EN ISO 21536-2009 en Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (Incorporates Amendment A1 2014)《非活性外科植入物.pdf

1、BSENISO21536:2009ICS11.040.40NOCOPYINGWITHOUTBSIPERMISSIONEXCEPTASPERMITTEDBYCOPYRIGHTLAWBRITISHSTANDARDNon-activesurgicalimplantsJointreplacementimplantsSpecificrequirementsforknee-jointreplacementimplants(ISO21536:2007)+A1:2014 Incorporating corrigendum March 2016National forewordThis British Stan

2、dard is the UK implementation of EN ISO 21536:2009+A1:2014. It is identical to ISO 21536:2007, incorporating amendment 1:2014. It supersedes BS EN ISO 21536:2009 which is withdrawn.The UK participation in its preparation was entrusted by Technical Committee CH/150, Implants for surgery to Subcommitt

3、ee CH/150/4, Surgical Implants - Bone and Joint Replacements.A list of organizations represented on this subcommittee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application

4、.Compliance with a British Standard cannot confer immunity from legal obligations.BS EN ISO 21536:2009+A1:2014This British Standardwas published under theauthority of the StandardsPolicy and StrategyCommittee on 31 October2009Amendments/corrigenda issued since publicationDate Comments 30 April 2014

5、Implementation of ISO amendment 1:2014 with CEN endorsement A1:2014: New normative reference added to clause 2, subclause 5.4 inserted. Annex ZA amendedISBN 978 0 580 92634 1 The British StandardsInstitution 2016. Published byBSI Standards Limited 2016Implementation of CEN Correction Notice 2 July 2

6、014:Table ZA.1 updated31 March 2016 EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMICS 11.040.40English VersionNon-active surgical implants - Joint replacement implants -Specific requirements for knee-joint replacement implants (ISO21536:2007)Implants chirurgicaux non actifs - Implants deremplacemen

7、t darticulation - Exigences spcifiquesrelatives aux implants de remplacement de larticulation dugenou (ISO 21536:2007)Nichtaktive chirurgische Implantate - Implantate zumGelenkersatz - Besondere Anforderungen an Implantate frden Kniegelenkersatz (ISO 21536:2007)This European Standard was approved by

8、 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 such nationalstandards

9、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 language and notified to the C

10、EN 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, Luxembourg, Malta, Netherlands

11、, 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 exploitation in any form

12、 and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 21536:2009: EEN ISO 21536:2009+A1March 2014Foreword The text of ISO 21536:2007 has been prepared by Technical Committee ISO/TC150 “ Implants for surgery” ofthe International Organization for Standardization (ISO) and has be

13、en taken over asEN ISO 21536:2009 byTechnical Committee CEN/TC 285 “Non-active surgical implants” the secretariat of which is held by DIN.This European Standard shall be given the status ofa national standard, either by publication of an identical text or by endorsement, at the latest by November 20

14、09, 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 identifying any orall such patent rights.

15、This document supersedes EN ISO 21536:2007.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 Dire ctive.For relationship with EU Directive, see informative Annex ZA, which is an i

16、ntegral part of this document. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the followingcountries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, CzechRepublic, Denmark, Estonia, Finland, France, Germany, Greece, Hunga

17、ry, Iceland, Ireland, Italy, Latvia,Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the UnitedKingdom. Endorsement noticeThe text of ISO 21536:2007 has been approved by CEN as a EN ISO21536:2009without any modification.

18、This document (EN ISO 21536:2009/A1:2014) has been prepared by Technical Committee ISO/TC 150 “Implants for surgery“ in collaboration 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 21536:2009 shall

19、 be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by September 2014, and conflicting national standards shall be withdrawn at the latest by September 2014. Attention is drawn to the possibility that some of the elements of this d

20、ocument 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 has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential require

21、ments of EU Directive(s). For relationship with EU Directive(s), 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: Aus

22、tria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, 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, Swed

23、en, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 21536:2007/Amd 1:2014 has been approved by CEN as EN ISO 21536:2009/A1:2014 without any modification. Foreword to amendment A1BS EN ISO 21536:2009+A1:2014 EN ISO 21536:2009+A1:2014 (E)iiBS EN ISO 21536:2009+A1:2014 EN

24、 ISO 21536:2009+A1:2014 (E)Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Assoc

25、iation 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 Union under that Directive and has been implemented as a national standard in at least one Member State, c

26、ompliance with the clauses of this standard given in Table ZA.1 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.1 Correspondence between this European Stand

27、ard and Directive 93/42/EEC on medical devices Clause(s)/sub-clause(s) of this European Standard Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 5, 6 7.1, 1st indent This ER is not covered by these clauses 5.3 7.1, 2nd indent 7.1 7.1, 3rd indent 5, 7, 8, 10 7.2 5, 6, 8,

28、10 7.3 Clause 10 packaging not covered by this ER 6 7.4 Covered in respect of medicinal products by reference to Clause 6 of EN ISO 14630 from Clause 6 of ISO 21534:2007 5.3, 6, 8 7.5 5.3, 6, 8 7.6 5, 6, 8, 9 8.1 6 8.2 Covered in respect of tissues of animal origin by reference to Clause 6 of EN ISO

29、 14630 from Clause 6 of ISO 21534:2007 9, 10 8.3 Covered in respect of sterilisation and packaging only 9 8.4 8, 9 8.5 Clauses 8 and 9 do not through their references address the environmental conditions of manufacture 9, 10 8.6 11 8.7 iii5 BS EN ISO 21536:2009+A1:2014 EN ISO 21536:2009+A1:2014 (E)5

30、, 6, 11.3 9.1 5, 6, 7 9.2, 1st indent 5, 6, 7 9.2, 2nd indent 5 9.2, 3rd indent 5, 6, 7 9.2, 1st indent 5, 6, 7 9.2, 2nd indent 5 9.2, 3rd indent 5, 6 9.2, 4th indent 11 13.1 11 13.2 11.1, 11.2 13.3 WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within

31、 the scope of this standard. iv ISO 2007 All rights reservedContents PageForeword viIntroduction. vii1Scope. 12Normative references. 13Terms and definitions. 14Intended performance 25Design attributes. 25.1 General. 25.2 Thickness of ultra-high molecular weight polyethylene (UHMWPE) in tibial compon

32、ents and meniscal components. 25.3 Finish of non-articulating regions of metallic knee joint components. 36Materials 37Design evaluation. 37.1 General. 37.2 Preclinical evaluation. 38Manufacture. 39Sterilization 410 Packaging 411 Information to be supplied by the manufacturer. 411.1 General. 411.2 I

33、nformation supplied on the label. 411.3 Constructional compatibility of components 411.4 Information for the patient. 411.5 Marking 4Annex A (informative) Evaluation of range of relative angular motion of components of fullyconstrained total knee joint replacement implants. 5BS EN ISO 21536:2009+A1:

34、2014 ISO 21536:2009+A1:2014 (E)vvi 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 com

35、mittees. Each member body interested in a subject for which a tec hnical committee has beenestablished 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 closelywith the

36、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 Internationa

37、l Standardsadopted 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 be the

38、subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 21536 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

39、 21536:2002),which has been technicallyrevised.BS EN ISO 21536:2009+A1:2014 ISO 21536:2009+A1:2014 (E) ISO 2007 All rights reserved viiIntroduction There are three levels ofInternational Standard dealing with non-active surgical implants. These are asfollows, with level 1 being the highest: level 1:

40、 general requirements 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

41、 3 standard and contains requirements applying specifically to knee joint replacements. The level 1 standard contains requirements that apply to all non-active surgical implants.It alsoindicates that there are additional requirements in the level 2 and level 3 standards. The level 2 standards apply

42、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 21536:2009+A1:2014 ISO 21536:2009+

43、A1:2014 (E)BS EN ISO 21536:2009+A1:2014 ISO 21536:2009+A1:2014 (E)INTERNATIONAL STANDA RD ISO 2007 All rights reserved 1Non-active surgical implants Joint replacement implants Specific requirements for knee-joint replacement implants 1 Scope This International Standard provides specific requirements

44、 for knee 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 the manufacturerand methods of test. 2 Normativeref

45、erencesThe following referenced documents are indispensable for the application of this document. For datedreferences, only the edition cited applies. For undated references, the latest edition of the referenceddocument (including any amendments) applies.ISO 7207-1, Implants for surgery Components f

46、or partial and total knee joint prostheses Part1:Classification, definitions and designation of dimensionsISO 14243-1, Implants for surgery Wear of total knee-joint prostheses Part1: Loading and displacementparameters for wear-testing machines with load control and corresponding environmental condit

47、ions for testISO 14243-2, Implants for surgery Wear of total knee-joint prostheses Part2:Me thods of measurementISO 14243-3, Implants for surgery Wear of total knee-joint prostheses Pa rt 3: Loading and displacementparameters for wear-testing machines with displacement control and corresponding envi

48、ronmental conditions for testISO 14630:1), Non-active surgical implants General requirementsISO 14879-1, Implants for surgery Total knee joint prostheses Part1: Determination of enduranceproperties of knee tibial traysISO 21534:2007, Non-active surgical implants Joint replacement implants Particular

49、 requirements3 Terms and definitions For the purposes of this document the terms and definitions of ISO 21534 and ISO 7207-1 together with thefollowing apply. 3.1 femoral component component of a total knee joint replacement intended to be secured to the femur to replace its articulating surfacesNOTE These implants can be manufactured as one component or a set of components to be assembled by the user. 1) To be published. (Revision of ISO 14630:2005) ISO 21536:2009+A1:2014 (E)BS EN ISO 21536:2009+A1:2014 ISO 72