BS EN ISO 21535-2009 Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants《非活性外科植入物 关节置换植入物 髋关节置换植入物的专门要求》.pdf

1、BS EN ISO21535:2009ICS 11.040.40NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDNon-active surgicalimplants Jointreplacementimplants Specificrequirements for hip-joint replacementimplants (ISO21535:2007)Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 21/1

2、2/2009 02:05, Uncontrolled Copy, (c) BSIThis British Standardwas published under theauthority of the StandardsPolicy and StrategyCommittee on 31 October2009 BSI 2009ISBN 978 0 580 68119 6Amendments/corrigenda issued since publicationDate CommentsBS EN ISO 21535:2009National forewordThis British Stan

3、dard is the UK implementation of EN ISO 21535:2009.It is identical to ISO 21535:2007. It supersedes BS EN ISO 21535:2007which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/150/4, Bone and joint replacements.A list of organizations represented on this com

4、mittee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisionsof a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunityfrom legal obligations.Licensed Copy: Wang Bin, ISO/EXC

5、HANGE CHINA STANDARDS, 21/12/2009 02:05, Uncontrolled Copy, (c) BSIEUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 21535May 2009ICS 11.040.40 Supersedes EN ISO 21535:2007 English VersionNon-active surgical implants - Joint replacement implants -Specific requirements for hip-joint replacement i

6、mplants (ISO21535:2007)Implants chirurgicaux non actifs - Implants deremplacement darticulation - Exigences spcifiquesrelatives aux implants de remplacement de larticulation dela hanche (ISO 21535:2007)Nichtaktive chirurgische Implantate - Implantate zumGelenkersatz - Besondere Anforderungen an Impl

7、antate frden Hftgelenkersatz (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 EuropeanStandard the status of a national standard without any alteration.

8、 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, German). A version in any other language made by translationu

9、nder 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 Republic, Denmark, Estonia, Finland,France, Germany, Greece,

10、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 NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre

11、: 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 21535:2009: ELicensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 21/12/2009 02:05, Uncontrolled Copy, (c) BSIBS EN ISO 21535:2009EN ISO 2

12、1535:2009 (E) 3 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

13、 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

14、 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

15、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 st

16、andards 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,

17、 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. Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 21/12/2009 02:05, Uncontrolled Cop

18、y, (c) BSIBS EN ISO 21535:2009EN ISO 21535:2009 (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 European Commission and the European Free Tra

19、de 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 M

20、ember 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 Euro

21、pean 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 European Standard. The part of ER 7.1 relat

22、ing 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 resear

23、ch 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 research is not addressed by this European

24、 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

25、of ER 7.1 relating to results of biophysical and modelling research is not addressed by this European Standard. Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 21/12/2009 02:05, Uncontrolled Copy, (c) BSIBS EN ISO 21535:2009EN ISO 21535:2009 (E) 5 8 1, 2, 3, 4, 5, 7.1, 7.2, 7.3 The part of ER

26、 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 address

27、ed 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 o

28、f 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 sco

29、pe of this standard. Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 21/12/2009 02:05, Uncontrolled Copy, (c) BSIBS EN ISO 21535:2009ISO 21535:2007(E) ISO 2007 All rights reserved iiiContents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references . 1 3 Terms and definitions. 1 4 I

30、ntended 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 I

31、nformation 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 Licensed

32、Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 21/12/2009 02:05, Uncontrolled Copy, (c) BSIBS EN ISO 21535:2009ISO 21535:2007(E) iv ISO 2007 All rights reservedForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies).

33、 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-

34、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

35、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

36、 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 S

37、C 4, Bone and joint replacements. This second edition cancels and replaces the first edition (ISO 21535:2002), which has been technically revised. Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 21/12/2009 02:05, Uncontrolled Copy, (c) BSIBS EN ISO 21535:2009ISO 21535:2007(E) ISO 2007 All rig

38、hts reserved vIntroduction 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:

39、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 Standa

40、rd, 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 osteosynth

41、esis, cardiovascular surgery or joint replacement. To address all requirements, it is recommended that a standard of the lowest available level be consulted first. Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 21/12/2009 02:05, Uncontrolled Copy, (c) BSIBS EN ISO 21535:2009Licensed Copy: Wa

42、ng Bin, ISO/EXCHANGE CHINA STANDARDS, 21/12/2009 02:05, Uncontrolled Copy, (c) BSIBS EN ISO 21535:2009INTERNATIONAL STANDARD ISO 21535:2007(E) ISO 2007 All rights reserved 1Non-active surgical implants Joint replacement implants Specific requirements for hip-joint replacement implants 1 Scope This I

43、nternational 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

44、 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 amendme

45、nts) 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 7

46、206-4, 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

47、 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 imp

48、lants 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 mo

49、nobloc or modular construction. 1) To be published. (Revision of ISO 14630:2005) Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 21/12/2009 02:05, Uncontrolled Copy, (c) BSIBS EN ISO 21535:2009ISO 21535:2007(E) 2 ISO 2007 All rights reserved3.2 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 componen