BS ISO 19045:2015 BSI Standards Publication Ophthalmic optics Contact lens care products Method for evaluating Acanthamoeba encystment by contact lens care products bsi. ..making excellence a habit. BSISO19045:2015 BRITISHSTANDARD National foreword This British Standard is the UK implementation ofISO 19045:2015. The UK participation in its preparation was entrusted to Technical Committee CH/172/9,Contactlenses and contact lenscareproducts. A list of organizations represented on this committee can be obtained on request to its secretary. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. @ The British Standards Institution 2015. Published by BSI Standards Limited 2015 ISBN9780580856297 ICS 11.040.70 Compliance with a British Standard cannot confer immunity from legal obligations. This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 April 2015. Amendments issued since publication Date Text affected BS ISO 19045:2015 ISO INTERNATIONAL STANDARD 19045 First edition 2015-04-01 Ophthalmic optics Contact lens care products - Method for evaluating Acanthamoeba encystment by contact lens care products Optiqueophtalmique-Produitsd'entretiendelentillesdecontact Methoded'évaluation de I'enkystementdeAcanthamoebaau contact desproduitsd'entretiendeslentillesdecontact Reference number IS0 19045:2015(E) ISo @IS02015 BSISO19045:2015 IS0 19045:2015(E) COPYRIGHTPROTECTEDDOCUMENT IS02015 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 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 ii @ IS0 2015 - All rights reserved BSISO19045:2015 IS0 19045:2015(E) Contents Page Foreword ..iv Introduction. ..V 1 Scope. ..1 2 Terms and definitions ..1 3 Principle .2 3.1 General. .2 3.2 Encystmenttest 2 Encystment test method 2 4 4.1 General. 2 4.2 Test organism. 2 4.3 Culture media and reagents 22 4.4 Testmaterials 4.5 Test samples 3 4.6 Culture maintenance. 3 4.7 Preparation of microbial challenge 3 4.8 Encystmentprocedure .4 4.8.1 General. 4 4.8.2 Controlplate .4 4.8.3 Test samples .5 4.9 Encystment calculation. 7 5 Controls. ..7 AnnexA(normative)Acanthamoebagrowthmedium(Ac#6) .9 AnnexB(informative)1/4strengthRinger'sSolution ..10 AnnexC(informative)Sarkosyl-CalcofluorWhitesolution. .11 AnnexD(informative)Preparationofencystmentcontrolsolutions .12 AnnexE (informative)MaintenanceofAcanthamoebatrophozoitesandpreparationfortesting...14 Bibliography .15 @ IS0 2015 - All rights reserved iii BSISO19045:2015 IS0 19045:2015(E) Foreword Iso (theInternational Organizationfor Standardization)is a worldwidefederation ofnational standards bodies (IsO member bodies). The work of preparing International Standards is normally carried out through Iso technical committees.Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations,governmental and non-governmental, in liaison with Iso, also takepart in the work. ISo collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnicalstandardization. The procedures used to develop this document and those intended for its further maintenance are described in the ISO/lEC Directives, Part 1. In particular the different approval criteria needed for the different types of Iso documents should be noted. This document was drafted in accordance with the editorial rules of the ISo/IEC Directives, Part 2 (see www.iso.org/directives). Attention is drawn tothepossibilitythat some ofthe elements of this docu