EN ISO 11981-2009 en Ophthalmic optics - Contact lenses and contact lens care products - Determination of physical compatibility of contact lens care products with contact lenses《眼.pdf

1、BS EN ISO11981:2009ICS 11.040.70NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDOphthalmic optics Contact lensesand contact lenscare products Determination ofphysical compatibilityof contact lens careproducts with contactlenses (ISO 11981:2009)This British Stand

2、ard was published under the authority of the Standards Policy and Strategy Committee on 31 July 2009 BSI 2009ISBN 978 0 580 65276 9Amendments/corrigenda issued since publicationDate CommentsBS EN ISO 11981:2009National forewordThis British Standard is the UK implementation of EN ISO 11981:2009. It s

3、upersedes BS EN ISO 11981:1999 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/172/9, Contact lenses and contact lens care products.A list of organizations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 request to its secretary.This publication do

4、es not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunity from legal obligations.EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 11981July 2009ICS 11.040.70 Supersedes EN ISO

5、 11981:1999 English VersionOphthalmic optics - Contact lenses and contact lens careproducts - Determination of physical compatibility of contact lenscare products with contact lenses (ISO 11981:2009)Optique ophtalmique - Lentilles de contact et produitsdentretien des lentilles de contact - Dterminat

6、ion de lacompatibilit physique des produits dentretien des lentillesde contact avec les lentilles de contact (ISO 11981:2009)Augenoptik - Kontaktlinsen und Kontaktlinsenpflegemittel -Bestimmung der Vertrglichkeit vonKontaktlinsenpflegemitteln mit Kontaktlinsen (ISO11981:2009)This European Standard w

7、as approved by CEN on 27 June 2009.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such natio

8、nalstandards may be obtained on application to the CEN 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 translationunder the responsibility of a CEN member into its own language and noti

9、fied to the CEN Management Centre has the same status as theofficial versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta

10、, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitatio

11、n in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 11981:2009: EBS EN ISO 11981:2009EN ISO 11981:2009 (E) 3 Foreword This document (EN ISO 11981:2009) has been prepared by Technical Committee ISO/TC 172 “Optics and optical instruments” in collaboration with Tec

12、hnical 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 latest by January 2010, and conflicting national standards shall be w

13、ithdrawn at the latest by January 2010. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 11981:1999. Ac

14、cording to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, La

15、tvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 11981:2009 has been approved by CEN as a EN ISO 11981:2009 without any modification. BS EN ISO 11981:2009ISO 1

16、1981:2009(E) ISO 2009 All rights reserved iiiForeword ISO (the International Organization 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 memb

17、er 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 take part in the work. ISO collaborates closely with the International Ele

18、ctrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adop

19、ted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of pate

20、nt rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 11981 was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 7, Ophthalmic optics and instruments. This second edition cancels and replaces the first edition (ISO 11981:1999

21、) as well as ISO 11981:1999/Cor.1:2005, which has undergone minor revision to update all normative references and to add a NOTE 2 to subclause 5.2. BS EN ISO 11981:2009BS EN ISO 11981:2009INTERNATIONAL STANDARD ISO 11981:2009(E) ISO 2009 All rights reserved 1Ophthalmic optics Contact lenses and cont

22、act lens care products Determination of physical compatibility of contact lens care products with contact lenses 1 Scope This International Standard describes the general procedure and performance criteria for assessing the physical compatibility of contact lens care products with contact lenses and

23、 for determining whether the observed changes are reversible. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document

24、(including any amendments) applies. ISO 18369-1, Ophthalmic optics Contact lenses Part 1: Vocabulary, classification system and recommendations for labelling specifications ISO 18369-2, Ophthalmic optics Contact lenses Part 2: Tolerances ISO 18369-3:2006, Ophthalmic optics Contact lenses Part 3: Mea

25、surement methods 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 18369-1 and the following apply. 3.1 cycle sequence of events, following instructions for use or recommendations by the manufacturer of the contact lens care product, to occur between t

26、he time the contact lens is removed from the eye and before it is placed back into the eye 3.2 active control contact lens that is cycled according to the test procedure using standard saline solution or appropriate justified contact lens care product(s) instead of the contact lens care product unde

27、r evaluation NOTE Active controls are not required to comply with this International Standard, but can be used to gain further information about the test. 4 Principle 4.1 Detection of changes in contact lens characteristics See Figure 1. BS EN ISO 11981:2009ISO 11981:2009(E) 2 ISO 2009 All rights re

28、servedFigure 1 Flowchart BS EN ISO 11981:2009ISO 11981:2009(E) ISO 2009 All rights reserved 34.1.1 Before cycling, contact lenses shall be equilibrated in isotonic standard saline solution (see ISO 18369-3:2006, 4.7) for at least 15 min or for the time necessary to stabilize the contact lens paramet

29、ers. 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 simulates the procedures given in the manufacturers instructions for use of the product(s) to be tested. 4.1.3 Where a range of contact times is permitted, t

30、he cycle giving rise to the most arduous conditions should be used. 4.1.4 Before and after cycling, certain physical parameters shall be measured to determine any changes. Changes shall be evaluated with reference to the manufacturers finished product specifications and relevant specifications and t

31、olerances given in ISO 18369-2. NOTE 1 Contact lens care products should be tested using types of material representative of those with which these products are intended to be used. NOTE 2 It may be advisable to check contact lens parameters mid-way through the test cycles. 4.2 Method to distinguish

32、 reversible from irreversible changes in contact lens characteristics 4.2.1 This method applies only to contact lens care products for which the changes observed in the contact lens characteristics are outside the manufacturers finished product specifications and relevant specifications and toleranc

33、es given in ISO 18369-2 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 isotonic standard saline solution (see ISO 18369-3:2006, 4.7) and measure to distinguish reversible from irreversible changes. 4.2.3 Evaluate contact

34、 lens parameters measured in isotonic standard saline solution (see ISO 18369-3:2006, 4.7) with respect to the manufacturers finished product specifications and relevant specifications and tolerances given in ISO 18369-2. NOTE For certain types of contact lens material, e.g. ionic, the ionic strengt

35、h of standard saline solution (see ISO 18369-3:2006, 4.7) may affect the parameters, compared to the label claim. 5 Selection of test lenses 5.1 A suitable number of contact lenses for test and, where necessary, for active controls is required for each type of contact lens material to be studied. Th

36、e average of the results shall be based on a minimum of at least ten contact lenses for each lens group tested. 5.2 Contact lens material groups tested shall represent those types of contact lenses for which the contact lens care product is intended to be used. Contact lens material groups are descr

37、ibed in ISO 18369-1. NOTE 1 The study should include test lenses of the extreme powers available within the total of a minimum of ten contact lenses tested for each lens group. NOTE 2 Based on recent reports of the incompatibility of some silicone-containing hydrogels with some contact lens care sys

38、tems, consideration should be given for separate compatibility testing of these types of material with contact lens care systems. BS EN ISO 11981:2009ISO 11981:2009(E) 4 ISO 2009 All rights reserved6 Procedure 6.1 Test method to detect changes in contact lens characteristics 6.1.1 Record in detail b

39、oth the characteristics of the contact lenses to be tested and the regimen to be followed. The record shall include contact lens care products/test methods to be used and the sequence and method of their use. 6.1.2 For contact lens care products intended for use on a daily basis, perform 30 cycles o

40、n 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 at least five exposures to the product. 6.1.4 For each contact lens care regimen being

41、tested, test a minimum of ten contact lenses for each lens group tested, and when required, a minimum of ten contact lenses with the active-control regimen. 6.1.5 Allow the contact lenses to equilibrate in isotonic standard saline solution before testing for a minimum of 15 min or the time necessary

42、 to stabilize the contact lens parameters. Determine the contact lens characteristics and record the data. As a minimum, the properties listed in Table 1 should be determined. Table 1 Properties and test methods Property Standard test method in accordance with Diameter (hydrogel lenses only) ISO 183

43、69-3:2006, 4.3 Curvature (rigid lenses only) ISO 18369-3:2006, 4.1 Back vertex power (spherical lenses) ISO 18369-3:2006, 4.2 Spectral transmittance (cosmetic tinted and UV-absorbing lenses only) ISO 18369-3:2006, 4.6 Physical appearance (e.g. surface defects, colour) ISO 18369-3:2006, 4.5 6.1.6 Cyc

44、le the contact lenses and record the time of each cycle. NOTE Particular attention should be given to recording the times allocated to each of the components of the regimen. 6.1.7 After cycling, measure the contact lens characteristics in the test solution. Active-control contact lenses should be me

45、asured in the active-control solution. 6.1.8 Determine changes in contact lens characteristics and compare to the manufacturers finished product specifications and relevant specifications and tolerances defined in ISO 18369-2. 6.2 Test method to distinguish reversible from irreversible changes in co

46、ntact lens characteristics 6.2.1 Perform this test if the changes observed in the characteristics of the test lenses having undergone the test method in 6.1 fall outside the manufacturers finished product specifications and relevant specifications and tolerances given in ISO 18369-2. 6.2.2 Soak the

47、same contact lenses used in 6.1 in isotonic standard saline solution (see ISO 18369-3:2006, 4.7) and allow to equilibrate at least for 15 min or the time necessary to stabilize the contact lens parameters. 6.2.3 After equilibration and while soaking in isotonic standard saline solution (see ISO 1836

48、9-3:2006, 4.7), measure the contact lens characteristics. BS EN ISO 11981:2009ISO 11981:2009(E) ISO 2009 All rights reserved 56.2.4 Determine the changes from the initial values obtained in isotonic standard saline solution and compare to the manufacturers finished product specifications and relevan

49、t specifications and tolerances defined in ISO 18369-2. 6.3 Interpretation of results 6.3.1 If the changes observed in the contact lens characteristics are within the manufacturers finished product specifications and relevant specifications and tolerances defined in ISO 18369-2 after completing the test described in 6.1, the test product(s) is/are judged to be physically compatible with the contact lens material. 6.3.2 If the changes observed in the contact lens characteristics are within the manufacturers finished produc