EN ISO 11986-2017 Ophthalmic optics - Contact lenses and contact lens care products - Determination of preservative uptake and release.pdf

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1、BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06Ophthalmic optics Contact lenses and contact lens care products Determination of preservative uptake and releaseBS EN ISO 11986:2017National forewordThis British Standard is the UK implementation of EN ISO 11986:2017. I

2、t is identical to ISO 11986:2017. It supersedes BS EN ISO 11986:2010, which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/172/9, Contact lenses and contact lens care products.A list of organizations represented on this committee can be obtained on reque

3、st 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 2018 Published by BSI Standards Limited 2018ISBN 978 0 580 95867 0ICS 11.040.70Compliance with a British S

4、tandard cannot confer immunity from legal obligations. This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 January 2018.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN ISO 11986:2017EUROPEAN STANDARDNORME

5、EUROPENNEEUROPISCHE NORMEN ISO 11986December 2017ICS 11.040.70 Supersedes EN ISO 11986:2010EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGCEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2017 CEN Ref. No. EN ISO 11986:2017: EAll righ

6、ts of exploitation in any form and by any means reserved worldwide for CEN national MembersOphthalmic optics - Contact lenses and contact lens care products - Determination of preservative uptake and release (ISO 11986:2017)Optique ophtalmique - Lentilles de contact et produits dentretien pour lenti

7、lles de contact - Dtermination de labsorption/adsorption et du relargage des conservateurs (ISO 11986:2017)Augenoptik - Kontaktlinsen und Kontaktlinsenpflegemittel - Bestimmung der Aufnahme und Wiederfreisetzung von Konservierungsmitteln (ISO 11986:2017)This European Standard was approved by CEN on

8、21 November 2017.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may

9、 be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to

10、 the CEN-CENELEC Management Centre has the same status as the official versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, I

11、reland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.English VersionEN ISO 11986:2017 (E)European forewordThis document (EN ISO 11986:2017) has been prepared by Technical

12、 Committee ISO/TC 172 “Optics and photonics“ in collaboration with Technical Committee CEN/TC 170 “Ophthalmic optics” the secretariat of which is held by DIN.This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the

13、latest by June 2018, and conflicting national standards shall be withdrawn at the latest by June 2018.Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN shall not be held responsible for identifying any or all such patent rights.

14、This document supersedes EN ISO 11986:2010.According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former

15、Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.Endorsement noticeThe text of ISO 119

16、86:2017 has been approved by CEN as EN ISO 11986:2017 without any modification.2BS EN ISO 11986:2017ISO 11986:2017(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Principle 15 Procedure. 25.1 General . 25.2 Uptake of preservatives from test product . 25.3 R

17、elease of preservatives from test lenses 36 Expression of results 37 Test report . 4Bibliography 6 ISO 2017 All rights reserved iiiContents PageBS EN ISO 11986:2017ISO 11986:2017(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies

18、 (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,

19、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 intended for its further mai

20、ntenance 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 www.iso.org/directives).Att

21、ention 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 document will be in the Introducti

22、on 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 voluntary nature of standards, the meaning of ISO specific terms

23、 and expressions related to conformity assessment, as well as information about ISOs adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.This document was prepared by Technical Committee ISO/TC 172,

24、Optics and photonics, Subcommittee SC 7, Ophthalmic optics and instruments.This third edition cancels and replaces the second edition (ISO 11986:2010), which has been technically revised.The main changes compared to the previous edition are as follows: the cross references were aligned with the revi

25、sed editions of ISO 18369-1 and ISO 18369-3; the expression of results in the test report has been clarified; editorial corrections have been applied.iv ISO 2017 All rights reservedBS EN ISO 11986:2017ISO 11986:2017(E)IntroductionContact lens care products are a complex mixture of organic and inorga

26、nic substances. For reasons of microbiological safety, contact lens disinfecting solutions, as well as care products in multi-use containers, contain substances with antimicrobial activity. From many years of experience in contact lens wear, it is known that irritation and sensitization problems som

27、etimes occur due to these preservatives being absorbed and released by the matrix of the contact lens. For these reasons, it is necessary to be able to estimate the extent of preservative uptake and release by contact lenses.The preservative uptake and release test provides a general method for meas

28、uring the uptake of preservatives in solution by contact lenses and the release of preservatives from contact lenses in an aqueous medium. The analytical method to be used for quantification of specific preservatives is not indicated here. Chemical characteristics of the preservative, as well as con

29、centration in the contact lens care product and degree of uptake by the contact lens, can be taken into consideration in selecting an appropriate analytical method. Contact lens uptake and release data can be useful in characterizing the potential for a new or modified contact lens material to produ

30、ce a toxic or irritating reaction in the eye from the uptake and binding or release of preservatives from currently marketed contact lens care products. ISO 2017 All rights reserved vBS EN ISO 11986:2017This page deliberately left blankOphthalmic optics Contact lenses and contact lens care products

31、Determination of preservative uptake and release1 ScopeThis document provides general procedures for the selection of methods, preparation of samples, and the conduct of testing for the uptake and release of preservatives from contact lenses.NOTE 1 Due to the manifest difficulties of reproducibility

32、 when coating contact lenses with mineral and organic deposits encountered during lens wear, these methods are only applicable to new and unused contact lenses.NOTE 2 Preservative depletion by a contact lens in the limited volume of a lens case could compromise disinfection performance. This documen

33、t does not measure disinfection performance.2 Normative referencesThe following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest ed

34、ition of the referenced document (including any amendments) applies.ISO 18369-3:2017, Ophthalmic optics Contact lenses Part 3: Measurement methods3 Terms and definitionsNo terms and definitions are listed in this document.ISO and IEC maintain terminological databases for use in standardization at th

35、e following addresses: IEC Electropedia: available at http:/www.electropedia.org/ ISO Online browsing platform: available at http:/www.iso.org/obp4 PrincipleThe contact lenses to be tested are immersed in the test product at 25 C 2 C and the preservative content is analysed at regular intervals of t

36、ime until a steady-state condition has been achieved.After reaching the steady-state condition, each contact lens is immersed in 1 ml of saline solution for contact lens testing, the saline solution is prepared in accordance with ISO 18369-3:2017, 4.9, at 37 C 2 C. At discrete intervals up to and in

37、cluding 16 h, and at intervals until no additional release is observed, if required, the solution is analysed for the amount of preservative that has been extracted at each time point.INTERNATIONAL STANDARD ISO 11986:2017(E) ISO 2017 All rights reserved 1BS EN ISO 11986:2017ISO 11986:2017(E)5 Proced

38、ure5.1 GeneralThe following information shall be obtained before commencing the estimation:a) evidence that the selected test method is suitable for the detection and estimation of the particular preservative;NOTE 1 Examples of methods suitable for analysing some preservatives are presented in US FD

39、A guidelines (see Reference 2).b) evidence that the test method has the required repeatability and reproducibility, and a detection limit suitable for the assay;c) the number of determinations required to satisfy b);NOTE 2 Multiple determinations might be necessary when the analysis result is close

40、to the limit of detection and/or when the analysis method has a low precision.d) the criteria needed to confirm that equilibrium has been achieved in the extraction process;e) the volume of test solution used will need to ensure that the quantity of absorbed preservative does not reduce the concentr

41、ation of the preservative in the test solution to less than 25 % of the initial preservative concentration in the test solution;f) a sufficient number of contact lenses of each material type shall be used to ensure that the quantity of absorbed and released preservative is higher than the detection

42、limit of the method of analysis, and also ensure that enough lenses are available for preservative release measurement at each time point.5.2 Uptake of preservatives from test product5.2.1 Select the appropriate contact lens care product and/or the appropriate contact lens material for testing.5.2.1

43、.1 To determine the preservative uptake of a new or modified contact lens material, select the appropriate contact lens care product based on the intended use of the contact lens care product (e.g. recommended for use with hydrogel contact lenses or rigid gas-permeable contact lenses).5.2.1.2 To det

44、ermine the uptake of a new or modified preservative in the contact lens care product, select the appropriate contact lens materials for testing from currently marketed contact lenses based on the intended use of the contact lens care product (e.g. recommended for use with hydrogel contact lenses or

45、rigid gas-permeable contact lenses).The selection of test lenses and lens care products should be justified. For hydrogel lenses, representatives from low water and medium/high water ionic and non-ionic lens groups (Groups 1 to 4) and from silicone hydrogel lenses (Group 5) should be included. For r

46、igid lenses, representative lenses from silicone, fluorine and silicon-fluorine lens groups should be included. See ISO 18369-1:2017, Table 2 and Table 3 for the classification and group descriptions.5.2.2 Determine the initial preservative level in the test solution.5.2.3 Record the volume of soak

47、solution and immerse the test lenses in the test solution in a suitable closed container (see the following paragraph) at 25 C 2 C, and shake occasionally (to ensure adequate mixing of the solution surrounding the contact lens during the study). Take aliquot portions of the test solution at differen

48、t time intervals and analyse each for its preservative content. During day 1, take aliquot portions at the proposed regimen time, at 8 h and at 24 h. Continue the procedure at intervals of 2 ISO 2017 All rights reservedBS EN ISO 11986:2017ISO 11986:2017(E)not less than 24 h until the aliquot portion

49、s show that no more preservative has been absorbed, or the maximum recommended storage time for the lenses in the contact lens care product has been reached. Additional time points during the first day can be included to determine the uptake profile.It is preferable to use containers that have been demonstrated to absorb insignificant amounts of the preservative. However, if the container does absorb the preservative, this should be allowed for when carrying out the test procedure. In this case, for example, an appropriate control