BS EN ISO 21534-2009 Non-active surgical implants - Joint replacement implants - Particular requirements《无源外科植入物 关节置换植入物 详细要求》.pdf

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2、g11g6g13Non-active surgical implants Joint replacement implants Particular requirements (ISO 21534:2007)g5g6g7g8g3g9g10g7g11g7g8g6g3g12g11g13g14g15g13g10g15g40g13g8g3g20g39g49g21g7g8g6g16g15g3g39g14g15g16g10g3g11g6g16g13g39g11g6g22g10g7g11g51g3g22g23g3g11g6g16g3g12g11g13g14g15g13g10g15g8g53g22g21g7g

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8、g14g3g15g22g16g8g3g14g22g11g3g20g39g10g20g22g10g11g3g11g22g3g7g14g37g21g39g15g16g3g13g21g21g3g11g6g16g3g14g16g37g16g8g8g13g10g51g3g20g10g22g52g7g8g7g22g14g8g22g23g3g13g3g37g22g14g11g10g13g37g11g36g3g17g8g16g10g8g3g13g10g16g3g10g16g8g20g22g14g8g7g49g21g16g3g23g22g10g3g7g11g8g3g37g22g10g10g16g37g11g3g

9、13g20g20g21g7g37g13g11g7g22g14g36g30g22g31g32g24g21g19g23g33g27g3g28g21g20g34g3g19g3g5g26g21g20g21g35g34g3g6g20g19g23g29g19g26g29g3g33g19g23g23g22g20g3g33g22g23g25g27g26g3g21g31g31g36g23g21g20g37g25g26g22g31g3g24g27g38g19g24g3g22g39g24g21g38g19g20g21g22g23g35g40EUROPEAN STANDARDNORME EUROPENNEEUROPI

10、SCHE NORMEN ISO 21534May 2009ICS 11.040.40 Supersedes EN ISO 21534:2007 English VersionNon-active surgical implants - Joint replacement implants -Particular requirements (ISO 21534:2007)Implants chirurgicaux non actifs - Implants deremplacement darticulation - Exigences particulires (ISO21534:2007)N

11、ichtaktive chirurgische Implantate - Implantate zumGelenkersatz - Besondere Anforderungen (ISO21534:2007)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 EuropeanStanda

12、rd the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning 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, G

13、erman). A version in any other language made by translationunder the responsibility of a CEN member into its own language 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 R

14、epublic, 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 STANDARDIZATIONCOMIT EUROPEN DE

15、NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of 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 IS

16、O 21534:2007 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 21534:2009 by Technical Committee CEN/TC 285 “Non-active surgical implants” the secretariat of which is held by DIN. T

17、his 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

18、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 21534:2007. This document has been prepared under a mandate given to CEN by the European Commission and t

19、he 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

20、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,

21、 Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 21534:2007 has been approved by 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

22、 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

23、 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 pr

24、esumption 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-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying re

25、marks/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 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 re

26、sults 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, 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 r

27、esearch 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. 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 r

28、elating 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. 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

29、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 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

30、Standard. The ER 13.3 f is only partly addressed in this European Standard: safety issue of single use. The part of ER 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

31、 corresponding clauses of EN 14630 WARNING Other requirements and other EU Directives may be applicable to the product(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 Normati

32、ve references . 1 3 Terms and definitions. 2 4 Intended performance 2 5 Design attributes. 3 5.1 General. 3 5.2 Surface 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

33、 of convex, spherically-conforming metallic or ceramic implants articulating on UHMWPE 3 5.5 Surfaces of spherically-conforming 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

34、 Design evaluation . 4 7.1 General. 4 7.2 Preclinical evaluation . 4 7.3 Clinical investigation 5 7.4 Post market surveillance . 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 Pa

35、ckaging 6 11 Information supplied by the manufacturer 6 11.1 General. 6 11.2 Labelling of implants for use on one side 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.

36、7 11.7 Re-sterilization of zirconia ceramics 7 11.8 Labelling of implants for use with or without bone cement. 7 Annex 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

37、found acceptable or not acceptable for articulating surfaces of implants. 9 BS EN ISO 21534:2009ISO 21534:2007(E) iv ISO 2007 All rights reservedAnnex C (informative) List of materials found acceptable or non-acceptable for metallic combinations for non-articulating contacting surfaces of implants .

38、 11 Bibliography . 12 BS EN ISO 21534:2009ISO 21534:2007(E) ISO 2007 All rights reserved vForeword 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 ou

39、t 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 co

40、llaborates 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

41、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 element

42、s 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 21534 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 4, Bone and joint replacements. This second edition cancels and rep

43、laces the first edition (ISO 21534:2002), which has been technically revised. BS EN ISO 21534:2009ISO 21534:2007(E) vi 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 hig

44、hest: g127 level 1: general requirements for non-active surgical implants and instrumentation used in association with implants; g127 level 2: particular requirements for families of non-active surgical implants; g127 level 3: specific requirements for types of non-active surgical implant. This Inte

45、rnational Standard is a level 2 standard and contains requirements that apply to all non-active surgical implants in the family of joint replacement implants. The level 1 standard contains requirements that apply to all non-active surgical implants. It also indicates that there are additional requir

46、ements in the level 2 and level 3 standards. The level 1 standard has been published as ISO 14630. Level 3 standards apply to specific 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 consu

47、lted first. BS EN ISO 21534:2009INTERNATIONAL STANDARD ISO 21534:2007(E) ISO 2007 All rights reserved 1Non-active surgical implants Joint replacement implants Particular requirements 1 Scope This International Standard specifies particular requirements for total and partial joint replacement implant

48、s, artificial ligaments and bone cement, hereafter referred to as implants. For the purposes of this International Standard, artificial ligaments and their associated fixing devices are included in the term “implant“. It specifies requirements for intended performance, design attributes, materials,

49、design evaluation, manufacturing, sterilization, packaging and information to be supplied by the manufacturer. Some tests required to 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, the latest edition of the referenced document (including any amendments) applies. ISO 4287, Geometrical Product Spe