EN ISO 21535-2009 en Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (Incorporates Amendment A1 2016)《非活性外科植入物 .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)This British Standardwas published under theauthority of th

2、e StandardsPolicy and StrategyCommittee on 31 October2009 BSI 2009ISBN 978 0 580 68119 6Amendments/corrigenda issued since publicationDate CommentsBS EN ISO 21535:2009National forewordThis British Standard is the UK implementation of EN ISO 21535:2009.It is identical to ISO 21535:2007. It supersedes

3、 BS EN ISO 21535:2007which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/150/4, Bone and joint replacements.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all

4、the necessary provisionsof a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunityfrom legal obligations.EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 21535May 2009ICS 11.040.40 Supersedes EN ISO 21535:2007 English VersionNon-ac

5、tive surgical implants - Joint replacement implants -Specific requirements for hip-joint replacement implants (ISO21535:2007)Implants chirurgicaux non actifs - Implants deremplacement darticulation - Exigences spcifiquesrelatives aux implants de remplacement de larticulation dela hanche (ISO 21535:2

6、007)Nichtaktive chirurgische Implantate - Implantate zumGelenkersatz - Besondere Anforderungen an Implantate 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

7、 conditions for giving this EuropeanStandard 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 t

8、hree official versions (English, French, German). 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 A

9、ustria, 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 COMM

10、ITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE 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 21535:2009: EBS EN ISO 21535:2009EN IS

11、O 21535:2009 (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”

12、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

13、 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 giv

14、en 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

15、 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, Pola

16、nd, 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. BS EN ISO 21535:2009EN ISO 21535:2009 (E) 4 Annex ZA (informative) Relationship betwee

17、n 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 Di

18、rective 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

19、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-clause(s) of this EN Essential Requirements

20、(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 relating to results of biophysical and modelling research is not addressed by this European Standard.

21、 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, 9.2 T

22、he 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 verification of the me

23、dicinal 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 Eur

24、opean Standard. BS 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 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 Sta

25、ndard. 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 addresse

26、d 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. WARN

27、ING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. BS 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.

28、 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

29、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 BS

30、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). The work of preparing International Standards is normally carried out through ISO technical

31、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

32、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 Interna

33、tional 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 b

34、e 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

35、(ISO 21535:2002), which has been technically revised. BS EN ISO 21535:2009ISO 21535:2007(E) ISO 2007 All rights 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 re

36、quirements 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

37、 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

38、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. BS EN ISO 21535:2009BS EN IS

39、O 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 International Standard provides specific requirements for hip joint replacement implants. W

40、ith 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 do

41、cuments 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

42、 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 o

43、f 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 prosthes

44、es 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 th

45、e 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) BS EN ISO

46、 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 ac

47、etabulum 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 compo

48、nent 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 surfa

49、ce 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 bio