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1、BS EN ISO 21534:2007 ICS 11.040.40 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW BRITISH STANDARD Non-active surgical implants Joint replacement implants Particular requirements (ISO 21534:2007) Licensed CopyChinese University of Hong Kong, 21/10/2008 02:49, Uncontrolled Cop
2、y, (c) BSI This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 September 2008 BSI 2008 ISBN 978 0 580 53871 1 Amendments/corrigenda issued since publication DateComments BS EN ISO 21534:2007 National foreword This British Standard is the UK im
3、plementation of EN ISO 21534:2007. It supersedes BS EN 12010:1998 which is withdrawn. The UK participation in its preparation was entrusted to Technical Committee CH/150/4, Bone and joint replacements. A list of organizations represented on this committee can be obtained on request to its secretary.
4、 This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard cannot confer immunity from legal obligations. Licensed CopyChinese University of Hong Kong, 21/10/2008 02:49, Uncontrolled
5、Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 21534 September 2007 ICS 11.040.40Supersedes EN 12010:1998 English Version Non-active surgical implants - Joint replacement implants - Particular requirements (ISO 21534:2007) Implants chirurgicaux non actifs - Implants de rempla
6、cement darticulation - Exigences particulires (ISO 21534:2007) Nichtaktive chirurgische Implantate - Implantate zum Gelenkersatz - Besondere Anforderungen (ISO 21534:2007) This European Standard was approved by CEN on 16 August 2007. CEN members are bound to comply with the CEN/CENELEC Internal Regu
7、lations which stipulate the 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
8、 European Standard exists 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 t
9、he 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, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerla
10、nd and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2007 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN
11、ISO 21534:2007: E Licensed CopyChinese University of Hong Kong, 21/10/2008 02:49, Uncontrolled Copy, (c) BSI BS EN ISO 21534:2007 EN ISO 21534:2007 (E) 3 Foreword This document (EN ISO 21534:2007) has been prepared by Technical Committee ISO/TC 150 “Implants for surgery“ in collaboration with Techni
12、cal 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 March 2008, and conflicting national standards sha
13、ll be withdrawn at the latest by March 2008. This document supersedes EN 12010:1998. 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 EC Directive(s). For relationship with EC Direc
14、tive(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: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark,
15、 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 United Kingdom. Endorsement notice The text of ISO 21534:2007 has been approved b
16、y CEN as a EN ISO 21534:2007 without any modification. Licensed CopyChinese University of Hong Kong, 21/10/2008 02:49, Uncontrolled Copy, (c) BSI BS EN ISO 21534:2007 EN ISO 21534:2007 (E) 4 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Direc
17、tive 93/42/EEC This European Standard has been prepared under a mandate given to CEN by the European Commission to provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC. Once this standard is cited in the Official Journal of the European Communities under th
18、at 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.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Dire
19、ctive and associated EFTA regulations. Table ZA Correspondence between this International Standard and Directive 93/42/EEC Clause(s)/sub-clause(s) of this International Standard Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 4 1, 2, 3, 4, 5, 7.1, 7.2, 9.2 5 1, 2, 3, 4,
20、5, 6, 7.1, 9.1, 9.2 6 1, 2, 3, 4, 7.1, 7.2, 7.3, 7.4, 8.2, 9.1, 9.2 7 1, 2, 3, 4, 5, 6, 7.1, 7.2, 7.3, 14 8 1, 2, 3, 4, 5, 7.1, 7.2, 7.3 9 3, 8.1, 8.3, 8.4, 8.5, 8.6, 8.7, 13.3 10 3, 5, 7.2, 8.1, 8.3, 8.4, 8.5, 8.6, 8.7 11 9.1, 13 NOTE All clauses supplement and are dependent on the corresponding cl
21、auses of EN 14630 WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. Licensed CopyChinese University of Hong Kong, 21/10/2008 02:49, Uncontrolled Copy, (c) BSI BS EN ISO 21534:2007 ISO 21534:2007(E) ISO 2007 All rights re
22、served iii Contents Page Foreword. v Introduction. vi 1 Scope . 1 2 Normative references. 1 3 Terms and definitions. 2 4 Intended performance 2 5 Design attributes. 3 5.1 General. 3 5.2 Surface finish of metallic or ceramic implants articulating on ultra-high-molecular-weight polyethylene (UHMWPE) 3
23、 5.3 Surface finish of metallic or ceramic partial implants 3 5.4 Surfaces of convex, spherically-conforming metallic or ceramic implants articulating on UHMWPE 3 5.5 Surfaces of spherically-conforming metallic or ceramic partial implants 3 5.6 Surfaces of concave, spherically-conforming UHMWPE comp
24、onents. 3 6 Materials 4 6.1 General. 4 6.2 Dissimilar metals or alloys 4 7 Design evaluation. 4 7.1 General. 4 7.2 Preclinical evaluation. 4 7.3 Clinical investigation 5 7.4 Post market surveillance . 5 8 Manufacture and inspection 5 8.1 General. 5 8.2 Metal surfaces. 5 8.3 Plastic surfaces. 5 8.4 C
25、eramic surfaces 5 9 Sterilization 6 9.1 General. 6 9.2 Expiry. 6 10 Packaging 6 11 Information supplied by the manufacturer 6 11.1 General. 6 11.2 Labelling of implants for use on one side of the body only. 6 11.3 Instructions for orientation of implants 6 11.4 Markings for orientation of the implan
26、ts 6 11.5 Placing of markings on implants 6 11.6 Restrictions on use. 7 11.7 Re-sterilization of zirconia ceramics 7 11.8 Labelling of implants for use with or without bone cement. 7 Annex A (informative) List of International Standards for materials found acceptable for the manufacture of implants
27、8 Annex B (informative) List of International Standards for materials found acceptable or not acceptable for articulating surfaces of implants. 9 Licensed CopyChinese University of Hong Kong, 21/10/2008 02:49, Uncontrolled Copy, (c) BSI BS EN ISO 21534:2007 ISO 21534:2007(E) iv ISO 2007 All rights r
28、eserved Annex C (informative) List of materials found acceptable or non-acceptable for metallic combinations for non-articulating contacting surfaces of implants.11 Bibliography .12 Licensed CopyChinese University of Hong Kong, 21/10/2008 02:49, Uncontrolled Copy, (c) BSI BS EN ISO 21534:2007 ISO 21
29、534:2007(E) ISO 2007 All rights reserved v Foreword 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 committees. Each member
30、 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 the International Elect
31、rotechnical 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 International Standards adopte
32、d 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 subject of patent
33、 rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 21534 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 21534:2002), which
34、 has been technically revised. Licensed CopyChinese University of Hong Kong, 21/10/2008 02:49, Uncontrolled Copy, (c) BSI BS EN ISO 21534:2007 ISO 21534:2007(E) vi ISO 2007 All rights reserved Introduction There are three levels of International Standard dealing with non-active surgical implants. Th
35、ese 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: particular requirements for families of non-active surgical implants; level 3: specific requirements for types of non-act
36、ive surgical implant. 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 t
37、hat there are additional 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
38、lowest available level be consulted first. Licensed CopyChinese University of Hong Kong, 21/10/2008 02:49, Uncontrolled Copy, (c) BSI BS EN ISO 21534:2007 INTERNATIONAL STANDARD ISO 21534:2007(E) ISO 2007 All rights reserved 1 Non-active surgical implants Joint replacement implants Particular requir
39、ements 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 International Standard, artificial ligaments and their associated fixing de
40、vices 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 manufacturer. Some tests required to demonstrate conformance to this Internatio
41、nal 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 applies. For undated references, the latest edition of the referenced docum
42、ent (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 joint prostheses Part 4: Determination of endurance properties of stemme
43、d 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 for human subjects Part 1: General requirements ISO 14242-1, Implants
44、 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 prostheses Part 2: Methods of measurement ISO 14243-2, Implants for sur
45、gery 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 endurance properties of knee tibial trays 1) To be published. (Revision of IS
46、O 14630:2005) Licensed CopyChinese University of Hong Kong, 21/10/2008 02:49, Uncontrolled Copy, (c) BSI BS EN ISO 21534:2007 ISO 21534:2007(E) 2 ISO 2007 All rights reserved 3 Terms and definitions For the purposes of this document, the terms and definitions in ISO 14630 together with the following
47、 apply. 3.1 artificial ligament device, including 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 wh
48、ich is connected to the corresponding bones 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 sur
49、face and the radius to the point on the spherical 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 address the following matters: a) intended minimum and maximum relative angular movement between the skeletal parts to which the joint replacement implant is