DIN EN ISO 14534-2015 Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534 2011) German version EN ISO 14534 2015《眼科光学 隐形眼镜和隐形眼镜护.pdf

1、August 2015Translation by DIN-Sprachendienst.English price group 12No 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).ICS

2、11.040.70!%E2“2341598www.din.deDDIN EN ISO 14534Ophthalmic optics Contact lenses and contact lens care products Fundamental requirements (ISO 14534:2011);English version EN ISO 14534:2015,English translation of DIN EN ISO 14534:2015-08Augenoptik Kontaktlinsen und Kontaktlinsenpflegemittel Grundlegen

3、de Anforderungen (ISO 14534:2011);Englische Fassung EN ISO 14534:2015,Englische bersetzung von DIN EN ISO 14534:2015-08Optique ophtalmique Lentilles de contact et produits dentretien des lentilles de contact Exigences fondamentales (ISO 14534:2011);Version anglaise EN ISO 14534:2015,Traduction angla

4、ise de DIN EN ISO 14534:2015-08SupersedesDIN EN ISO 14534:2011-06www.beuth.deIn case of doubt, the German-language original shall be considered authoritative.Document comprises 23 pages07.15 DIN EN ISO 14534:2015-08 2 A comma is used as the decimal marker. National foreword This document (EN ISO 145

5、34:2015) has been prepared by Technical Committee ISO/TC 172 “Optics and photonics”, Subcommittee SC 7 “Ophthalmic optics and instruments” in collaboration with Technical Committee CEN/TC 170 “Ophthalmic optics” (both secretariats are held by DIN, Germany). The responsible German body involved in it

6、s preparation was the DIN-Normenausschuss Feinmechanik und Optik (DIN Standards Committee Optics and Precision Mechanics), Working Committee NA 027-01-08 AA Augenoptik, Working Group NA 027-01-08-04 AK Kontaktlinsen. This standard contains specifications meeting the essential requirements set out in

7、 EU Directive 93/42/EEC on medical devices. The DIN Standards corresponding to the International Standards referred to in Clause 2 of this standard are as follows: ISO 10993-1 DIN EN ISO 10993-1 ISO 11978 DIN EN ISO 11978 ISO 11980 DIN EN ISO 11980 ISO 11986 DIN EN ISO 11986 ISO 11987 DIN EN ISO 119

8、87 ISO 13212 DIN EN ISO 13212 ISO 14155 DIN EN ISO 14155 ISO 14729 DIN EN ISO 14729 ISO 14730 DIN EN ISO 14730 ISO 14971 DIN EN ISO 14971 ISO 15223-1 DIN EN ISO 15223-1 ISO 18369-1 DIN EN ISO 18369-1 ISO 18369-2 DIN EN ISO 18369-2 ISO 22442 DIN EN ISO 22442 Reference is made to the extensive Bibliog

9、raphy in the original ISO Standard. In the German language version of the present standard, DIN EN ISO 14534, all German titles of the ISO Standards (as titles of the respective DIN EN ISO Standards) listed in the Bibliography that had existed at the time the present document was published are given

10、 in the National Annex. All EN Standards listed in the Bibliography are also available as DIN EN Standards, and thus have German titles. This is why they are not listed in the National Annex. Amendments This standard differs from DIN EN ISO 14534:2011-06 as follows: a) a table has been included rela

11、ting to correlations between undated normative references and dated EN and ISO standards; b) Annex ZA (informative) “Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices” has been updated. Previous editions DIN EN ISO 14534: 1998-04,

12、 2002-10, 2009-07, 2011-06 DIN EN ISO 14534:2015-08 3 National Annex NA (informative) Bibliography DIN EN ISO 9001, Quality management systems Requirements DIN EN ISO 9004, Managing for the sustained success of an organization A quality management approach DIN EN ISO 9394, Ophthalmic optics Contact

13、lenses and contact lens care products Determination of biocompatibility by ocular study with rabbit eyes DIN EN ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management system DIN EN ISO 10993-3, Biological evaluation of medical devices Part 3: Te

14、sts for genotoxicity, carcinogenicity and reproductive toxicity DIN EN ISO 10993-5, Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity DIN EN ISO 10993-9, Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degra

15、dation products DIN EN ISO 10993-10, Biological evaluation of medical devices Part 10: Tests for irritation and skin sensiti-zation DIN EN ISO 10993-12, Biological evaluation of medical devices Part 12: Sample preparation and reference materials DIN EN ISO 11135-1, Sterilization of health care produ

16、cts Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices DIN EN ISO 11137-1, Sterilization of health care products Radiation Part 1: Requirements for develop-ment, validation and routine control of a sterilization process

17、for medical devices DIN EN ISO 11137-2, Sterilization of health care products Radiation Part 2: Establishing the sterilization dose DIN EN ISO 11137-3, Sterilization of health care products Radiation Part 3: Guidance on dosimetric aspects DIN EN ISO 11138-1, Sterilization of health care products Bio

18、logical indicators Part 1: General require-ments DIN EN ISO 11138-2, Sterilization of health care products Biological indicators Part 2: Biological indicators for ethylene oxide sterilization processes DIN EN ISO 11138-3, Sterilization of health care products Biological indicators Part 3: Biological

19、 indicators for moist heat sterilization processes DIN EN ISO 11138-4, Sterilization of health care products Biological indicators Part 4: Biological indicators for dry heat sterilization processes DIN EN ISO 11138-5, Sterilization of health care products Biological indicators Part 5: Biological ind

20、icators for low-temperature steam and formaldehyde sterilization processes DIN EN ISO 14534:2015-08 4 DIN EN ISO 11140-1, Sterilization of health care products Chemical indicators Part 1: General require-ments DIN EN ISO 11140-3, Sterilization of health care products Chemical indicators Part 3: Clas

21、s 2 indicator systems for use in the Bowie and Dick-type steam penetration test DIN EN ISO 11140-4, Sterilization of health care products Chemical indicators Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration DIN EN ISO 11607-1, Packaging

22、for terminally sterilized medical devices Part 1: Requirements for 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 11737-1, Steriliz

23、ation of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products DIN EN ISO 11737-2, Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization proc

24、ess DIN EN ISO 11978, Ophthalmic optics Contact lenses and contact lens care products Labelling DIN EN ISO 11980, Ophthalmic optics Contact lenses and contact lens care products Guidance for clinical investigations DIN EN ISO 11981, Ophthalmic optics Contact lenses and contact lens care products Det

25、ermination of physical compatibility of contact lens care products with contact lenses DIN EN ISO 11985, Opthalmic optics Contact lenses Ageing by exposure to UV and visible radiation (in vitro method) DIN EN ISO 11986, Ophthalmic optics Contact lenses and contact lens care products Determination of

26、 preservative uptake and release DIN EN ISO 11987, Ophthalmic optics Contact lenses Determination of shelf-life DIN EN ISO 12864, Ophthalmic optics Contact lenses Determination of scattered light DIN EN ISO 13212, Ophthalmic optics Contact lens care products Guidelines for determination of shelf-lif

27、e DIN EN ISO 13408-1, Aseptic processing of health care products Part 1: General requirements DIN EN ISO 13408-2, Aseptic processing of health care products Part 2: Filtration DIN EN ISO 13408-3, Aseptic processing of health care products Part 3: Lyophilization DIN EN ISO 13408-4, Aseptic processing

28、 of health care products Part 4: Clean-in-place technologies DIN EN ISO 13408-5, Aseptic processing of health care products Part 5: Sterilization in place DIN EN ISO 13408-6, Aseptic processing of health care products Part 6: Isolator systems DIN EN ISO 13485, Medical devices Quality management syst

29、ems Requirements for regulatory purposes DIN EN ISO 14534:2015-08 5 DIN EN ISO 14155, Clinical investigation of medical devices for human subjects Good clinical practice DIN EN ISO 14729, Ophthalmic optics Contact lens care products Microbiological requirements and test methods for products and regi

30、mens for hygienic management of contact lenses DIN EN ISO 14730, Ophthalmic optics Contact lens care products Antimicrobial preservative efficacy testing and guidance on determining discard date DIN EN ISO 14971, Medical devices Application of risk management to medical devices DIN EN ISO 15223-1, M

31、edical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements DIN EN ISO 17665-1, Sterilization of health care products Moist heat Part 1: Requirements for develop-ment, validation and routine control of a sterilization process fo

32、r medical devices 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: Measu

33、rement methods DIN EN ISO 18369-4, Ophthalmic optics Contact lenses Part 4: Physicochemical properties of contact lens materials DIN EN ISO 18472, Sterilization of health care products Biological and chemical indicators Test equip-ment DIN EN ISO 22442 (all parts), Medical devices utilizing animal t

34、issues and their derivatives DIN EN ISO 14534:2015-08 6 This page is intentionally blank EN ISO 14534January 2015 ICS 11.040.70 Supersedes EN ISO 14534:2011English Version Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011) Optique ophtalmiqu

35、e - Lentilles de contact et produits dentretien des lentilles de contact - Exigences fondamentales (ISO 14534:2011) Augenoptik - Kontaktlinsen und Kontaktlinsenpflegemittel - Grundlegende Anforderungen (ISO 14534:2011) This European Standard was approved by CEN on 7 January 2015. CEN members are bou

36、nd 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 be obtained on application to the C

37、EN-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 the CEN-CENELEC Management Centre

38、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, Ireland, Italy, Latvia, Lithuania,

39、Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey andUnited Kingdom. CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN na

40、tional Members. Ref. No. EN ISO 14534:2015 EEUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGContents Page Foreword . 3 Introduction . 5 1 Scope . 6 2 Normative references. 6 3 Terms and definitions 7 4 S

41、afety and performance 7 5 Risk assessment 7 6 Design . 8 8 Clinical evaluation 8 9 Manufacturing . 8 10 Microbiological requirements . 9 10.1 Contact lenses 9 10.2 Contact lens care products . 9 10.3 Other accessories for contact lenses 9 11 Packaging . 10 12 Shelf-life and discard date 10 13 Labell

42、ing and information supplied by the manufacturer 10 13.1 General 10 13.2 Additional information requirements for contact lenses . 10 13.3 Additional information requirements for contact lens care products 11 Annex ZA (informative) Relationship between this European Standard and the Essential Require

43、ments of EU Directive 93/42/EEC on Medical Devices 12 Bibliography 14 2DIN EN ISO 14534:2015-08 EN ISO 14534:2015 (E) Foreword The text of ISO 14534:2011 has been prepared by Technical Committee ISO/TC 172 “Optics and photonics” of the International Organization for Standardization (ISO) and has bee

44、n taken over as EN ISO 14534:2015 by 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 latest by July 2015, and conf

45、licting national standards shall be withdrawn at the latest by July 2015. 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 documen

46、t supersedes EN ISO 14534:2011. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integr

47、al part of this document. 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 Yugoslav Republic

48、 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 the United Kingdom. 3DIN EN ISO 14534:2015-08EN ISO 14534:2015 (E)Table Correlati

49、ons between undated normative references and dated EN and ISO standards Normative references Equivalent dated standard as listed in Clause 2 EN ISO ISO 10993-1 EN ISO 10993-1:2009 + AC:2010 ISO 10993-1:2009 + Cor.1:2010 ISO 11978 EN ISO 11978:2014 ISO 11978:2014 ISO 11980 EN ISO 11980:2012 ISO 11980:2012 ISO 11986 EN IS