International ISo Standard IS014630 Fifth edition Non-active surgical implants - 2024-09 General requirements Implants chirurgicaux non actifs-Exigences generales Referencenumber ISO14630:2024(en) @ISO2024 IS0 14630:2024(en) COPYRIGHTPROTECTEDDOCUMENT @IS02024 All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be requested from either IsO at the address below or Iso's member body in the country of the requester. ISO copyright office CP 40i: Ch.de Blandonnet 8 CH-1214 Vernier,Geneva Phone: +41 22 749 01 11 Email: [email protected] Website: www.iso.org Published in Switzerland @IS0 2024-All rights reserved ii IS0 14630:2024(en) Contents Page Foreword. ..iv Introduction .vi 1 Scope. .1 2 Normative references .1 3 Terms and definitions. .2 .6 4 Intended performance. 5 Design attributes 6 Selection of materials .7 .8 7 Design evaluation 7.1 General. ..8 7.2 Pre-clinical evaluation ..8 7.3 Clinical evaluationand clinical investigation ..10 7.4 Post-market surveillance .11 8 Manufacture .11 9 Sterilization .11 9.1 Implants supplied sterile. ..11 9.2 Implants supplied non-sterile .12 9.3 Re-sterilizableimplants ..12 9.4 Sterilization residuals 12 10 Packaging. ..12 10.1 Protection from damage in transport, storage and handling ..12 10.2 Maintenance of sterility in transport, storage and handling. ..13 10.3 Usebydate. .13 11 Information supplied bythemanufacturer .13 11.1 .13 General. 11.2 Marking on implants .14 11.3 Label. .14 11.4 Instructionsfor use .16 11.5 Patient record label(s) .17 11.6 Implantcard ..18 11.7 Implantsforspecial purposes .18 Bibliography .19 @IS0 2024-All rights reserved ii