1、BSI Standards PublicationBS ISO 18259:2014Ophthalmic optics Contactlens care products Methodto assess contact lens careproducts with contact lensesin a lens case, challenged withbacterial and fungal organismsBS ISO 18259:2014 BRITISH STANDARDNational forewordThis British Standard is the UK implement
2、ation of ISO 18259:2014.The UK participation in its preparation was entrusted to TechnicalCommittee CH/172/9, Contact lenses and contact lens care products.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include al
3、l the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2014. Published by BSI StandardsLimited 2014ISBN 978 0 580 80185 3ICS 11.040.70Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Sta
4、ndard was published under the authority of theStandards Policy and Strategy Committee on 30 September 2014.Amendments issued since publicationDate Text affectedBS ISO 18259:2014 ISO 2014Ophthalmic optics Contact lens care products Method to assess contact lens care products with contact lenses in a
5、lens case, challenged with bacterial and fungal organismsOptique ophtalmique Produits dentretien de lentilles de contact Mthode dvaluation des produits dentretien des lentilles de contact avec les lentilles de contact dans leur tui, en prsence de contamination par des bactries et champignonsINTERNAT
6、IONAL STANDARDISO18259First edition2014-10-01Reference numberISO 18259:2014(E)BS ISO 18259:2014ISO 18259:2014(E)ii ISO 2014 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2014All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in
7、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 ISOs member body in the country of the requester.ISO copyright officeCase posta
8、le 56 CH-1211 Geneva 20Tel. + 41 22 749 01 11Fax + 41 22 749 09 47E-mail copyrightiso.orgWeb www.iso.orgPublished in SwitzerlandBS ISO 18259:2014ISO 18259:2014(E) ISO 2014 All rights reserved iiiContents PageForeword iv1 Scope . 12 Normative references 13 Terms and definitions . 14 Principle 15 Rati
9、onale . 26 Methodology . 26.1 General . 26.2 Test procedure . 27 Performance criteria 4Annex A (normative) Preparation of challenge organisms in organic soil . 5Bibliography 7BS ISO 18259:2014ISO 18259:2014(E)ForewordISO (the International Organization for Standardization) is a worldwide federation
10、of national 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. I
11、nternational organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.The procedures used to develop this document and those
12、intended for its further maintenance are described in the ISO/IEC 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
13、 www.iso.org/directives).Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the docume
14、nt will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and ex
15、pressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 172, Optics and photonics, Subcommit
16、tee SC 7, Ophthalmic optics and instruments.iv ISO 2014 All rights reservedBS ISO 18259:2014INTERNATIONAL STANDARD ISO 18259:2014(E)Ophthalmic optics Contact lens care products Method to assess contact lens care products with contact lenses in a lens case, challenged with bacterial and fungal organi
17、sms1 ScopeThis International Standard specifies an antimicrobial efficacy end point methodology to determine compatibility of contact lens solutions, lens cases and hydrogel lenses for disinfection. This provides a process for evaluating compatibility of solutions used for disinfection with contact
18、lenses and lens cases using an antimicrobial efficacy end point. Specifically, the microbiological effect of the antimicrobial agent(s) while in the presence of the lens cases and/or lenses will be evaluated as described in the soak step of the label instructions.For practical purposes, this does no
19、t apply to oxidative systems.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced d
20、ocument (including any amendments) applies.ISO 14729, Ophthalmic optics Contact lens care products Microbiological requirements and test methods for products and regimens for hygienic management of contact lensesISO 18369-1, Ophthalmic optics Contact lenses Part 1: Vocabulary, classification system
21、and recommendations for labelling specificationsISO 18369-3, Ophthalmic optics Contact lenses Part 3: Measurement methods3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 18369-1 apply.4 PrincipleThe antimicrobial efficacy of the test solution in combin
22、ation with a lens and a lens case will be evaluated at various times following inoculation with organisms in the presence of organic soil. New lenses and new lens cases shall be used unless otherwise justified. This test will simulate microbial contamination introduced by patient handling.Place a le
23、ns in a well of a lens case and inoculate each lens with 1,0 105to 1,0 106cfu; leave inoculum in contact with the lens for 3 min to 10 min and dispense the appropriate volume (minimum of 2 ml) of the test solution into each well. The inoculated lenses in solutions will be allowed to soak for various
24、 storage times (the labelled regimen soaking period, at 24 h, at 7 days and at the maximum labelled storage in the lens case) in order to evaluate the effects of the lens case and the lens on the antimicrobial activity of the test solution. A separate set of lens case wells shall be prepared for eac
25、h time point; three wells shall be evaluated for each unique test condition. Additional time points can be evaluated.A variety of lenses shall be evaluated, e.g. Group I, Group IV, and Group V. The lens case(s) recommended for use with the test solution shall be evaluated at a minimum.All five chall
26、enge organisms specified in ISO 14729 shall be used. ISO 2014 All rights reserved 1BS ISO 18259:2014ISO 18259:2014(E)Log reductions will be evaluated for all exposure times.The data generated from this method should be assessed in conjunction with preservative uptake and release data (ISO 11986).5 R
27、ationaleThese studies are designed to simulate the recommended soaking and storage periods wherein the contaminating microorganisms are introduced by patient handling.6 Methodology6.1 GeneralUse ISO 14729 for media, challenge organisms, culture maintenance, test equipment, and other details for cond
28、ucting the Stand Alone Test with the exception of using lens cases for the microbial challenge.6.2 Test procedure6.2.1 Conduct the test using lens types representative of those with which the solution is intended to be used, e.g. low-water non-ionic lens (Group I), high-water ionic lens (Group IV),
29、and representative silicone hydrogel lens (Group V). Use 3,00 D lenses. New and unused lenses shall be used unless otherwise justified.The lens cases recommended for use with the test solution shall be evaluated at a minimum. The lens cases used in this test shall be new and unused with no precondit
30、ioning unless otherwise justified. Prepare three lens case wells per lens type per time point to be examined for the test samples; additionally, prepare control lens cases for each evaluation time point without lenses. Therefore, for the evaluation of one lens case with one solution and one lens typ
31、e, a total of 6 lens case wells (three wells for the test and three wells for the control) will be prepared for each of the five challenge organisms for each time point or 24 lens case wells for a minimum of four time points per challenge organism are to be evaluated. Additional time points can be e
32、valuated.If more than one lens type is evaluated in a test, only one set of control lens cases is required per inoculum preparation.The inoculum shall be prepared using organic soil as specified in Annex A.6.2.2 Aseptically remove a new, unused lens from its sterile packaging. Aseptically blot the l
33、ens on sterile gauze. Each lens will be soaked for 24 h 1 h in 10 ml ISO saline/lens directly out of the blister pack prior to use in the assay. See ISO 18369-3 for ISO saline formulation.6.2.3 Prepare the lens cases (test and control) by removing the caps. Aseptically remove a lens soaked in ISO sa
34、line and aseptically blot the lens on sterile gauze and place one lens inside each test well with the concave side up. Prepare three lens case wells without lenses for use as controls.Care should be taken to keep the shape of the lens concave.6.2.4 Inoculate each test and control well with 0,10 ml o
35、f the inoculum suspension prepared with organic soil to result in a final count of between 1,0 105and 1,0 106cfu per well. Gently dispense the inoculum directly onto the concave surface of the lens for the test wells and into the well for each control well then cover the wells.6.2.5 Leave the inocul
36、um in contact with the test lens for 3 min to 10 min and then aseptically dispense a known volume of the test solution gently into each test and control lens case well so that each lens 2 ISO 2014 All rights reservedBS ISO 18259:2014ISO 18259:2014(E)is completely immersed in the solution. Each well
37、shall contain a minimum of 2 ml unless otherwise justified. Do not agitate the contents of the lens case at this time since contamination of the cap can occur.6.2.6 Place the caps on the inoculated lens case wells tightly and store the inoculated lens cases at 20 C to 25 C. The temperature shall be
38、monitored using a calibrated device and the temperature documented.Care should be taken in moving the inoculated lens cases since contamination of the caps can occur.6.2.7 Prepare an inoculum baseline check for each challenge organism suspension.It is suggested that 0,10 ml of the inoculum suspensio
39、n be dispensed into a sterile tube containing a volume of PBST equivalent to the volume of test solution contained in the lens case well. Vortex and serially dilute a 1,0 ml aliquot of the inoculated PBST and plate out the dilutions in triplicate.6.2.8 Solutions will be sampled at least at the minim
40、um regimen soaking time(s) (10 min), 24 h 1 h, at 7 0,25 days and at the proposed maximum lens storage period of 0,25 days. Additional time points can be evaluated. If a regimen time point is less than 30 min, the sample shall be taken within +30 s. Solution from both test and control wells will be
41、sampled at each time point. Each lens case well will be sampled at one time point only. The following procedure will be used at each sampling time:6.2.8.1 Ensure each well is tightly capped.6.2.8.2 Orient the case well perpendicular to the vortexing surface (hold the case vertically with the inocula
42、ted well in contact with the surface of the vortex instrument) and vortex each well separately immediately before sampling on the high speed setting for a minimum of 30 s.6.2.8.3 Using aseptic technique, immediately remove the lens taking care to shake the excess liquid from the lens into the lens c
43、ase well. Discard the lens.6.2.8.4 Using aseptic technique, immediately remove a 1 ml aliquot from the vortexed lens case well using a sterile pipet and dilute in 9 ml of a validated neutralizing media.6.2.8.5 Perform serial dilutions in validated neutralizing media. Mix each dilution well by vortex
44、ing vigorously prior to preparing the subsequent dilutions. Let stand to allow neutralization to be completed. Neutralization conditions shall be based on recovery medium control testing according to ISO 14729.6.2.8.6 If an antimicrobial agent in the formulation cannot be adequately inactivated or n
45、eutralized, eliminate it using a validated membrane filtration procedure.NOTE For procedures that can be appropriate, see ISO 14729, Annex B.6.2.9 Determine the viable count of organisms in appropriate dilutions by preparation of triplicate plates (unless otherwise justified) of a suitable recovery
46、medium (e.g. TSA for bacteria and SDA for mould and yeast).If membrane filtration has been employed to remove or neutralize antimicrobial agents, culture the membranes on these media as appropriate.If the pour plate method is utilized, keep the agar for pour plates below 50 C prior to pouring.The ag
47、ar media used for the determination of viable counts may also contain antimicrobial inactivators or neutralizers, if required.6.2.10 Incubate bacterial recovery plates at 30 C to 35 C. Incubate yeast recovery plates at 20 C to 25 C or 30 C to 35 C. Incubate mould recovery plates at 20 C to 25 C. Inc
48、ubation times for optimal recovery of bacteria, yeast, and moulds shall be determined. Minimum incubation times shall be based ISO 2014 All rights reserved 3BS ISO 18259:2014ISO 18259:2014(E)on recovery medium control testing (according to ISO 14729). Record the number of all cfu observed on countab
49、le plates.Plates should be observed periodically during incubation to prevent the occurrence of uncountable plates due to overgrowth.Countable plates refer to 30 cfu/plate to 300 cfu/plate for bacteria and yeast and 8 cfu/plate to 80 cfu/plate for moulds, except when colonies are observed only for the 100or 101dilution plates. The absence of microorganisms shall be documented, e.g. by recording a “0” or “NR” (no recovery), when plates for all dilutions of a sample at a single time point have zero co
