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1、BS EN ISO 14889:2009 ICS 11.040.70 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW BRITISH STANDARD Ophthalmic optics Spectacle lenses Fundamental requirements for uncut finished lenses (ISO 14889:2003) This British Standard was published under the authority of the Standards P
2、olicy and Strategy Committee on 30 April 2009 BSI 2009 ISBN 978 0 580 65429 9 Amendments/corrigenda issued since publication DateComments BS EN ISO 14889:2009 National foreword This British Standard is the UK implementation of EN ISO 14889:2009. It is identical to ISO 14889:2003. It supersedes BS EN
3、 ISO 14889:2003 which is withdrawn.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 pro
4、visions of a contract. Users are responsible for its correct application. Compliance with a British Standard cannot confer immunity from legal obligations. EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 14889 March 2009 ICS 11.040.70Supersedes EN ISO 14889:2003 English Version Ophthalmic o
5、ptics - Spectacle lenses - Fundamental requirements for uncut finished lenses (ISO 14889:2003) Optique ophtalmique - Verres de lunettes - Exigences fondamentales relatives aux verres finis non dtours (ISO 14889:2003) Augenoptik - Brillenglser - Grundlegende Anforderungen an rohkantige fertige Brille
6、nglser (ISO 14889:2003) This European Standard was approved by CEN on 7 March 2009. 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 an
7、d 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 translation under the responsi
8、bility 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, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Icela
9、nd, 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 NORMUNG Management Centre: Avenue
10、Marnix 17, B-1000 Brussels 2009 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 14889:2009: E BS EN ISO 14889:2009 EN ISO 14889:2009 (E) 3 Foreword The text of ISO 14889:2003 has been prepared by Technical Committee ISO/TC 172 “
11、Optics and optical instruments” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 14889:2009 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 stand
12、ard, either by publication of an identical text or by endorsement, at the latest by September 2009, and conflicting national standards shall be withdrawn at the latest by March 2010. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights.
13、 CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 14889:2003. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential require
14、ments 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, see informative Annex ZA, which is an integral part of this document. According to the CEN/CENELEC Internal Regulations, the national standards organi
15、zations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Rom
16、ania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 14889:2003 has been approved by CEN as a EN ISO 14889:2009 without any modification. BS EN ISO 14889:2009 EN ISO 14889:2009 (E) 4 Annex ZA (informative) Relationship between this European
17、Standard and the Essential Requirements of EU Directive 93/42/EEC This 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/EE
18、C on medical devices. Once this standard is cited in the Official Journal of the European Communities 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
19、scope of this standard, a presumption of conformity with the corresponding 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 Dir
20、ective 93/42/EEC Qualifying remarks/Notes 4, 5 I.1, I.3 4.2, 4.3.1 I.2, I.6, I.6 a) New ER I.6 a) is implicitly covered by subclause 4.3.1 of EN ISO 14889. Manufacturers will have to take new ER I.6.a) into consideration when preparing their declaration of conformity. 4.3.1, 4.3.2, 4.4, 5.2, 5.3 II.
21、7.1 4.4, 5.3 II.9.2 4.3.2, 5.2 II.9.3 6 II.13.1, II.13.3 The relevant Essential Requirement of II.13.3 a) is only partly addressed in subclause 6.1 e) of EN ISO 14889. BS EN ISO 14889:2009 EN ISO 14889:2009 (E) 5 For devices intended by the manufacturer to be for dual use in accordance with Article
22、1(6) of Directive 93/42 EEC the following Table ZA.2 details the relevant essential requirements of Directive 89/686/EC on Personal Protective Equipment and their corresponding clauses of this European Standard. Table ZA.2 however, does not imply any citation in the OJEU under the PPE directive and
23、thus does not provide presumption of conformity for the PPE directive. Table ZA.2 Relevant Essential Requirements from Directive 89/686/EEC on Personal 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
24、) of this EN Essential Requirements (ERs) of Directive 89/686/EEC Qualifying remarks/Notes - - General A manufacturer may claim that his lenses in addi- tion of being corrective lenses be protective lenses that provide personal eye protection to the user. As a matter of fact, personal eye protection
25、 can relate to various kinds of risk, e.g. sunglare (indirect solar radiation1), radiation other than indirect solar radiation, mechanical impact, etc. Some 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
26、 EN ISO 14889, the following applies. - - Corrective lenses with filter properties against sunglare (indirect solar radiation) In accordance with the European Commissions “GUIDELINES ON THE APPLICATION OF COUNCIL DIRECTIVE 89/686/EEC OF 21 DECEMBER 1989 ON THE APPROXIMATION OF THE LAWS OF THE MEMBER
27、 STATES RELATING TO PERSONAL PROTECTIVE EQUIPMENT“ such lenses are categorized as medical devices, thus falling under Directive 93/42/EEC. Compliance with the ERs 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. - - Corre
28、ctive lenses designed to provide protection other than protection against sunglare (indirect solar radiation) Where corrective lenses are designed to provide protection other than protection against sunglare (indirect solar radiation), the relevant basic health and safety requirements of Directive 8
29、9/ 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 requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. 1 Indirect sola
30、r radiation implies general use for protection against solar radiation but not for direct observation of the sun. BS EN ISO 14889:2009 ISO 14889:2003(E) ISO 2003 All rights reserved iii Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards
31、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 technical committee has been established has the right to be represented on that committee. International organizat
32、ions, 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 electrotechnical standardization. International Standards are drafted in accordance with the rules given in th
33、e ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of
34、the member bodies casting a vote. 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 patent rights. ISO 14889 was prepared by Technical Committee ISO/TC 172, Optics an
35、d optical instruments, Subcommittee SC 7, Ophthalmic optics and instruments. This second edition cancels and replaces the first edition (ISO 14889:1997), which has been technically revised. BS EN ISO 14889:2009 BS EN ISO 14889:2009 INTERNATIONAL STANDARD ISO 14889:2003(E) ISO 2003 All rights reserve
36、d 1 Ophthalmic optics Spectacle lenses Fundamental requirements for uncut finished lenses 1 Scope This International Standard specifies fundamental requirements for uncut finished spectacle lenses. This International Standard is not applicable to protective spectacle lenses. This International Stand
37、ard takes precedence over the corresponding requirements of other standards, if differences exist. 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 lates
38、t edition of the referenced document (including any amendments) applies. ISO 8980-1, Ophthalmic optics Uncut finished spectacle lenses Part 1: Specifications for single-vision and multifocal lenses ISO 8980-2, Ophthalmic optics Uncut finished spectacle lenses Part 2: Specifications for progressive p
39、ower lenses ISO 8980-3, Ophthalmic optics Uncut finished spectacle lenses Part 3: Transmittance specifications and test methods ISO 8980-4, Ophthalmic optics Uncut finished spectacle lenses Part 4: Specifications and test methods for anti-reflective coatings ISO 13666, Ophthalmic optics Spectacle le
40、nses Vocabulary 3 Terms and definitions For the purposes of this International Standard, the terms and definitions given in ISO 13666 as well as the following. 3.1 manufacturer (of an uncut finished spectacle lens) natural or legal person who places the uncut finished lens on the market BS EN ISO 14
41、889:2009 ISO 14889:2003(E) 2 ISO 2003 All rights reserved 4 Fundamental requirements for spectacle lenses 4.1 Performance In addition to the requirements specified in this International Standard, uncut finished lenses shall comply with the relevant parts of ISO 8980. 4.2 Design Spectacle lenses shal
42、l be designed so that the overall risk associated with their use according to the conditions intended by the manufacturer, relative to the risk when the spectacle lenses are not used, is reduced to a level consistent with the materials used and compatible with the generally acknowledged state- of-th
43、e-art. 4.3 Materials 4.3.1 Physiological compatibility Lenses shall not be made from materials known to be physiologically incompatible or known to create allergic or toxic reactions amongst a significant proportion of wearers when the lenses are used as intended by the manufacturer. 4.3.2 Inflammab
44、ility When the lens is tested as described in 5.2, there shall be no continued combustion after withdrawal of the test rod. 4.4 Mechanical strength Uncut spectacle lenses shall withstand the quasi-static loading type test for minimum robustness described in 5.3. The requirement for minimum robustnes
45、s shall be satisfied if the spectacle lens withstands the application of a 22 mm diameter steel ball with a force of (100 2) N, when tested as described in 5.3. This test shall be carried out immediately after conditioning at a temperature of (23 5) C. After this test, the following defects shall no
46、t be apparent: a) lens fracture A spectacle lens shall be considered to have fractured if it has cracked through its entire thickness into two or more pieces or if more than 5 mg of the lens material has become detached from the surface away from the one in contact with the ball or if the ball has p
47、assed through the test specimen. b) lens deformation A spectacle lens shall be considered to have been deformed if a mark has appeared on the white paper underneath the lens. NOTE If the spectacle lens is intended for use for industrial or other purposes where mechanical hazards exist, a higher leve
48、l of mechanical strength or robustness may be required. If eye protection is required, the specific requirements are given in the appropriate International Standard. BS EN ISO 14889:2009 ISO 14889:2003(E) ISO 2003 All rights reserved 3 4.5 Transmittance 4.5.1 General requirements The transmittance s
49、hall conform to the requirements specified in ISO 8980-3. When using illuminant D 65, the luminous transmittance v of spectacle lenses shall not be u 3 % at the design reference point. 4.5.2 Additional requirements for lenses intended for use when driving 4.5.2.1 General Spectacle lenses having a luminous transmittance u 8 % are not intended for driving or road use. This clause therefore does not contain requirements for such lenses. 4.5.2.2 Spectral transmittance The spectral transmittance () at
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