BS EN ISO 11980-2012 Ophthalmic optics Contact lenses and contact lens care products Guidance for clinical investigations《眼科光学 隐形眼镜和隐形眼镜防护产品 临床检测指南》.pdf

1、BSI Standards PublicationOphthalmic optics Contact lenses and contact lens care products Guidance for clinical investigationsBS EN ISO 11980:2012BS EN ISO 11980:2012Incorporating corrigendum December 2012BS EN ISO 11980:2012 BRITISH STANDARDNational forewordThis British Standard is the UK implementa

2、tion of EN ISO 11980:2012. It is identical to ISO 11980:2012, incorporating corrigendum December 2012. It supersedes BS EN ISO 11980:2009 which is withdrawn.The UK participation in its preparation was entrusted by Technical Committee CH/172, Ophthalmic optics, to Subcommittee CH/172/9, Contact lense

3、s and contact lens care products.A list of organizations represented on this subcommittee 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 Inst

4、itution 2013. Published by BSI Standards Limited 2013ISBN 978 0 580 81665 9ICS 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 December 2012.Amendmen

5、ts/corrigenda issued since publicationDate Text affected31 October 2013 Implementation of ISO corrigendum December 2012: Standard replaced with ISO corrected versionEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11980 November 2012 ICS 11.040.70 Supersedes EN ISO 11980:2009English Version

6、Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations (ISO 11980:2012)Optique ophtalmique - Lentilles de contact et produits dentretien pour lentilles de contact - Directives pour les investigations cliniques (ISO 11980:2012) Augenoptik - Kontaktlin

7、sen und Kontaktlinsenpflegemittel - Leitfaden fr die klinische Prfung (ISO 11980:2012) This European Standard was approved by CEN on 14 November 2012. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status

8、 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, French, Germ

9、an). 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, Bulgaria, Croatia

10、, 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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and Unit

11、ed Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2012 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11980:20

12、12: EBS EN ISO 11980:2012EN ISO 11980:2012 (E) 3 Foreword This document (EN ISO 11980:2012) 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 by DIN. This European Stand

13、ard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by May 2013, and conflicting national standards shall be withdrawn at the latest by May 2013. Attention is drawn to the possibility that some of the elements of this docu

14、ment 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 11980:2009. According to the CEN/CENELEC Internal Regulations, the national standards organisations of the following countries are

15、 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, Poland, Por

16、tugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 11980:2012 has been approved by CEN as a EN ISO 11980:2012 without any modification. BS EN ISO 11980:2012ISO 11980:2012(E) ISO 2012 All rights reserved iiiContents PageFo

17、reword ivIntroduction v1 Scope 12 Normative references . 13 Terms and definitions . 14 Clinical investigational requirements 14.1 General . 14.2 Additional requirements 14.3 Other considerations 4Annex A (informative) Elements of a clinical investigation . 5Annex B (informative) Procedures for the e

18、valuation of safety, physiological performance and effect on ocular tissues .18Annex C (informative) The evaluation of visual, refractive and lens performance and subject acceptance .23Bibliography .26ISO 11980:2012(E) ISO 2012 All rights reserved iiiContents PageForeword ivIntroduction v1 Scope 2 N

19、ormative references 3 Terms and definitions .4 Clinical investigational requirements 14.1 General . 14.2 Additional requirements 14.3 Other considerations 4Annex A Elements of a clinical investigation . 5Annex B (informative) Procedures for the evaluation of safety, physiological performance and eff

20、ect on ocular tissues .18Annex C (informative) The evaluation of visual, refractive and lens performance and subject acceptance .23Bibliography .26BS EN ISO 11980:2012EN ISO 11980:2012 (E)ISO 11980:2012(E) ISO 2012 All rights reserved iiiContents PageForeword ivIntroduction v1 Scope 12 Normative ref

21、erences . 13 Terms and definitions . 14 Clinical investigational requirements 14.1 General . 14.2 Additional requirements 14.3 Other considerations 4Annex A (informative) Elements of a clinical investigation . 5Annex B (informative) Procedures for the evaluation of safety, physiological performance

22、and effect on ocular tissues .18Annex C (informative) The evaluation of visual, refractive and lens performance and subject acceptance .23Bibliography .26ISO 11980:2012(E) ISO 2012 All rights reserved iiiContents PageForeword ivIntroduction v1 Scope 2 Normative references 3 Terms and definitions .4

23、Clinical investigational requirements 14.1 General . 14.2 Additional requirements 14.3 Other considerations 4A Elements of a clinical investigation . 5Annex B (informative) Procedures for the evaluation of safety, physiological performance and effect on ocular tissues .18Annex C (informative) The ev

24、aluation of visual, refractive and lens performance and subject acceptance .23Bibliography .26BS EN ISO 11980:2012ISO 11980:2012 (E)ISO 11980:2012(E)Introduction 1 = presence)B.8 Palpebral conjunctival observations7KHVHYHULWRIWKHPDLPDOSDOSHEUDOFRQMXQFWLYDOUHVSRQVHVKRXOGEHGRFXPHQWHGDFFRUGLQJWRWKHIROO

25、RZLQJVFDOH0 = none XQLIRUPVDWLQDSSHDUDQFHRIWKHFRQMXQFWLYD WUDFH VOLJKWFRQMXQFWLYDOLQMHFWLRQZLWKRXWWHWXUH ISO 2012 All rights reserved 21BS EN ISO 11980:2012ISO 11980:2012 (E)ISO 11980:2012(E)2 = mild PPWRPPYHVVHOSHQHWUDWLRQ PRGHUDWH !PPWRPPYHVVHOSHQHWUDWLRQ4 = severe YHVVHOSHQHWUDWLRQ!PP7KHGHSWKDQGO

26、RFDWLRQRIYHVVHOSHQHWUDWLRQVKRXOGEHUHSRUWHGDVIROORZVDepth: D VXSHUFLDOE VWURPDO/RFDWLRQ 1 QDVDO7 WHPSRUDOI = inferiorS = superior 1 = presence)B.8 Palpebral conjunctival observations7KHVHYHULWRIWKHPDLPDOSDOSHEUDOFRQMXQFWLYDOUHVSRQVHVKRXOGEHGRFXPHQWHGDFFRUGLQJWRWKHIROORZLQJVFDOH0 = none XQLIRUPVDWLQDS

27、SHDUDQFHRIWKHFRQMXQFWLYD WUDFH VOLJKWFRQMXQFWLYDOLQMHFWLRQZLWKRXWWHWXUH ISO 2012 All rights reserved 21BS EN ISO 11980:2012ISO 11980:2012 (E)ISO 11980:2012(E)2 = mild PLOGRUVFDWWHUHGSDSLOODHIROOLFOHVOHVVWKDQPPLQGLDPHWHU PRGHUDWH D VLJQLFDQWSDSLOODHIROOLFOHVOHVVWKDQPPLQGLDPHWHUDQGRUPDUNHGFRQMXQFWLYDO

28、LQMHFWLRQE VWDLQLQJRIWKHWRSRIRQHSDSLOOD4 = severe D ORFDOLHGRUJHQHUDOLHGSDSLOODHIROOLFOHVPPRUPRUHLQGLDPHWHUE VWDLQLQJRIWKHWRSRIPRUHWKDQRQHSDSLOOD7KHORFDWLRQRIWKHPDLPDOSDOSHEUDOFRQMXQFWLYDOUHVSRQVHVKRXOGEHUHFRUGHGIRUHDFKRIWKHVLOLGDUHDV VHH)LJXUH% Key5 ULJKWHHOLG/ OHIWHHOLGUpper lid 6 VXSHULRUWDUVDOFR

29、QMXQFWLYD & PLGGOHWDUVDOFRQMXQFWLYD , LQIHULRUWDUVDOFRQMXQFWLYD 1 QDVDOWDUVDOFRQMXQFWLYD 7 WHPSRUDOWDUVDOFRQMXQFWLYDLower lid (not shown) / ORZHUOLGFRQMXQFWLYDFigure B.3 Upper lid areas% $QWHULRUVHJPHQWLQDPPDWLRQ(QGRWKHOLDOGXVWLQJ 0 = none 1 = present$QWHULRUFKDPEHUDUH 0 = none 1 = present.HUDWLWLFS

30、UHFLSLWDWHV 0 = none 1 = present+SRSRQ 0 = none 1 = present22 ISO 2012 All rights reserved ISO 11980:2012(E)Annex C LQIRUPDWLYH The evaluation of visual, refractive and lens performance and subject acceptanceC.1 General7KHIROORZLQJFODVVLFDWLRQVVKRXOGEHFRQVLGHUHGZKHQHYHUWKHSURFHGXUHLVLQFOXGHGLQWKH&,3

31、C.2 Visual performance7RDVVHVVYLVXDOSHUIRUPDQFHYLVXDODFXLWVKRXOGEHPHDVXUHG7UDGLWLRQDOO6QHOOHQFKDUWVKDYHEHHQXVHGWRPHDVXUHYLVXDODFXLWEXWWKHLQFRUSRUDWHXQHTXDOVWHSVEHWZHHQVXFFHVVLYHOLQHV7KHXVHRI/RJ0$5SURJUHVVLRQYLVXDODFXLW 9$ FKDUWVZLWKHTXDOVWHSVEHWZHHQVXFFHVVLYHOLQHVLVUHFRPPHQGHG6HYHUHORVVLQYLVXDOSHUIR

32、UPDQFHVKRXOGEHDWZROLQHRUPRUHORVVRQWKH/RJ0$5SURJUHVVLRQVFDOHRULWV6QHOOHQHTXLYDOHQW,QWKRVHFDVHVZKHUHDVHSDUDWHFODLPLVPDGHIRUDQHDUYLVLRQUHIUDFWLYHHIIHFWQHDUYLVXDODFXLWXVLQJDUHGXFHG/RJ0$5RU6QHOOHQFKDUWRUUHDGLQJDQHDUFKDUWVKRXOGEHUHFRUGHG2SWLRQDOOORZFRQWUDVWYLVXDODFXLWFRQWUDVWVHQVLWLYLWDQGYLVXDOSHUIRUPDQFH

33、PHDVXUHPHQWLQWKHSUHVHQFHRIDJODUHVRXUFHPDDOVREHWHVWHGC.3 Refractive performance5HIUDFWLYHFKDQJHV DEVROXWHPHDQVSKHULFDODQGFOLQGULFDOYDOXHV IURPEDVHOLQHWRWKHQDOYLVLWVKRXOGEHSURYLGHGC.4 Keratometric measurement7KHNHUDWRPHWULFQGLQJVVKRXOGEHUHSRUWHGDVHLWKHUWKHFRUQHDOUDGLXVLQHDFKSULQFLSDOPHULGLDQRUWKHFRUQH

34、DOSRZHULQHDFKSULQFLSDOPHULGLDQ& /HQVWWLQJFKDUDFWHULVWLFVC.5.1 General7KHOHQVWWLQJFKDUDFWHULVWLFVVKRXOGEHDVVHVVHGWRHYDOXDWHWKHRQHHSHUIRUPDQFHXVLQJWKHIROORZLQJFODVVLFDWLRQC.5.2 Lens position/HQVFHQWUDWLRQIRUWKHHHLQSULPDUSRVLWLRQ UHODHGORRNLQJVWUDLJKWDKHDG VKRXOGEHUHFRUGHGRQDWKUHHSRLQWVFDOHDVIROORZV RS

35、WLPDOOHQVFHQWUDWLRQ DFFHSWDEOHGHFHQWUDWLRQ XQDFFHSWDEOHGHFHQWUDWLRQ ISO 2012 All rights reserved 23BS EN ISO 11980:2012ISO 11980:2012 (E)ISO 11980:2012(E)2 = mild PLOGRUVFDWWHUHGSDSLOODHIROOLFOHVOHVVWKDQPPLQGLDPHWHU PRGHUDWH D VLJQLFDQWSDSLOODHIROOLFOHVOHVVWKDQPPLQGLDPHWHUDQGRUPDUNHGFRQMXQFWLYDOLQMH

36、FWLRQE VWDLQLQJRIWKHWRSRIRQHSDSLOOD4 = severe D ORFDOLHGRUJHQHUDOLHGSDSLOODHIROOLFOHVPPRUPRUHLQGLDPHWHUE VWDLQLQJRIWKHWRSRIPRUHWKDQRQHSDSLOOD7KHORFDWLRQRIWKHPDLPDOSDOSHEUDOFRQMXQFWLYDOUHVSRQVHVKRXOGEHUHFRUGHGIRUHDFKRIWKHVLOLGDUHDV VHH)LJXUH% Key5 ULJKWHHOLG/ OHIWHHOLGUpper lid 6 VXSHULRUWDUVDOFRQMXQFWLYD & PL