ISO INTERNATIONAL STANDARD 14602 Second edition 2010-04-15 Non-active surgical implants Implants for osteosynthesis Particular requirements Implants chirurgicaux non actifs Implants pour osteosynthese Exigences particulieres Reference number ISO 14602:2010(E) @ ISO 2010 Not for Resale ISO 14602:2010(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 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 COPYRIGHTPROTECTEDDOCUMENT @ISO2010 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 memberbody 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 @ Iso 2010 - All rights reserved ed without license from IHS Not for Resale ISO 14602:2010(E) Contents Page Foreword Introduction 1 Scope 2 Normative references 3 Terms and definitions 4 Intended performanc 4.1 General 4.2 Intended purpose . 4.3 Functionalcharacteristics. 4.4 Intended conditions of use. 5 Design attributes 6 Materials 7 Design evaluation 7.1 General 7.2 Pre-clinical evaluation. 7.3 Clinical evaluation .... 7.4 Post-market surveillance 8 Manufacturing. 9 Sterilization 10 Packaging.. 11 Information supplied by manufacturer... 11.1 General. 11.2 11.3 Instructions for use ... 11.4 Restrictions on combinations 11.5 Marking on implant.. 11.6 Marking for special purposes Annex A (informative) Correspondence of the clauses of this International Standard to the fundamental principles outlined in ISO/TR 14283.... Annex B (informative) Iso standards referring to implants and associated instruments found acceptable through clinical use for given applications in osteosynthesis... Annex C (informative) Iso Standards referring to materials found acceptable through proven clinical use ..... Annex D (informative) Standards related to testing and design evaluation . Bibliography... CopyrghtInternational OrganizaionSadardizaoghtsreserved ii out license from IHS Not for Resale