EN ISO 11981-2017 en Ophthalmic optics - Contact lenses and contact lens care products -Determination of physical compatibility of contact lens care products with contact lenses.pdf

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 physical compatibility of contact lens care products with contact lensesBS EN ISO 11981:2017National forewordThis British Standard is the

2、UK implementation of EN ISO 11981:2017. It is identical to ISO 11981:2017. It supersedes BS EN ISO 11981:2009, which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/172/9, Contact lenses and contact lens care products.A list of organizations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 o

3、n 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 2018 Published by BSI Standards Limited 2018ISBN 978 0 580 94518

4、2ICS 11.040.70Compliance 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 31 January 2018.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS

5、 EN ISO 11981:2017EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 11981December 2017ICS 11.040.70 Supersedes EN ISO 11981:2009EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGCEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2017

6、CEN Ref. No. EN ISO 11981:2017: EAll rights 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 physical compatibility of contact lens care products with contact lenses (ISO 11981:

7、2017)Optique ophtalmique - Lentilles de contact et produits dentretien des lentilles de contact - Dtermination de la compatibilit physique des produits dentretien des lentilles de contact avec les lentilles de contact (ISO 11981:2017)Augenoptik - Kontaktlinsen und Kontaktlinsenpflegemittel - Bestimm

8、ung der physikalischen Vertrglichkeit von Kontaktlinsenpflegemitteln mit Kontaktlinsen (ISO 11981:2017)This European Standard was approved by CEN on 4 November 2017.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Stand

9、ard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.This European Standard exists in three official versions (English,

10、 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 the CEN-CENELEC Management Centre has the same status as the official versions.CEN members are the national standards bodies of Austria, Belgium, Bulga

11、ria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former 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, Switzerl

12、and, Turkey and United Kingdom.English VersionEN ISO 11981:2017 (E)European forewordThis document (EN ISO 11981:2017) has been prepared by Technical Committee ISO/TC 172 “Optics and photonics“ in collaboration with Technical Committee CEN/TC 170 “Ophthalmic optics” the secretariat of which is held b

13、y 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 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

14、 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.This document supersedes EN ISO 11981:2009.According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following coun

15、tries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Po

16、land, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.Endorsement noticeThe text of ISO 11981:2017 has been approved by CEN as EN ISO 11981:2017 without any modification.2BS EN ISO 11981:2017ISO 11981:2017(E)Foreword iv1 Scope . 12 Normative r

17、eferences 13 Terms and definitions . 14 Principle 24.1 Detection of changes in contact lens characteristics 24.2 Method to distinguish reversible from irreversible changes in contact lens characteristics 35 Selection of test lenses . 46 Procedure. 46.1 Test method to detect changes in contact lens c

18、haracteristics . 46.2 Test method to distinguish reversible from irreversible changes in contact lens characteristics 56.3 Interpretation of results . 57 Test report . 5Bibliography 7 ISO 2017 All rights reserved iiiContents PageBS EN ISO 11981:2017ISO 11981:2017(E)ForewordISO (the International Org

19、anization for Standardization) is a worldwide federation 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 establi

20、shed has the right to be represented on that committee. International 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 standardizatio

21、n.The procedures used to develop this document and those 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 t

22、he editorial rules of the ISO/IEC Directives, Part 2 (see 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 pate

23、nt rights identified during the development of the document 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 a

24、n explanation on the voluntary nature of standards, the meaning of ISO specific terms 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

25、org/iso/foreword.html.This document was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 7, Ophthalmic optics and instruments.This third edition cancels and replaces the second edition (ISO 11981:2009), which has been revised for clarity and to update all normative

26、references.iv ISO 2017 All rights reservedBS EN ISO 11981:2017Ophthalmic optics Contact lenses and contact lens care products Determination of physical compatibility of contact lens care products with contact lenses1 ScopeThis document describes the general procedure and performance criteria for ass

27、essing the physical compatibility of contact lens care products with contact lenses and for determining whether the observed changes are reversible.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 th

28、is document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 18369-1:2017, Ophthalmic optics Contact lenses Part 1: Vocabulary, classification system and recommendations for labelling s

29、pecificationsISO 18369-2, Ophthalmic optics Contact lenses Part 2: TolerancesISO 18369-3:2017, 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 and the following apply.ISO and IEC main

30、tain terminological databases for use in standardization at the following addresses: IEC Electropedia: available at http:/www.electropedia.org/ ISO Online browsing platform: available at https:/www.iso.org/obp3.1cyclesequence of events, following instructions for use or recommendations by the manufa

31、cturer of the contact lens care product, to occur between the time the contact lens is removed from the eye and before it is placed back into the eye3.2standard saline solutionspecific phosphate buffered saline at a pH of 7,4 0,1 and a nominal osmolarity of 310 5 mOsmNote 1 to entry: The provisions

32、for formulation and preparation of standard saline solution are given in ISO 18369-3:2017, 4.9.3.3control solutionstandard saline solution or appropriate justified alternative solution used to cycle contact lensesNote 1 to entry: Control solutions are not required to comply with this document, but c

33、an be used to gain further information about the test.INTERNATIONAL STANDARD ISO 11981:2017(E) ISO 2017 All rights reserved 1BS EN ISO 11981:2017ISO 11981:2017(E)4 Principle4.1 Detection of changes in contact lens characteristicsSee Figure 1.a If the parameters are different from the values provided

34、 by the contact lens manufacturer, the new baseline values should be used to compare results of test product.2 ISO 2017 All rights reservedBS EN ISO 11981:2017ISO 11981:2017(E)a If the parameters are different from the values provided by the contact lens manufacturer, the new baseline values should

35、be used to compare results of test product.Figure 1 Flowchart for determination of physical compatibility of contact lens care products with contact lenses4.1.1 Before cycling, contact lenses shall be equilibrated in standard saline solution for sufficient time so that the contact lens parameters to

36、 be measured remain constant. Document the volume and temperature used for equilibration. ISO 18369-3 shall be used for methods of measurement for contact lenses.NOTE An equilibration time of up to 24 h can be required for some hydrogel lenses.4.1.2 Contact lenses shall be cycled in a manner which s

37、imulates the procedures given in the manufacturers instructions for use of the contact lens care product(s), and tested in volumes in accordance with the manufacturers instructions.During the cycles, temperature should be considered. Unless otherwise specified the temperature should be 20 C to 25 C.

38、Volumes for soaking should be at least the amount used to fill a standard lens case used for the care product(s).NOTE Use of organic soil (0,1 ml per contact lens as per ISO 18259:2014, Annex A) or other specified artificial tear fluid can be considered for in-eye simulation.In evaluating product(s)

39、 being used during on-eye wear, justification of cycling parameters should be documented with regard to simulation of real world conditions.4.1.3 Where a range of contact times is permitted, the cycle giving rise to the worst case conditions should be used.4.1.4 Lens characteristics shall be measure

40、d after cycling, in the contact lens care product or standard saline solution to determine any changes. Changes in the average results shall be evaluated with reference to values obtained at baseline and tolerances given in ISO 18369-2 unless other tolerances have been justified. See Table 1 for pro

41、perties and test methods.It might be advisable to check contact lens parameters mid-way through the test cycles.4.1.5 If the average results from 4.1 are within the tolerances, the contact lens care solution and contact lens are compatible. If the average results from 4.1 are not within tolerances,

42、proceed to 4.2.4.2 Method to distinguish reversible from irreversible changes in contact lens characteristics4.2.1 This method applies only to contact lens care products for which the changes observed in the contact lens characteristics are outside the baseline values obtained by equilibration in st

43、andard saline solution (see 4.1.1) and tolerances given in ISO 18369-2 unless other tolerances have been justified after following the test method given in 4.1.4.2.2 Re-equilibrate the same contact lenses measured in test solution in 4.1 in standard saline solution and measure to distinguish reversi

44、ble from irreversible changes. See Table 1 for properties and test methods.4.2.3 Evaluate contact lens characteristics measured in standard saline solution with baseline values and tolerances given in ISO 18369-2. Differences should be reported. ISO 2017 All rights reserved 3BS EN ISO 11981:2017ISO

45、11981:2017(E)NOTE For certain types of contact lens material, e.g. ionic, the ionic strength of standard saline solution can affect the parameters compared to the label values.5 Selection of test lenses5.1 A suitable number of contact lenses, for test and where necessary for controls, is required fo

46、r each type of contact lens material to be studied. The average of the contact lens characteristics shall be based on a minimum of at least 10 test contact lenses for each combination of contact lens material and contact lens care product.5.2 Contact lens material groups tested shall represent those

47、 types of contact lenses for which the contact lens care product is intended to be used. Contact lens material groups are described in ISO 18369-1.Contact lenses from at least groups 1 through 4 should be tested if the care product(s) are used with non-hydrogel contact lenses (see ISO 18369-1:2017,

48、Table 2). Contact lenses from at least groups 1, 4, 5A, 5B, and 5C should be tested if the care product(s) are used with hydrogel contact lenses (see ISO 18369-1:2017, Table 3).6 Procedure6.1 Test method to detect changes in contact lens characteristics6.1.1 Record in detail both the characteristics

49、 of the contact lenses to be tested and the regimen to be followed. The record shall include contact lens care products and test methods to be used, and the sequence and method of their use. Pass/fail criteria shall be specified.6.1.2 For contact lens care products intended for use on a daily basis, perform 30 cycles on each material.6.1.3 For products recommended for use on a scheduled basis as part of a contact lens care regimen (e.g. enzymatic cleaners), the number of cycles shall represent one months use of the product or