DIN EN ISO 11987-2012 Ophthalmic optics - Contact lenses - Determination of shelf-life (ISO 11987 2012) German version EN ISO 11987 2012《眼科光学 接触镜 储存寿命的测定(ISO 11987-2012) 德文版本EN ISO.pdf

1、November 2012Translation by DIN-Sprachendienst.English price group 10No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).IC

2、S 11.040.70!$QD“1924633www.din.deDDIN EN ISO 11987Ophthalmic optics Contact lenses Determination of shelf-life (ISO 11987:2012);English version EN ISO 11987:2012,English translation of DIN EN ISO 11987:2012-11Augenoptik Kontaktlinsen Bestimmung der Lagerdauer (ISO 11987:2012);Englische Fassung EN IS

3、O 11987:2012,Englische bersetzung von DIN EN ISO 11987:2012-11Optique ophtalmique Lentilles de contact Dtermination de la dure de conservation (ISO 11987:2012);Version anglaise EN ISO 11987:2012,Traduction anglaise de DIN EN ISO 11987:2012-11SupersedesDIN EN ISO 11987:1998-02www.beuth.deIn case of d

4、oubt, the German-language original shall be considered authoritative.Document comprises 14 pages11.12 DIN EN ISO 11987:2012-11 2 A comma is used as the decimal marker. National foreword This standard has been prepared by Technical Committee ISO/TC 172 “Optics and photonics”, Subcommittee SC 7 “Ophth

5、almic optics and instruments” (Secretariat: DIN, Germany) in collaboration with Technical Committee CEN/TC 170 “Ophthalmic optics” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the Normenausschuss Feinmechanik und Optik (Optics and Precision Mechanics Stand

6、ards Committee), Working Committee NA 027-01-08 AA Augenoptik, Working Group NA 027-01-08-04 AK Kontaktlinsen. In Germany, use of the symbol “dpt” for dioptre (expressed in m1) is legally required and this symbol is to be used rather than the symbol D used in other countries. The DIN Standards corre

7、sponding to the International Standards referred to in this document are as follows: ISO 11607-1 DIN EN ISO 11607-1 ISO 11607-2 DIN EN ISO 11607-2 ISO 18369-1 DIN EN ISO 18369-1 ISO 18369-2 DIN EN ISO 18369-2 ISO 18369-3 DIN EN ISO 18369-3 ISO 18369-4 DIN EN ISO 18369-4 Amendments This standard diff

8、ers from DIN EN ISO 11987:1998-02 as follows: a) normative references have been updated; b) the requirement to perform a risk assessment has been specified; c) specifications relating to the materials and apparatus, the test procedure and the expression of results and the test report have been rende

9、red more precise; d) the revised International Standard ISO 11987:2012 has been adopted. Previous editions DIN EN ISO 11987: 1998-02 DIN EN ISO 11987:2012-11 3 National Annex NA (informative) Bibliography DIN EN ISO 11607-1, Packaging for terminally sterilized medical devices Part 1: Requirements fo

10、r materials, sterile barrier systems and packaging systems DIN EN ISO 11607-2, Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes DIN EN ISO 14534, Ophthalmic optics Contact lenses and contact lens care products Fundamental

11、 requirements DIN EN ISO 18369-1, Ophthalmic optics Contact lenses Part 1: Vocabulary, classification system and recommendations for labelling specifications DIN EN ISO 18369-2, Ophthalmic optics Contact lenses Part 2: Tolerances DIN EN ISO 18369-3, Ophthalmic optics Contact lenses Part 3: Measureme

12、nt methods DIN EN ISO 18369-4, Ophthalmic optics Contact lenses Part 4: Physicochemical properties of contact lens materials DIN EN ISO 11987:2012-11 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11987 July 2012 ICS 11.040.70 Supersedes EN ISO 11987:1997

13、English Version Ophthalmic optics - Contact lenses - Determination of shelf-life (ISO 11987:2012) Optique ophtalmique - Lentilles de contact - Dtermination de la dure de conservation (ISO 11987:2012) Augenoptik - Kontaktlinsen - Bestimmung der Lagerdauer (ISO 11987:2012) This European Standard was a

14、pproved by CEN on 14 July 2012. 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 nationa

15、l 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, German). A version in any other language made by translation under the responsibility of a CEN member into its own language

16、 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, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hu

17、ngary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. Management Centre: Avenue Marnix 17, B-1000 Brussels 2012 CEN All rights of exploitation in any form and by

18、 any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11987:2012: EEUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGContents Page Foreword 3 Introduction 4 1 Scope 5 2 Normative references . 5 3 erms and definitions . 5 4 Principle .

19、 5 5 General requirements and recommendations . 5 6 Test and measurement media 6 7 Apparatus . 6 8 Test samples 6 9 Test procedure 7 9.1 Real-time studies. 7 9.2 Accelerated ageing studies 8 10 Expression of results 9 11 Test report 9 Bibliography . 10 2DIN EN ISO 11987:2012-11 EN ISO 11987:2012 (E)

20、 Foreword This document (EN ISO 11987:2012) 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 Standard shall be given the status of a national stan

21、dard, either by publication of an identical text or by endorsement, at the latest by January 2013, and conflicting national standards shall be withdrawn at the latest by January 2013. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights

22、. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 11987:1997. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standa

23、rd: 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, Portugal, Romania, Slovakia, Slovenia, Spai

24、n, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 11987:2012 has been approved by CEN as a EN ISO 11987:2012 without any modification. 3DIN EN ISO 11987:2012-11EN ISO 11987:2012 (E) Introduction7KHWHVWVLQFOXGHGLQWKLV,QWHUQDWLRQDO6WDQGDUGDUHGHVLJQHGWRREWDLQLQIR

25、UPDWLRQWKDWHQDEOHVSURSRVDOVWREHPDGHIRUWKHVKHOIOLIHRIDFRQWDFWOHQVDQGVWRUDJHFRQGLWLRQVWREHUHFRPPHQGHG+RZHYHULQSUDFWLFDOWHUPVLWLVWKHVWDELOLWRIWKHPDWHULDOIURPZKLFKWKHFRQWDFWOHQVLVPDGHWKDWLVEHLQJWHVWHGDORQJZLWKWKHLQWHJULWRIWKHSDFNDJLQJWKDWPDLQWDLQVWKHHQYLURQPHQWQHFHVVDUIRUWKHFRQWDFWOHQV7KHSXUSRVHRIWKHVWD

26、ELOLWVWXGLHVLVWRDVFHUWDLQKRZWKHTXDOLWRIWKHFRQWDFWOHQVYDULHVDVDIXQFWLRQRIWLPHDQGXQGHUWKHLQXHQFHRIDYDULHWRIHQYLURQPHQWDOIDFWRUV2QWKHEDVLVRIWKHLQIRUPDWLRQWKXVREWDLQHGVWRUDJHFRQGLWLRQVFDQEHUHFRPPHQGHGWKDWJXDUDQWHHWKHPDLQWHQDQFHRIWKHTXDOLWRIWKHFRQWDFWOHQVLQUHODWLRQWRLWVVDIHWHIFDFDQGDFFHSWDELOLWWKURXJKRXW

27、WKHSURSRVHGVKHOIOLIH LHGXULQJVWRUDJHDQGGLVWULEXWLRQXQWLOWKHPRPHQWRIGLVSHQVLQJ 4DIN EN ISO 11987:2012-11 EN ISO 11987:2012 (E) 1 Scope7KLV,QWHUQDWLRQDO6WDQGDUGVSHFLHVWHVWSURFHGXUHVIRUGHWHUPLQLQJWKHVWDELOLWRIFRQWDFWOHQVHVRQFHWKHDUHSODFHGLQWKHLUQDOSDFNDJLQJGXULQJVWRUDJHDQGGLVWULEXWLRQ127( 7KHUHVXOWVREW

28、DLQHGFDQEHXVHGIRUGHWHUPLQLQJWKHHSLUGDWH2 Normative references7KHIROORZLQJUHIHUHQFHGGRFXPHQWVDUHLQGLVSHQVDEOHIRUWKHDSSOLFDWLRQ RI WKLV GRFXPHQW )RU GDWHGUHIHUHQFHVRQOWKHHGLWLRQFLWHGDSSOLHV)RUXQGDWHGUHIHUHQFHVWKHODWHVWHGLWLRQRIWKHUHIHUHQFHGGRFXPHQW LQFOXGLQJDQDPHQGPHQWV DSSOLHV,62 2SKWKDOPLF RSWLFV ;,97KH8QLWHG6WDWHV3KDUPDFRSHLD7ZHQW7KLUG5HYLVLRQ8QLWHG6WDWHV3KDUPDFRSHLDO&RQYHQWLRQ5RFNYLOOH086$10DIN EN ISO 11987:2012-11 EN ISO 11987:2012 (E)