ISO INTERNATIONAL STANDARD 10993-1 Fifth edition 2018-08 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process Evaluation biologique des dispositifs medicaux - Partie 1: Evaluation et essais au sein d'un processus de gestion du risque Reference number IS0 10993-1:2018(E) rso @ IS0 2018 censefromIHS Not for Resale, 08/20/2018 20:10:24 MDT IS0 10993-1:2018(E) COPYRIGHTPROTECTEDDOCUMENT @ IS0 2018 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 401 : Ch. de Blandonnet 8 CH-1214 Vernier, Geneva Phone: +4122 749 0111 Fax: +41 22 749 09 47 Email: [email protected] Website: www.iso.org Published in Switzerland @ IS0 2018 - All rights reserved No reproduction Not for Resale, 08/20/2018 20:10:24 MDT IS0 10993-1:2018(E) Contents Page Foreword ..iv Introduction. ..V 1 Scope. .1 2 Normative references 3 Terms and definitions ..2 4 General principles applying to biological evaluation of medical devices .5 5 Categorization ofmedical devices. .9 5.1 General .9 5.2 Categorization by nature of body contact. .9 5.2.1 Non-contacting medical devices .9 5.2.2 Surface-contacting medical devices .10 5.2.3 Externally communicating medical devices .10 5.2.4 Implantmedicaldevices 11 5.3 Categorization by duration of contact .11 5.3.1 Contactdurationcategories .11 5.3.2 Transitory-contacting medical devices .11 5.3.3 Medical devices with multiple contact duration categories .11 6 Biological evaluation process ..12 6.1 Physical and chemical information for biological risk analysis .12 6.2 Gap analysis and selection of biological endpoints forassessment .12 6.3 Biological testing 13 6.3.1 General .13 6.3.2 Testing for evaluation ..14 7 Interpretation of biological evaluation data and overall biological risk assessment ..18 Annex A (informative) Endpoints to be addressed in a biological risk assessment .20 Annex B (informative) Guidance on the conduct of biological evaluation within a risk managementprocess .25 Annex C (informative) Suggested procedure for literature review ..38 Bibliography .40 iii ut license from IHS Not for Resale, 08/20/2018 20:10:24 MDT