1、August 2009DEUTSCHE NORM English price group 12No part of this standard 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!$YAH“1543037w
2、ww.din.deDDIN EN ISO 21534Non-active surgical implants Joint replacement implants Particular requirements (ISO 21534:2007)English version of DIN EN ISO 21534:2009-08Nichtaktive chirurgische Implantate Implantate zum Gelenkersatz Besondere Anforderungen (ISO 21534:2007)Englische Fassung DIN EN ISO 21
3、534:2009-08SupersedesDIN EN ISO 21534:2007-12See start of validitywww.beuth.deDocument comprises 22 pagesDIN EN ISO 21534:2009-08 2 Start of validity This standard takes effect on 1 August 2009. DIN EN ISO 21534:2007-12 may be used in parallel until 21 March 2010. National foreword This standard has
4、 been prepared by Technical Committee ISO/TC 150 “Implants for surgery” in collaboration with Technical 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
5、Precision Mechanics Standards Committee), Technical Committee NA 027-02-15 AA Endo-prothetik und Osteosynthese. This standard contains specifications meeting the essential requirements set out in EU Directive 93/42/EEC on medical devices. The DIN Standards corresponding to the International and Euro
6、pean Standards referred to in clause 2 of this document are as follows: ISO 4287 DIN EN ISO 4287 ISO 14155-1 DIN EN ISO 14155-1 ISO 14630 DIN EN ISO 14630 Amendments This standard differs from DIN EN ISO 21534:2007-12 as follows: a) Annex ZA (informative) concerning the relationship between this Eur
7、opean Standard and the essential requirements of EU Directive 93/42/EEC on medical devices has been updated on the basis of EU Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directives 90/385/EEC on the approximation of the laws of the Member
8、States relating to active implantable medical devices and 93/42/EEC on medical devices and EU Directive 98/8/EC on the placing on the market of biocidal products. Previous editions DIN EN 12010: 1998-05 DIN EN ISO 21534: 2007-12 National Annex NA (informative) Bibliography DIN EN ISO 4287, Geometric
9、al Product Specifications (GPS) Surface texture: Profile method Terms, definitions and surface texture parameters DIN EN ISO 14155-1, Clinical investigation of medical devices for human subjects Part 1: General requirements DIN EN ISO 14630, Non-active surgical implants General requirements EUROPEAN
10、 STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 21534 May 2009 ICS 11.040.40 Supersedes EN ISO 21534:2007English Version Non-active surgical implants - Joint replacement implants - Particular requirements (ISO 21534:2007) Implants chirurgicaux non actifs - Implants de remplacement darticulation - E
11、xigences particulires (ISO 21534:2007) Nichtaktive chirurgische Implantate - Implantate zum Gelenkersatz - Besondere Anforderungen (ISO 21534:2007) 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 t
12、he conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN Management Centre or to any CEN member. This European Standard exists
13、 in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the official versions. CEN members are the national standards bod
14、ies of 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, Switzerland and United Kingdom. EU
15、ROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 21534:2009: EContents
16、2 Page Foreword .4 Introduction.5 1 Scope6 2 Normative references6 3 Terms and definitions .7 4 Intended performance.7 5 Design attributes .8 5.1 General .8 5.2 Surface finish of metallic or ceramic implants articulating on ultra-high-molecular-weight polyethylene (UHMWPE).8 5.3 Surface finish of me
17、tallic or ceramic partial implants.8 5.4 Surfaces of convex, spherically-conforming metallic or ceramic implants articulating on UHMWPE 8 5.5 Surfaces of spherically-conforming metallic or ceramic partial implants 8 5.6 Surfaces of concave, spherically-conforming UHMWPE components .8 6 Materials .9
18、6.1 General .9 6.2 Dissimilar metals or alloys .9 7 Design evaluation9 7.1 General .9 7.2 Preclinical evaluation9 7.3 Clinical investigation.10 7.4 Post market surveillance 10 8 Manufacture and inspection.10 8.1 General .10 8.2 Metal surfaces10 8.3 Plastic surfaces .10 8.4 Ceramic surfaces.10 9 Ster
19、ilization 11 9.1 General .11 9.2 Expiry11 10 Packaging.11 11 Information supplied by the manufacturer .11 11.1 General .11 11.2 Labelling of implants for use on one side of the body only .11 11.3 Instructions for orientation of implants 11 11.4 Markings for orientation of the implants.11 11.5 Placin
20、g of markings on implants.11 11.6 Restrictions on use .12 11.7 Re-sterilization of zirconia ceramics.12 11.8 Labelling of implants for use with or without bone cement .12 Annex A (informative) List of International Standards for materials found acceptable for the manufacture of implants.13 Annex B (
21、informative) List of International Standards for materials found acceptable or not acceptable for articulating surfaces of implants .14 DIN EN ISO 21534:2009-08 EN ISO 21534:2009 (E) 3 Annex C (informative) List of materials found acceptable or non-acceptable for metallic combinations for non-articu
22、lating contacting surfaces of implants. 16 Bibliography. 17 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC. 19 EN ISO 21534:2009 (E) DIN EN ISO 21534:2009-08 Foreword 4 The text of ISO 21534:2007 has been prepared by Techni
23、cal Committee ISO/TC 150 “Implants for surgery” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 21534:2009 by Technical Committee CEN/TC 285 “Non-active surgical implants” the secretariat of which is held by DIN. This European Standard shall be given the
24、 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 document may be the
25、 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 21534:2007. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and
26、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 implement this Eu
27、ropean 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, Switzerland and the Unit
28、ed Kingdom. Endorsement notice DIN EN ISO 21534:2009-08 EN ISO 21534:2009 (E) The text of ISO 21534:2007 has been approved by CEN as EN ISO 21534:2009 without any modification. Introduction There are three levels of International Standard dealing with non-active surgical implants. These are as follo
29、ws, with level 1 being the highest: level 1: 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 imp
30、lant. This International Standard is a level 2 standard and contains requirements that apply to all non-active surgical implants in the family of joint replacement implants. The level 1 standard contains requirements that apply to all non-active surgical implants. It also indicates that there are ad
31、ditional requirements in the level 2 and level 3 standards. The level 1 standard has been published as ISO 14630. Level 3 standards apply to specific types of implants within a family, such as knee and hip joints. To address all requirements, it is recommended that a standard of the lowest available
32、 level be consulted first. 5 EN ISO 21534:2009 (E) DIN EN ISO 21534:2009-08 1 Scope This International Standard specifies particular requirements for total and partial joint replacement implants, artificial ligaments and bone cement, hereafter referred to as implants. For the purposes of this Intern
33、ational Standard, artificial ligaments and their associated fixing devices are included in the term “implant“. It specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information to be supplied by the manufactur
34、er. Some tests required to demonstrate conformance to this International Standard are contained in or referenced in level 3 standards. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applie
35、s. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 4287, Geometrical Product Specifications (GPS) Surface texture: Profile method Terms, definitions and surface texture parameters ISO 7206-4, Implants for surgery Partial and total hip joi
36、nt prostheses Part 4: Determination of endurance properties of stemmed femoral components ISO 7206-8, Implants for surgery Partial and total hip joint prostheses Part 8: Methods of determining endurance performance of stemmed femoral components ISO 14155-1, Clinical investigation of medical devices
37、for human subjects Part 1: General requirements ISO 14242-1, Implants for surgery Wear of total hip-joint prostheses Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for tests ISO 14242-2, Implants for surgery Wear of total hip joint pr
38、ostheses Part 2: Methods of measurement ISO 14243-2, Implants for surgery Wear of total knee-joint prostheses Part 2: Methods of measurement ISO 14630:1), Non-active surgical implants General requirements ISO 14879-1, Implants for surgery Total knee-joint prostheses Part 1: Determination of enduranc
39、e properties of knee tibial trays 1) To be published. (Revision of ISO 14630:2005) 6 DIN EN ISO 21534:2009-08 EN ISO 21534:2009 (E) 3 Terms and definitions For the purposes of this document, the terms and definitions in ISO 14630 together with the following apply. 3.1 artificial ligament device, inc
40、luding its necessary fixing devices, intended to augment or replace the natural ligament 3.2 joint replacement implant implantable device, including ancillary implanted components and materials, intended to provide function similar to a natural joint and which is connected to the corresponding bones
41、 3.3 mean centre position within the spherical head for which the average of the distances to a set of points uniformly distributed over the surface of the sphere is minimum 3.4 radial separation value difference between the mean radius of the spherical surface and the radius to the point on the sph
42、erical surface furthest from the mean centre NOTE The units of the radial separation value are in micrometres. 4 Intended performance For the purpose of this International Standard, the intended performance of implants shall conform to Clause 4 of ISO 14630:, and the design input shall additionally
43、address the following matters: a) intended minimum and maximum relative angular movement between the skeletal parts to which the joint replacement implant is attached; b) expected maximum load actions (forces and moments) to be transmitted to the bony parts to which the joint replacement implant is
44、attached; c) dynamic response of the body to the shape/stiffness of the implants; d) expected wear of articulating surfaces; e) suitability of the dimensions and shape of the implant for the population for which it is intended; f) strength of the adhesion and durability of surface coatings or surfac
45、e treatments. NOTE 1 The clinical indications and contra-indications for the use of a particular implant are complex and should be reviewed by the surgeons when they are selecting implants to be used for particular patients, relying upon their own personal judgment and experience. NOTE 2 The lifetim
46、e of an implant depends on the interaction of various factors; some are the responsibility of the manufacturer, some, such as the implantation technique, are the responsibility of the surgeon in conducting the operation, and some relate to the patient, for example, the biological and physiological r
47、esponse to the implant, the medical condition of the patient, the conduct of the patient in respect of increasing body weight, carriage of heavy loads and adopting a high level of physical activity. 7 EN ISO 21534:2009 (E) DIN EN ISO 21534:2009-08 5 Design attributes 5.1 General The development of t
48、he design attributes to meet the performance intended by the manufacturer shall conform to the requirements of Clause 5 of ISO 14630:, and in addition, account shall be taken of the following points: a) the strength of adhesion and durability of surface coatings and surface treatments; b) the wear o
49、f the articulating and other surfaces; c) stability of the implant while allowing prescribed minimum and maximum relative movements between the skeletal parts; d) avoidance of cutting or abrading tissue during function other than insertion or removal; e) the creep resistance and rupture characteristics, particularly as they relate to ligaments. NOTE 1 Methods of assessment of the wear of articulating and other surfaces are prescribed in, e.g. ISO 14242-2 and ISO 14243-1, -2 and -3. NOTE 2 More specific requirements, such as th
