1、November 2010 Translation by DIN-Sprachendienst.English price group 7No 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).IC
2、S 11.040.70!$l1c“1731464www.din.deDDIN EN 14139Ophthalmic optics Specifications for ready-to-wear spectaclesEnglish translation of DIN EN 14139:2010-11Augenoptik Anforderungen an FertigbrillenEnglische bersetzung von DIN EN 14139:2010-11Optique ophtalmique Spcifications pour les lunettes prmontesTra
3、duction anglaise de DIN EN 14139:2010-11SupersedesDIN EN 14139:2003-03 andDIN EN 14139 www.beuth.deIn case of doubt, the German-language original shall be considered authoritative.Document comprises 9 pagesCorrigendum1:2006-11 11.10 DIN EN 14139:2010-11 2 A comma is used as the decimal marker. Natio
4、nal foreword This standard has been prepared by Technical Committee CEN/TC 170 “Ophthalmic optics” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the Normenausschuss Feinmechanik und Optik (Optics and Precision Mechanics Standards Committee), Working Committ
5、ee NA 027-01-08 AA Augenoptik. This standard contains specifications meeting the essential requirements set out in EU Directive 93/42/EEC on medical devices. Amendments This standard differs from DIN EN 14139:2003-03 and DIN EN 14139 Corrigendum 1:2006-11 as follows: a) it has been clarified that th
6、e marking of ready-to-wear spectacles according to DIN EN ISO 12870 is optional (see NOTE to Subclause 5.1); b) requirements regarding the information to be provided by the manufacturer have been amended (see Subclause 5.2); c) Annex ZA “Relationship between this European Standard and the Essential
7、Requirements of EU Directive 93/42/EEC on medical devices” has been included; d) the revised European Standard EN 14139:2010, placed under EC Mandate (Directive 93/42/EEC on medical devices), has been adopted. Previous editions DIN EN 14139: 2003-03 DIN EN 14139 Corrigendum 1: 2006-11 EUROPEAN STAND
8、ARD 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 prmontes Augenoptik - Anforderungen an Fertigbrillen This European Standa
9、rd 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. Up-to-date lists and bibliographical references concerning such
10、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 translation under the responsibility of a CEN member into its own language
11、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, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuani
12、a, 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 NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2010 CEN
13、All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 14139:2010: EEN 14139:2010 (E) 2 Contents Page Foreword 31 Scope 42 Normative references 43 Terms and definitions .44 Performance requirements .44.1 General 44.2 General requirements 44.3
14、 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 packaging, instruction for use 55.1 Marking .55.2 Indications on packaging and warning
15、s .5Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices .7DIN EN 14139:2010-11 EN 14139:2010 (E) 3 Foreword This document (EN 14139:2010) has been prepared by Technical Committee CEN/TC 170 “Ophthalmic optics”
16、, 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 conflicting national standards shall be withdrawn at the latest by December 2010. Atte
17、ntion 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 14139:2002. It has been adapted from ISO 16034:2002. This docu
18、ment 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 relationship with EU Directive 93/42/EEC as amended by Directive 2007/47/EC,
19、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 12870 is optional (note to subclause 5.1). - amendment of requirements regar
20、ding 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 the CEN/CENELEC Internal Regulations, the national standards organizations of
21、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, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Roman
22、ia, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. DIN EN 14139:2010-11 EN 14139:2010 (E) 4 1 Scope This European Standard specifies the minimum requirements for complete ready-to-wear spectacles. These are not intended for regular use without the approval of an eye-care prof
23、essional. 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 referenced document (including any amendments) applies. EN ISO 7998, Oph
24、thalmic 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 finished spectacle lenses Part 1: Specifications for single-vision and mult
25、ifocal 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, Ophthalmic optics Spectacle lenses Fundamental requirements for uncut finished le
26、nses (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 near vision and reading use only having or incorporating a pair of single
27、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 this European Standard is restricted to spectacles having or incorporating
28、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 to the need of a qualified practitioners prescription and dispensing for
29、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 ISO 14889. DIN EN 14139:2010-11 EN 14139:2010 (E) 5 The frame of ready-to
30、-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 that movement or rotation in the frame cannot occur under any conditio
31、n 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 values declared by the manufacturer shall comply with EN ISO 8980-1.
32、 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 the frame according to EN ISO 8624. Vertical: The design reference p
33、oints 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 design reference points specified by the manufacturer, shall not exc
34、eed 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 for use 5.1 Marking Spectacles shall be permanently marked with the
35、 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. 5.2 Indications on packaging and warnings Manufacturers declared ce
36、ntration distance, in mm, shall be marked on the frame or on the hang tag or applied sticker. DIN EN 14139:2010-11 EN 14139:2010 (E) 6 Warning of the unsuitability for driving or road use shall be indicated by the symbol given in Figure 1. Figure 1 Symbol “not suitable for driving and road use” A le
37、gible 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 determine your visual needs and eye health Not for driving or v
38、ehicle 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 device. For devices imported into the Community, the name and addr
39、ess 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 this European Standard, its number and year shall be included
40、 either on the packaging or in the available literature. DIN EN 14139:2010-11 EN 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 This European Standard has been prepared under a mandate gi
41、ven 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 Journal of the European Union under that Directive and has
42、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 Essential Requirements of that Directive and associated
43、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, 7.5, 9.1, 9.2, 9.3 These ERs are covered by normative r
44、eference 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 therein, and is partially covered in EN ISO 12870:2009 (this
45、 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 Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. DIN EN 14139:2010-11
