ISO/TR TECHNICAL REPORT 22979 Second edition 2017-05 Ophthalmic implants Intraocular lenses Guidance on assessment of the need for clinical investigation of intraocular lens design modifications Implants ophtalmiques Lentilles intraoculairesDirectives relatives a I'évaluation de la nécessité d'investigation clinique pour les modificationsdeconceptiondeslentillesintraoculaires Reference number ISO/TR 22979:2017(E) International Organization for Standardization @ IS0 2017 e=ZHEJIANG INST OF STANDARDIZATION C1 5956617 ted without license from IHS IS0/TR 22979:2017(E) COPYRIGHT PROTECTED DOCUMENT 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 [email protected] www.iso.org Licensee-ZHEJIANG INST OF STANDARDIZAISQ 017 - All rights reserVed networking permited without license from IHS IS0/TR 22979:2017(E) Contents Page Foreword ..iv 1 Scope .1 2 Normative references 3 Terms and definitions 4 Modifications to parent models ..1 4.1 General .1 4.2 Modification levels 4.2.1 General 2 4.2.2 Level A modifications .2 4.2.3 Level B modifications. 2 4.2.4 Level C modifications 2 4.2.5 Clinical investigation with multiple IOL models 3 5 Considerations for the assignment of modification level .3 5.1 General ..3 5.2 Risk assessment. .3 5.3 Special considerations. .3 5.3.1 Phakic lenses .3 5.3.2 Anterior chamber lenses 3 5.3.3 Posterior chamber lenses intended for implantation in the sulcus ..4 6 Modifications of optical design features 6.1 Optical design changes 4 6.2 Multifocal lenses (MIOL) 6.3 Toric lenses (TIOL) .4 6.4 Accommodating lenses (AIOL) .4 7 Modifications to the mechanical design 7.1 General .5 7.2 Mechanical analysis .5 8 Modifications to material 8.1 Interchanging IOL materials .5 8.2 New materials. ..5 Annex A (informative) Examples of modifications to a parent IoL model .6 Annex B (informative) Mechanical data analysis ..11 Bibliography .22 ii icensee=ZHEJIANG INST OF STANDARDIZATION C1 5956617 vided by IHS under lic d without license from IHS