DIN EN ISO 9801-2010 Ophthalmic instruments - Trial case lenses (ISO 9801 2009) German version EN ISO 9801 2009《眼科仪器 测试箱镜头 (ISO 9801-2009) 德文版本 EN ISO 9801-2009》.pdf

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1、April 2010 Translation by DIN-Sprachendienst.English price group 11No 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).ICS

2、11.040.70!$aR“1629247www.din.deDDIN EN ISO 9801Ophthalmic instruments Trial case lenses (ISO 9801:2009)English translation of DIN EN ISO 9801:2010-04Ophthalmische Instrumente Refraktionsglser (ISO 9801:2009)Englische bersetzung von DIN EN ISO 9801:2010-04Instruments ophtalmiques Verres de bote dessa

3、i (ISO 9801:2009)Traduction anglaise de DIN EN ISO 9801:2010-04SupersedesDIN EN ISO 9801:1999-07www.beuth.deIn case of doubt, the German-language original shall be considered authoritative.Document comprises 18 pages04.10 DIN EN ISO 9801:2010-04 2 A comma is used as the decimal marker. National fore

4、word This standard has been prepared by Technical Committee ISO/TC 172 “Optics and photonics”, Subcommittee SC 7 “Ophthalmic optics and instruments” (Secretariat: DIN, Germany) in collaboration with Technical Committee CEN/TC 170 “Ophthalmic optics” (Secretariat: DIN, Germany). The responsible Germa

5、n body involved in its preparation was the Normenausschuss Feinmechanik und Optik (Optics and Precision Mechanics Standards Committee), Working Committee NA 027-01-08 AA Augenoptik, Working Group NA 027-01-08-06 AK Ophthalmische Instrumente. The DIN Standards corresponding to the International Stand

6、ards referred to in clause 2 of this document are as follows: ISO 7944 DIN EN ISO 7944 ISO 13666 DIN EN ISO 13666 ISO 15004-1 DIN EN ISO 15004-1 In Germany, use of the symbol “dpt” for dioptre (expressed in m1) is legally required and this symbol is to be used rather than the symbol D used in other

7、countries. Amendments This standard differs from DIN EN ISO 9801:1999-07 as follows: a) Normative references and the bibliography have been updated. b) In subclause 4.3.2 “Dimensions”, a second smaller dimension (28 mm) has been added. c) The equation in Annex A.1 has been corrected. d) The standard

8、 has been editorially revised. e) The revised International Standard ISO 9801:2009 has been adopted. Previous editions DIN 58207: 1968-07, 1977-11 DIN EN ISO 9801: 1999-07 DIN EN ISO 9801:2010-04 3 National Annex NA (informative) Bibliography DIN EN ISO 7944, Optics and optical instruments Reference

9、 wavelengths DIN EN ISO 8429, Optics and optical instruments Ophthalmology Graduated dial scale DIN EN ISO 8598, Optics and optical instruments Focimeters DIN EN ISO 12867, Ophthalmic instruments Trial frames DIN EN ISO 13666, Ophthalmic optics Spectacle lenses Vocabulary DIN EN ISO 15004-1, Ophthal

10、mic instruments Fundamental requirements and test methods Part 1: General requirements applicable to all ophthalmic instruments DIN EN ISO 9801:2010-04 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 9801 December 2009 ICS 11.040.70 Supersedes EN ISO 9801:

11、1999English Version Ophthalmic instruments - Trial case lenses (ISO 9801:2009) Instruments ophtalmiques - Verres de bote dessai (ISO 9801:2009) Ophthalmische Instrumente - Refraktionsglser (ISO 9801:2009) This European Standard was approved by CEN on 4 December 2009. CEN members are bound to comply

12、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 may be obtained on application to the CEN Management

13、 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 to the CEN Management Centre has the same status as the of

14、ficial versions. CEN members are the national standards 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,

15、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 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for C

16、EN national Members. Ref. No. EN ISO 9801:2009: EContents DIN EN ISO 9801:2010-04 EN ISO 9801:2009 (E) 2 Page Foreword3 1 Scope 4 2 Normative references 4 3 Terms and definitions .4 4 Requirements.5 4.1 General5 4.2 Optical requirements.5 4.3 Construction.7 4.4 Material and surface quality .8 5 Test

17、 methods8 5.1 General8 5.2 Checking the optical requirements8 5.3 Checking material and surface quality9 5.4 Checking construction9 6 Functional marking9 7 Information supplied by the manufacturer .9 7.1 Accompanying documents.9 7.2 Identification of the trial case lens set 10 Annex A (informative)

18、Example of test device for checking accuracy of trial case lens elements. 11 Annex B (informative) Example of test device and method for checking material and surface quality 13 Bibliography. 14 Foreword collaboration with Technical Committee CEN/TC 248 “Textiles and textile products” the secretaria

19、t of which is held by BSI. 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 June 2010, and conflicting national standards shall be withdrawn at the latest by June 2010. Attention is drawn to the po

20、ssibility 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 ISO 2062:1995. According to the CEN/CENELEC Internal Regulations, the national standar

21、ds organizations 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, Port

22、ugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 2062:2009 has been approved by CEN as a EN ISO 2062:2009 without any modification. This document (EN ISO 2062:2009) has been prepared by Technical Committee ISO/TC 38 “Textiles” i

23、n DIN EN ISO 9801:2010-04 EN ISO 9801:2009 (E) 3 1 Scope This International Standard specifies requirements for mounted ophthalmic full and/or reduced aperture trial case lenses for the determination of the refractive error of the eye. This International Standard takes priority over ISO 15004-1, if

24、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 latest edition of the referenced document (including any amendments) applies. ISO 794

25、4, Optics and optical instruments Reference wavelengths ISO 13666, Ophthalmic optics Spectacle lenses Vocabulary ISO 15004-1:2006, Ophthalmic instruments Fundamental requirements and test methods Part 1: General requirements applicable to all ophthalmic instruments 3 Terms and definitions For the pu

26、rposes of this document, the terms and definitions given in ISO 13666 and the following apply. 3.1 trial case lens lens, in a mount, used to assess the refractive error of the human eye 3.2 full-aperture trial case lens trial case lens with a protective mount of maximal practical wall thickness of a

27、pproximately 1 mm, allowing the maximum available free lens aperture 3.3 reduced-aperture trial case lens trial case lens with the designated free lens aperture significantly less than the mount outer diameter, allowing for considerable reductions in lens thicknesses to be made 3.4 additive power tr

28、ial case lens set train of spherical, cylindrical or spherocylindrical combination of trial case lenses, in which the measured back-vertex power at the last surface equals the meridional sums of the labelled values of the train lenses when each element is placed in its specified frame cell NOTE See

29、ISO 12867. DIN EN ISO 9801:2010-04 EN ISO 9801:2009 (E) 4 3.5 lens power spherical lens back-vertex power, expressed in dioptres (D) 3.6 lens power cylindrical lens back-vertex power in the principal meridian not equal to zero, expressed in dioptres (D) NOTE Cylindrical trial case lenses have one pr

30、incipal meridian with zero power. 3.7 prismatic power prismatic lens, prism prismatic effect, measured as the displacement, in centimetres, of the light ray in a plane perpendicular to its line of incidence on the lens at a distance of 1 m NOTE 1 Prismatic power is expressed in prism dioptres (). NO

31、TE 2 The prism base is marked by a line or triangle on the mount (see Clause 6). The position of the prism base is indicated according to ISO 8429. 4 Requirements 4.1 General The trial case lenses shall conform to the requirements specified in ISO 15004-1. Conformity to the requirements specified in

32、 4.2, 4.3 and 4.4 shall be verified as described in Clause 5. 4.2 Optical requirements The trial case lenses shall conform to the requirements specified in Tables 1 to 6. Conformity to these requirements shall be verified as described in 5.2. The dioptric powers indicated in Tables 1 to 4 shall be r

33、eferenced to the wavelength = 546,07 nm or alternatively = 587,56 nm, in accordance with ISO 7944. If the requirements are not met for both wavelengths, the reference wavelength used shall be indicated. The requirements for lenses with nominal zero power (plano) are given in Table 1. Table 1 Toleran

34、ces on lenses with zero power Tolerance on mean power residual astigmatism prismatic power Nominal lens power 122SS+12SS D D D 0 0,03 0,03 0,06 NOTE S1and S2refer to the vertex powers in the principal meridians. DIN EN ISO 9801:2010-04 EN ISO 9801:2009 (E) 5 The requirements for lenses with spherica

35、l power are given in Table 2. Table 2 Tolerances on lenses with spherical power Tolerance on mean power residual astigmatism Nominal spherical power (absolute) 122SS+12SS D D D 0,12 0,03 0,03 0,12 to 6,00 0,06 0,03 6,00 to 12,00 0,09 0,03 12,00 0,12 0,03 NOTE S1and S2refer to the vertex powers in th

36、e principal meridians. The requirements for lenses with cylindrical power are as follows: a) The tolerances in the afocal principal meridian shall be 0,03 D and 0,12 . b) The tolerances on the cylindrical power principal meridian are given in Table 3. Table 3 Tolerances on lenses with cylindrical po

37、wer Nominal cylindrical power D Tolerance D 0,12 0,03 0,12 to 1,00 0,06 1,00 to 4,00 0,09 4,00 to 6,00 0,12 6,00 0,18 The requirements for lenses with prismatic power are given in Table 4. Table 4 Tolerances on lenses with prismatic power Prismatic power Tolerance D nominal tolerance spherical astig

38、matic u 6 0,12 0,03 0,03 6 0,25 0,03 0,03 DIN EN ISO 9801:2010-04 EN ISO 9801:2009 (E) 6 The accuracy of the optical centring of spherical and cylindrical lenses shall be as given in Table 5. Table 5 Tolerances on centration Nominal lens power (absolute) D Tolerance on at the geometric centre of the

39、 mount W 0,12 to 2,00 0,12 2,00 to 5,00 0,25 5,00 to 8,00 0,38 8,00 to 12,00 0,50 12,00 0,75 The accuracy of the positions of the cylinder axis or the prism base in relation to their corresponding marks (see Clause 6) shall be as given in Table 6. Table 6 Tolerances on the marking of the cylinder ax

40、is and the prism base Nominal cylindrical powerD Tolerance u 0,25 3 0,25 to 0,50 2 Lenses with cylindrical power 0,50 1 Nominal prismatic power Tolerance u 0,5 7 0,5 to 1,0 4 1,0 to 2,0 2 2,0 to 10,0 1,5 Lenses with prismatic power 10,0 1 4.3 Construction 4.3.1 General The following requirements sha

41、ll apply to all mounts and mounted lenses. 4.3.2 Dimensions Trial case lenses shall have a circular mount, the rounded edges of which shall have a maximum radius of 1,4 mm. The outer diameter of the mounted lens shall be either 00,238mm or 00,228mm (for small frames). NOTE 1 For full- and reduced-ap

42、erture mounts in current use, the outer diameters of both mount types are equal. The maximum thickness of the trial case lens including the mount shall not exceed 2,8 mm. NOTE 2 Trial case lenses are intended to fit into a trial frame with a lens separation of 3 mm as specified in ISO 12867. DIN EN

43、ISO 9801:2010-04 EN ISO 9801:2009 (E) 7 Full-aperture lenses with power in excess of 5,00 D may exceed this thickness limit. Full-aperture prismatic lenses and reduced-aperture prismatic lenses with power in excess of 3,0 may exceed this thickness limit on the side nearer the object. 4.3.3 Free lens

44、 aperture For trial case lenses with a nominal lens power of not more than 12,00 D, the diameter of the free lens aperture shall be not less than 18 mm. For trial case lenses with a nominal lens power greater than 12,00 D, the diameter of the free lens aperture shall be not less than 16 mm. NOTE An

45、aperture diameter of 16 mm is acceptable for most purposes. A larger diameter is sometimes preferred. 4.3.4 Prismatic lenses Prismatic lenses shall be mounted so that the surface nearer the eye is parallel to the plane of the mount. The prismatic power marked on the mount shall be the power for ligh

46、t incident normal to the surface nearer the eye. NOTE This value corresponds to the result measured with a focimeter. 4.3.5 Mount The mount shall contain no surfaces, sharp edges or corners which could cause injury to the patient or practitioner under normal conditions of use. Marks shall be applied

47、 to the mount as described in Clause 6. 4.4 Material and surface quality 4.4.1 The lens shall have no blisters, blurs, scratches or other defects, nor any irregularities of the surface which can be recognized with the unaided (naked) eye. These requirements shall be met over the full free lens apert

48、ure. 4.4.2 Materials used in the construction shall be of non-corrosive composition or suitably surface-treated to render them non-corrosive in clinical atmospheric conditions. 5 Test methods 5.1 General All tests described in this International Standard are type tests. 5.2 Checking the optical requ

49、irements Conformity to the requirements specified in 4.2 shall be tested using a device which does not exceed a measuring error of 0,01 D or 20 % of the given tolerance for vertex power, whichever is greater, and of 0,5 for cylinder axis direction and prism base setting. DIN EN ISO 9801:2010-04 EN ISO 9801:2009 (E) 8 Measurements shall be carried out at the aperture centre of the trial case lens and shall be referred to the reference plane of the test device. NO