BRITISH STANDARD BS EN ISO

21535:2009

Non-active surgical
implants — Joint
replacement
implants — Specific
requirements for hip-
joint replacement
implants (ISO
21535:2007)

ICS 11.040.40

NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW

BS EN ISO 21535:2009

National foreword

This British Standard is the UK implementation of EN ISO 21535:2009.

It is identical to ISO 21535:2007. It supersedes BS EN ISO 21535:2007
which is withdrawn.
The UK participation in its preparation was entrusted to Technical
Committee CH/150/4, Bone and joint replacements.
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.
Compliance with a British Standard cannot confer immunity
from legal obligations.

This British Standard Amendments/corrigenda issued since publication

was published under the
authority of the Standards
Policy and Strategy Date Comments
Committee on 31 October
2009
© BSI 2009

ISBN 978 0 580 68119 6

EUROPEAN STANDARD EN ISO 21535
NORME EUROPÉENNE
EUROPÄISCHE NORM May 2009

ICS 11.040.40 Supersedes EN ISO 21535:2007

English Version

Non-active surgical implants - Joint replacement implants -

Specific requirements for hip-joint replacement implants (ISO
21535:2007)

Implants chirurgicaux non actifs - Implants de Nichtaktive chirurgische Implantate - Implantate zum
remplacement d'articulation - Exigences spécifiques Gelenkersatz - Besondere Anforderungen an Implantate für
relatives aux implants de remplacement de l'articulation de den Hüftgelenkersatz (ISO 21535:2007)
la hanche (ISO 21535:2007)

This European Standard was approved by CEN on 12 April 2009.

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 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 Management Centre has the same status as the
official versions.

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

EUROPEAN COMMITTEE FOR STANDARDIZATION

COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels

© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 21535:2009: E
worldwide for CEN national Members.
BS EN ISO 21535:2009
EN ISO 21535:2009 (E)

Foreword
The text of ISO 21535:2007 has been prepared by Technical Committee ISO/TC 150 “Implants for surgery” of
the International Organization for Standardization (ISO) and has been taken over as EN ISO 21535:2009 by
Technical Committee CEN/TC 285 “Non-active surgical implants” 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 November 2009, and conflicting national standards shall be withdrawn
at the latest by March 2010.

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 supersedes EN ISO 21535:2007.

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.

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, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.

Endorsement notice

The text of ISO 21535:2007 has been approved by CEN as a EN ISO 21535:2009 without any modification.

3
 BS EN ISO 21535:2009
EN ISO 21535:2009 (E)

Annex ZA
(informative)

Relationship between this European Standard and the Essential Requirements of

EU Directive 93/42/EEC

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 Communities 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 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 — Correspondence between this European Standard and Directive 93/42/EEC

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

clause(s) of this EN Directive 93/42/EEC

4 1, 2, 3, 4, 5, 7.1, 7.2, 9.2 The part of ER 1 relating to the risk of

use error is not addressed in this
European Standard. The part of ER 7.1
relating to results of biophysical and
modelling research is not addressed by
this European Standard.

5 1, 2, 3, 4, 5, 6, 7.1, 9.1, 9.2 The part of ER 1 relating to the risk of

use error is not addressed in this
European Standard .The part of ER 7.1
relating to results of biophysical and
modelling research is not addressed by
this European Standard.

6 1, 2, 3, 4, 7.1, 7.2, 7.3, 7.4, 8.2, 9.1, The part of ER 1 relating to the risk of
9.2 use error is not addressed in this
European Standard .The part of ER 7.1
relating to results of biophysical and
modelling research is not addressed by
this European Standard.The part of ER
7.4 relating to the regulatory provision
for the verification of the medicinal
product is not addressed in this
European Standard.

7 1, 2, 3, 4, 5, 6, 6a., 7.1, 7.2, 7.3, The part of ER 1 relating to the risk of

use error is not addressed in this
European Standard.

The part of ER 7.1 relating to results of

biophysical and modelling research is
not addressed by this European
Standard.

4
BS EN ISO 21535:2009
EN ISO 21535:2009 (E)

8 1, 2, 3, 4, 5, 7.1, 7.2, 7.3 The part of ER 1 relating to the risk of

use error is not addressed in this
European Standard.

The part of ER 7.1 relating to results of

biophysical and modelling research is
not addressed by this European
Standard.

9 3, 8.1, 8.3, 8.4, 8.5, 8.6, 8.7, 13.3 Via ISO 14630

The modification of ER 13.3 f is not

addressed in this European Standard.

10 3, 5, 7.2, 8.1, 8.3, 8.4, 8.5, 8.6, 8.7 Via ISO 14630

11 9.1, 13 The part of ER 13.3.a concerning the

information on the authorized
representative is not addressed in this
European Standard.

ER 13.3 f is only partly addressed in

this European Standard: safety issue of
single use.

ER 13.6 q is not addressed by this

International Standard.

NOTE Clauses 4, 5, 6, 7, 8 and subclause 11.5 supplement and are dependent on the corresponding clauses of
ISO 21534.

WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.
 BS EN ISO 21535:2009
ISO 21535:2007(E)

Contents Page

Foreword............................................................................................................................................................ iv
Introduction ........................................................................................................................................................ v
1 Scope ..................................................................................................................................................... 1
2 Normative references ........................................................................................................................... 1
3 Terms and definitions........................................................................................................................... 1
4 Intended performance .......................................................................................................................... 2
5 Design attributes................................................................................................................................... 3
5.1 General................................................................................................................................................... 3
5.2 Tolerances and dimensions ................................................................................................................ 3
5.3 Thickness of UHMWPE in acetabular components and bipolar heads........................................... 3
6 Materials ................................................................................................................................................ 3
7 Design evaluation ................................................................................................................................. 4
7.1 General................................................................................................................................................... 4
7.2 Preclinical evaluation ........................................................................................................................... 4
8 Manufacture........................................................................................................................................... 4
9 Sterilization............................................................................................................................................ 5
10 Packaging .............................................................................................................................................. 5
11 Information to be supplied by the manufacturer............................................................................... 5
11.1 General................................................................................................................................................... 5
11.2 Dimensions............................................................................................................................................ 5
11.3 Structural and functional compatibility of components ................................................................... 5
11.4 Marking .................................................................................................................................................. 5
11.5 Information for the patient ................................................................................................................... 6
Annex A (informative) Evaluation of relative angular motion of components............................................. 7
Bibliography ....................................................................................................................................................... 9

© ISO 2007 – All rights reserved iii

BS EN ISO 21535:2009
ISO 21535:2007(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 21535 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 4,
Bone and joint replacements.

This second edition cancels and replaces the first edition (ISO 21535:2002), which has been technically
revised.

iv © ISO 2007 – All rights reserved

 BS EN ISO 21535:2009
ISO 21535:2007(E)

Introduction
There are three levels of International Standard dealing with non-active surgical implants. These are as
follows, with level 1 being the highest:

⎯ level 1: general requirements for non-active surgical implants and instrumentation used in association
with implants;

⎯ level 2: particular requirements for families of non-active surgical implants;

⎯ level 3: specific requirements for types of non-active surgical implant.

This International Standard is a level 3 standard and contains requirements applying specifically to hip joint
replacements.

The level 1 International Standard, ISO 14630, contains requirements that apply to all non-active surgical
implants. It also indicates that there are additional requirements in the level 2 and level 3 standards. The
level 2 standards apply to more restricted sets or families of implants such as those designed for use in
osteosynthesis, cardiovascular surgery or joint replacement.

To address all requirements, it is recommended that a standard of the lowest available level be consulted first.

© ISO 2007 – All rights reserved v

BS EN ISO 21535:2009
 BS EN ISO 21535:2009
INTERNATIONAL STANDARD ISO 21535:2007(E)

Non-active surgical implants — Joint replacement implants —

Specific requirements for hip-joint replacement implants

1 Scope
This International Standard provides specific requirements for hip joint replacement implants. With regard to
safety, this International Standard specifies requirements for intended performance, design attributes,
materials, design evaluation, manufacture, sterilization, packaging, information supplied by the manufacturer,
and methods of test.

2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.

ISO 7206-1, Implants for surgery — Partial and total hip joint prostheses — Part 1: Classification and
designation of dimensions

ISO 7206-2:1996, Implants for surgery — Partial and total hip joint prostheses — Part 2: Articulating surfaces
made of metallic, ceramic and plastics materials

ISO 7206-4, Implants for surgery — Partial and total hip joint prostheses — Part 4: Determination of
endurance properties of stemmed femoral components

ISO 7206-6:1992, Implants for surgery — Partial and total hip joint prostheses — Part 6: Determination of
endurance properties of head and neck region of stemmed femoral components

ISO 7206-10, Implants for surgery — Partial and total hip joint prostheses — Part 10: Determination of
resistance to static load of modular femoral heads

ISO 14630:—1), Non-active surgical implants — General requirements

ISO 21534:2007, Non-active surgical implants — Joint replacement implants — Particular requirements

3 Terms and definitions

For the purposes of this document the terms and definitions in ISO 21534 and ISO 7206-1 together with the
following apply.

3.1
acetabular component
implant intended to be fixed to the prepared biological acetabulum

NOTE The component can be of monobloc or modular construction.

1) To be published. (Revision of ISO 14630:2005)

© ISO 2007 – All rights reserved 1

BS EN ISO 21535:2009
ISO 21535:2007(E)

3.2
bipolar head
component of a hip joint replacement with a concave (inner) surface intended to articulate with the spherical
head of the femoral component and a convex (outer) spherical surface intended to articulate with the
biological acetabulum

3.3
femoral component
part of a total or partial hip joint replacement which is intended to be attached to the femur

3.4
hip joint replacement
hip arthroplasty
implant used to replace one or both of the articulating surfaces of the hip joint

3.5
modular component
femoral or acetabular component that is assembled by the user from a number of sub-components

3.6
monobloc component
femoral or acetabular component that is supplied as a single unit

3.7
partial hip joint replacement
hip hemiarthroplasty
implant comprising a femoral component intended to replace the femoral articulating surface of the hip joint

NOTE 1 Partial hip joint replacement implants incorporate either a bipolar or a unipolar head.

NOTE 2 The component can be of monobloc or modular construction.

3.8
total hip joint replacement
total hip arthroplasty
implant comprising a femoral component and an acetabular component intended to replace both of the
articulating surfaces of the hip joints

NOTE The component can be of monobloc or modular construction.

3.9
unipolar head
head of a femoral component intended to articulate with the biological acetabulum

4 Intended performance
The requirements of Clause 4 of ISO 21534:2007 shall apply together with the following.

The range of angular movement between the femoral and acetabular components shall have the following
minimum values:

⎯ 100° in flexion/extension;

⎯ 60° in abduction/adduction;

⎯ 90° in internal/external rotation.

NOTE Annex A shows a method by which this can be measured.

2 © ISO 2007 – All rights reserved

 BS EN ISO 21535:2009
ISO 21535:2007(E)

5 Design attributes

5.1 General

The requirements of Clause 5 of ISO 21534:2007 shall apply together with the following requirements
specified in 5.2 and 5.3.

5.2 Tolerances and dimensions

NOTE Concerning requirements for metal-on-metal and ceramic-on-ceramic articulating surfaces, there is not yet
sufficient information on the surface roughness, tolerance on diameters and clearances to allow specification of these
parameters in this edition of this International Standard.

5.2.1 Tolerances and dimensions of taper connections

Particular attention should be paid to at least the following: diameter, taper angle, straightness, roundness,
micro and macro surface texture.

In the design of modular femoral components the risk of generation of wear particles and occurrence of
corrosion at modular component interfaces should be taken into account.

5.2.2 Tolerances on diameters of articulating surfaces

The tolerances on the diameters of the articulating surfaces of metallic or ceramic femoral components
intended to be used with ultra-high molecular weight polyethylene (UHMWPE) acetabular components and the
tolerance on the diameters of the articulating surface of UHMWPE acetabular components shall be in
accordance with ISO 7206-2:1996, 4.1.3 and 4.2.3 respectively.

NOTE The requirements for sphericity and surface finish for UHMWPE on metal and on ceramic are prescribed in
ISO 7206-2.

5.3 Thickness of UHMWPE in acetabular components and bipolar heads

5.3.1 Acetabular components

For acetabular components of outside diameter 42 mm or more, the UHMWPE component shall have the
following minimum thickness in the loaded sector:

a) 5 mm for components with a metal or other backing;

b) 6 mm for components without backing.

5.3.2 Bipolar heads

For bipolar heads of outside diameter W 44 mm, the minimum thickness of UHMWPE liners shall be 5 mm.

NOTE Where the skeletal size of the population for which these implants are intended requires an acetabular
component of less than 42 mm diameter or a bipolar component of less than 44 mm diameter it might be necessary to use
thickness values less than those specified.

6 Materials

The requirements of Clause 6 of ISO 21534:2007 shall apply together with the following.

Unalloyed titanium and titanium alloys shall not be used as the articulating surfaces of total hip joint
replacements, unless an appropriate surface treatment is undertaken and demonstrated to be suitable in
clinical use.

© ISO 2007 – All rights reserved 3

BS EN ISO 21535:2009
ISO 21535:2007(E)

7 Design evaluation

7.1 General

The requirements of Clause 7 of ISO 21534:2007 shall apply together with the following.

One or more of the tests in 7.2 of ISO 21534:2007 might not be required:

a) for every component within a range of components (product family);

b) where the required test results already exist for the same or a similar component.

In these cases a justification for omitting any given test on any given component shall be documented.

7.2 Preclinical evaluation

7.2.1 Endurance testing of femoral components

Femoral components of total hip joint replacement implants shall be tested in accordance with ISO 7206-4.
The results of the test shall be recorded.

NOTE Work is in progress to produce a revised version of ISO 7206-4 incorporating test configurations from the test
specified in ISO 7206-8 and prescribing the test parameters for cyclic tests to determine the endurance of femoral
components with stem lengths in three different ranges.

7.2.2 Endurance properties of head and neck region of stemmed femoral components

The head and neck region of stemmed femoral components shall be tested in accordance with 7.2 of
ISO 7206-6:1992.

7.2.3 Pull-off characteristics of heads

The relevant clauses of ISO 7206-10 shall apply.

7.2.4 Wear testing of total hip joint replacements

The wear characteristics of total hip joint replacement implants comprising a femoral component with an
integral head or a modular head articulating on a metal, ceramic or UHMWPE acetabular component, shall be
tested in accordance with a controlled, validated and documented procedure.

7.2.5 Minimum and maximum angles

The intended minimum and maximum angles between the skeletal parts referred to in 4 a) of ISO 21534:2007
shall be determined as described in Annex A.

8 Manufacture
The requirements of Clause 8 of ISO 21534:2007 shall apply together with the following.

⎯ Implants manufactured from cast cobalt chromium alloys shall be solution treated if appropriate.

⎯ Any heat treatment undertaken shall be recorded and documented.

NOTE One example of solution heat treatment found to be satisfactory is holding the castings for 4 h at a
temperature of 1 200 °C.

4 © ISO 2007 – All rights reserved

 BS EN ISO 21535:2009
ISO 21535:2007(E)

9 Sterilization
The requirements of Clause 9 of ISO 14630:— shall apply.

10 Packaging
The requirements of Clause 10 of ISO 14630:— shall apply.

11 Information to be supplied by the manufacturer

11.1 General

The requirements of Clause 11 of ISO 14630:—, and Clause 11 of ISO 21534:2007, shall apply together with
the following.

11.2 Dimensions

The following shall be recorded on the label, instruction leaflet or manual as indicated:

a) product type;

b) nominal head diameter (see ISO 7206-1) for a hip joint monobloc femoral component or for a modular
femoral head (label, instruction leaflet and/or manual);

c) nominal diameter (see ISO 7206-1) of the articulating surface of an acetabular component (label,
instruction leaflet and/or manual);

d) symbols defining the connection between head and neck for a modular implant (instruction leaflet and/or
manual).

11.3 Structural and functional compatibility of components

11.3.1 For a femoral component or a modular femoral head which is intended to be structurally and
functionally compatible only with specific acetabular cups, the label, instruction leaflet or manual shall state
the acetabular cups with which it is compatible.

11.3.2 For an acetabular component which is intended to be structurally and functionally compatible only with
specific femoral components, the label, instruction leaflet or manual shall state the femoral components with
which it is compatible.

11.3.3 For a femoral component and head of modular construction, the label, instruction leaflet or manual
shall state for each, the corresponding components with which they are structurally and functionally
compatible.

NOTE In general, components manufactured by one company might not be compatible with components
manufactured by another company. This applies in particular to modular components which incorporate a male or female
taper connections.

11.4 Marking

11.4.1 The nominal diameter of the femoral head shall be marked on a monobloc femoral component.

11.4.2 A mark or marks shall be placed on a modular femoral head to identify its nominal outer diameter and
the characteristics of the cone and bore connection. This marking shall be legible using normal or corrected
vision.

© ISO 2007 – All rights reserved 5

BS EN ISO 21535:2009
ISO 21535:2007(E)

11.4.3 The stemmed part of a modular femoral component of a hip joint replacement implant having a
male/female cone connection for a modular head shall carry a mark indicating the category of the connection
provided that this does not impair the intended function of the component. Marking shall be placed on the
neck of the femoral component of a hip replacement implant for identification or other reasons, only if it is
demonstrated that is does not impair the endurance strength. For implants with modular heads, the marking
should be placed on the plane area at the proximal end of the conical region to which the head is fitted. This
marking shall be legible using normal or corrected vision.

11.4.4 The acetabular component which bears the articulating surface of a total hip joint replacement shall
carry a mark indicating the nominal diameter of the articulating surface. This marking shall be legible using
normal or corrected vision.

11.5 Information for the patient

The manufacturer shall include in the instructional leaflet or manual at least the following statement or
equivalent.

“Patients receiving hip joint replacements should be advised that the longevity of the implant may depend on
their weight and level of activity.”

6 © ISO 2007 – All rights reserved

 BS EN ISO 21535:2009
ISO 21535:2007(E)

Annex A
(informative)

Evaluation of relative angular motion of components

A.1 Secure the acetabular component in an appropriate vice or other fixture.

A.2 Secure the femoral component, which might be integral or modular, in a rig in order to allow the
articulating surfaces of the femoral and the acetabular component to be in contact and rotate about axes
through the centre of the articulating surface of the acetabulum. Using an appropriate protractor or
corresponding angular measuring instrument, move by hand the femoral component in the plane of its stem
and neck until the neck of the femoral component makes contact with the acetabulum at the medial surface
and then at the lateral surface. Measure the angle, ε, between the two positions to an accuracy of ± 1° as
shown in Figure A.1 a). This angle, ε, is the angle of abduction/adduction.

A.3 Repeat A.2 producing movement in the plane through the centre of the head perpendicular to that of the
stem and neck as shown in Figure A.1 b) and measure the angle, δ, between the two extreme positions
shown. This angle, δ, is the angle of flexion/extension.

A.4 With the acetabular component initially in the position illustrated in Figures A.1 b) and A.1 c), rotate the
femoral component about axis AA first in one direction and then in the other and measure the angle, γ,
corresponding to the range of free movement from one limit to the other. The angle γ is the angle of
internal/external rotation.

A.5 An evaluation by CAD is also possible. The drawing shall specify the angles and the identification of the
components (size, neck length).

© ISO 2007 – All rights reserved 7

BS EN ISO 21535:2009
ISO 21535:2007(E)

a) Hip joint replacement — Abduction/adduction

b) Hip joint replacement — Flexion/extension c) Hip joint replacement — Internal/external

rotation

Key
γ angle of internal/external rotation.
ε angle of abduction/adduction;
δ angle of flexion/extension

a Set acetabular component to 45° or angle prescribed by manufacturer.

Figure A.1 — Relative angular motions of components

8 © ISO 2007 – All rights reserved

 BS EN ISO 21535:2009
ISO 21535:2007(E)

Bibliography

[1] ISO 7206-8, Implants for surgery — Partial and total hip joint prostheses — Part 8: Methods of
determining endurance performance of stemmed femoral components

[2] ISO/TR 9325, Implants for surgery — Partial and total hip joint prostheses — Recommendations for
simulators for evaluation of hip joint prostheses

[3] ISO/TR 9326, Implants for surgery — Partial and total hip joint prostheses — Guidance for laboratory
evaluation of change of form of bearing surfaces

[4] ISO 14242-1, Implants for surgery — Wear of total hip joint prostheses — Part 1: Loading and
displacement parameters for wear-testing machines and corresponding environmental conditions for
test

[5] ISO 14242-2, Implants for surgery — Wear of total hip joint prostheses — Part 2: Methods of
measurement

© ISO 2007 – All rights reserved 9

BS EN ISO
21535:2009
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