ISO INTERNATIONAL STANDARD 11979-6 Third edition 2014-10-01 Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing Implants ophtalmiques - Lentilles intraoculaires - Partie 6: Duree de conservation et stabilite pendant le transport Reference number ISO 11979-6:2014(E) ISO @ IS0 2014 No repr ted without license from IHS Not for Resale IS0 11979-6:2014(E) COPYRIGHT PROTECTED DOCUMENT @ISO2014 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form 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 No reproduction or networking permited without license from IHS Not for Resale IS0 11979-6:2014(E) Contents Page Foreword ..iv Introduction. ..V 1 Scope. 2 Normative references 3 Terms and definitions 4 Requirements ..1 4.1 General. .1 4.2 Materials and methods .2 4.3 Product stability. .2 4.4 Package integrity. ..4 4.5 Transport stability .5 4.6 Results 5 Test methods and sampling ..6 Annex A (informative) Shelf-life study example Annex B (informative) Tests for shelf-life studies ..10 Bibliography ..11 Copyritnteatinal Organizasn t? Sanadizah rights reserved ii se with ISt ed without license from IHS Not for Resale