EN ISO 21987-2009 en Ophthalmic optics - Mounted spectacle lenses《眼科光学 安装式眼镜镜片》.pdf

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1、BS EN ISO21987:2009ICS 11.040.70NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDOphthalmic optics Mounted spectaclelenses (ISO 21987:2009)This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 December 2009 B

2、SI 2009ISBN 978 0 580 63498 7Amendments/corrigenda issued since publicationDate CommentsBS EN ISO 21987:2009National forewordThis British Standard is the UK implementation of EN ISO 21987:2009.It supersedes BS 2738-1:1998 which will be withdrawn on 1 February 2010.The major differences between BS EN

3、 ISO 21987:2009 and BS 2738-1:1998 are in the tolerances on:the cylinder axis direction; the prism imbalance (relative prism error) for pairs of single-vision and multifocal lenses; and the reliance on the optical centration of the uncut lenses before glazing for progressive power lenses and their c

4、orrect positioning during mounting.The UK participation in its preparation was entrusted to TechnicalCommittee CH/172/3, Spectacles.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisio

5、nsof a contract. Users are responsible for its correct application. Compliance with a British Standard cannot confer immunityfrom legal obligations.EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 21987 October 2009 ICS 11.040.70 English Version Ophthalmic optics - Mounted spectacle lenses (

6、ISO 21987:2009) Optique ophtalmique - Verres ophtalmiques monts (ISO 21987:2009) Augenoptik - Fertig montierte Korrektionsbrillenglser (ISO 21987:2009) This European Standard was approved by CEN on 17 September 2009. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which sti

7、pulate 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 may be obtained on application to the CEN Management Centre or to any CEN member. This European Standar

8、d 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 to the CEN Management Centre has the same status as the official versions. CEN members are the national stand

9、ards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kin

10、gdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 21987:2009: EB

11、S EN ISO 21987:2009EN ISO 21987:2009 (E) 3 Foreword This document (EN ISO 21987:2009) 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 sh

12、all be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by April 2010, and conflicting national standards shall be withdrawn at the latest by April 2010. Attention is drawn to the possibility that some of the elements of this docume

13、nt 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 has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements

14、 of EU Directive. For relationship with 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, Belgi

15、um, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice

16、The text of ISO 21987:2009 has been approved by CEN as a EN ISO 21987:2009 without any modification. BS EN ISO 21987:2009EN ISO 21987:2009 (E) 4 Annex ZA (informative) Relationship between this International Standard and the Essential Requirements of EU Directive 93/42/EEC This International Standar

17、d has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide one means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC, Medical devices: General. Once this standard is cited in the Official Journal of t

18、he European Union under that Directive and has been implemented as a national standard in at least one Member State, compliance with the normative 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

19、 Essential Requirements of that Directive and associated EFTA regulations. Table ZA.1 - Correspondence between this International Standard and Directive 93/42/EEC Clause(s)/sub-clause(s) of this International Standard Essential requirements (ERs) of EU Directive 93/42/EEC Qualifying remarks/Notes 5.

20、2 1, 2, 3, 4, 6, 6a), 7.1, 9.2, 9.3 These ERs are covered by normative reference to ISO 14889:2003. 5.3, 5.4, 5.5 3 7, 8 13.1, 13.3 These ERs are covered by clause 7, and by the normative reference to ISO 14889:2003 in clause 8. NOTE ER 13.3.a) is only partly addressed in ISO 14889:2003. WARNING: Ot

21、her requirements and other EU Directives may be applicable to the products falling within the scope of this standard. BS EN ISO 21987:2009ISO 21987:2009(E) ISO 2009 All rights reserved iiiContents Page Foreword iv 1 Scope1 2 Normative references1 3 Terms and definitions .1 4 Classification .2 5 Requ

22、irements.2 5.1 Reference temperature .2 5.2 Lenses used in manufacturing complete spectacles 2 5.3 Optical requirements.2 5.4 Thickness tolerance 6 5.5 Positioning tolerances6 6 Test methods .8 6.1 General .8 6.2 Measurement method for the back vertex power of single-vision lenses and the distance p

23、ortion of multifocal and progressive-power lenses and near portion of degressive-power lenses8 6.3 Measurement method for cylinder axis.8 6.4 Addition power measurement8 6.5 Method for measuring position and tilt.10 6.6 Material and surface quality .10 6.7 Prism imbalance (relative prism error) meas

24、urement method for pairs of single-vision and multifocal lenses .10 7 Marking for progressive-power and degressive-power lenses 10 7.1 Permanent marking .10 7.2 Non-permanent marking.11 8 Identification 11 9 Reference to ISO 21987.11 Annex A (informative) Material and surface quality 12 Annex B (inf

25、ormative) Recommendations on mounting.13 Annex C (informative) Alternative methods for measuring prism imbalance (relative prism error) for pairs of single-vision and multifocal lenses.15 Bibliography17 BS EN ISO 21987:2009ISO 21987:2009(E) iv ISO 2009 All rights reservedForeword ISO (the Internatio

26、nal Organization for Standardization) is a worldwide federation of national standards 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

27、established has the right to be represented on that committee. International organizations, 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 standar

28、dization. International Standards are drafted in accordance with the rules given in the 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 v

29、oting. Publication as an International Standard requires approval by at least 75 % of 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 s

30、uch patent rights. ISO 21987 was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 7, Ophthalmic optics and instruments. BS EN ISO 21987:2009INTERNATIONAL STANDARD ISO 21987:2009(E) ISO 2009 All rights reserved 1Ophthalmic optics Mounted spectacle lenses 1 Scope This

31、International Standard specifies requirements for mounted spectacle lenses relative to the prescription order. 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 reference

32、s, the latest edition of the referenced document (including any amendments) applies. ISO 7944, Optics and optical instruments Reference wavelengths ISO 8429, Optics and optical instruments Ophthalmology Graduated dial scale ISO 8598, Optics and optical instruments Focimeters ISO 8624, Ophthalmic opt

33、ics Spectacle frames Measuring system and terminology 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-power lenses ISO 898

34、0-3, 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 8980-5, Ophthalmic optics Uncut finished spectacle lense

35、s Part 5: Minimum requirements for spectacle lens surfaces claimed to be abrasion-resistant ISO 13666, Ophthalmic optics Spectacle lenses Vocabulary ISO 14889:2003, Ophthalmic optics Spectacle lenses Fundamental requirements for uncut finished lenses 3 Terms and definitions For the purposes of this

36、document, the terms and definitions given in ISO 13666 apply. BS EN ISO 21987:2009ISO 21987:2009(E) 2 ISO 2009 All rights reserved4 Classification Finished, mounted lenses are classified as follows: a) single-vision finished lenses; b) multifocal finished lenses; c) progressive-power and degressive-

37、power finished lenses. 5 Requirements 5.1 Reference temperature The tolerances shall apply at a temperature of 23 C 5 C. 5.2 Lenses used in manufacturing complete spectacles Lenses used in manufacturing complete spectacles shall meet the requirements of ISO 14889:2003, 4.1, 4.2, 4.3.1, 4.3.2 and 4.5

38、. Lenses shall also have been shown to meet the requirements ISO 14889:2003, 4.4 unless a national standard or law specifies mechanical strength requirements, in which case the national standard or law will take precedence. ISO 14889:2003, 4.1 requires that the uncut finished lenses used in manufact

39、uring complete spectacles comply with the relevant parts of ISO 8980. Lenses in mounted spectacles shall also comply with other requirements of the prescription order not included in this International Standard. 5.3 Optical requirements 5.3.1 General The optical characteristics shall be determined u

40、sing a focimeter complying with ISO 8598. Where the power is measured in the presence of more than 0,50 the optical power shall be the off-axis power. The optical tolerances shall apply at the reference point(s) of the lenses at either of the reference wavelengths specified in ISO 7944. If the manuf

41、acturer has applied corrections to compensate for the “as-worn” position, then the tolerances shall apply to this “as-worn” corrected dioptric power. 5.3.2 Back vertex power tolerance The tolerances in Table 1 apply to all single-vision lenses and the distance portion of multifocal lenses, including

42、 those with aspherical or atoroidal surfaces. The tolerances in Table 2 apply to the distance portion of progressive-power lenses and the near portion of degressive-power lenses. The back vertex power shall be measured using the method described in 6.2. 5.3.3 Cylinder axis direction tolerance The di

43、rection of the cylinder axis shall be measured using the method described in 6.3, and shall be specified in accordance with ISO 8429. The tolerances on the direction of the cylinder axis are specified in Table 3. BS EN ISO 21987:2009ISO 21987:2009(E) ISO 2009 All rights reserved 3NOTE 1 To allow for

44、 some tolerance in mounting, the tolerance on the direction of cylinder axis has generally been increased over the tolerances found in the ISO uncut finished lens standards ISO 8980-1 and ISO 8980-2. NOTE 2 Compensation for the “as-worn” position might result in cylinder powers of less than 0,12 D,

45、in which case there are no applicable axis tolerances. 5.3.4 Addition power tolerance for multifocal and progressive-power lenses The addition power shall be measured using the method described in 6.4. The tolerances on addition power are specified in Table 4. Table 1 Tolerances on the back vertex p

46、ower of single-vision and multifocal lenses Values in dioptres Tolerance of the cylindrical power Power of principal meridian with higher absolute back vertex power Tolerance on the back vertex power of each principal meridian W 0,00 and u 0,75 0,75 and u 4,00 4,00 and u 6,00 6,00 W 0,00 and u 3,00

47、0,12 0,09 0,12 0,18 3,00 and u 6,00 0,12 0,12 0,12 0,18 0,25 6,00 and u 9,00 0,12 0,12 0,18 0,18 0,25 9,00 and u12,00 0,18 0,12 0,18 0,25 0,25 12,00 and u 20,00 0,25 0,18 0,25 0,25 0,25 20,00 0,37 0,25 0,25 0,37 0,37 Table 2 Tolerances on the back vertex power of progressive- and degressive-power le

48、nses Values in dioptres Tolerance of the cylindrical power Power of principal meridian with higher absolute back vertex power Tolerance on the back vertex power of each principal meridian W 0,00 and u 0,75 0,75 and u 4,00 4,00 and u 6,00 6,00 W 0,00 and u 6,00 0,12 0,12 0,18 0,18 0,25 6,00 and u 9,0

49、0 0,18 0,18 0,18 0,18 0,25 9,00 and u12,00 0,18 0,18 0,18 0,25 0,25 12,00 and u 20,00 0,25 0,18 0,25 0,25 0,25 20,00 0,37 0,25 0,25 0,37 0,37 Table 3 Tolerances on the direction of cylinder axis Absolute cylindrical power dioptres W 0,125 and u 0,25 0,25 and u 0,50 0,50 and u 0,75 0,75 and u 1,50 1,50 and u 2,50 2,50 Tolerance on the axis direction degrees 16 9 6 4 3 2 Table 4 Tol