ISO INTERNATIONAL STANDARD 14729 First edition 2001-04-15 Ophthalmic optics Contact lens care products Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses Optique ophtalmique - Produits d'entretien des lentilles de contact- Exigences microbiologiques et methodes d'essai des produits et protocoles d'entretiendeslentillesdecontact Reference number ISO 14729:2001(E) ISO @ ISO 2001 THS under I without license from IHS Not for Resale ISO14729:2001(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this area. Adobe is a trademarkof Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event @ISO2001 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 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.ch Printed in Switzerland @ISO2001-All rightsreserved py IHS unde ermittedwithoutlicense from IHS Not for Resale ISO 14729:2001(E) Contents Page Foreword Introduction 1 Scope 2 Normative references. 3 Terms and definitions 4 Principle 4.1 General... 4.2 Stand-alone test (lnoculum challenge test) 4.3 Regimen test .. 5 Performance requirements. 5.1 Stand-alonetest:Primarycriteria(seealsoTable1) 5.2 Stand-alone test: Secondary criteria (see also Table 1) 5.3 Regimen test: Regimen criteria (see also Table 1)... 6 Test methods... 6.1 Materials and reagents... 6.2 Preparation of microbial challenge (lnoculum) 6.3 Stand-alone procedure... 6.4 Regimen procedure.. 10 Annex A (informative) Test organisms from other culture collections, 13 Annex B (informative) Example of a membrane filtration procedure 14 Annex C (informative) Technical report: Virus testing... 16 Annex D (informative) Technical report: Acanthamoeba testing... 17 Annex E (informative) Technical report: Artificial tears (organic soil) in laboratory testing .... Bibliography 19 ili py IHS under se from IHS Not for Resale