ISO INTERNATIONAL STANDARD 10993-16 Third edition 2017-05 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables Evaluation biologique des dispositifs médicaux Partie 16: Conception des études toxicocinetiques des produits de dégradation et des substances relargables Reference number IS0 10993-16:2017(E) osi @ IS0 2017 IS0 10993-16:2017(E) COPYRIGHT PROTECTED DOCUMENT @ IS0 2017, Published in Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form writtenpermission.Permission canberequestedfromeitherIsOattheaddressbelow orIso'smemberbodyinthecountryof the requester. ISO copyrightoffice Ch. de Blandonnet 8 · CP 401 CH-1214 Vernier, Geneva, Switzerland Tel. +41 22 749 01 11 Fax +41 22 749 09 47 copyright@iso.org www.iso.org ii @ IS0 2017 - All rights reserved IS0 10993-16:2017(E) Contents Page Foreword ..iv Introduction. ..V 1 Scope. 2 Normative references 3 Terms and definitions 4 Principles for design of toxicokinetic studies ..3 5 Guidance on test methods. .3 5.1 General considerations 3 5.2 Guidance on specific types of test .5 5.2.1 General .5 5.2.2 Absorption. .5 5.2.3 Distribution .5 5.2.4 Metabolismandexcretion .6 Annex A (normative) Circumstances in which toxicokinetic studies shall be considered 7 Bibliography 9 @ IS0 2017 - All rights reserved iii