TECHNICAL ISO/TR REPORT 14283 Third edition 2018-01-12 Implants for surgery Essential principles of safety and performance Implants chirurgicaux - Principes essentiels de la seécurite et les performances Reference number A IS0/TR 14283:2018(E) ISO @IS02018 IS0/TR14283:2018(E) COPYRIGHTPROTECTEDDOCUMENT IS0 2018, Published in Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form written permission. Permission can be requested from either ISO at the address below or ISO's member body in the country of the requester. IsOcopyrightoffice Ch. de Blandonnet 8 . CP 401 CH-1214 Vernier, Geneva, Switzerland Tel. +41 22 749 01 11 Fax +41 22 749 09 47 [email protected] www.iso.org ii @ IS0 2018 - All rights reserved IS0/TR 14283:2018(E) Contents Page Foreword ..iv Introduction. ..V 1 Scope. .1 2 Normative references ..1 3 Terms and definitions ..1 4 Application of essential principles ..4 5 Essentialprinciples applicableto implants .4 5.1 General 4 5.2 Chemical, physical and biological properties .5 5.3 Infection and microbial contamination .5 5.4 Implants incorporating a substance considered to be a medicinal product/drug. ..6 5.5 Implants incorporating materials of biological origin .6 5.6 Environmentalproperties 7 5.7 Implants with a diagnostic or measuring function 8 5.8 Protection against radiation. .8 5.8.1 General .8 5.8.2 Intended radiation. .8 5.8.3 Unintended radiation. .9 5.8.4 Ionizing radiation. 9 5.9 Implants that incorporate software .9 5.10 Active implants and devices connected to them .9 5.11 Protection against mechanical risks 10 5.12 Protection against the risks posed to the patient or user by supplied energy or substances .10 5.13 Label and Instructions for Use ..11 5.13.1 General principles. .11 5.13.2 Content of the label. .12 5.13.3 Content of the instructions for use .13 5.14 Clinicalevaluation .15 Annex A (informative) Corresponding regulatory requirements ..16 Bibliography .19 @ IS0 2018 - All rights reserved iii