EN ISO 14889-2013 en Ophthalmic optics - Spectacle lenses - Fundamental requirements for uncut finished lenses《眼科光学 眼镜镜片 未切边成品眼镜片的基本要求》.pdf

1、BSI Standards PublicationBS EN ISO 14889:2013Incorporating corrigendum December 2013BS EN ISO 14889:2013Ophthalmic optics Spectaclelenses Fundamentalrequirements for uncut finishedlensesBS EN ISO 14889:2013 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 148

2、89:2013. It supersedes BS EN ISO 14889:2009 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/172, Ophthalmic optics, to Subcommittee CH/172/3, Spectacles. A list of organizations represented on this subcommittee can be obtained on request to its secr

3、etary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2013. Published by BSI Standards Limited 2013ISBN 978 0 580 84837 7ICS 11.040.70Compliance with a British Standard canno

4、t confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 October 2013.Amendments/corrigenda issued since publicationDate Text affected31 December 2013 Implementation of CEN correction notice 09 October 2013:

5、 Note 1, Annex ZA insertedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 14889 October 2013 ICS 11.040.70 Supersedes EN ISO 14889:2009English Version Ophthalmic optics - Spectacle lenses - Fundamental requirements for uncut finished lenses (ISO 14889:2013) Optique ophtalmique - Verres de l

6、unettes - Exigences fondamentales relatives aux verres finis non dtours (ISO 14889:2013) Augenoptik - Brillenglser - Grundlegende Anforderungen an rohkantige fertige Brillenglser (ISO 14889:2013) This European Standard was approved by CEN on 7 September 2013. CEN members are bound to comply with the

7、 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 CEN-CENELEC Management

8、 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 has the same status a

9、s 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, Luxembourg, Malta, Ne

10、therlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2013 CEN All

11、rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 14889:2013: EBS EN ISO 14889:2013EN ISO 14889:2013 (E)3ForewordThis document (EN ISO 14889:2013) has been prepared by Technical Committee ISO/TC 172 “Optics and photonics“ in collaboratio

12、n 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 standard, either by publication of an identical text or by endorsement, at the latest by April 2014, and conflicting national standards sha

13、ll be withdrawn at the latest by April 2014.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 14889:2009.

14、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.For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document.According to t

15、he 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 of Macedonia, France, Germany, Greece,

16、Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.Endorsement noticeThe text of ISO 14889:2013 has been approved by CEN as EN ISO 14889:2013 without any

17、 modification.BS EN ISO 14889:2013EN ISO 14889:2013 (E)3ForewordThis document (EN ISO 14889:2013) 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

18、Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by April 2014, and conflicting national standards shall be withdrawn at the latest by April 2014.Attention is drawn to the possibility that some of the elements of t

19、his 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 14889:2009.This document has been prepared under a mandate given to CEN by the European Commission and the European Free Tr

20、ade Association, and supports essential requirements of EU Directive.For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document.According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound t

21、o 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, Portugal, Ro

22、mania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.Endorsement noticeThe text of ISO 14889:2013 has been approved by CEN as EN ISO 14889:2013 without any modification.BS EN ISO 14889:2013EN ISO 14889:2013 (E)3ForewordThis document (EN ISO 14889:2013) has been prepar

23、ed 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 standard, either by publication of an identical text or by endor

24、sement, at the latest by April 2014, and conflicting national standards shall be withdrawn at the latest by April 2014.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 identifyin

25、g any or all such patent rights.This document supersedes EN ISO 14889:2009.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.For relationship with EU Directive, see info

26、rmative Annex ZA, which is an integral 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

27、, 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 the United Kingdom.Endorsement noticeThe text

28、of ISO 14889:2013 has been approved by CEN as EN ISO 14889:2013 without any modification.BS EN ISO 14889:2013EN ISO 14889:2013 (E)4Annex ZA(informative)Relationship between this European Standard and the EssentialRequirements of EU Directive 93/42/EECThis European Standard has been prepared under a

29、mandate given to CEN by the European Commissionand the European Free Trade Association to provide a means of conforming to Essential Requirements ofthe New Approach Directive 93/42/EEC on medical devices.Once this standard is cited in the Official Journal of the European Union under that Directive a

30、nd has beenimplemented as a national standard in at least one Member State, compliance with the clauses of thisstandard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption ofconformity with the corresponding Essential Requirements of that Directive and associa

31、ted EFTAregulations.Table ZA.1 Correspondence between this European Standard and Directive 93/42/EECClause(s)/sub-clause(s)of this ENEssential Requirements(ERs)Qualifying remarks/Notes4.3.1, 4.3.2, 4.4 7.1 Only in respect of toxicity and flammability.Testing acc. to subclauses 5.2 and 5.3.4.4 9.2 Te

32、sting acc. to subclause 5.3.4.3.2 9.3 Testing acc. to subclause 5.2.6.1 13.1, 13.3 ER 13.3 a) is only partly addressed insubclause 6.1 e) of ISO 14889.For devices intended by the manufacturer to be for dual use in accordance with Article 1(6) ofDirective 93/42 EEC the following Table ZA.2 details th

33、e relevant essential requirements of Directive89/686/EC on Personal Protective Equipment and their corresponding clauses of this EuropeanStandard. Table ZA.2 however, does not imply any citation in the OJEU under the PPE directive and thusdoes not provide presumption of conformity for the PPE direct

34、ive.EN ISO 14889:2013 (E)4Annex ZA(informative)Re ationship between this European Standard and the EssentialRequirements of EU Directive 93/42/EECThis European Standard has been prepared under a mandate given to CEN by the European Commissionand the European Free Trade Association to provide a means

35、 of conforming to Essential Requirements ofthe New Approach Directive 93/42/EEC on medical devices.Once this tandard is cited in the Official Journal of the European Union under that Directive and has beenimplemented as a national standard in at least one Member State, compliance with the clauses of

36、 thisstandard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption ofconformity with the corresponding Essential Requirements of that Directive and associated EFTAregulations.Table ZA.1 Correspondence between this European Standard and Directive 93/42/EECClause

37、(s)/sub-clause(s)of this ENEssential Requirements(ERs)Qualifying remarks/Notes4.3.1, 4.3.2, 4.4 7.1 Only in respect of toxicity and flammability.Testing acc. to subclauses 5.2 and 5.3.4.4 9.2 Testing acc. to subclause 5.3.4.3.2 9.3 Testing acc. to subclause 5.2.6.1 13.1, 13.3 ER 13.3 a) is only part

38、ly addressed insubclause 6.1 e) of ISO 14889.For devices intended by the manufacturer to be for dual use in accordance with Article 1(6) ofDirective 93/42 EEC the following Table ZA.2 details the relevant essential requirements of Directive89/686/EC n Personal Protective Equipment and their correspo

39、nding clauses of this EuropeanStandard. Table ZA.2 however, does not imply any citation in the OJEU under the PPE directive and thusdoes not provide presumption of conformity for the PPE directive.StandaurEN ISO 14889:2013 (E)5Table ZA.2 Relevant Essential Requirements from Directive 89/686/EEC on P

40、ersonal Protective Equipment that are addressed by this European Standard (according to Article 1 (6) of amended Directive 93/42/EEC)Clause(s)/sub-clause(s) of this ENEssential Requirements (ERs) of Directive 89/686/EECQualifying remarks/Notes GeneralA manufacturer may claim that his lenses in addit

41、ion of being corrective lenses be protective lenses that provide personal eye protection to the user.As a matter of fact, personal eye protection can relate to various kinds of risk, e.g. sunglare (indirect solar radiation1), radiation other than indirect solar radiation, mechanical impact, etc.Some

42、 of those risks call for requirements that go beyond those for lenses the primary function of which is correction of vision. For the purposes of EN ISO 14889, the following applies. Corrective lenses with filter properties against sunglare (indirect solar radiation)In accordance with the European Co

43、mmissions “GUIDELINES ON THE APPLICATION OF COUNCIL DIRECTIVE 89/686/EEC OF 21 DECEMBER 1989 ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO PERSONAL PROTECTIVE EQUIPMENT” such lenses are categorized as medical devices, thus falling under Directive 93/42/EEC. Compliance with the ER

44、s of Directive 93/42/EEC, and of EN ISO 14889 as detailed by the above Table ZA.1 implies that the relevant requirements are met. Corrective lenses designed to provide protection other than protection against sunglare (indirect solar radiation)Where corrective lenses are designed to provide protecti

45、on other than protection against sunglare (indirect solar radiation), the relevant basic health and safety requirements of Directive 89/ 686/EEC apply.These are not addressed in EN ISO 14889. Refer to Directive 89/686/EEC and the relevant European Standard(s) on personal eye protection.WARNING Other

46、 requirements and other EU Directives may be applicable to the product(s)falling within the scope of this standard.1) Indirect solar radiation implies general use for protection against solar radiation but not for direct observation of the sun.BS EN ISO 14889:2013EN ISO 14889:2013 (E)3ForewordThis d

47、ocument (EN ISO 14889:2013) 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 standard, either by p

48、ublication of an identical text or by endorsement, at the latest by April 2014, and conflicting national standards shall be withdrawn at the latest by April 2014.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 s

49、hall not be held responsible for identifying any or all such patent rights.This document supersedes EN ISO 14889:2009.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.For relationship with EU Directive, see informative Annex ZA, which is an integral 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 St