ISO INTERNATIONAL STANDARD 10993-3 Third edition 2014-10-01 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity Evaluation biologique des dispositifs medicaux - Partie 3: Essais concernant la génotoxicite, la cancerogénicite et la toxicité sur la reproduction Reference number IS0 10993-3:2014(E) ISO @ IS0 2014 ed without license from IHS Not for Resale IS0 10993-3:2014(E) COPYRIGHTPROTECTEDDOCUMENT @ISO2014 All rights reserved. Unless otherwise specified, 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 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 [email protected] Web www.iso.org Published in Switzerland @ IS0 2014 - All rights reserved or networking permited without license from IHS Not for Resale IS0 10993-3:2014(E) Contents Page Foreword ..iv Introduction. ...vi 1 Scope. 2 Normative references 3 Terms and definitions ..2 4 Requirements for test strategies. .2 4.1 General. .2 4.2 Additional requirements for carcinogenicitytesting .3 4.3 Additional requirements for reproductive toxicity testing .3 5 Genotoxicity tests .4 5.1 General. ..4 5.2 Test strategy .4 5.3 Sample preparation .6 6 Carcinogenicity tests 6.1 General 7 6.2 Evaluation strategy 7 6.3 Sample preparation .8 6.4 Test methods ..8 7 Reproductive and developmental toxicity tests .9 7.1 General .9 7.2 Test strategy .9 7.3 Sample preparation .10 7.4 Test methods. .10 8 Test report ..11 Annex A (informative) Guidance on selecting an appropriate sample preparation procedure in genotoxicity testing .12 Annex B (informative) Flowchart for follow-up evaluation ..20 Annex C (informative) Rationale of test systems .21 AnnexD(informative)Celltransformationtestsvstems ..23 Annex E (normative) Considerations for carcinogenicity studies performed as implantation studies ..24 Annex F (informative) In vitro tests for embryo toxicity ..25 Bibliography .27 ii e with I: d without license from IHS Not for Resale