ISO INTERNATIONAL STANDARD 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity Evaluation biologique des dispositifs medicaux Partie 5: Essais concernant la cytotoxicite in vitro Reference number ISO10993-5:2009(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 instailed 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 that a problem relating to it is found, please inform the Central Secretariat at the address given below. COPYRIGHTPROTECTEDDOCUMENT @ISO2009 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, 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 [email protected] Web www.iso.org Published in Switzerland Contents Page Foreword . iv Introduction. 1 Scope 2 Normative references. 3 Terms and definitions. 4 Sample and control preparation... 4.1 General ... 4.2 Preparation of liquid extracts of material. 4.3 Preparation of material for direct-contact tests 4.4 Preparation of controls..... 5 Cell lines. 6 Culture medium 7 Preparation of cell stock culture . 8 Test procedures. 8.1 Number of replicates 8.2 Test onextracts .... 8.3 Testbydirectcontact. 8.4 Testbyindirectcontact. 8.5 Determination of cytotoxicity .... 9 Test report... 10 Assessment of results. Annex A (informative) Neutral red uptake (NRU) cytotoxicity test . 12 Annex B (informative) Colony formation cytotoxicity test .. Annex C (informative) MTT cytotoxicity test... Annex D (informative) XTT cytotoxicity test. 29 Bibliography. 34 Copyright InternationalOrganization for StandardizatinhtSreserved d without license from IHS