1、July 2014 Translation by DIN-Sprachendienst.English price group 9No 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
2、.040.40!%2w“2158488www.din.deDDIN EN ISO 21536Non-active surgical implants Joint replacement implants Specific requirements for knee joint replacement implants(ISO 21536:2007 + Amd.1:2014);English version EN ISO 21536:2009 + A1:2014,English translation of DIN EN ISO 21536:2014-07Nichtaktive chirurgi
3、sche Implantate Implantate zum Gelenkersatz Besondere Anforderungen an Implantate fr den Kniegelenkersatz (ISO 21536:2007 +Amd.1:2014);Englische Fassung EN ISO 21536:2009 + A1:2014,Englische bersetzung von DIN EN ISO 21536:2014-07Implants chirurgicaux non actifs Implants de remplacement darticulatio
4、n Exigences spcifiques relatives aux implants de remplacement de larticulation du genou(ISO 21536:2007 + Amd.1:2014);Version anglaise EN ISO 21536:2009 + A1:2014,Traduction anglaise de DIN EN ISO 21536:2014-07SupersedesDIN EN ISO 21536:2009-08www.beuth.deDocument comprises pagesIn case of doubt, the
5、 German-language original shall be considered authoritative.1306.14 DIN EN ISO 21536:2014-07 2 A comma is used as the decimal marker. National foreword This document (EN ISO 21536:2009 + A1:2014) has been prepared by Technical Committee ISO/TC 150 “Implants for surgery” in collaboration with Technic
6、al Committee CEN/TC 285 “Non-active surgical implants” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the Normenausschuss Feinmechanik und Optik (Optics and Precision Mechanics Standards Committee), Working Committee NA 027-02-15 AA Endoprothetik und Osteosy
7、nthese. This standard includes Amendment A1 approved by CEN on 04 January 2014. The start and finish of text introduced or altered by amendment is indicated in the text by tags !“. The DIN Standards corresponding to the European and International Standards referred to in this document are as follows
8、: ISO 14630:2008 DIN EN ISO 14630:2009-08 ISO 21534:2009 DIN EN ISO 21534:2009-08 Amendments This standard differs from DIN EN ISO 21536:2009-08 as follows: a) Amendment EN ISO 21536:2009/A1:2014 has been incorporated; b) Subclause 5.4 “Surface finish of articulating surfaces of knee joint component
9、s” has been added; c) Annex ZA (informative) has been updated. Previous editions DIN EN 12564: 1999-02 DIN EN ISO 21536: 2007-12, 2009-08 National Annex NA (informative) Bibliography DIN EN ISO 14630:2009-08, Non-active surgical implants General requirements DIN EN ISO 21534:2009-08, Non-active surg
10、ical implants Joint replacement implants Particular requirements EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 21536 May 2009 + A1 March 2014 ICS 11.040.40 English Version Non-active surgical implants - Joint replacement implants - Specific requirements for knee joint replacement implants
11、 (ISO 21536:2007 + Amd. 1:2014) Implants chirurgicaux non actifs - Implants de remplacement darticulat ion - Exigences spcifiques relatives aux implants de remplacement de larticulation du genou Nichtaktive chirurgische Implantate - Implantate zum Gelenkersatz - Besondere Anforderungen an Implantate
12、 fr den Kniegelenkersatz (ISO 21536:2007 + Amd. 1:2014) EN ISO 21536:2009 was approved by CEN on 2009-04-12 and Amendment A1:2014 on 2014-01-04. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a
13、national 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 European Standard exists in three official versions (English, French, German). A
14、 version in 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, Cypr
15、us, 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, Sweden, Switzerland, Turkey and United Kin
16、gdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2014 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 21536:2009 + A
17、1:2014 E(ISO 21536:2007 + Amd. 1:2014) EN ISO 21536:2009 + A1:2014 (E) 2 Contents Page Foreword to EN ISO 21536:2009 3 !Foreword to EN ISO 21536:2009/A1:2014 .4 Introduction .5 1 Scope 6 2 Normative references 6 3 Terms and definitions .6 4 Intended performance .7 5 Design attributes7 5.1 General 7
18、5.2 Thickness of ultra-high molecular weight polyethylene (UHMWPE) in tibial components and meniscal components 7 5.3 Finish of non-articulating regions of metallic knee joint components 7 !5.4 Surface finish of articulating surfaces of knee joint components .8 6 Materials .8 7 Design evaluation 8 7
19、.1 General 8 7.2 Preclinical evaluation 8 8 Manufacture 8 9 Sterilization .9 10 Packaging .9 11 Information to be supplied by the manufacturer 9 11.1 General 9 11.2 Information supplied on the label 9 11.3 Constructional compatibility of components .9 11.4 Information for the patient 9 11.5 Marking
20、.9 Annex A (informative) Evaluation of range of relative angular motion of components of fully constrained total knee joint replacement implants 10 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices .11 DIN E
21、N ISO 21536:2014-07 EN ISO 21536:2009 + A1:2014 (E) 3Foreword to EN ISO 21536:2009 The text of ISO 21536:2007 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 21536:2009 by Technic
22、al Committee CEN/TC 285 “Non-active surgical implants” 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 sh
23、all 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 or all such patent rights. This document supersedes EN ISO 21536:20
24、07. 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. For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document. Accordin
25、g to the CEN/CENELEC Internal Regulations, the national 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,
26、Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 21536:2007 has been approved by CEN as EN ISO 21536:2009 without any modification. DIN EN ISO 21536:2014-07 EN ISO 2
27、1536:2009 + A1:2014 (E) 4 !Foreword to EN ISO 21536:2009/A1:2014 This document (EN ISO 21536:2009/A1:2014) 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 b
28、y DIN. This Amendment to the European Standard EN ISO 21536:2009 shall 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. Att
29、ention 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 has been prepared under a mandate given to CEN by the European Commission a
30、nd the European Free Trade Association, and supports essential requirements 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
31、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, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlan
32、ds, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, 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.“ DIN EN ISO 21536:2014-07EN ISO 21536:2009 +
33、A1:2014 (E) 5Introduction 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: p
34、articular 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 knee joint replacements. The level 1 standard contains re
35、quirements 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 osteosynthesis, cardiovascular surge
36、ry or joint replacement. To address all requirements, it is recommended that a standard of the lowest available level be consulted first. DIN EN ISO 21536:2014-07 EN ISO 21536:2009 + A1:2014 (E) 6 1 Scope This International Standard provides specific requirements for knee joint replacement implants.
37、 With 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 d
38、ocuments 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 7207-1, Implants for surgery Components for partial and total knee join
39、t prostheses Part 1: Classification, definitions and designation of dimensions !ISO 7207-2, Implants for surgery Components for partial and total knee joint prostheses Part 2: Articulating surfaces made of metal, ceramic and plastics materials“ ISO 14243-1, Implants for surgery Wear of total knee-jo
40、int prostheses Part 1: Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test ISO 14243-2, Implants for surgery Wear of total knee-joint prostheses Part 2: Methods of measurement ISO 14243-3, Implants for surgery Wear of to
41、tal knee-joint prostheses Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test ISO 14630:1), Non-active surgical implants General requirements ISO 14879-1, Implants for surgery Total knee joint prostheses
42、Part 1: Determination of endurance properties of knee tibial trays ISO 21534:2007, Non-active surgical implants Joint replacement implants Particular requirements 3 Terms and definitions For the purposes of this document the terms and definitions of ISO 21534 and ISO 7207-1 together with the followi
43、ng apply. 3.1 femoral component component of a total knee joint replacement intended to be secured to the femur to replace its articulating surfaces NOTE These implants can be manufactured as one component or a set of components to be assembled by the user. 3.2 tibial component component of a total
44、knee joint replacement intended to be secured to the tibia to replace its articulating surfaces NOTE 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) DIN EN ISO 21536:2014-07 EN ISO 21536:2009 + A
45、1:2014 (E) 73.3 tibial tray sub-component used to support and secure the articulating sub-component of a tibial component of a unicompartmental or total knee joint prosthesis 3.4 patellar component component of a total or partial knee joint replacement which is used to replace the articulating surfa
46、ce of the patella 3.5 patellar tray sub-component used to support and secure the articulating sub-component of a patellar component 3.6 unicompartmental knee joint prosthesis knee joint prosthesis designed to replace the femoral and tibial bearing surfaces in one compartment of the knee NOTE Adapted
47、 from ISO 7207-1, definition 3.1.2. 3.7 meniscal component component of certain total knee joint prostheses which is intended to transmit tibio-femoral load and which moves relative to both the tibial and femoral components 4 Intended performance The requirements of Clause 4 of ISO 21534:2007 shall
48、apply together with the following. The intended range of angular movement between the skeletal parts referred to in 4 a) of ISO 21534:2007 shall be determined. Annex A gives a suitable method for measurement of the range of movement of fully constrained knee joints. 5 Design attributes 5.1 General T
49、he requirements of Clause 5 of ISO 21534:2007 shall apply together with the following. 5.2 Thickness of ultra-high molecular weight polyethylene (UHMWPE) in tibial components and meniscal components For tibial components and meniscal components made of UHMWPE, the UHMWPE component or sub-component shall have the following minimum thickness in the load bearing area: a) 6 mm for components having a tibial tray; b) 9 mm for components without
