欢迎来到麦多课文档分享! | 帮助中心 海量文档,免费浏览,给你所需,享你所想!
麦多课文档分享
全部分类
  • 标准规范>
  • 教学课件>
  • 考试资料>
  • 办公文档>
  • 学术论文>
  • 行业资料>
  • 易语言源码>
  • ImageVerifierCode 换一换
    首页 麦多课文档分享 > 资源分类 > PDF文档下载
    分享到微信 分享到微博 分享到QQ空间

    DIN EN 14139-2010 Ophthalmic optics - Specifications for ready-to-wear spectacles German version EN 14139 2010《眼科光学 试戴镜规范 德文版本EN 14139-2010》.pdf

    • 资源ID:666986       资源大小:321.98KB        全文页数:9页
    • 资源格式: PDF        下载积分:10000积分
    快捷下载 游客一键下载
    账号登录下载
    微信登录下载
    二维码
    微信扫一扫登录
    下载资源需要10000积分(如需开发票,请勿充值!)
    邮箱/手机:
    温馨提示:
    如需开发票,请勿充值!快捷下载时,用户名和密码都是您填写的邮箱或者手机号,方便查询和重复下载(系统自动生成)。
    如需开发票,请勿充值!如填写123,账号就是123,密码也是123。
    支付方式: 支付宝扫码支付    微信扫码支付   
    验证码:   换一换

    加入VIP,交流精品资源
     
    账号:
    密码:
    验证码:   换一换
      忘记密码?
        
    友情提示
    2、PDF文件下载后,可能会被浏览器默认打开,此种情况可以点击浏览器菜单,保存网页到桌面,就可以正常下载了。
    3、本站不支持迅雷下载,请使用电脑自带的IE浏览器,或者360浏览器、谷歌浏览器下载即可。
    4、本站资源下载后的文档和图纸-无水印,预览文档经过压缩,下载后原文更清晰。
    5、试题试卷类文档,如果标题没有明确说明有答案则都视为没有答案,请知晓。

    DIN EN 14139-2010 Ophthalmic optics - Specifications for ready-to-wear spectacles German version EN 14139 2010《眼科光学 试戴镜规范 德文版本EN 14139-2010》.pdf

    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


    注意事项

    本文(DIN EN 14139-2010 Ophthalmic optics - Specifications for ready-to-wear spectacles German version EN 14139 2010《眼科光学 试戴镜规范 德文版本EN 14139-2010》.pdf)为本站会员(arrownail386)主动上传,麦多课文档分享仅提供信息存储空间,仅对用户上传内容的表现方式做保护处理,对上载内容本身不做任何修改或编辑。 若此文所含内容侵犯了您的版权或隐私,请立即通知麦多课文档分享(点击联系客服),我们立即给予删除!




    关于我们 - 网站声明 - 网站地图 - 资源地图 - 友情链接 - 网站客服 - 联系我们

    copyright@ 2008-2019 麦多课文库(www.mydoc123.com)网站版权所有
    备案/许可证编号:苏ICP备17064731号-1 

    收起
    展开