EN 14139-2010 en Ophthalmic optics - Specifications for ready-to-wear spectacles《眼科光学 试戴镜规范》.pdf

1、BS EN 14139:2010ICS 11.040.70NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDOphthalmic optics Specificationsfor ready-to-wearspectaclesThis British Standardwas published under theauthority of the StandardsPolicy and StrategyCommittee on 30 June2010 BSI 2010ISBN

2、 978 0 580 67900 1Amendments/corrigenda issued since publicationDate CommentsBS EN 14139:2010National forewordThis British Standard is the UK implementation of EN 14139:2010. Itsupersedes BS EN 14139:2002 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee

3、CH/172/3, Spectacles.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisionsof a contract. Users are responsible for its correct application.Compliance with a British Standard cannot co

4、nfer immunityfrom legal obligations.BS EN 14139:2010EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 14139 June 2010 ICS 11.040.70 Supersedes EN 14139:2002English Version Ophthalmic optics - Specifications for ready-to-wear spectacles Optique ophtalmique - Spcifications pour les lunettes prmonte

5、s Augenoptik - Anforderungen an Fertigbrillen This European Standard was approved by CEN on 13 May 2010. 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

6、. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN 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 translati

7、on under the responsibility of a CEN member into its own language and notified to the CEN 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, France, G

8、ermany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORM

9、UNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2010 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 14139:2010: EBS EN 14139:2010EN 14139:2010 (E) 2 Contents Page Foreword 31 Scope 42 Normative references 43 Terms and def

10、initions .44 Performance requirements .44.1 General 44.2 General requirements 44.3 Optical power range 54.4 Optical power tolerances 54.5 Reference points and prismatic power tolerances 54.5.1 Design reference points 54.5.2 Prismatic power tolerances 55 Marking on the spectacles, indications on pack

11、aging, instruction for use 55.1 Marking .55.2 Indications on packaging and warnings .5Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices .7BS EN 14139:2010EN 14139:2010 (E) 3 Foreword This document (EN 14139:

12、2010) has been prepared 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 December 2010, and conflicti

13、ng national standards shall be withdrawn at the latest by December 2010. 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

14、 supersedes EN 14139:2002. It has been adapted from ISO 16034:2002. 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 93/42/EEC, as amended by Directive 2007/47/EC. For

15、relationship with EU Directive 93/42/EEC as amended by Directive 2007/47/EC, see informative Annex ZA, which is an integral part of this document. Significant technical changes from the previous edition of the document: - clarification that the marking of ready-to-wear spectacles according to EN ISO

16、 12870 is optional (note to subclause 5.1). - amendment of requirements regarding the information to be provided by the manufacturer (subclause 5.2). - the new edition of the standard is placed under EC Mandate (Directive 93/42/EEC on medical devices ) and an Annex ZA was hence added. According to t

17、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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvi

18、a, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. BS EN 14139:2010EN 14139:2010 (E) 4 1 Scope This European Standard specifies the minimum requirements for complete ready-to-wear spectacles. These a

19、re not intended for regular use without the approval of an eye-care professional. 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

20、referenced document (including any amendments) applies. EN ISO 7998, Ophthalmic optics Spectacle frames Lists of equivalent terms and vocabulary (ISO 7998:2005) EN ISO 8624, Ophthalmic optics Spectacle frames Measuring system and terminology (ISO 8624:2002) EN ISO 8980-1, Ophthalmic optics Uncut fin

21、ished spectacle lenses Part 1: Specifications for single-vision and multifocal lenses (ISO 8980-1:2004) EN ISO 12870, Ophthalmic optics Spectacle frames Requirements and test methods (ISO 12870:2004) EN ISO 13666, Ophthalmic optics Spectacle lenses Vocabulary (ISO 13666:1998) EN ISO 14889, Ophthalmi

22、c optics Spectacle lenses Fundamental requirements for uncut finished lenses (ISO 14889:2003) 3 Terms and definitions For the purposes of this document, the terms and definitions given in EN ISO 7998 and in EN ISO 13666 and the following apply. 3.1 ready-to-wear spectacles spectacles intended for ne

23、ar vision and reading use only having or incorporating a pair of single vision lenses of equal positive spherical power in which the glazing has not been carried out in direct response to a written prescription by a qualified practitioner NOTE The term “ready-to-wear spectacles“ as understood by thi

24、s European Standard is restricted to spectacles having or incorporating single vision lenses. The rationale for this restriction is that spectacle lenses other than single vision lenses (e.g. bifocal, multifocal, progressive-power lenses) are not recommended for use in ready-to-wear spectacles due t

25、o the need of a qualified practitioners prescription and dispensing for such lenses. 4 Performance requirements 4.1 General The tolerances shall apply at a temperature of 23 C 5 C. 4.2 General requirements The spectacle lenses of ready-to-wear spectacles shall fulfil the general requirements of EN I

26、SO 14889. BS EN 14139:2010EN 14139:2010 (E) 5 The frame of ready-to-wear spectacles shall fulfil the requirements of EN ISO 12870. The glazing of spectacle lenses shall be verified by the lens retention test as specified in EN ISO 12870. The spectacle lenses shall be securely held in position so tha

27、t movement or rotation in the frame cannot occur under any condition of intended use. 4.3 Optical power range The lenses for ready-to-wear spectacles shall have equal nominal spherical power within the range from +1,00 to +3,50 dioptres. 4.4 Optical power tolerances Tolerances to be applied to the v

28、alues declared by the manufacturer shall comply with EN ISO 8980-1. 4.5 Reference points and prismatic power tolerances 4.5.1 Design reference points Horizontal: The design reference points are specified by the manufacturer and are spaced symmetrically with respect to the vertical symmetry axis of t

29、he frame according to EN ISO 8624. Vertical: The design reference points may be specified by the manufacturer and shall be at the same height for each lens. 4.5.2 Prismatic power tolerances The deviation of prismatic power (horizontal: per lens; vertical: difference between lenses) measured at the d

30、esign reference points specified by the manufacturer, shall not exceed the values given in Table 1. Table 1 Prismatic tolerances Horizontal tolerance 0,33 cm/m absolute each lens Vertical tolerance 0,33 cm/m imbalance between lenses 5 Marking on the spectacles, indications on packaging, instruction

31、for use 5.1 Marking Spectacles shall be permanently marked with the following minimum information: a) name or trade mark of manufacturer or distributor; b) manufacturers declared spherical power, in dioptres. NOTE Additional marking of ready-to-wear spectacles according to EN ISO 12870 is optional.

32、5.2 Indications on packaging and warnings Manufacturers declared centration distance, in mm, shall be marked on the frame or on the hang tag or applied sticker. BS EN 14139:2010EN 14139:2010 (E) 6 Warning of the unsuitability for driving or road use shall be indicated by the symbol given in Figure 1

33、. Figure 1 Symbol “not suitable for driving and road use” A legible notice is required in the national language of the intended destination in the form of an affixed label or swing tag, as follows: WARNING For near vision and reading use only Only regular eye-care professional eye examinations can d

34、etermine your visual needs and eye health Not for driving or vehicle operation Not for distance vision Not for use as eye protection The name and address of the manufacturer shall be marked on the frame or be given on the hang tag or applied sticker or packaging or information provided with the devi

35、ce. For devices imported into the Community, the name and address of the authorized representative in the Community shall be marked on the frame or be given on the hang tag or applied sticker or packaging or information provided with the device. If the manufacturer or supplier claims compliance with

36、 this European Standard, its number and year shall be included either on the packaging or in the available literature. BS EN 14139:2010EN 14139:2010 (E) 7 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices Th

37、is 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 Official Jo

38、urnal 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 corresponding

39、 Essential Requirements of that Directive and associated EFTA regulations. Table ZA.1 Correspondence between this European Standard and Directive 93/42/EEC Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 4.2 1, 2, 3, 4, 6, 7.1, 7.2, 7.3

40、, 7.5, 9.1, 9.2, 9.3 These ERs are covered by normative reference to harmonized EN ISO 12870 and harmonized EN ISO 14889. ER 6 a) (clinical evaluation): This ER is implicitly covered via the normative reference to EN ISO 14889:2009 that will be revised with the intention to explicitly address it the

41、rein, and is partially covered in EN ISO 12870:2009 (this standard is under revision to cover this requirement). ER 7.5 This ER is only partially addressed in EN ISO 12870:2009 (this standard is under revision to cover this requirement). 4.3 1, 3 4.4, 4.5 3, 7.1 5.1, 5.2 13.1, 13.2, 13.3 WARNING Oth

42、er requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. BS EN14139:2010BSI GroupHeadquarters 389Chiswick High Road,London, W4 4AL, UKTel +44 (0)20 8996 9001Fax +44 (0)20 8996 - British Standards InstitutionBSI is the independent nationa

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