ISO INTERNATIONAL STANDARD 18189 First edition 2016-06-01 Ophthalmic optics Contact lenses and contact lens care products Cytotoxicity testing of contact lenses in combination with lens care solution to evaluate lens/solution interactions Optique ophtalmique - Lentilles de contact et produits d'entretien des lentilles de contact - Essais de cytotoxicité des lentilles de contact en association avec une solution d'entretien des lentilles de contact pour évaluer les interactions solution/lentille Reference number ISO 18189:2016(E) ISO International Organization for Standardization ZHEJIANG INST OF STANDARDIZATION C15956617 @IS02016 ded by IHS unde ted without license from IHS IS0 18189:2016(E) COPYRIGHTPROTECTEDDOCUMENT IS0 2016, 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 01 11 Fax +41 22 749 09 47 [email protected] www.iso.org Licensee-ZHEJIANG INST OF STANDARDIZzRoISQ6 - All rights reserved Not for Resale, 2016/8/17 06:53:10 networking permited without license from IHS IS0 18189:2016(E) Contents Page Foreword ..iv 1 Scope .1 2 Normative references 3 Terms and definitions 4 Principle 5 Direct contact cytotoxicity test for lens/lens care solution combination ..1 5.1 General .1 5.2 Experimentalprocedure .2 5.2.1 Basic procedure. .2 5.2.2 Material .2 5.2.3 Preparation of test sample 3 5.2.4 Methods 3 6 Assessment of results 7 Test report ..5 Annex A (normative) Measurement of zone of cell lysis for the direct contact cytotoxicity test method for testing contact lens in combination with lens care solution. 7 Bibliography 6 ii nSee=ZHEJIANG INST OF STANDARDIZATION C15956617 ithout license from IHS