ISO INTERNATIONAL STANDARD 10993-13 Secondedition 2010-06-15 Biological evaluation of medical devices Part 13: Identification and quantification of degradation products from polymeric medical devices Evaluation biologique des dispositifs medicaux - Partie 13: ldentification et quantification de produits de degradation de dispositifsmedicauxabasedepolymeres Reference number ISO 10993-13:2010(E) so @ISO2010 Copyright International Organization for Standardizatior Not for Resale ISO10993-13:2010(E) PDFdisclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by IsO member bodies. In COPYRIGHTPROTECTEDDOCUMENT ISO2010 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either Iso at the address below or IsO's member body in the country of the requester. ISO copyright office Case postale 56.CH-1211 Geneva 20 Tel. + 4122 749 01 11 Fax + 4122749 09 47 E-mail [email protected] Web www.iso.org Published in Switzerland @IsO2010-Allrightsreserved Not for Resale ISO 10993-13:2010(E) Contents Page Foreword .iv Introduction .vi 1 Scope.. 2 Normative references. 1 3 Terms and definitions. 2 4 Degradation test methods.. 4.1 General procedures.... 4.2 Accelerated degradation test .... 4.3 Real-time degradation test in a simulated environment 5 Test procedures... 5.1 General 5.2 Initial material characterization.. 5.3 Accelerated degradation test.... 5.4 Real-time degradation test in a simulated environment .9 6 Testreport .10 AnnexA(informative)Analyticalmethods AnnexB(informative)Environmental stress cracking (EsC)of polymers. 12 Bibliography... .14 ili e with IS ense from IHS Notfor Resi