DIN EN ISO 21535-2017 Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO 21535 2007 + Amd 1 2016) German vers.pdf

1、April 2017 English price group 12No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11.040.40!%dN“2654396www.din.deDIN

2、 EN ISO 21535Nonactive surgical implants Joint replacement implants Specific requirements for hipjoint replacement implants (ISO 21535:2007 + Amd 1:2016);English version EN ISO 21535:2009 + A1:2016,English translation of DIN EN ISO 21535:2017-04Nichtaktive chirurgische Implantate Implantate zum Gele

3、nkersatz Besondere Anforderungen an Implantate fr den Hftgelenkersatz (ISO 21535:2007 + Amd 1:2016);Englische Fassung EN ISO 21535:2009 + A1:2016,Englische bersetzung von DIN EN ISO 21535:2017-04Implants chirurgicaux non actifs Implants de remplacement darticulation Exigences spcifiques relatives au

4、x implants de remplacement de larticulation de la hanche (ISO 21535:2007 + Amd 1:2016);Version anglaise EN ISO 21535:2009 + A1:2016,Traduction anglaise de DIN EN ISO 21535:2017-04SupersedesDIN EN ISO 21535:200908www.beuth.deDocument comprises 21 pagesDTranslation by DIN-Sprachendienst.In case of dou

5、bt, the German-language original shall be considered authoritative.05.17 DIN EN ISO 21535:2017-04 2 A comma is used as the decimal marker. National foreword This document (EN ISO 21535:2009 + A1:2016) has been prepared by Technical Committee ISO/TC 150 “Implants for surgery” in collaboration with Te

6、chnical Committee CEN/TC 285 “Non-active surgical implants” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was DIN-Normenausschuss Feinmechanik und Optik (DIN Standards Committee Optics and Precision Mechanics), Working Committee NA 027-02-15 AA “Endoprosthesis

7、and osteosynthesis”. This standard includes Amendment A1 approved by CEN on 14 October 2016. The start and finish of text introduced or altered by amendment is indicated in the text by tags !“. The DIN Standards corresponding to the International Standards referred to in this document are as follows

8、 ISO 14630:2012 DIN EN ISO 14630:2013-03 ISO 21534:2007 DIN EN ISO 21534:2009-08 Amendments This standard differs from DIN EN ISO 21535:2009-08 as follows: a) Amendment EN ISO 21535:2009/A1:2016 has been incorporated. Previous editions DIN EN 12563: 1999-02 DIN EN ISO 21535: 2007-12, 2009-08 DIN EN

9、 ISO 21535:2017-04 3 National Annex NA (informative) Bibliography DIN EN ISO 14630:2013-03, Non-active surgical implants General requirements (ISO 14630:2012) DIN EN ISO 21534:2009-08, Non-active surgical implants Joint replacement implants Particular requirements (ISO 21534:2007) DIN EN ISO 21535:2

10、017-04 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 21535:2009 May 209 +A1 December 2016 ICS 11.040.40 English Version Non-active surgical implants Joint replacement implants Specific requirements for hip-joint replacement implants (ISO 21535:2007 + Amd

11、 1:2016) Implants chirurgicaux non actifs Implants de remplacement darticulation Exigences spcifiques relatives aux implants de remplacement de larticulation de la hanche (ISO 21535:2007 + Amd 1:2016) Nichtaktive chirurgische Implantate Implantate zum Gelenkersatz Besondere Anforderungen an Implanta

12、te fr den Hftgelenkersatz (ISO 21535:2007 + Amd 1:2016) This European Standard was approved by CEN on 2009-04-12 and Amendment on 2016-10-14. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of this amendment into the relevant nat

13、ional standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This amendment exists in three official versions (English, French, German). A version in

14、 any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech R

15、epublic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey andUnited Kingdom. EUROPE

16、AN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2016 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 21535:2009+ A1:

17、2016 EEN ISO 21535:2009 + A1:2016 (E) 2 Contents Page Foreword to DIN EN ISO 21535:2017 . 3 !European foreword to Amendment A1 of DIN EN ISO 21535“ . 4 Introduction 5 1 Scope 6 2 Normative references 6 3 Terms and definitions . 6 4 Intended performance 7 5 Design attributes . 8 5.1 General 8 5.2 Tol

18、erances and dimensions. 8 5.2.1 Tolerances and dimensions of taper connections . 8 5.2.2 Tolerances on diameters of articulating surfaces . 8 5.2.3 !Sphericity of femoral heads and plastic acetabular components . 8 5.2.4 Surface finish of femoral heads and plastic acetabular components . 8 5.3 Thick

19、ness of UHMWPE in acetabular components and bipolar heads 8 5.3.1 Acetabular components 8 5.3.2 Bipolar heads 8 6 Materials . 9 7 Design evaluation 9 7.1 General 9 7.2 Preclinical evaluation 9 7.2.1 Endurance testing of femoral components 9 7.2.2 Endurance properties of !deleted“ neck region of stem

20、med femoral components . 9 7.2.3 Pull-off characteristics of !femoral“ heads . 9 7.2.4 Wear testing of total hip joint replacements. 9 7.2.5 Minimum and maximum angles . 9 8 Manufacture . 10 9 Sterilization 10 10 Packaging 10 11 Information to be supplied by the manufacturer . 10 11.1 General . 10 1

21、1.2 Dimensions . 10 11.3 Structural and functional compatibility of components 10 11.4 Marking 11 11.5 Information for the patient 11 (informative) Evaluation of relative angular motion of components . 12 Annex ABibliography . 14 Annex ZA (informative) Relationship between this European Standard and

22、 the Essential Requirements of EU Directive 93/42/EEC 15 Annex ZB (informative) !Correlations between undated normative references and dated EN and ISO standards“ . 17 DIN EN ISO 21535:2017-04 EN ISO 21535:2009 + A1:2016 (E) 3 Foreword to DIN EN ISO 21535:2017 The text of ISO 21535:2007 has been pre

23、pared 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 sha

24、ll 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 docu

25、ment 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 As

26、sociation, 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 im

27、plement 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, Switzerla

28、nd 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. DIN EN ISO 21535:2017-04 EN ISO 21535:2009 + A1:2016 (E) 4 !European foreword to Amendment A1 of DIN EN ISO 21535“ !This document (EN ISO 21535:2009/A1:2

29、016) has been prepared by Technical Committee ISO/TC 150 “Implants for surgery” in collaboration with Technical Committee CEN/TC 285 “Non-active surgical implants” the secretariat of which is held by DIN. This Amendment to the European Standard EN ISO 21535:2009 shall be given the status of a nation

30、al standard, either by publication of an identical text or by endorsement, at the latest by June 2017, and conflicting national standards shall be withdrawn at the latest by June 2017. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent right

31、s. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. 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(s). According to the

32、 CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hu

33、ngary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 21535:2007/Amd 1:2016 has been approved by CEN as EN ISO 21535:2009/

34、A1:2016 without any modification. “DIN EN ISO 21535:2017-04 EN ISO 21535:2009 + A1:2016 (E) 5 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 su

35、rgical 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 a

36、pplying 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 rest

37、ricted 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. DIN EN ISO 21535:2017-04 EN ISO 21535:2009 + A1:2016 (E)

38、 6 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, inform

39、ation 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 (incl

40、uding 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, Implants for surgery Partial and total hip joint prostheses Part 2: Articulating surfaces made of metallic, ceramic and plastics ma

41、terials ISO 7206-4, Implants for surgery Partial and total hip joint prostheses Part 4: Determination of endurance properties and performance of stemmed femoral components ISO 7206-6, Implants for surgery Partial and total hip joint prostheses Part 6: Endurance properties testing and performance req

42、uirements of 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 14242-1, Implants for surgery Wear of total hip-joint prostheses Part 1: Loading and displa

43、cement parameters for wear-testing machines and corresponding environmental conditions for test ISO 14242-2, Implants for surgery Wear of total hip-joint prostheses Part 2: Methods of measurement ISO 14242-3, Implants for surgery Wear of total hip-joint prostheses Part 3: Loading and displacement pa

44、rameters for orbital bearing type wear testing machines and corresponding environmental conditions for test ISO 14630:2012, Non-active surgical implants General requirements ISO 21534:2007, Non-active surgical implants Joint replacement implants Particular requirements“ 3 Terms and definitions For t

45、he 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. 3.2 bipolar head component

46、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 DIN EN ISO 21535:2017-04 EN ISO 21535:2009 + A1:2016 (E) 7 3.3 femoral compon

47、ent 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 t

48、he 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

49、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