DIN EN ISO 10342-2010 Ophthalmic instruments - Eye refractometers (ISO 10342 2010) German version EN ISO 10342 2010《眼科仪器 眼睛折射计(ISO 10342-2010) 德文版本EN ISO 10342-2010》.pdf

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1、November 2010 Translation by DIN-Sprachendienst.English price group 8No 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).IC

2、S 11.040.70!$l1“1731495www.din.deDDIN EN ISO 10342Ophthalmic instruments Eye refractometers (ISO 10342:2010)English translation of DIN EN ISO 10342:2010-11Ophthalmische Instrumente Augenrefraktometer (ISO 10342:2010)Englische bersetzung von DIN EN ISO 10342:2010-11Instruments ophtalmiques Rfractomtr

3、es (ISO 10342:2010)Traduction anglaise de DIN EN ISO 10342:2010-11SupersedesDIN EN ISO 10342:2003-12www.beuth.deDocument comprises pagesIn case of doubt, the German-language original shall be considered authoritative.1311.10 DIN EN ISO 10342:2010-11 2 A comma is used as the decimal marker. National

4、foreword 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 G

5、erman 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 S

6、tandards referred to in Clause 2 of this document are as follows: ISO 7944 DIN EN ISO 7944 ISO 8429 DIN EN ISO 8429 ISO 13666 DIN EN ISO 13666 ISO 15004-1 DIN EN ISO 15004-1 IEC 60601-1 DIN EN 60601-1 In Germany, use of the symbol “dpt” for dioptre (expressed in m1) is legally required and this symb

7、ol is to be used rather than the symbol D used in other countries. Amendments This standard differs from DIN EN ISO 10342:2003-12 as follows: a) Clause 1 “Scope” has been rendered more precise: the standard is limited to the measurement of spherocylindrical refractive error; b) Clause 6 “Accompanyin

8、g documents” now includes a new item “e) instructions for checking the calibration of the instrument”; c) normative references have been updated; d) the revised International Standard ISO 10342:2010 has been adopted. Previous editions DIN EN ISO 10342: 1999-07, 2003-12 DIN EN ISO 10342:2010-11 3 Nat

9、ional Annex NA (informative) Bibliography DIN EN 60601-1, Medical electrical equipment Part 1: General requirements for basic safety and essential performance DIN EN ISO 7944, Optics and optical instruments Reference wavelengths DIN EN ISO 8429, Optics and optical instruments Ophthalmology Graduated

10、 dial scale DIN EN ISO 13666, Ophthalmic optics Spectacle lenses Vocabulary DIN EN ISO 15004-1, Ophthalmic instruments Fundamental requirements and test methods Part 1: General requirements applicable to all ophthalmic instruments DIN EN ISO 10342:2010-11 4 This page is intentionally blank EUROPEAN

11、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 10342:2010) Ophthalmische Instrumente - Augenrefraktometer (ISO 10342:20

12、10) 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 standard without any alteration. Up-to-date lists and bibliographical ref

13、erences 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 language made by translation under the responsibility of a CEN membe

14、r 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, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland,

15、 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 EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B

16、-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: EContents DIN EN ISO 10342:2010-11 EN ISO 10342:2010 (E) 2 Page Foreword3 1 Scope 4 2 Normative references 4 3 Terms and definitions .4 4 Requireme

17、nts.5 4.1 General5 4.2 Optical requirements.5 4.3 Measuring range 5 4.4 Eyepiece (if applicable).6 5 Test methods6 5.1 General6 5.2 Checking the vertex power .6 5.3 Checking the cylinder axis .6 6 Accompanying documents.6 7 Marking .7 Annex A (normative) Test device for eye refractometers .8 Forewor

18、d This document (EN ISO 10342:2010) 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, eit

19、her by publication of an identical 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 a

20、nd/or CENELEC shall not be 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: Aus

21、tria, Belgium, Bulgaria, Croatia, 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.

22、 Endorsement notice The text of ISO 10342:2010 has been approved by CEN as a EN ISO 10342:2010 without any modification. “ DIN EN ISO 10342:2010-11 EN ISO 10342:2010 (E) 3 1 Scope This International Standard, together with ISO 15004-1, specifies requirements and test methods for eye refractometers u

23、sing 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 documents are indispensable for the application of this

24、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, Optics and optical instruments Ophthalmology Graduated di

25、al 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 electrical equipment Part 1: General requirements for b

26、asic 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 used for measuring the refractive errors of the eye 3.2 to

27、lerance range of permissible difference between mean measured value and nominal value DIN EN ISO 10342:2010-11 EN ISO 10342:2010 (E) 4 4 Requirements 4.1 General The eye refractometer shall conform to the general requirements specified in ISO 15004-1. 4.2 Optical requirements The eye refractometer s

28、hall 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 indication of the readings of cylinder power shall be possible in plus or minu

29、s 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 (maximum meridional vertex power) 0,25 D 15 D 0,50 D Cylindrical vertex power 0

30、 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 Cylinder axis shall be indicated as specified in ISO 8429.Table 2 Requireme

31、nts 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 0,50 D Cylindrical vertex power 0 D to 6 D 0,25 D 0,25 D Cylinder axisbfor c

32、ylinder 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 specified in ISO 8429.4.3 Measuring range The eye refractometer shall have a minim

33、um 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 range of 0 to 180. DIN EN ISO 10342:2010-11 EN ISO 10342:2010 (E) 5 4.4 E

34、yepiece (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. Test results shall be evaluated according to the general rules of statistics. 5.2 Checking

35、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 be made at least every 5 D over the claimed measuring range of the instrument, i.e. at 15 D,

36、 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, shall be verified using the special test device specified in Annex A. The orientation of the c

37、ylinder 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 the tolerances given in Tables 1 and 2. 6 Accompanying documents The eye refractometer shall

38、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 effective disinfection of the eye refractometer with particular reference to instruments returned to

39、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; d) any additional documents as specified in 7.9 of IEC 60601-1:2005; e) instructions for chec

40、king the calibration of the instrument. DIN EN ISO 10342:2010-11 EN ISO 10342:2010 (E) 6 7 Marking The eye refractometer shall be permanently marked with at least the following information: a) name and address of manufacturer or supplier; b) name and model of eye refractometer; c) additional marking

41、 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. DIN EN ISO 10342:2010-11 EN ISO 10342:2010 (E) 7 Annex A (normative) Test device for eye refractometers A.1 Design specif

42、ications 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 polished to an optical finish and the plano back surface should be lightly frosted. All other surface shall be clear but may be roughly

43、 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 refractometer does not provide an artificial pupil, type a) with a pupil diameter between 3 mm and 4 mm should be used. For testing the cylin

44、der 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 test 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

45、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 astigmatic difference and the axis direction. The test device shall be placed in a suitable holder and attached to the eye refractometer s

46、o 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 painted 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

47、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 and the vertex distance shall be specified. DIN EN ISO 10342:2010-11 EN ISO 10342:2010 (E) 8 Calculated nominal power value should be

48、 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 refractometers 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

49、 the following methods. a) Measure the refractive power using precision retinoscopy on an optical bench or a collimating telescope together with a refractor 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 refra