................................................................................................................................7
4.1 General ....................................................................................................................................................7
4.2 Dimensions .............................................................................................................................................7
4.3 Mass ........................................................................................................................................................8
4.4 Loading capacity....................................................................................................................................8
4.5 Frame ......................................................................................................................................................8
4.5.1 General ....................................................................................................................................................8
4.5.2 Stretcher parts .......................................................................................................................................8
4.5.3 Undercarriage.........................................................................................................................................8
4.5.4 Power source .........................................................................................................................................9
4.6 Restraint systems ..................................................................................................................................9
4.7 Flammability – toxicity burning gases ................................................................................................9
4.8 Deformation of the frame ......................................................................................................................9
4.9 Fixation ................................................................................................................................................ 10
4.10 Deformation of the lying area ............................................................................................................ 10
4.11 Resistance to torsion ......................................................................................................................... 10
4.12 Splaying of the wheels ....................................................................................................................... 10
5 Test methods....................................................................................................................................... 10
5.1 Permanent deformation of the frame ................................................................................................ 10
5.1.1 Stretcher frame ................................................................................................................................... 10
5.1.2 Undercarriage frame ........................................................................................................................... 11
5.2 Fixation inside the ambulance .......................................................................................................... 11
5.3 Permanent deformation of the lying area ......................................................................................... 11
5.4 Resistance to twisting/torsion ........................................................................................................... 12
5.5 Splaying of the wheels ....................................................................................................................... 12
6 Marking ................................................................................................................................................ 12
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical Devices ...................................................... 13
Bibliography ..................................................................................................................................................... 15

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Foreword

This document (EN 1865-3:2012+A1:2015) has been prepared by Technical Committee CEN/TC 239 “Rescue
systems”, the secretariat of which is held by DIN.

This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by September 2015, and conflicting national standards shall be
withdrawn at the latest by September 2015.

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

This document includes Amendment 1 approved by CEN on 20 December 2014.

!This document supersedes EN 1865-3:2012."

The start and finish of text introduced or altered by amendment is indicated in the text by tags !".

With respect to EN 1865:1999 the following changes were made:

a) it shall be possible to increase the width of the lying part to minimum of 750 mm;

b) the weight of the device was changed from 51 kg to maximum 65 kg;

c) the capacity was changed from 150 kg to minimum 250 kg;

d) the undercarriage, if power assisted, has no limits in height or in variable positions;

e) the power source of the stretcher was defined;

f) permanent deformation test of the frame shall be done with 400 kg instead of 250 kg and if the lateral
extensions are fitted 75 kg shall be evenly set on each extension;

g) permanent deformation test of the frame shall be done with 250 kg instead of 150 kg;

h) splaying of the wheels test shall be done with 400 kg instead of 250 kg;

i) the standard has been modified/integrated to meet the Medical Device Directive 93/42/EEC requirements

j) the standard has been modified/integrated to comply with the Machinery Directive 2006/42/EC and its
Essential Health and Safety Requirements (EHSRs).

This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive.

For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document.

!This European Standard is a part of EN 1865, Patient handling equipment used in road ambulances, which
consists of the following parts:

— Part 1: General stretcher systems and patient handling equipment;

— Part 2: Power assisted stretcher;

— Part 3: Heavy duty stretcher [the present document];

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— Part 4: Foldable patient transfer chair;

— Part 5: Stretcher support."

According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.

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EN 1865-3:2012+A1:2015 (E)

Introduction

In this European Standard, reference is made to !EN 1789:2007+A2:2014", which specifies design
requirements and test methods for road ambulances, which are relevant for checking requirements for such
handling equipment.

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1 Scope

This European Standard specifies minimum requirements for the design and performance of heavy duty
stretchers used in road ambulances for the treatment and transportation of patients. It aims to ensure patient
safety and minimize the physical effort required by staff operating the equipment.

2 Normative references

The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.

!EN 597-1:1994", Furniture — Assessment of the ignitability of mattresses and upholstered bed bases —
Part 1: Ignition source: Smouldering cigarette

!(deleted text)"

!EN 1041:2008+A1:2013", Information supplied by the manufacturer of medical devices

!EN 1789:2007+A2:2014", Medical vehicles and their equipment — Road ambulances

!EN 1865-1:2010", Patient handling equipment used in road ambulances — Part 1: General stretcher
systems and patient handling equipment

!EN 60601-1-2:2014, Medical electrical equipment — Part 1-2: General requirements for basic safety and
essential performance — Collateral Standard: Electromagnetic disturbances — Requirements and tests
(IEC 60601-1-2:2014)"

!EN 62366:2008, Medical devices — Application of usability engineering to medical devices

(IEC 62366:2007)"

!EN ISO 14971:2012, Medical devices — Application of risk management to medical devices
(ISO 14971:2007, Corrected version 2007-10-01)"

!EN ISO 15223-1:2012, Medical devices — Symbols to be used with medical device labels, labelling and
information to be supplied — Part 1: General requirements (ISO 15223-1:2012)"

3 Terms and definitions

For the purposes of this document, the following term and definition apply.

3.1
heavy duty stretcher
stretcher designed for the treatment and transportation of patients where the weight or dimensions of the
patient exceed those of the operating capability of the main stretcher

Note 1 to entry: The term "main stretcher" is defined in !EN 1865-1:2010".

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4 Requirements

4.1 General

Heavy duty stretchers shall be operated and maintained according to the instructions of the manufacturer.
Risks shall be reduced to an acceptable level by using risk management principles in accordance with
!EN ISO 14971:2012" in normal and single fault condition.

Heavy duty stretchers shall:

— be manually or power operated;

— guarantee a safe and smooth operation;

— be free of sharp edges or deformation that could cause damage to persons or other equipment on board;

— have patient restraint-systems available; these restraint-systems shall have quick release systems;

— immobilize the patient, but at the same time shall permit treatment of the patient;

— ensure that the lying-sitting part is made of a strong material, which is bacterial resistant, fungal resistant,
stain resistant, putrid resistant, easy to clean, washable and petrol-oil resistant.

The heavy duty stretcher shall be designed to transport patients with a weight that exceeds the load capacity
of the main stretcher in !EN 1865-1:2010".

It shall be designed so that during loading and unloading the maximum burden on any personnel is half of the
total weight of patient and stretcher and for the minimum possible time and in an optimal ergonomic position
so that back bending is minimized.

4.2 Dimensions

Dimensions shall be measured from the outermost edges.

— Stretcher part: length: +120

!(1 950 −50 )" mm

To accommodate tall patients it may be possible to increase the

length of the stretcher by a further 200 mm.
width: +60
!(550 ± −20 ) mm"

It shall be possible to increase the width of the lying part to a

minimum of 750 mm.
height: maximum 300 mm from loading holding assembly to unloaded lying
part. This height dimension does not apply to stretchers with
monoblock undercarriages. If a monoblock is not available, the
stretcher shall be constructed such that it is detachable from the
undercarriage. Where a stretcher support is used the measurement
shall be taken from the top surface of the stretcher support to the
lying part of the stretcher.
— Undercarriage: length and width of the frame of the undercarriage when located in the ambulance shall
not exceed length and width of the stretcher part.

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4.3 Mass

— Stretcher part: 23 kg
— Undercarriage including stretcher: !80 kg" max. (combined weight)
NOTE In all cases the mass should be as low as possible.

4.4 Loading capacity

The loading capacity shall be a minimum of 250 kg.

4.5 Frame

4.5.1 General

The frame shall be in sturdy lightweight non twisting construction enabling use of cardiopulmonary
resuscitation. All corners of the frame shall be radiused for greater safety.

It shall be possible to lock and secure the stretcher against lateral, longitudinal, vertical and oblique
movements.

All mechanisms shall be constructed to prevent damage to the user and the patient.

4.5.2 Stretcher parts

a) If side rails are mounted, they shall have a minimum length of 500 mm and a height between 150 mm and
200 mm measured from the top of the stretcher frame to the top of the side rail.

b) If longitudinal handles are incorporated they shall be fitted to the ends of the longitudinal frame such that
they lock and do not twist when they are stowed or in use. They shall be designed to minimise the risk of
injuries to the hands and wrists when being operated or the stretcher is carried at angles. It shall allow the
fixation and use of a carrying harness.

c) The stretcher shall have either a water and scratch resistant paint finish or be manufactured of corrosion
resistant material. Both versions shall be unaffected by disinfectants.

d) If intended to be used without undercarriage there shall be 4 wheels with a minimum diameter of 100 mm
suitably placed to ensure stability.

e) If intended to be used with undercarriage the stretcher shall be able to be fixed to the undercarriage
without using supplementary means. A safe handling and lowering of the undercarriage shall be ensured.

f) The fixed stretcher shall be easy to release from the stretcher fastener or the undercarriage.

NOTE There should be a facility to attach a support for infusion.

4.5.3 Undercarriage

a) The undercarriage shall be fitted with 4 wheels with a diameter of at least 100 mm. At the foot end there
shall be a minimum of two wheels that swivel 360 degrees and at least two wheels shall be fitted with a
brake.

b) The undercarriage shall be designed for loading and unloading at a maximum height of 750 mm.

c) For manual undercarriages, these shall have a simple mechanism for height adjustment and shall have a
minimum of 2 levels (car position and fully unfolded).

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d) For power assisted undercarriages, these shall have variable height between the lowest and upper
position and be able to hold the rated load capacity in any position.

e) The supporting mechanism shall automatically stay in place when fully unfolded.

The operating controls shall be ergonomically designed to take into consideration human body
dimensions, physical strength and anatomical and physiological requirements of human beings. The
operating controls shall be clearly and permanently labelled, preferably with graphical symbols, indicating
their positions and settings. If the controls can initiate movements which could be dangerous to persons,
they shall be secured against unintentional operation.

All functions of the stretcher shall remain completely unimpaired when it is connected to the
undercarriage.

f) The undercarriage shall have a water and scratch resistant paint finish or be manufactured of corrosion
resistant material. Both shall be unaffected by disinfectants.

g) If the undercarriage is used with a detachable stretcher it shall be possible either to connect or disconnect
them. The stretcher shall be secured in such a manner that unintentional separation of undercarriage and
stretcher cannot occur. It shall be possible to load and unload the undercarriage and stretcher to ensure
the safety and comfort of the patient and the operators.

4.5.4 Power source

a) The undercarriage height adjustment mechanism shall have an integral safety feature to prevent stretcher
collapsing in the event of failure (stretcher to lower at a controlled rate). If a battery is required to power
the lifting mechanism then an override system shall be provided to allow the stretcher to be used
manually.

b) If a battery is fitted it shall be supplied with a facility to charge from both the vehicle DC voltage or from an
external AC power supply. The system shall also indicate the battery power condition.

If electrical and electronic items are used, and connected to the ambulance electrical circuits, these
should conform to the European Directive 2004/108/EC as amended. If they are connected to the
stretcher's internal power supply, then the electrical systems of the stretcher should conform to the
European Directive 2006/28/EC.

c) The operating controls shall be designed in accordance with the body dimensions, physical strength and
anatomical and physiological requirements of human beings. The operating controls shall be clearly and
permanently labelled, preferably with graphical symbols, indicating their positions and settings according
to !EN 60601-1-2:2014" and !EN 62366:2008".

4.6 Restraint systems

The stretcher shall have a minimum of two quick-release patient restraints capable of accepting a device for
restraining children.

4.7 Flammability – toxicity burning gases

There shall be no progressive smouldering or flaming ignition when tested in accordance with !EN 597-
1:1994".

4.8 Deformation of the frame

The frame shall not bend or break when tested in accordance with 5.1.

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4.9 Fixation

The requirement of the fixation shall be in accordance with !EN 1789:2007+A2:2014", 4.5.9. There shall
be no deformation of the fixation when tested in accordance with 5.2.

4.10 Deformation of the lying area

There shall be no remaining deformation of the lying area when tested in accordance with 5.3.

4.11 Resistance to torsion

There shall be no remaining deformation to torsion when tested in accordance with 5.4.

4.12 Splaying of the wheels

The wheels shall not splay more than 2 mm in total during the test specified in 5.5 and there shall be no
permanent deformation.

5 Test methods

5.1 Permanent deformation of the frame

5.1.1 Stretcher frame

Dimensions in millimetres

Figure 1 — Permanent bending deformation test of a heavy duty stretcher frame

For the test of permanent deformation (bending), the stretcher shall be positioned with the fully extended,
handles rested on support (see Figure 1). The test shall be performed on a flat firm ground.

The heavy duty stretcher shall be loaded evenly with 400 kg (e.g. 8 sandbags) according to Figure 1. Where
lateral extensions are fitted 75 kg of the load shall be evenly positioned on each of the extensions. The
sandbags shall not rest on the longitudinal bars.

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The extension mechanism used to adjust between the inner and outer positions, shall remain fully operational
when the sandbags are removed. There shall be no remaining deformation or defects to the mechanism.

5.1.2 Undercarriage frame

Following this test, the stretcher bearing the 400 kg load shall be moved so that one wheel collides frontally
with a 100 mm high, vertical and rigid obstacle at a speed of 4 km/h.

Unload and examine for deflections and/or failures.

5.2 Fixation inside the ambulance

The requirement of the fixation shall be in accordance with !EN 1789:2007+A2:2014, 4.5.9 and 5.4".

5.3 Permanent deformation of the lying area

Dimensions in millimetres

Figure 2 — Permanent deformation test of a heavy duty stretcher lying area

For the test of permanent deformation the stretcher shall be loaded with a sandbag of 250 kg according to
Figure 2.

Unload the lying area and examine for deflection and/or failures. There shall be no remaining deformation or
defects.

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5.4 Resistance to twisting/torsion

Dimensions in millimetres

Figure 3 — Testing against torsion of a heavy duty stretcher

To run the test on resistance against torsion the non-loaded stretcher shall be fixed at one end in the middle of
the completely pulled out handles, on the other side the longitudinal bars shall be laid on a test stand. At this
free end a lever shall be fitted out to the pulled out handles. The lever shall be loaded with 100 N according to
Figure 3.

The longitudinal bar shall lift itself from the surface of the test stand by max. 50 mm, measured from the upper
edge of the test stand to the lower edge of the longitudinal bar. No remaining deformation shall occur.

5.5 Splaying of the wheels

To carry out the splaying test of the wheels the stretcher/undercarriage shall be placed on a flat plane and
moved forward and backward 500 mm each. The stretcher shall be loaded evenly with 400 kg (e.g. with
8 sandbags).

6 Marking

The stretchers and other patient handling equipment covered by this European Standard shall be labelled in
accordance with !EN ISO 15223-1:2012"and !EN 1041:2008+A1:2013".

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Annex ZA
(informative)

Relationship between this European Standard and the Essential

Requirements of EU Directive 93/42/EEC on Medical Devices

This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 93/42/EEC on Medical Devices.

Once this standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.

Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC on
Medical devices

Clause(s)/sub-clause(s) of this Essential Requirements (ERs) Qualifying remarks/Notes

EN of Directive 93/42/EEC
4.5, 4.7 7.1 Covered as far as the first and
second indents are concerned
except for toxicity
4.1, 4.5.2 c), 4.5.3 f) 7.3
4 (all subclauses) 8.1
4 (all subclauses), 5 (all 9.2 Covered for the risk of injury in
subclauses) connection with physical features
4.7 9.3
4.5.4 b) 12.2
4 (all subclauses), 5 (all 12.7.1
subclauses)
6 13
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.

For devices which are also machinery within the meaning of Article 2(a) of Directive 2006/42/EC on
Machinery, in accordance with Article 3 of Directive 93/42/EEC the following Table ZA.2 details the relevant
essential health and safety requirements of Directive 2006/42/EC on Machinery to the extent to which they are
more specific than those of Directive 93/42/EEC along with the corresponding clauses of this European
Standard. Table ZA.2, however, does not imply any citation in the OJEU under the machinery directive and
thus do not provide presumption of conformity for the machinery directive.

Determination of whether a certain EHSR is “relevant” and thus applies to a particular device, pertains to the
responsible parties (e.g. manufacturer, notified bodies, competent authorities) in accordance with the
applicable procedures.

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Table ZA.2 — Relevant Essential Health and Safety Requirements from Directive 2006/42/EC on
machinery that are addressed by this European Standard
(according to Article 3 of amended Directive 93/42/EEC)

Clause(s)/sub-clause(s) of this Essential Health and Safety Qualifying remarks/Notes

EN Requirements (EHSRs) of
Directive 2006/42/EC
4.1 1.3.1 If a relevant hazard exists, the
manufacturer has to cover this
EHSR. Covered by reference to
!EN ISO 14971:2012".
4.1, 4.5.3 e), 4.12 1.3.7 If a relevant hazard exists, the
manufacturer has to cover this
EHSR. Covered by these clauses
and by reference to
!EN ISO 14971:2012".
4.1, 4.5.4 a), 4.9 1.3.9 If a relevant hazard exists, the
manufacturer has to cover this
EHSR. Covered by these clauses
and by reference to
!EN ISO 14971:2012".
4.1, 4.5.4 c), 4.6 1.4.3 If a relevant hazard exists, the
manufacturer has to cover this
EHSR. Partly covered by these
clauses and by reference to
!EN ISO 14971:2012" as far
as risk management is concerned.
- 1.6.2 If a relevant hazard exists, the
manufacturer has to cover this
EHSR. Not covered by this
standard.
- 1.6.3 If a relevant hazard exists, the
manufacturer has to cover this
EHSR. Not covered by this
standard.
- 3.6.2 To comply with this EHSR the
manufacturer has to legibly and
indelibly mark the machinery with
the mass and nominal power. Not
covered by this standard.

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Bibliography

[1] EN 1021-1, Furniture — Assessment of the ignitability of upholstered furniture — Part 1: Ignition
source smouldering cigarette

[2] EN ISO 12100, Safety of machinery — General principles for design — Risk assessment and risk
reduction (ISO 12100)

[3] Council Directive 93/42/EEC of 14 June 1993 concerning medical devices

[4] Directive 2004/108/EC of the European Parliament and of the Council of 15 December 2004 on the
approximation of the laws of the Member States relating to electromagnetic compatibility and repealing
Directive 89/336/EEC

[5] Commission Directive 2006/28/EC of 6 March 2006 amending, for the purposes of their adaptation to
technical progress, Council Directive 72/245/EEC of 20 June 1972 relating to the radio interference
(electromagnetic compatibility) of vehicles and Council Directive 70/156/EEC on the approximation of
the laws of the Member States relating to the type-approval of motor vehicles and their trailers

[6] Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery,
and amending Directive 95/16/EC (recast)

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