ISO INTERNATIONAL STANDARD 10993-11 Third edition 2017-09 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity Evaluation biologique des dispositifs medicaux Partie11:Essais detoxicite systemique Referencenumber IS010993-11:2017(E) ISO @IS02017 IS010993-11:2017(E) GetmoreFREEstandardsfromStandardSharingGroupandourchats COPYRIGHTPROTECTEDDOCUMENT IS0 2017, Published in Switzerland 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 Ch.de Blandonnet 8·CP 401 CH-1214 Vernier, Geneva, Switzerland Tel. +41 22 749 0111 Fax +41 22 749 09 47 [email protected] www.iso.org ii IS0 2017-All rights reserved IS010993-11:2017(E) Contents Page Foreword .v Introduction ..vi 1 Scope ..1 2 Normativereferences 3 Terms and definitions ..3 4 General considerations 4.1 General 3 .3 4.2 Selectionofanimal species 4.3 Animal status.. .3 4.4 Animal care and husbandry .3 4.5 Sizeandnumberofgroups 4 4.5.1 Size of groups. 4 4.5.2 Numberofgroups. 4 4.5.3 Treatment controls 4 .5 4.6 Route ofexposure. 4.7 Samplepreparation 5 4.8 Dosing 5 4.8.1 Testsampleadministration 5 4.8.2 Dosage volumes 5 4.8.3 Dosagefrequency 6 4.9 Bodyweightandfood/waterconsumption 6 4.10 Clinical observations 6 4.11 Clinical pathology 6 4.12 Anatomicpathology .7 4.13 Study designs .7 4.14 Qualityof investigation .7 .1 5 Acute systemictoxicity 5.1 General 7 5.2 .8 Study design. 5.2.1 Preparations 8 5.2.2 Experimentalanimals .8 5.2.3 8 Test conditions. 5.2.4 Body weights 9 5.2.5 Clinical observations 9 5.2.6 Pathology 9 5.3 Evaluation criteria. .10 5.3.1 General 10 .10 5.3.2 Evaluation of results 5.4 Final report 10 6 Repeated exposure systemic toxicity (subacute, subchronic and chronic systemictoxicity) 12 6.1 General 12 6.2 Study design. 12 6.2.1 Preparations 12 6.2.2 Experimental animals 12 6.2.3 Test conditions. 13 6.2.4 Body weights 13 6.2.5 Clinicalobservations 13 6.2.6 Pathology .13 6.3 Evaluation criteria .14 6.3.1 .14 General 6.3.2 Evaluationof results .14 @ IS0 2017 -All rights reserved ili