ISO INTERNATIONAL STANDARD 10993-18 Secondedition 2020-01 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process Evaluation biologique des dispositifs medicaux - Partie 18: Caracterisation chimique des materiaux des dispositifs medicaux au sein d'un processus de gestion du risque Referencenumber ISO10993-18:2020(E) @IS02020 IS010993-18:2020(E) COPYRIGHTPROTECTEDDOCUMENT @ISO2020 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 orIso's memberbody in the countryof therequester. ISO copyright office CP 401 : Ch. de Blandonnet 8 CH-1214 Vernier, Geneva Phone:+41227490111 Fax:+4122749 09 47 Email: [email protected] Website: www.iso.org Published in Switzerland ii @ IS0 2020 - All rights reserved