1、BSI Standards PublicationBS EN ISO 14534:2015Ophthalmic optics Contactlenses and contact lens careproducts Fundamentalrequirements (ISO 14534:2011)BS EN ISO 14534:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO14534:2015. It is identical to ISO 14534:20
2、11. It supersedes BS EN ISO14534:2011 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/172/9, Contact lenses and contact lens care products.A list of organizations represented on this committee can beobtained on request to its secretary.This publicati
3、on does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2015. Published by BSI StandardsLimited 2015ISBN 978 0 580 89633 0ICS 11.040.70Compliance with a British Standard cannot confer immunity froml
4、egal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 28 February 2015.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 14534 January 2015 ICS 11.040.70 Supersedes EN ISO
5、14534:2011English Version Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011) Optique ophtalmique - Lentilles de contact et produits dentretien des lentilles de contact - Exigences fondamentales (ISO 14534:2011) Augenoptik - Kontaktlinsen und
6、 Kontaktlinsenpflegemittel - Grundlegende Anforderungen (ISO 14534:2011) This European Standard was approved by CEN on 7 January 2015. 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 s
7、tandard 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, German). A version i
8、n 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, Cyprus, Czech
9、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 United Kingdom. EURO
10、PEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG 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 national Members. Ref. No. EN ISO 14534:2015 E
11、BS EN ISO 14534:2015EN ISO 14534:2015 (E) 3 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 been taken over as EN ISO 14534:2015 by Technical Committee CEN/TC 170 “Ophth
12、almic 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 conflicting national standards shall be withdrawn at the latest by July 2015.
13、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 14534:2011. This document has been prepared under a ma
14、ndate 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 integral part of this document. According to the CEN-CENELEC Internal Regulation
15、s, 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 of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
16、Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. BS EN ISO 14534:2015EN ISO 14534:2015 (E) 4 Table Correlations between undated normative references and dated EN and ISO standards Norm
17、ative 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 ISO 11986:2010 ISO 11986:2010 ISO 11987 EN ISO 11987:2012
18、 ISO 11987:2012 ISO 13212 EN ISO 13212:2014 ISO 13212:2014 ISO 14155 EN ISO 14155:2011 + AC:2011 ISO 14155:2011 + Cor.1:2011 ISO 14729:2001 + Amd.1:2010 EN ISO 14729:2001 + A1:2010 ISO 14729:2001 + Amd.1:2010 ISO 14730 EN ISO 14730:2014 ISO 14730:2014 ISO 14971 EN ISO 14971:2007 ISO 14971:2007 ISO 1
19、5223-1 EN ISO 15223-1:2012 ISO 15223-1:2012 ISO 18369-1 EN ISO 18369-1:2006 ISO 18369-1:2006 ISO 18369-2 EN ISO 18369-2:2012 ISO 18369-2:2012 ISO 22442 (all parts) EN ISO 22442-1:2007, EN ISO 22442-2:2007, EN ISO 22442-3:2007, ISO 22442-1:2007, ISO 22442-2:2007, ISO 22442-3:2007, ISO/TR 22442-4:2010
20、, Endorsement notice The text of ISO 14534:2011 has been approved by CEN as EN ISO 14534:2015 without any modification. BS EN ISO 14534:2015EN ISO 14534:2015 (E) 5 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical D
21、evices This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC on Medical Devices. Once this standard is cited in the Of
22、ficial Journal of the European Union under that Directive and has been implemented as a national standard in at least one Member State, compliance with the clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corr
23、esponding Essential Requirements of that Directive and associated EFTA regulations. Table ZA.1 Correspondence between this European Standard and Directive 93/42/EEC on Medical Devices Clause(s)/sub-clause(s) of this European Standard Essential Requirements (ERs) of Directive 93/42/EEC Qualifying rem
24、arks/Notes 4, 5, 10, 11 7.2 4, 7 7.3 4 7.5 4, 11 7.6 4, 10, 11 8.1 7 8.2 10, 11 8.3 9, 10 8.4 9, 10 8.5 11 8.6 11.4 8.7 4.2, 13.1 9.1 Sub-clause13.1 makes normative reference to EN ISO 11978. The relevant requirement for contact lenses is provided in EN ISO 11978:2014, Table 1, item 16 h). The relev
25、ant requirements for contact lens care products are provided in EN ISO 11978:2014, Table 2, items 10, 16, 19, 20, and 27. 5 9.2 4 10.1 BS EN ISO 14534:2015EN ISO 14534:2015 (E) 6 Clause(s)/sub-clause(s) of this European Standard Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/
26、Notes 13.1, 13.2, 13.3 13.1 Sub-clause13.1 makes normative reference to EN ISO 11978. The labelling requirements for contact lenses are provided in EN ISO 11978:2014, Table 1. The labelling requirements for contact lens care products are provided in EN ISO 11978:2014, Table 2. 13.1, 13.3.1 13.2 Sub-
27、clause13.1 makes normative reference to EN ISO 11978. The relevant requirement is provided in EN ISO 11978:2014, sub-clause 4.1. 13.1, 13.2, 13.3 13.3 Sub-clause13.1 makes normative reference to EN ISO 11978. The labelling requirements for contact lenses are provided in EN ISO 11978:2014, Table 1. T
28、he labelling requirements for contact lens care products are provided in EN ISO 11978:2014, Table 2. 13.1, 13.2, 13.3 13.4 Sub-clause13.1 makes normative reference to EN ISO 11978. The labelling requirements on intended purpose for contact lenses are provided in EN ISO 11978:2014, Table 1. The label
29、ling requirements on intended purpose for contact lens care products are provided in EN ISO 11978:2014, Table 2. 13.1, 13.2, 13.3 13.5 Sub-clause13.1 makes normative reference to EN ISO 11978. The relevant labelling requirements for contact lenses are provided in EN ISO 11978:2014, Table 1, items 2
30、and 4. The relevant labelling requirements for contact lens care products are provided in EN ISO 11978:2014, Table 2, items 2, 4 and 16. 13.1, 13.2, 13.3 13.6 Sub-clause13.1 makes normative reference to EN ISO 11978. The labelling requirements for contact lenses are provided in EN ISO 11978:2014, Ta
31、ble 1. The labelling requirements for contact lens care products are provided in EN ISO 11978:2014, Table 2. WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. BS EN ISO 14534:2015ISO 14534:2011(E) ISO 2011 All rights res
32、erved 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 member body interested in a subject for
33、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 Electrotechnical Commission (IEC) on al
34、l 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 adopted by the technical committees are
35、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 patent rights. ISO shall not be held res
36、ponsible for identifying any or all such patent rights. ISO 14534 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 14534:2002), which has been technically revise
37、d. BS EN ISO 14534:2015ISO 14534:2011(E) iv ISO 2011 All rights reservedIntroduction Currently, contact lenses and contact lens care products are regulated in different ways in different countries. This International Standard was mandated by the Commission of the European Communities to CEN and was
38、originally developed by a joint ISO/CEN working group to ensure a global input; its first edition was ISO 14534:1997. It is possible that other requirements are now needed in certain countries outside the European Union. It is hoped that the adoption of the third edition of this International Standa
39、rd will be yet another step towards the harmonization of standards and mutual recognition. BS EN ISO 14534:2015INTERNATIONAL STANDARD ISO 14534:2011(E) ISO 2011 All rights reserved 1Ophthalmic optics Contact lenses and contact lens care products Fundamental requirements 1 Scope This International St
40、andard specifies safety and performance requirements for contact lenses, contact lens care products, and other accessories for contact lenses. This International Standard does not specify electrical safety and electromagnetic compatibility considerations that might arise from the use of electrical e
41、quipment in conjunction with contact lenses or contact lens care products. 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 referen
42、ced document (including any amendments) applies. ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process ISO 11978, Ophthalmic optics Contact lenses and contact lens care products Information supplied by the manufacturer ISO 11980, Ophtha
43、lmic optics Contact lenses and contact lens care products Guidance for clinical investigations ISO 11986, Ophthalmic optics Contact lenses and contact lens care products Determination of preservative uptake and release ISO 11987, Ophthalmic optics Contact lenses Determination of shelf-life ISO 13212
44、, Ophthalmic optics Contact lens care products Guidelines for determination of shelf-life ISO 14155, Clinical investigation of medical devices for human subjects Good clinical practice ISO 14729:2001 + Amd.1:2010, Ophthalmic optics Contact lens care products Microbiological requirements and test met
45、hods for products and regimens for hygienic management of contact lenses ISO 14730, Ophthalmic optics Contact lens care products Antimicrobial preservative efficacy testing and guidance on determining discard date ISO 14971, Medical devices Application of risk management to medical devices ISO 15223
46、-1, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements BS EN ISO 14534:2015ISO 14534:2011(E) 2 ISO 2011 All rights reservedISO 18369-1, Ophthalmic optics Contact lenses Part 1: Vocabulary, classification system and rec
47、ommendations for labelling specifications ISO 18369-2, Ophthalmic optics Contact lenses Part 2: Tolerances ISO 22442 (all parts), Medical devices utilizing animal tissues and their derivatives 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 18369-1 a
48、pply. 4 Safety and performance 4.1 The intended purpose of a contact lens, contact lens care product, or other accessory for contact lenses shall be documented. 4.2 The performance shall be demonstrated by an evaluation of existing information and history of human use, together with, if necessary, p
49、reclinical and clinical testing. In assessing safety and performance, each of the following shall be considered and the decisions shall be documented: a) functional characteristics, intended purpose, and conditions of use; b) specific requirements for rigid contact lenses and hydrogel contact lenses as specified in ISO 18369-2; c) microbiological properties, including bioburden, sterility, contact lens disinfection, and preservation activities (see Clause 10); d) biocompatibility, including ex
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