1、BS EN ISO 21534:2009ICS 11.040.40NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDNon-active surgical implants Joint replacement implants Particular requirements (ISO 21534:2007)This British Standardwas published under theauthority of the StandardsPolicy and Stra
2、tegyCommittee on 31 October2009 BSI 2009ISBN 978 0 580 68118 9Amendments/corrigenda issued since publicationDate CommentsBS EN ISO 21534:2009National forewordThis British Standard is the UK implementation of EN ISO 21534:2009.It is identical to ISO 21534:2007. It supersedes BS EN ISO 21534:2007which
3、 is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/150/4, Bone and joint replacements.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisionsof
4、 a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunityfrom legal obligations.EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 21534May 2009ICS 11.040.40 Supersedes EN ISO 21534:2007 English VersionNon-active surgical implants - J
5、oint replacement implants -Particular requirements (ISO 21534:2007)Implants chirurgicaux non actifs - Implants deremplacement darticulation - Exigences particulires (ISO21534:2007)Nichtaktive chirurgische Implantate - Implantate zumGelenkersatz - Besondere Anforderungen (ISO21534:2007)This European
6、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 EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning
7、 such nationalstandards 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 translationunder the responsibility of a CEN member into its own langua
8、ge and notified to the CEN Management Centre has the same status as theofficial 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, Luxemb
9、ourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of
10、exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 21534:2009: EBS EN ISO 21534:2009EN ISO 21534:2009 (E) 3 Foreword The text of ISO 21534:2007 has been prepared by Technical Committee ISO/TC 150 “Implants for surgery” of the International Organizati
11、on for Standardization (ISO) and has been taken over as EN ISO 21534:2009 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 b
12、y 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
13、 identifying any or all such patent rights. This document supersedes EN ISO 21534:2007. 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 Direc
14、tive, 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, E
15、stonia, 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 21534:2007 has been approved by
16、CEN as a EN ISO 21534:2009 without any modification. BS EN ISO 21534:2009EN ISO 21534:2009 (E) 4 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 Eu
17、ropean 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 implement
18、ed 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
19、. Table ZA Correspondence between this European Standard and Directive 93/42/EEC Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 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
20、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.
21、4, 8.2, 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. The part of ER 7.4 relating to the regulatory provision for the ver
22、ification of the medicinal product is not addressed in this European Standard. BS EN ISO 21534:2009EN ISO 21534:2009 (E) 5 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
23、biophysical and modelling research is not addressed by this European Standard. 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. 9 3, 8.1, 8.3, 8.4, 8.5, 8.6, 8.7, 13.3 The part of ER 13.3 f is not addressed in this European
24、 Standard. 10 3, 5, 7.2, 8.1, 8.3, 8.4, 8.5, 8.6, 8.7 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. The ER 13.3 f is only partly addressed in this European Standard: safety issue of single use. The part of ER
25、13.6.h) relating to single use is not addressed in this European Standard. ER 13.6 q is not addressed in this European Standard. NOTE All clauses supplement and are dependent on the corresponding clauses of EN 14630 WARNING Other requirements and other EU Directives may be applicable to the product(
26、s) falling within the scope of this standard. BS EN ISO 21534:2009ISO 21534:2007(E) ISO 2007 All rights reserved iiiContents Page Foreword. v Introduction . vi 1 Scope . 1 2 Normative references . 1 3 Terms and definitions. 2 4 Intended performance 2 5 Design attributes. 3 5.1 General. 3 5.2 Surface
27、 finish of metallic or ceramic implants articulating on ultra-high-molecular-weight polyethylene (UHMWPE) 3 5.3 Surface finish of metallic or ceramic partial implants 3 5.4 Surfaces of convex, spherically-conforming metallic or ceramic implants articulating on UHMWPE 3 5.5 Surfaces of spherically-co
28、nforming metallic or ceramic partial implants 3 5.6 Surfaces of concave, spherically-conforming UHMWPE components. 3 6 Materials 4 6.1 General. 4 6.2 Dissimilar metals or alloys 4 7 Design evaluation . 4 7.1 General. 4 7.2 Preclinical evaluation . 4 7.3 Clinical investigation 5 7.4 Post market surve
29、illance . 5 8 Manufacture and inspection 5 8.1 General. 5 8.2 Metal surfaces . 5 8.3 Plastic surfaces. 5 8.4 Ceramic surfaces 5 9 Sterilization 6 9.1 General. 6 9.2 Expiry . 6 10 Packaging 6 11 Information supplied by the manufacturer 6 11.1 General. 6 11.2 Labelling of implants for use on one side
30、of the body only. 6 11.3 Instructions for orientation of implants 6 11.4 Markings for orientation of the implants 6 11.5 Placing of markings on implants 6 11.6 Restrictions on use. 7 11.7 Re-sterilization of zirconia ceramics 7 11.8 Labelling of implants for use with or without bone cement. 7 Annex
31、A (informative) List of International Standards for materials found acceptable for the manufacture of implants 8 Annex B (informative) List of International Standards for materials found acceptable or not acceptable for articulating surfaces of implants. 9 BS EN ISO 21534:2009ISO 21534:2007(E) iv IS
32、O 2007 All rights reservedAnnex C (informative) List of materials found acceptable or non-acceptable for metallic combinations for non-articulating contacting surfaces of implants . 11 Bibliography . 12 BS EN ISO 21534:2009ISO 21534:2007(E) ISO 2007 All rights reserved vForeword ISO (the Internation
33、al 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 e
34、stablished 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 standard
35、ization. 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 vo
36、ting. 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 su
37、ch patent rights. ISO 21534 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 21534:2002), which has been technically revised. BS EN ISO 21534:2009ISO 21534:2007(E) vi
38、ISO 2007 All rights reservedIntroduction 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 impla
39、nts; 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 2 standard and contains requirements that apply to all non-active surgical implants in the family of joi
40、nt replacement implants. The level 1 standard 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 1 standard has been published as ISO 14630. Level 3 standards apply to specific
41、 types of implants within a family, such as knee and hip joints. To address all requirements, it is recommended that a standard of the lowest available level be consulted first. BS EN ISO 21534:2009INTERNATIONAL STANDARD ISO 21534:2007(E) ISO 2007 All rights reserved 1Non-active surgical implants Jo
42、int replacement implants Particular requirements 1 Scope This International Standard specifies particular requirements for total and partial joint replacement implants, artificial ligaments and bone cement, hereafter referred to as implants. For the purposes of this International Standard, artificia
43、l ligaments and their associated fixing devices are included in the term “implant“. It specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information to be supplied by the manufacturer. Some tests required to
44、demonstrate conformance to this International Standard are contained in or referenced in level 3 standards. 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,
45、the latest edition of the referenced document (including any amendments) applies. ISO 4287, Geometrical Product Specifications (GPS) Surface texture: Profile method Terms, definitions and surface texture parameters ISO 7206-4, Implants for surgery Partial and total hip joint prostheses Part 4: Deter
46、mination of endurance properties of stemmed femoral components ISO 7206-8, Implants for surgery Partial and total hip joint prostheses Part 8: Methods of determining endurance performance of stemmed femoral components ISO 14155-1, Clinical investigation of medical devices for human subjects Part 1:
47、General requirements 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 tests ISO 14242-2, Implants for surgery Wear of total hip joint prostheses Part 2: Methods of
48、 measurement ISO 14243-2, Implants for surgery Wear of total knee-joint prostheses Part 2: Methods of measurement ISO 14630:1), Non-active surgical implants General requirements ISO 14879-1, Implants for surgery Total knee-joint prostheses Part 1: Determination of endurance properties of knee tibial
49、 trays 1) To be published. (Revision of ISO 14630:2005) BS EN ISO 21534:2009ISO 21534:2007(E) 2 ISO 2007 All rights reserved3 Terms and definitions For the purposes of this document, the terms and definitions in ISO 14630 together with the following apply. 3.1 artificial ligament device, including its necessary fixing devices, intended to augment or replace the natural ligament 3.2 joint replacement implant implantable device, including ancillary implanted components and materials, intended to provid
