ISO INTERNATIONAL STANDARD 11979-8 Third edition 2017-04 Ophthalmic implants Intraocular lenses - Part 8: Fundamental requirements Implants ophtalmiques Lentilles intraoculaires Partie 8: Exigences fondamentales Reference number IS0 11979-8:2017(E) International Organization for Standardization @ IS0 2017 ee=ZHEJIANG INST OF STANDARDIZATION C1 5956617 mitted without license from IHS IS0 11979-8:2017(E) COPYRIGHT PROTECTEDDOCUMENT 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 01 11 Fax +41 22 749 09 47 copyright@iso.org www.iso.org Licensee-ZHEJIANG INST OF STANDARDIzoISQ 07 - All rights reserved HS und networking permited without license from IHS IS0 11979-8:2017(E) Contents Page Foreword ..iv 1 Scope .1 2 Normative references 3 Terms and definitions 4 Safety and performance. 5 Optical and mechanical properties 6 Biocompatibility ..2 7 Clinical evaluation 8 Manufacturing. ..2 6 Sterilization ..2 9.1 General. 9.2 Bacterial endotoxins. ..3 10 Packaging and shelf-life ..3 11 Labelling and information ..3 12 Documentation. ..3 Bibliography .4 ntemaional oganzation@sS2017 -All rights reserved ii icensee=ZHEJIANG INST OF STANDARDIZATION C1 5956617 vided by IHS under I se with ISt ed without license from IHS