ISO INTERNATIONAL STANDARD 13212 Third edition 2014-09-01 Ophthalmic optics Contact lens care products Guidelines for determination of shelf-life Optique ophtalmique - Produits d'entretien pour lentilles de contact - Lignes directrices pour la détermination de la durée de conservation Reference number IS0 13212:2014(E) ISO @IS02014 No reproduction or networking permitted without license from IHS Not for Resale IS0 13212:2014(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 13212:2014(E) Contents Page Foreword ..iv Introduction. ..V 1 Scope. ..1 2 Normative references 3 Terms and definitions 4 General requirements ..1 5 Determination of finished product stability 5.1 Objective. .1 5.2 Study methods .2 5.3 Description of the product under study 3 5.4 Characteristics. 5.5 Evaluation methods. 4 5.6 Presentation of results .4 5.7 Discussion, interpretation, and conclusions 4 5.8 Ongoing stability 5 Annex A (informative) Example of a stability testing plan for the finished contact lens care product .6 Bibliography 7 Copyriotnteatinal rganiason te Sanarizal rights reserved iii se with ISt ed without license from IHS Not for Resale