ISO INTERNATIONAL STANDARD 10993-14 First edition 2001-11-15 Biological evaluation of medical devices Part 14: Identification and quantification of degradation products from ceramics Evaluation biologique des dispositifs médicaux- Partie 14: ldentification et quantification des produits de dégradation des céramiques Reference number E ISO 10993-14:2001(E) ISO @ ISO 2001 HS under ted without license from IHS Not for Resale ISO 10993-14:2001(E) PDF disclaimer 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 downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISo Central Secretariat 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 the unlikely event @ISO2001 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. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyright@iso.ch Web www.iso.ch Printed in Switzerland @ISO2001-All rightsreserved py IHS unde ermittedwithoutlicense from IHS Not for Resale ISO 10993-14:2001(E) Contents Page Foreword. .iv Introduction 1 Scope. 2 Normative references . 3 Terms and definitions .. 4 Test procedures 4.1 Principle..... 4.2 Testing of dental devices 4.3 Generaltestingtechniques. 4.4 Extreme solution test. 4.5 Simulation solution test. 5 Analysis of filtrate... 5.1 General........ .9 5.2 Choice of chemicals or elements to be analysed. 5.3 Sensitivity of the analysis method...... 6 Test report Bibliography Copyright Intenafona Organizain for Standardizalinserved ii by IHS under ut license from IHS Not for Resale