EN ISO 12870-2018 en Ophthalmic optics - Spectacle frames - Requirements and test methods.pdf

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1、BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06Ophthalmic optics - Spectacle frames - Requirements and test methodsBS EN ISO 12870:2018National forewordThis British Standard is the UK implementation of EN ISO 12870:2018. It is identical to ISO 12870:2016. It superse

2、des BS EN ISO 12870:2014, which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/172, Ophthalmic optics.A list of organizations represented on this committee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 n

3、ecessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2018 Published by BSI Standards Limited 2018ISBN 978 0 580 89767 2ICS 11.040.70Compliance with a British Standard cannot confer immunity from legal obligations.This British Standar

4、d was published under the authority of the Standards Policy and Strategy Committee on 31 May 2018.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN ISO 12870:2018EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 12870May 2018ICS 11.040.70 Supersedes EN ISO 128

5、70:2014EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGCEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2018 CEN Ref. No. EN ISO 12870:2018: EAll rights of exploitation in any form and by any means reserved worldwide for CEN national

6、MembersOphthalmic optics - Spectacle frames - Requirements and test methods (ISO 12870:2016)Optique ophtalmique - Montures de lunettes - Exigences et mthodes dessai (ISO 12870:2016)Augenoptik - Brillenfassungen - Anforderungen und Prfverfahren (ISO 12870:2016)This European Standard was approved by C

7、EN on 26 April 2018.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 national standards

8、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 translation under the responsibility of a CEN member into its own language and notified

9、 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland

10、, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.English VersionEN ISO 12870:2018 (E)European forewordThe text of ISO 12870:2016 has been prepared by Technical Com

11、mittee ISO/TC 172 “Optics and photonics” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 12870:2018 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 nation

12、al standard, either by publication of an identical text or by endorsement, at the latest by November 2018, and conflicting national standards shall be withdrawn at the latest by November 2018.Attention is drawn to the possibility that some of the elements of this document may be the subject of paten

13、t rights. CEN shall not be held responsible for identifying any or all such patent rights.This document supersedes EN ISO 12870:2014.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

14、 EU Directive(s).For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document.Endorsement noticeThe text of ISO 12870:2016 has been approved by CEN as EN ISO 12870:2018 without any modification.2BS EN ISO 12870:2018ISO 12870:2016Foreword v1 Scope . 12 N

15、ormative references 13 Terms and definitions . 14 Requirements 24.1 General . 24.2 Physiological compatibility 34.2.1 Construction 34.2.2 General physiological compatibility 34.2.3 Nickel release 34.2.4 Clinical evaluation. 44.3 Measurement system. 44.4 Dimensional tolerances on nominal size 44.5 To

16、lerance on screw threads . 44.6 Dimensional stability at elevated temperature. 44.7 Resistance to perspiration 44.8 Mechanical stability 54.8.1 Bridge deformation . 54.8.2 Lens retention characteristics 54.8.3 Endurance 54.9 Resistance to ignition 64.10 Resistance to optical radiation 65 Selection o

17、f test samples 65.1 General . 65.2 Testing for nickel release 65.3 Change in spectacle frame model . 66 Preparation and conditioning 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

18、87.3 Compliance . 88 Test methods . 98.1 General . 98.2 Test for dimensional stability at elevated temperature 108.2.1 Apparatus 108.2.2 Procedure 108.3 Test for resistance to perspiration 108.3.1 Apparatus and reagents 108.3.2 Procedure 118.4 Bridge deformation and lens retention test 118.4.1 Appar

19、atus 118.4.2 Procedure 128.5 Endurance test . 138.5.1 Apparatus 138.5.2 Procedure 148.6 Test for resistance to ignition 158.6.1 Apparatus 158.6.2 Procedure 158.7 Test for resistance to optical radiation 158.7.1 Apparatus 15 ISO 2016 All rights reserved iiiContents PageBS EN ISO 12870:2018ISO 12870:2

20、0168.7.2 Procedure 169 Marking .1610 Additional information to be supplied by the manufacturer or other person placing the product on the market 1711 Reference to this International Standard 18Annex A (informative) Recommendations for the design of spectacle frames 19Annex B (informative) Examples o

21、f layout of test equipment .22Annex C (informative) European requirements and legislation on nickel release .25Bibliography .26iv ISO 2016 All rights reservedBS EN ISO 12870:2018ISO 12870:2016ForewordISO (the International Organization for Standardization) is a worldwide federation of national stand

22、ards 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 orga

23、nizations, 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.The procedures used to develop this document and those intended for its

24、further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/dire

25、ctives).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. Details of any patent rights identified during the development of the document will be in the

26、 Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents). Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions relate

27、d to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 172, Optics and photonics, Subcommittee SC 7, Ophtha

28、lmic optics and instruments.This fourth edition cancels and replaces the third edition (ISO 12870:2012), which has been technically revised with the following change: 8.8 and Annex C are now covered in more specific standards (ISO/TS 24348:2014 and EN 16128:2015, respectively) and are now included a

29、s appropriate reference to this International Standard (see 4.2.3 and Annex C). ISO 2016 All rights reserved vBS EN ISO 12870:2018This page deliberately left blankOphthalmic optics - Spectacle frames - Requirements and test methods1 ScopeThis International Standard specifies fundamental requirements

30、 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, including rimless mounts, semi-rimless mounts and fold

31、ing 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 spectacle frames or to products designed specifically to pr

32、ovide personal eye protection.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced

33、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 3696, Water for analytical labor

34、atory 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 its presentationISO 8624:2011, Ophthalmic optics Spectacle frames Measuring system and terminologyISO 1

35、1380, Optics and optical instruments Ophthalmic optics FormersISO 11381, Optics and optical instruments Ophthalmic optics Screw threadsISO/TS 24348:2014, Ophthalmic optics Spectacle frames Method for the simulation of wear and detection of nickel release from metal and combination spectacle frames3

36、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 common design, using the same materials (but not necessarily the same pigmentation) and surface treatmentINTE

37、RNATIONAL STANDARD ISO 12870:2016 ISO 2016 All rights reserved 1BS EN ISO 12870:2018ISO 12870:20163.2natural organic materialmaterial that has not been synthesized from other raw organic materials and, when processed, remains essentially in its original stateNote 1 to entry: Processing in this case

38、is defined as cutting, shaping, laminating, bonding, bending, polishing and heating.EXAMPLE Natural horn, bamboo and wood.3.3custom-made spectacle framespectacle frame made to special order for a named patientEXAMPLE Spectacle frames specially manufactured for wearers with unusual facial characteris

39、tics.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 “general” (g). Requirements marked “O” are optional, but can be req

40、uired by legislation in some countries.Table 1 Requirements applicable to different types of spectacle framesFrame typeSubclausea4.2.1 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 typesbg g O O g g g g g g g OKeygFrame type s

41、hall meet the requirements of this subclause in order to comply with this International Standard.O Compliance with this subclause is optional.4.2.14.2.24.2.34.2.44.34.44.54.64.74.84.94.10ConstructionGeneral physiological compatibilityNickel releaseClinical evaluationMeasurement systemDimensional tol

42、erances on nominal sizeTolerance on screw threadsDimensional stability at elevated temperatureResistance to perspirationMechanical stabilityResistance to ignitionResistance to optical radiationaUnder European legislation, 4.2.1, 4.2.2, 4.2.3, 4.2.4, 4.5, 4.6, 4.7, 4.8 and 4.9 cover some essential re

43、quirements.b“All other frame types” include plastics and metal spectacle frames, including folding spectacle frames, that have a rim that completely surrounds the lens periphery.2 ISO 2016 All rights reservedBS EN ISO 12870:2018ISO 12870:20164.2 Physiological compatibility4.2.1 ConstructionWhen test

44、ed under the inspection conditions given in 7.2, areas of the spectacle frame that can, either by design or accident, come into contact with the wearer should be smooth, without sharp protuberances, and all edges should be rounded.4.2.2 General physiological compatibilitySpectacle frames shall be de

45、signed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise the health (and safety) of the wearer. The risks posed by substances leaking (migrating) from the device that might come into prolonged contact with the skin shall be re

46、duced by the manufacturer to a practicable minimum and within the limits of any appropriate regulatory requirement. Special attention shall be given to substances that are known to be allergenic, carcinogenic, mutagenic or toxic to reproduction.NOTE 1 The following list, which is given for informati

47、on, provides examples of documents that can be examined when checking the innocuousness of materials: specification of the materials used; safety data sheets relating to the materials; information relating to the suitability of the materials for use with food, in medical devices, or other relevant a

48、pplications; information relating to investigations into the allergenic, carcinogenic, toxicological or mutagenic properties of the materials, or their toxicity with regard to reproduction; information relating to ecotoxicological and other environmental investigations on the materials.NOTE 2 Reacti

49、ons can be generated by excessive pressure, for example, due to a poor fit on the face, chemical irritation or allergy. Rare or idiosyncratic reactions can occur to any material and indicate the need for the individual to avoid particular types of frames.NOTE 3 In some countries, specific material properties are mandatory.4.2.3 Nickel releaseThose parts of metal spectacle frames and those metal parts of combination spectacle frames that come into direct and prolonged contact with the skin of the wearer shall not have a ni