ISO INTERNATIONAL STANDARD 14949 First edition 2001-10-15 Implants for surgery - Two-part addition- cure silicone elastomers Implants chirurgicaux- Elastomeres de silicone a deux composants a réticulation par réaction d'addition Reference number A ISO 14949:2001(E) TSO @ISO2001 y IHS under Not for Resale ISO14949:2001(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 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 in the country of the requester. ISO copyright office Case postale 56. CH-1211 Geneva 20 Tel. + 4122 749 01 11 Fax + 41 22 749 09 47 E-mail [email protected] Web www.iso.ch Printed in Switzerland ISO 2001 - All rights reserved itted without license from IHS Not for Resale ISO 14949:2001(E) Contents Page Foreword. Introduction 1 Scope. 2 Normative references.. 3 Terms and definitions. 4 Formulation.. 4.1 Composition.. 4.2 Raw materials assessment. 5 Biocompatibility.. 6 Characterization and testing 6.1 Test slab preparation 6.2 Identification .. 6.3 Purity testing.. 6.4 Cure rate.... 6.5 Physicomechanical properties and characterization 7 Documentation.. 7.1 Data sheet... 7.2 Certificateofanalysis Annex A (normative) Determination of substances soluble in hexane Annex B (normative) Determination of volatile matter. 12 Bibliography. ili HS under from IHS