ISO INTERNATIONAL STANDARD 14630 Fourth edition 2012-12-01 Non-active surgical implants General requirements Implants chirurgicaux non actifs - Exigences generales Reference number ISO 14630:2012(E) LSO @ISO2012 y IHS under lic No reproductic r networking permitted without license from IHS Not for Resale ISO 14630:2012(E) COPYRIGHTPROTECTEDDOCUMENT ISO2012 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or 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 @ ISO 2012 -All rights reserved etworking permitted without license from IHS Not for Resale ISO 14630:2012(E) Contents Page Foreword ..iv Introduction 1 Scope. 2 Normative references 3 Terms and definitions. .2 4 Intended performance 3 5 Design attributes .3 6 Materials. 4 7 Design evaluation 5 7.1 General 5 7.2 Pre-clinical evaluation 5 7.3 Clinical evaluation. 6 7.4 Post-market surveillance. 6 8 Manufacture 6 9 Sterilization 6 9.1 General. 6 9.2 Products supplied sterile 6 9.3 Sterilization by the user. 9.4 Sterilization residuals.. 10 Packaging... 10.1 Protection from damage in storage and transport 10.2 Maintenanceofsterilityintransit 11 Information supplied by the manufacturer. 8 11.1 General.... 8 11.2 Labelling 8 11.3 Instructions for use... 11.4 Restrictions on combinations. 10 11.5 Marking on implants. 10 11.6 Markingforspecial purposes 11 Bibliography 12 ili e with IS ed without license from IHS Not for Resale