ISO INTERNATIONAL STANDARD 21534 Second edition 2007-10-01 Non-active surgical implants Joint replacement implants Particular requirements Implants chirurgicaux non actifs Implants de remplacement d'articulation- Exigences particulieres Reference number ISO 21534:2007(E) @ISO2007 by IHS under Not for Resale ISO21534:2007(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The IsO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by IsO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below. COPYRIGHT PROTECTED DOCUMENT @ISO2007 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, IsO's member body in the country of the requester. ISO copyright office Case postale 56 . CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail [email protected] Web www.iso.org Published in Switzerland @ IS0 2007 - All rights reserved py IHS unde I without license from IHS Not for Resale ISO21534:2007(E) Contents Page Foreword. Introduction .vi 1 Scope 2 Normative references 3 Terms and definitions. 4 Intended performance 2 5 Design attributes. 5.1 General. 5.2 Surface finish of metallic or ceramic implants articulating on ultra-high-molecular-weight 5.3 Surface finish of metallic or ceramic partial implants ... 3 5.4 Surfaces of convex, spherically-conforming metallic or ceramic implants articulating on 3 5.5 Surfaces of spherically-conforming metallic or ceramic partial implants.. 5.6 Surfaces of concave, spherically-conforming UHMwPE components... 6 Materials 6.1 General. 6.2 Dissimilar metals or alloys 7 Design evaluation 7.1 General.. 7.2 Preclinical evaluation ... 7.3 Clinical investigation... 7.4 Post market surveillance 8 Manufacture and inspection .... 8.1 General.. 8.2 Metal surfaces ... 8.3 Plastic surfaces.... 8.4 Ceramic surfaces. 9 Sterilization 9.1 General. 9.2 Expiry 10 Packaging 11 Information supplied by the manufacturer 11.1 11.2 Labeiling of impiants for use on one side of tne body oniy ... 11.3 Instructions for orientation of implants.... 11.4 Markings for orientation of the implants .... 11.5 Placing of markings on implants . 11.6 Restrictions on use............ 11.7 Re-sterilization of zirconia ceramics . 11.8 Labelling of implants for use with or without bone cement..... Annex A (informative) List of International Standards for materials found acceptable for the manufacture ofimplants.. Annex B (informative) List of International Standards for materials found acceptable or not acceptable for articulating surfaces of implants.... CopyrghtInternational Organizaionsandardizaoghtsreserved ili ted without license from IHS Not for Resale ISO 21534:2007(E) Annex C (informative) List of materials found acceptable or non-acceptable for metallic combinations for non-articulating contacting surfaces of implants ... ..11 Bibliography ...12 IsO 2007-All rights reserved vided by IHS under lid nited without license from IHs Not for Resale ISO 21534:2007(E) 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 body interested in a