EN ISO 12870-2012 en Ophthalmic optics - Spectacle frames - Requirements and test methods《眼科光学 眼镜镜架 试验方法和要求》.pdf

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1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 12870:2012Ophthalmic optics Spectacle frames Requirements and test methods (ISO 12870:2012)BS EN ISO 12870:2012 BRITISH STANDARDNational forewordThis British Standard i

2、s the UK implementation of EN ISO 12870:2012. It supersedes BS EN ISO 12870:2009, which is withdrawn.The UK participation in its preparation was entrusted to T e c h n i c a l C o m m i t t e e C H / 1 7 2 / 3 , S p e c t a c l e s .A list of organizations represented on this committee can be obtain

3、ed on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2012Published by BSI Standards Limited 2012ISBN 978 0 580 67899 8 ICS 11.040.70 Compliance with

4、 a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 April 2012.Amendments issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM E

5、N ISO 12870 April 2012 ICS 11.040.70 Supersedes EN ISO 12870:2009English Version Ophthalmic optics - Spectacle frames - Requirements and test methods (ISO 12870:2012) Optique ophtalmique - Montures de lunettes - Exigences et mthodes dessai (ISO 12870:2012) Augenoptik - Brillenfassungen - Anforderung

6、en und Prfverfahren (ISO 12870:2012) This European Standard was approved by CEN on 23 March 2012. 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

7、-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC 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 translat

8、ion 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 official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland,

9、France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHE

10、S KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2012 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 12870:2012: EBS EN ISO 12870:2012EN ISO 12870:2012 (E) 3 Foreword This document (EN ISO 12870:2012)

11、has been prepared by Technical Committee ISO/TC 172 “Optics and photonics“ in collaboration with 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

12、text or by endorsement, at the latest by October 2012, and conflicting national standards shall be withdrawn at the latest by October 2012. 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 respo

13、nsible for identifying any or all such patent rights. This document supersedes EN ISO 12870:2009. 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. For relationship wit

14、h EU Directive, see informative Annex ZA, which is an integral part of this document. According to the 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 R

15、epublic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 12870

16、:2012 has been approved by CEN as a EN ISO 12870:2012 without any modification. BS EN ISO 12870:2012EN ISO 12870:2012 (E) 4 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EC Directive 93/42/EEC This European Standard has been prepared under a man

17、date 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 Journal of the European Union under that Directive a

18、nd 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 Essential Requirements of that Directive and asso

19、ciated EFTA regulations. Table ZA.1 Correspondence between this European Standard and Directive 93/42/EEC Clauses/subclauses of this European Standard Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/notes 4.1, 4.2, 4.5, 4.6, 4,7, 4.8, 4.9, 9, 10 1 The requirements declared as

20、optional in Table 1, but cited in the list given in footnote a, only provide presumption of conformity to their corresponding Essential Requirements if they are complied with. See below in the present table. 4.1, 4.2, 4.5, 4.6, 4,7, 4.8, 4.9, 9, 10 2 The requirements declared as optional in Table 1,

21、 but cited in the list given in footnote a, only provide presumption of conformity to their corresponding Essential Requirements if they are complied with. See below in the present table. 4 3 Testing in accordance with Clauses 5, 6, 7 and 8. 4.6 to 4.9 4 Testing in accordance with 8.2 to 8.6. 4.2.1,

22、 4.2.2, 4.2.3 6 Testing in accordance with 8.8. The requirement of 4.2.3 (i.e. 0,5 g/cm2/week) is the requirement set forth by Directive 94/27/EEC. The test in 8.8 makes reference to EN 16128 and EN 12472. See also explanations in Annex D. 4.2.4 6 a) 4.2.1, 4.2.2, 4.2.3 7.1 Testing in accordance wit

23、h 8.8. The requirement of 4.2.3 (i.e. 0,5 g/cm2/week) is the requirement set forth by Directive 94/27/EEC. The test in 8.8 makes reference to EN 16128 and EN 12472. See also explanations in Annex D. 4.6 to 4.9 7.1 Testing in accordance with 8.2 to 8.6. BS EN ISO 12870:2012EN ISO 12870:2012 (E) 5 Tab

24、le ZA.1 (end) Clauses/subclauses of this European Standard Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/notes 4.2.1, 4.2.2, 4.2.3 7.2 Testing in accordance with 8.8. The requirement of 4.2.3 (i.e. 0,5 g/cm2/week) is the requirement set forth by Directive 94/27/EEC. The test

25、 in 8.8 makes reference to EN 16128 and EN 12472. See also explanations in Annex D. 4.6 to 4.9 7.3 Testing in accordance with 8.2 to 8.6. 4.2.2, 4.2.3 7.5 Testing in accordance with 8.8. Essential Requirement 7.5 is only partly addressed in ISO 12870. To the extent that it is covered in ISO 12870, t

26、esting is carried out in accordance with 8.8. The requirement of 4.2.3 (i.e. 0,5 g/cm2/week) is the requirement set forth by Directive 94/27/EEC. The test in 8.8 makes reference to EN 16128 and EN 12472. See also explanations in Annex D. 4.8 9.1 Testing in accordance with 8.4 and 8.5. 4.9 9.3 Testin

27、g in accordance with 8.6. 9, 10 13.1 9, 10 13.3 The statement in 10.4 is true for the countries of the Community cf. ER 13.3 a). WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. BS EN ISO 12870:2012ISO 12870:2012(E) ISO

28、 2012 All rights reserved iiiContents PageForeword iv1 Scope 12 Normative references . 13 Terms and definitions . 14 Requirements . 24.1 General . 24.2 Physiological compatibility 34.3 Measurement system . 44.4 Dimensional tolerances on nominal size 44.5 Tolerance on screw threads . 44.6 Dimensional

29、 stability at elevated temperature 44.7 Resistance to perspiration 44.8 Mechanical stability 54.9 Resistance to ignition 64.10 Resistance to optical radiation 65 Selection of test samples 65.1 General . 65.2 Testing for nickel release 65.3 Change in spectacle frame model 66 Preparation and condition

30、ing of test samples 66.1 Test lenses 66.2 Sample conditioning and test conditions . 77 Testing, inspection and compliance 77.1 Testing 77.2 Inspection and examination . 87.3 Compliance . 88 Test methods 98.1 General . 98.2 Test for dimensional stability at elevated temperature . 98.3 Test for resist

31、ance to perspiration 108.4 Bridge deformation and lens retention test . 118.5 Endurance test .138.6 Test for resistance to ignition 148.7 Test for resistance to optical radiation 158.8 Nickel release .169 Marking .1810 Additional information to be supplied by the manufacturer or other person placing

32、 the product on the market 1911 Reference to ISO 12870 .20Annex A (informative) Recommendations for the design of spectacle frames .21Annex B (informative) Examples of layout of test equipment 23Annex C (informative) Examples of locations for cutting metal spectacle frames before testing for nickel

33、release 26Annex D (informative) European requirements and legislation on nickel release27Bibliography .28BS EN ISO 12870:2012ISO 12870:2012(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of prepa

34、ring 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 organizations, governmental and non-governmental, in l

35、iaison 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 the ISO/IEC Directives, Part 2.The main task of

36、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 the member bodies casting a vote.Attention is d

37、rawn 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 12870 was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 7, Ophthalmic optics

38、 and instruments.This third edition cancels and replaces the second edition (ISO 12870:2004) which has been technically revised.iv ISO 2012 All rights reservedBS EN ISO 12870:2012INTERNATIONAL STANDARD ISO 12870:2012(E)Ophthalmic optics Spectacle frames Requirements and test methods1 ScopeThis Inter

39、national Standard specifies fundamental requirements for unglazed spectacle frames designed for use with all prescription lenses. It is applicable to frames at the point of sale by the manufacturer or supplier to the retailer.This International Standard is applicable to all spectacle frame types, in

40、cluding rimless mounts, semi-rimless mounts and folding spectacle frames. It is also applicable to spectacle frames made from natural organic materials.NOTE See Annex A for recommendations on the design of spectacle frames.This International Standard is not applicable to complete custom-made spectac

41、le frames or to products designed specifically to provide personal eye protection.2 Normative referencesThe 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 r

42、eferenced document (including any amendments) applies.ISO 105-A02, Textiles Tests for colour fastness Part A02: Grey scale for assessing change in colourISO 105-B02, Textiles Tests for colour fastness Part B02: Colour fastness to artificial light: Xenon arc fading lamp testISO 3160-1, Watch cases an

43、d accessories Gold alloy coverings Part 1: General requirementsISO 3696:1987, Water for analytical laboratory use Specification and test methodsISO 7998, Ophthalmic optics Spectacle frames Lists of equivalent terms and vocabularyISO 8596, Ophthalmic optics Visual acuity testing Standard optotype and

44、 its presentationISO 8624:2011, Ophthalmic optics Spectacle frames Measuring system and terminologyISO 11380, Optics and optical instruments Ophthalmic optics FormersISO 11381, Optics and optical instruments Ophthalmic optics Screw threadsISO/TS 24348, Ophthalmic optics Spectacle frames Method for t

45、he simulation of wear and detection of nickel release from coated metal and combination spectacle frames3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 7998 and ISO 8624 and the following apply.3.1spectacle frame modelspectacle frame produced to a com

46、mon design, using the same materials (but not necessarily the same pigmentation) and surface treatment ISO 2012 All rights reserved 1BS EN ISO 12870:2012ISO 12870:2012(E)3.2natural organic materialmaterial that has not been synthesized from other raw organic materials and, when processed, remains es

47、sentially in its original stateEXAMPLES Natural horn, bamboo and wood.NOTE Processing in this case is defined as cutting, shaping, laminating, bonding, bending, polishing and heating.3.3custom-made spectacle framespectacle frame made to special order for a named patientEXAMPLE Spectacle frames speci

48、ally manufactured for wearers with unusual facial characteristics.4 Requirements4.1 GeneralThe requirements applicable to different types of spectacle frames are given in Table 1. All spectacle frame types covered by this International Standard shall comply with the requirements identified as “gener

49、al” (g). Requirements marked “O” are optional, but may be required by legislation in some countries.Table 1 Requirements applicable to different types of spectacle framesFrame typeSubclause a4.2.1 4.2.2 4.2.3 4.2.4 4.3 4.4 4.5 4.6 4.7 4.8 4.9 4.10Rimless and semi-rimless mountsg g O O O O g g g g g OAll other frame types bg g O O g g g g g g g OKeygFrame type shall meet the requirements of this subclause in order to comply with this International Standard.O Compliance with this subclause is optiona