EN ISO 21987-2017 en Ophthalmic optics - Mounted spectacle lenses.pdf

1、Ophthalmic optics Mounted spectacle lenses(ISO 21987:2017)BS EN ISO 21987:2017BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06National forewordThis British Standard is the UK implementation of EN ISO 21987:2017. It is identical to ISO 21987:2017. It supersedes BS EN

2、ISO 21987:2009, which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/172/3, Spectacles.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provis

3、ions of a contract. Users are responsible for its correct application. The British Standards Institution 2017 Published by BSI Standards Limited 2017ISBN 978 0 580 89525 8ICS 11.040.70Compliance with a British Standard cannot confer immunity from legal obligations. This British Standard was publishe

4、d under the authority of the Standards Policy and Strategy Committee on 30 September 2017.Amendments/corrigenda issued since publicationDate Text affected BRITISH STANDARDBS EN ISO 21987:2017EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 21987August 2017ICS 11.040.70 Supersedes EN ISO 21987:2

5、009EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGCEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2017 CEN Ref. No. EN ISO 21987:2017: EAll rights of exploitation in any form and by any means reserved worldwide for CEN national Memb

6、ersOphthalmic optics Mounted spectacle lenses (ISO 21987:2017)Optique ophtalmique Verres ophtalmiques monts (ISO 21987:2017)Augenoptik Fertig montierte Korrektionsbrillenglser (ISO 21987:2017)This European Standard was approved by CEN on 26 May 2017.CEN members are bound to comply with the CEN/CENEL

7、EC 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 Centre or

8、 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 as the offic

9、ial 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, Netherlands, N

10、orway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.English VersionEN ISO 21987:2017 (E)European forewordThis document (EN ISO 21987:2017) has been prepared by Technical Committee ISO/TC 172 “Optics and photonics“ in collaboration with

11、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 February 2018, and conflicting national standards shall b

12、e withdrawn at the latest by February 2018.Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN shall not be held responsible for identifying any or all such patent rights.This document supersedes EN ISO 21987:2009.This document ha

13、s 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 integral part of this document.The following referenced

14、 documents are indispensable for the application of this document. For undated references, the latest edition of the referenced document (including any amendments) applies. For dated references, only the edition cited applies. However, for any use of this standard within the meaning of Annex ZA, the

15、 user should always check that any referenced document has not been superseded and that its relevant contents can still be considered the generally acknowledged state-of-art.When an IEC or ISO standard is referred to in the ISO standard text, this shall be understood as a normative reference to the

16、corresponding EN standard, if available, and otherwise to the dated version of the ISO or IEC standard, as listed below.NOTE The way in which these referenced documents are cited in normative requirements determines the extent (in whole or in part) to which they apply.Table Correlation between norma

17、tive references and dated EN and ISO standardsNormative references as listed in Clause 2 of the ISO standardEquivalent dated standardEN ISO or IECISO 7944 EN ISO 7944:1998 + AC:2009 ISO 7944:1998 + Cor.1:2009ISO 8429 EN ISO 8429:1996 ISO 8429:1986ISO 8598-1 EN ISO 8598-1:2014 ISO 8598-1:2014ISO 8624

18、 EN ISO 8624:2011 + A1:2015 ISO 8624:2011+ Amd.1:2015ISO 8980-1 EN ISO 8980-1:2017 ISO 8980-1:2017ISO 8980-2 EN ISO 8980-2:2017 ISO 8980-2:2017ISO 13666 EN ISO 13666:2012 ISO 13666:2012ISO 14889 EN ISO 14889:2013 ISO 14889:2013According to the CEN-CENELEC Internal Regulations, the national standards

19、 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, Latvia, Lithuania, Luxemb

20、ourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. 2BS EN ISO 21987:2017EN ISO 21987:2017 (E)Endorsement noticeThe text of ISO 21987:2017 has been approved by CEN as EN ISO 21987:2017 without any modific

21、ation.3BS EN ISO 21987:2017EN ISO 21987:2017 (E)Annex ZA (informative) Relationship between this document and the Essential Requirements of Directive 93/42/EEC OJ L 169 aimed to be coveredThis document has been prepared under a Commissions standardization request M/023 concerning the development of

22、European Standards related to medical devices to provide one voluntary means of conforming to essential requirements of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices OJ L 169.Once this standard is cited in the Official Journal of the European Union under that Directive, comp

23、liance with the normative 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 corresponding essential requirements of that Directive and associated EFTA regulations.NOTE 1 Where a reference from a clause of this

24、standard to the risk management process is made, the risk management process needs to be in compliance with Directive 93/42/EEC as amended by 2007/47/EC. This means that risks have to be reduced as far as possible, to a minimum, to the lowest possible level, minimized or removed, according to the wo

25、rding of the corresponding essential requirement.NOTE 2 The manufacturers policy for determining acceptable risk must be in compliance with Essential Requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive.NOTE 3 This Annex ZA is based on normative references according to the table of reference

26、s in the European foreword, replacing the references in the core text.NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this document.Table ZA.1 Correspondence between this document and Annex I of Directive 93/42/EEC OJ L 169Essential Requiremen

27、ts of Directive 93/42/EECClause(s)/sub-clause(s) of this documentRemarks/Notes7.1 5.2, 5.3, 5.4, 5.5, 5.6 5.2 of the standard only meets the requirements of Annex I, 7.1 of the Directive in respect of toxicity and flammability.5.3 of the standard only meets the requirements of Annex I, 7.1 of the Di

28、rective in respect of optical performance.5.4 of the standard only meets the requirements of Annex I, 7.1 of the Directive in respect of lens thick-ness.5.5 of the standard only meets the requirements of Annex I, 7.1 of the Directive in respect of positioning of the various lens segments.5.6 of the

29、standard only meets the requirements of Annex I, 7.1 of the Directive in respect of the orienta-tion of polarizing lenses.9.2 5.2 5.2 of the standard only meets the requirements of Annex I, 9.2 of the Directive in respect of mechanical strength and material ageing.4BS EN ISO 21987:2017EN ISO 21987:2

30、017 (E)Essential Requirements of Directive 93/42/EECClause(s)/sub-clause(s) of this documentRemarks/Notes9.3 5.2 5.2 of the standard only meets the requirements of Annex I, 9.3 of the Directive in respect of flammabil-ity.11.3.1 5.2 5.2 of the standard only meets the requirements of Annex I, 11.3.1

31、of the Directive in respect of transmit-tance.13.1 Clause 7, Clause 9 Clause 7 of the standard only meets the requirements of Annex I, 13.1 of the Directive in respect of perma-nent or non-permanent marking. Clause 9 of the standard only meets the requirements of Annex I, 13.1 of the Directive in re

32、spect of product identification.13.3 Clause 9 Clause 9 of the standard only meets the requirements of Annex I, 13.3 of the Directive in respect of product trade name and manufacturer address.WARNING 1 Presumption of conformity stays valid only as long as a reference to this document is maintained in

33、 the list published in the Official Journal of the European Union. Users of this standard should consult frequently the latest list published in the Official Journal of the European Union.WARNING 2 Other Union legislation may be applicable to the products falling within the scope of this standard.5B

34、S EN ISO 21987:2017ISO 21987:2017(E)Foreword viii1 Scope . 12 Normative references 13 Terms and definitions . 14 Classification 35 Requirements 35.1 Reference temperature 35.2 Lenses used in manufacturing complete spectacles . 35.3 Optical requirements . 35.3.1 General 35.3.2 Back vertex power 45.3.

35、3 Direction of the cylinder axis 45.3.4 Addition power or variation power. 55.3.5 Prism imbalance (relative prism error) for mounted single-vision lenses (excluding position-specific single-vision lenses) and multifocal lenses . 55.3.6 Prism imbalance (relative prism error) for position-specific sin

36、gle-vision lenses and power-variation lenses . 75.4 Requirements for thickness . 75.5 Requirements for positioning 85.5.1 Multifocal lenses. 85.5.2 Position-specific single-vision lenses and power-variation lenses 95.6 Orientation requirement for polarizing lenses . 96 Verification methods 96.1 Gene

37、ral . 96.2 Verification method for back vertex power 96.3 Verification method for the direction of the cylinder axis. 96.4 Verification method for addition power or variation power .106.4.1 General. 106.4.2 Method for verification of addition power for multifocal lenses 106.4.3 Method for verificati

38、on of variation power (including addition power) for power-variation lenses 106.5 Verification method for position and tilt . 116.6 Verification method for prism imbalance (relative prism error) for mounted single-vision lenses (excluding position-specific single-vision lenses) and multifocal lenses

39、 . 116.7 Verification method for planes of transmission of polarizing lenses116.7.1 General. 116.7.2 Apparatus 116.7.3 Procedure 126.8 Inspection method for material and surface quality .127 Marking for position-specific single-vision lenses and power-variation lenses 127.1 Permanent marking . 127.2

40、 Optional non-permanent marking 138 Recommendations on mounting .139 Identification .1310 Reference to this document .13Annex A (informative) Material and surface quality.14Annex B (informative) Recommendations on mounting 15vi ISO 2017 All rights reservedContents PageBS EN ISO 21987:2017ISO 21987:2

41、017(E)Annex C (informative) Alternative method for measuring prism imbalance (relative prism error) for mounted single-vision lenses (excluding position-specific single-vision lenses) and multifocal lenses .17Bibliography .20 ISO 2017 All rights reserved viiBS EN ISO 21987:2017ISO 21987:2017(E)Forew

42、ordISO (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 which a technic

43、al 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 all matters of el

44、ectrotechnical standardization.The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was

45、 drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2.(see www.iso.org/directives).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 responsible for identifying any or all such paten

46、t rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).Any trade name used in this document is information given for the convenience of users and does not co

47、nstitute an endorsement.For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) s

48、ee the following URL: www.iso.org/iso/foreword.html.This document was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 7, Ophthalmic optics and instruments.This second edition cancels and replaces the first edition (ISO 21987:2009), which has been technically revised

49、.viii ISO 2017 All rights reservedBS EN ISO 21987:2017Ophthalmic optics Mounted spectacle lenses1 ScopeThis document specifies requirements and test methods for mounted spectacle lenses relative to the prescription order.2 Normative referencesThe following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) app