ISO INTERNATIONAL STANDARD 11979-3 Third edition 2012-12-01 Ophthalmic implants Intraocular lenses - Part 3: Mechanical properties and test methods Implants ophtalmiques - Lentilles intraoculaires - Partie 3: Propriétés mécaniques et meéthodes d'essai Reference number IS0 11979-3:2012(E) LSO IS02012 ed without license from IHS Not for Resale IS0 11979-3:2012(E) COPYRIGHTPROTECTEDDOCUMENT ISO2012 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either IsO at the addressbeloworIso'smemberbodyinthecountryoftherequester. ISO copyright office Case postale 56:CH-1211 Geneva 20 Tel.+41227490111 Fax +41 22 749 09 47 E-mail [email protected] Web www.iso.org Published in Switzerland @ IS0 2012 - All rights reserved No reproductic networking permited without license from IHS Not for Resale IS0 11979-3:2012(E) Contents Page Foreword ..iv Introduction. ..V 1 Scope. ..1 2 Normative references ..1 3 Terms and definitions ..1 4 Requirements .1 4.1 General .1 4.2 Tolerances and dimensions. .2 4.3 Clearance analysis (anterior chamber lenses only) 2 4.4 Compression force 2 4.5 Axial displacement in compression 2 4.6 Opticdecentration .3 4.7 Optictilt. .3 4.8 Angle of contact ..3 4.9 Compression force decay .3 4.10 Dynamic fatigue durability .3 4.11 Surgical manipulation. .4 4.12 Surface and bulk homogeneity .4 5 Recovery of properties following simulated surgical manipulation ..4 6 Additions for accommodating IOLs (AIOLs) ..4 Annex A (normative) Measurement of compression force ..6 Annex B (normative) Measurement of axial displacement in compression ...9 Annex C (normative) Measurement of optic decentration ..12 Annex D (normative) Measurement of optic tilt ..15 Annex E (normative) Measurement of angle of contact ..19 Annex F (normative) Testing of compression force decay ..22 Annex G (normative) Testing of dynamic fatigue durability ..23 Annex H (informative) Measurement of loop pull strength ..25 Annex I (informative) Clearance analysis.. ..27 Annex J (informative) Precision ..30 Bibliography .31 iii se with IS thout license from IHS Not for Resale