EN ISO 10342-2010 en Ophthalmic instruments - Eye refractometers《眼科仪器 眼睛折射计》.pdf

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1、BS EN ISO10342:2010ICS 11.040.70NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDOphthalmicinstruments Eyerefractometers (ISO10342:2010)This British Standardwas published under theauthority of the StandardsPolicy and StrategyCommittee on 30 June2010 BSI 2010ISBN

2、978 0 580 68836 2Amendments/corrigenda issued since publicationDate CommentsBS EN ISO 10342:2010National forewordThis British Standard is the UK implementation of EN ISO 10342:2010.It supersedes BS EN ISO 10342:2003 which is withdrawn.The UK participation in its preparation was entrusted to Technica

3、lCommittee 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 Bri

4、tish Standard cannot confer immunityfrom legal obligations.EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 10342 June 2010 ICS 11.040.70 Supersedes EN ISO 10342:2003English Version Ophthalmic instruments - Eye refractometers (ISO 10342:2010) Instruments ophtalmiques - Rfractomtres (ISO 1034

5、2:2010) Ophthalmische Instrumente - Augenrefraktometer (ISO 10342:2010) This European Standard was approved by CEN on 29 May 2010. 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 stand

6、ard 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 other

7、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, Croatia, Cyprus, Czech Republic, Denmark, E

8、stonia, 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 E

9、UROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2010 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 10342:2010: EBS EN ISO 10342:2010EN ISO 10342:2010 (E) 3 Foreword This document (EN ISO 103

10、42:2010) 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 i

11、dentical text or by endorsement, at the latest by December 2010, and conflicting national standards shall be withdrawn at the latest by December 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

12、 held responsible for identifying any or all such patent rights. This document supersedes EN ISO 10342:2003. 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, C

13、roatia, 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 The te

14、xt of ISO 10342:2010 has been approved by CEN as a EN ISO 10342:2010 without any modification. BS EN ISO 10342:2010ISO 10342:2010(E) ISO 2010 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 requi

15、rements.2 4.3 Measuring range2 4.4 Eyepiece (if applicable).3 5 Test methods .3 5.1 General .3 5.2 Checking the vertex power.3 5.3 Checking the cylinder axis .3 6 Accompanying documents.3 7 Marking.4 Annex A (normative) Test device for eye refractometers.5 BS EN ISO 10342:2010ISO 10342:2010(E) iv IS

16、O 2010 All rights reservedForeword 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

17、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 liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commi

18、ssion (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 technical committees is to prepare International Standards. Draft International Standards adopted by the technica

19、l 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 drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shal

20、l not be held responsible for identifying any or all such patent rights. ISO 10342 was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 7, Ophthalmic optics and instruments. This third edition cancels and replaces the second edition (ISO 10342:2003), which has underg

21、one minor revision to clarify the scope and to update normative references, where applicable. BS EN ISO 10342:2010INTERNATIONAL STANDARD ISO 10342:2010(E) ISO 2010 All rights reserved 1Ophthalmic instruments Eye refractometers 1 Scope This International Standard, together with ISO 15004-1, specifies

22、 requirements and test methods for eye refractometers using an objective measuring principle. It is limited to the measurement of spherocylindrical refractive error. This International Standard takes precedence over ISO 15004-1, if differences exist. 2 Normative references The following referenced d

23、ocuments 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 7944, Optics and optical instruments Reference wavelengths ISO 8429, Op

24、tics and optical instruments Ophthalmology Graduated dial scale 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 IEC 60601-1:2005, Medical

25、electrical equipment Part 1: General requirements for basic safety and essential performance 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 13666 as well as the following apply. 3.1 eye refractometer instrument with continuous or digital readout use

26、d for measuring the refractive errors of the eye 3.2 tolerance range of permissible difference between mean measured value and nominal value BS EN ISO 10342:2010ISO 10342:2010(E) 2 ISO 2010 All rights reserved4 Requirements 4.1 General The eye refractometer shall conform to the general requirements

27、specified in ISO 15004-1. 4.2 Optical requirements The eye refractometer shall conform to the requirements given in Table 1 or Table 2. The dioptric powers indicated in the requirements shall be referenced to the specific wavelengths used, = 546,07 nm or = 587,56 nm as required in ISO 7944. The indi

28、cation of the readings of cylinder power shall be possible in plus or minus cylinder convention. Table 1 Requirements for continuously indicating eye refractometers Criterion Measuring range Maximum scale interval Test deviceaTolerance 0 D, 5 D, 10 D 0,25 D Spherical vertex power 15 D to +15 D (maxi

29、mum meridional vertex power) 0,25 D 15 D 0,50 D Cylindrical vertex power 0 D to 6 D 0,25 D 0,25 D Cylinder axisbfor cylinder power 0 to 180 5 Sphere: approx. 0 D Cylinder: 3 D Axis: 0, 90 5 aThe refractive error of the test device shall not differ by more than 1,0 D from the nominal value above. b C

30、ylinder axis shall be indicated as specified in ISO 8429.Table 2 Requirements for digitally indicating eye refractometers Criterion Measuring range Maximum scale interval Test deviceaTolerance 0 D, 5 D, 10 D 0,25 D Spherical vertex power 15 D to +15 D (maximum meridional vertex power) 0,25 D 15 D 0,

31、50 D Cylindrical vertex power 0 D to 6 D 0,25 D 0,25 D Cylinder axisbfor cylinder power 0 to 180 1 Sphere: approx. 0 D Cylinder: 3 D Axis: 0, 90 5 a The refractive error of the test device shall not differ by more than 1,0 D from the nominal value above. bCylinder axis shall be indicated as specifie

32、d in ISO 8429.4.3 Measuring range The eye refractometer shall have a minimum measuring range for vertex power of 15 D to +15 D. Eye refractometers that indicate cylindrical power shall have a minimum measuring range for cylinder power of 0 D to 6 D. The eye refractometer shall have an axis direction

33、 range of 0 to 180. BS EN ISO 10342:2010ISO 10342:2010(E) ISO 2010 All rights reserved 34.4 Eyepiece (if applicable) The dioptric adjustment range of the operators eyepiece shall be a minimum of 4 D to +4 D. 5 Test methods 5.1 General All tests described in this International Standard are type tests

34、. Test results shall be evaluated according to the general rules of statistics. 5.2 Checking the vertex power The vertex power accuracy requirements as specified in Tables 1 and 2 shall be verified using the special test device specified in Annex A. Test measurements for spherical vertex power shall

35、 be made at least every 5 D over the claimed measuring range of the instrument, i.e. at 15 D, 10 D, 5 D, 0 D, +5 D, +10 D, +15 D. Test measurements for cylindrical vertex power shall be made at 3 D. 5.3 Checking the cylinder axis The astigmatic accuracy requirements, as specified in Tables 1 or 2, s

36、hall be verified using the special test device specified in Annex A. The orientation of the cylinder axis of the test device shall be known to within a tolerance of 1. Measurements shall be made in the two principal meridians. These two measurements shall give measurements for axis and power within

37、the tolerances given in Tables 1 and 2. 6 Accompanying documents The eye refractometer shall be accompanied by documents containing instructions for use and any necessary precautions. In particular, this information shall contain: a) name and address of the manufacturer; b) instructions for effectiv

38、e disinfection of the eye refractometer with particular reference to instruments returned to the manufacturer for repair and maintenance; c) if appropriate, a statement that the eye refractometer in its original packaging conforms to the transport conditions as specified in 5.3 of ISO 15004-1:2006;

39、d) any additional documents as specified in 7.9 of IEC 60601-1:2005; e) instructions for checking the calibration of the instrument. BS EN ISO 10342:2010ISO 10342:2010(E) 4 ISO 2010 All rights reserved7 Marking The eye refractometer shall be permanently marked with at least the following information

40、: a) name and address of manufacturer or supplier; b) name and model of eye refractometer; c) additional marking as required by IEC 60601-1; d) reference to this International Standard, i.e. ISO 10342:2010, if the manufacturer or supplier claims compliance with it; e) reference wavelength. BS EN ISO

41、 10342:2010ISO 10342:2010(E) ISO 2010 All rights reserved 5Annex A (normative) Test device for eye refractometers A.1 Design specifications The test device shall be made of optical glass, with the Abbe number, , in the range 58 to 60, as shown in Figure A.1. The spherical front surface shall be poli

42、shed to an optical finish and the plano back surface should be lightly frosted. All other surface shall be clear but may be roughly finished. For testing the spherical vertex power accuracy of the eye refractometer, the test device shall be used as shown in Figure A.1 a) or b). If the eye refractome

43、ter does not provide an artificial pupil, type a) with a pupil diameter between 3 mm and 4 mm should be used. For testing the cylinder axis and cylinder power accuracy, the device with front toric surface shall be used. If cylinder power/axis is tested by adding a cylindrical lens to the spherical t

44、est device, a thin rigid toric lens with an 8 mm base curve may be fixed on to the front surface of the device. The orientation of the cylinder axis shall be marked so that the device may be oriented in use. When the test device is modified in this fashion, it can only be used to measure the astigma

45、tic difference and the axis direction. The test device shall be placed in a suitable holder and attached to the eye refractometer so that its optical axis is parallel to that of the eye refractometer to a tolerance of 1. Dimensions in millimetres aPainted dark grey. NOTE The reflection rates of pain

46、ted fundus of model eye should be similar to that of the human fundus. Figure A.1 Test device A.2 Accuracy of refractive power The refractive power of the test devices used to verify the spherical vertex power of eye refractometers shall be known to 0,06 D. The wavelength used for the calculation an

47、d the vertex distance shall be specified. BS EN ISO 10342:2010ISO 10342:2010(E) 6 ISO 2010 All rights reservedCalculated nominal power value should be given to the second decimal place. A.3 Determination of refractive power When the test device is to be used to verify the accuracy of eye refractomet

48、ers that are of different types but have the same type of indication (digital or continuous), the refractive power value shall be determined by one of the following methods. a) Measure the refractive power using precision retinoscopy on an optical bench or a collimating telescope together with a ref

49、ractor head. When the refractive power of the test device is determined using this method, an aperture with a diameter of no more than 3 mm shall be placed coincident with the front surface to minimize the effects of spherical aberration. b) Measure the length, s, the radius of curvature of the front surface, r, and the index of refraction of the material, n, and calculate the refractive power using ray tracing in the following way. Find a point on the optical axis such that a