EN ISO 9801-2009 en Ophthalmic instruments - Trial case lenses《眼科仪器 测试箱镜头》.pdf

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1、BS EN ISO9801:2009ICS 11.040.70NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDOphthalmicinstruments Trialcase lenses (ISO9801:2009)This British Standardwas published under theauthority of the StandardsPolicy and StrategyCommittee on 31 January2010 BSI 2010ISBN

2、978 0 580 65277 6Amendments/corrigenda issued since publicationDate CommentsBS EN ISO 9801:2009National forewordThis British Standard is the UK implementation of EN ISO 9801:2009. Itsupersedes BS EN ISO 9801:1999 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCo

3、mmittee CH/172/6, Ophthalmic instruments.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 provisionsof a contract. Users are responsible for its correct application.Compliance with a Britis

4、h Standard cannot confer immunityfrom legal obligations.EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 9801 December 2009 ICS 11.040.70 Supersedes EN ISO 9801:1999English Version Ophthalmic instruments - Trial case lenses (ISO 9801:2009) Instruments ophtalmiques - Verres de bote dessai (IS

5、O 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 with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national

6、 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 Standard exists in three official versions (English, French, German). A version in any

7、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 standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Esto

8、nia, Finland, France, Germany, Greece, Hungary, Iceland, 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 EURO

9、PISCHES 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 9801:2009: EBS EN ISO 9801:2009EN ISO 9801:2009 (E) 3 Foreword This document (EN ISO 9801:2009

10、) 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 identica

11、l 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 possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsib

12、le for identifying any or all such patent rights. This document supersedes EN ISO 9801:1999. 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, Cyprus, Czech Rep

13、ublic, 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 The text of ISO 9801:2009 has b

14、een approved by CEN as a EN ISO 9801:2009 without any modification. BS EN ISO 9801:2009ISO 9801:2009(E) ISO 2009 All rights reserved iiiContents Page Foreword iv 1 Scope1 2 Normative references1 3 Terms and definitions .1 4 Requirements.2 4.1 General .2 4.2 Optical requirements.2 4.3 Construction 4

15、4.4 Material and surface quality .5 5 Test methods .5 5.1 General .5 5.2 Checking the optical requirements .5 5.3 Checking material and surface quality6 5.4 Checking construction6 6 Functional marking .6 7 Information supplied by the manufacturer .6 7.1 Accompanying documents.6 7.2 Identification of

16、 the trial case lens set 7 Annex A (informative) Example of test device for checking accuracy of trial case lens elements8 Annex B (informative) Example of test device and method for checking material and surface quality .10 Bibliography11 BS EN ISO 9801:2009ISO 9801:2009(E) iv ISO 2009 All rights r

17、eservedForeword ISO (the International 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 wh

18、ich a technical committee has been 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

19、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 technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are ci

20、rculated 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 drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held respo

21、nsible for identifying any or all such patent rights. ISO 9801 was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 7, Ophthalmic optics and instruments. This second edition cancels and replaces the first edition (ISO 9801:1997), which has undergone a minor revision

22、to update normative references and to include a second standard diameter (see 4.3.2). BS EN ISO 9801:2009INTERNATIONAL STANDARD ISO 9801:2009(E) ISO 2009 All rights reserved 1Ophthalmic instruments Trial case lenses 1 Scope This International Standard specifies requirements for mounted ophthalmic fu

23、ll 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 differences exist. 2 Normative references The following referenced documents are indispensable for the application of this document.

24、For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 7944, Optics and optical instruments Reference wavelengths ISO 13666, Ophthalmic optics Spectacle lenses Vocabulary ISO 15004-1:2006, Op

25、hthalmic instruments Fundamental requirements and test methods Part 1: General requirements applicable to all ophthalmic instruments 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 13666 and the following apply. 3.1 trial case lens lens, in a mount,

26、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 approximately 1 mm, allowing the maximum available free lens aperture 3.3 reduced-aperture trial case lens trial case lens with the de

27、signated free lens aperture significantly less than the mount outer diameter, allowing for considerable reductions in lens thicknesses to be made 3.4 additive power trial case lens set train of spherical, cylindrical or spherocylindrical combination of trial case lenses, in which the measured back-v

28、ertex 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 ISO 12867. BS EN ISO 9801:2009ISO 9801:2009(E) 2 ISO 2009 All rights reserved3.5 lens power spherical lens back-vertex power, express

29、ed 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 principal meridian with zero power. 3.7 prismatic power prismatic lens, prism prismatic effect, measured as the disp

30、lacement, 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 (). NOTE 2 The prism base is marked by a line or triangle on the mount (see Clause 6). The position of the prism base is

31、 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 4.2, 4.3 and 4.4 shall be verified as described in Clause 5. 4.2 Optical requirements The trial case lenses shall

32、 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 referenced to the wavelength = 546,07 nm or alternatively = 587,56 nm, in accordance with ISO 7944. If the requirem

33、ents 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 Tolerances on lenses with zero power Tolerance on mean power residual astigmatism prismatic power Nominal lens power 122S

34、S+12SS D D D 0 0,03 0,03 0,06 NOTE S1and S2refer to the vertex powers in the principal meridians. BS EN ISO 9801:2009ISO 9801:2009(E) ISO 2009 All rights reserved 3The requirements for lenses with spherical power are given in Table 2. Table 2 Tolerances on lenses with spherical power Tolerance on me

35、an 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 the principal meridians. The requirements for lenses with cylindrical power are as follows: a) Th

36、e 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 power 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

37、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 astigmatic u 6 0,12 0,03 0,03 6 0,25 0,03 0,03 BS EN ISO 9801:2009ISO 9801:2009(E) 4 ISO 2009 All ri

38、ghts reservedThe 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 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

39、 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 axis and the prism base Nominal cylindrical powerD Tolerance u 0,25 3 0,25 to

40、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 shall apply to all mounts and mounted lenses. 4.3.2 Dimensions Trial case lense

41、s 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-aperture mounts in current use, the outer diameters of both mount types are eq

42、ual. 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. BS EN ISO 9801:2009ISO 9801:2009(E) ISO 2009 All rights reserved 5Full-aperture len

43、ses 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 aperture For trial case lenses with a nominal lens power

44、 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 aperture diameter of 16 mm is acceptable for most purpose

45、s. 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 light incident normal to the surface nearer the eye. NOTE Thi

46、s 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 to the mount as described in Clause 6. 4.4 Material and

47、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 aperture. 4.4.2 Materials used in the construction shall be of

48、 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 requirements Conformity to the requirements specified in 4.2

49、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. BS EN ISO 9801:2009ISO 9801:2009(E) 6 ISO 2009 All rights reservedMeasurements 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. NOTE An example is given in Annex A. T