ISO INTERNATIONAL STANDARD 10993-18 Second edition 2020-01 AMENDMENT 1 2022-05 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process AMENDMENT 1: Determination of the uncertainty factor Evaluation biologiquedes dispositifs médicaux Partie 18: Caracterisation chimique des materiaux des dispositifs medicauxauseind'unprocessusdegestiondurisque AMENDEMENT1:Determination du coefficient d'incertitude Reference number IS010993-18:2020/Amd.1:2022(E) os1 @ ISO 2022 IS0 10993-18:2020/Amd.1:2022(E) COPYRIGHT PROTECTED DOCUMENT @IS02022 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 Email: [email protected] Website: www.iso.org Published in Switzerland ii @ IS0 2022 - All rights reserved