1、April 2013 Translation by DIN-Sprachendienst.English price group 9No 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 1
2、1.040.70!$Tc“1994964www.din.deDDIN EN ISO 10341Ophthalmic instruments Refractor heads (ISO 10341:2012);English version EN ISO 10341:2012,English translation of DIN EN ISO 10341:2013-04Ophthalmische Instrumente Phoropter (ISO 10341:2012);Englische Fassung EN ISO 10341:2012,Englische bersetzung von DI
3、N EN ISO 10341:2013-04Instruments ophtalmiques Ttes de rfracteurs (ISO 10341:2012);Version anglaise EN ISO 10341:2012,Traduction anglaise de DIN EN ISO 10341:2013-04SupersedesDIN EN ISO 10341:2009-10www.beuth.deDocument comprises 13 pagesIn case of doubt, the German-language original shall be consid
4、ered authoritative.03.13 DIN EN ISO 10341:2013-04 2 National foreword This document (EN ISO 10341:2012) has been prepared by Technical Committee ISO/TC 172/SC 7 “Optics and photonics”, Subcommittee SC 7 “Ophthalmic optics and instruments” in collaboration with Technical Committee CEN/TC 170 “Ophthal
5、mic optics” (both secretariats are held by DIN, Germany). The responsible German 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 Ophthalmische Instrumente
6、. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 7944 DIN EN ISO 7944 ISO 8429 DIN EN ISO 8429 ISO 8598 DIN EN ISO 8598 ISO 13666 DIN EN ISO 13666 ISO 15004-1 DIN EN ISO 15004-1 IEC 60601-1 DIN EN 60601-1 (VDE 0750-1) In Germany, use o
7、f 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 countries. Amendments This standard differs from DIN EN ISO 10341:2009-10 as follows: a) the requirements specified in Tables, 2, 3 and 4 have been revised; b)
8、the text of the revised version ISO 10341:2012 has been adopted in its entirety. Previous editions DIN EN ISO 10341: 1999-07, 2009-10 National Annex NA (informative) Bibliography DIN EN 60601-1 (VDE 0750-1), Medical electrical equipment Part 1: General requirements for basic safety and essential per
9、formance DIN EN ISO 7944, Optics and optical instruments Reference 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 13666, Ophthalmic optics Spectacle lenses Vocabulary DIN EN ISO 1500
10、4-1, Ophthalmic instruments Fundamental requirements and test methods Part 1: General requirements applicable to all ophthalmic instruments A comma is used as the decimal marker. EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 10341 December 2012 ICS 11.040.70 Supersedes EN ISO 10341:2009 E
11、nglish Version Ophthalmic instruments Refractor heads (ISO 10341:2012) Instruments ophtalmiques Ttes de rfracteurs (ISO 10341:2012) Ophthalmische Instrumente Phoropter (ISO 10341:2012) This European Standard was approved by CEN on 14 January 2013. CEN members are bound to comply with the CEN/CENELEC
12、 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-CENELEC Management Centre or t
13、o 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-CENELEC Management Centre has the same status as the offici
14、al versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, N
15、orway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2012 CEN All rights of exploitation i
16、n any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 10341:2012: E Contents Page Foreword . 3 1 Scope 4 2 Normative references 4 3 Terms and definitions . 4 4 Requirements . 4 4.1 General . 4 4.2 Measuring ranges 4 4.3 Optical requirements . 5 4.4 Construction and
17、 function 7 5 Test methods . 7 5.1 General . 7 5.2 Checking optical requirements 7 5.3 Checking construction and function . 7 6 Information supplied by the manufacturer . 8 6.1 Accompanying documents. 8 6.2 Marking of the auxiliary wheel . 8 6.3 Identification of the refractor head 8 Annex A (inform
18、ative) Example of test device for checking accuracy of refractor head elements 9 A.1 Determination of spherical and cylindrical power . 9 A.2 Prism power and base setting10 Bibliography 11 2DIN EN ISO 10341:2013-04 EN ISO 10341:2012 (E) Foreword This document (EN ISO 10341:2012) has been prepared by
19、 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 identical text or by endorseme
20、nt, at the latest by June 2013, and conflicting national standards shall be withdrawn at the latest by June 2013. 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 responsible for identifying any
21、 or all such patent rights. This document supersedes EN ISO 10341:2009. According to the CEN/CENELEC Internal Regulations, the national standards organisations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denma
22、rk, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement not
23、ice The text of ISO 10341:2012 has been approved by CEN as a EN ISO 10341:2012 without any modification. 3DIN EN ISO 10341:2013-04 EN ISO 10341:2012 (E) 1 ScopeThis International Standard specifies requirements and test methods for refractor heads used for the determination of refractive errors and
24、binocular functions of the human eye.This International Standard takes priority over ISO 15004-1, if differences exist.2 Normative referencesThe following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated re
25、ferences, the latest edition of the referenced document (including any amendments) applies.ISO 7944, Optics and optical instruments Reference wavelengthsISO 8429, Optics and optical instruments Ophthalmology Graduated dial scaleISO 13666, Ophthalmic optics Spectacle lenses VocabularyISO 15004-1:2006
26、, Ophthalmic instruments Fundamental requirements and test methods Part 1: General requirements applicable to all ophthalmic instrumentsIEC 60601-1, Medical electrical equipment Part 1: General requirements for basic safety and essential performance3 Terms and definitionsFor the purposes of this doc
27、ument, the terms and definitions given in ISO 13666 and the following apply.3.1refractor headinstrument providing a means of positioning spherical and cylindrical lenses, prisms and other optical devices in front of a subjects eyes for the purpose of determining refractive error and binocular functi
28、ons3.2reference planeplane at which the readings and the power tolerances of the refractor head apply3.3reference distancedistance between the reference plane of the refractor head and the corneal vertex4 Requirements4.1 GeneralThe refractor head shall conform to the requirements specified in ISO 15
29、004-1.4.2 Measuring rangesThe requirements specified in Table 1 for refractor heads shall apply.4DIN EN ISO 10341:2013-04 EN ISO 10341:2012 (E) Table 1 Measuring ranges for refractor headsCriterion Minimum measuring ranges for each sideSpherical power 0 D to +15 D in steps of 0,25 D 0 D to 15 D in s
30、teps of 0,25 DAstigmatic power 0 D to 5 D in steps of 0,25 D in plus or minus cylinder formCylinder axis a0 to 180 indicated in 5 steps; in addition, readings or estimates to 1 shall be possiblePrismatic power b0 to 10 in steps of 1 , or continuouslyPrism base a0 to 360 indicated in 5 steps; in addi
31、tion, readings or estimates to 1 shall be possible. Indication of the prism base by horizontal and vertical components is allowed as an alternativeaCylinder axis and prism base settings shall be indicated according to ISO 8429.bThe combined prismatic powers of both sides shall be at least 30 .4.3 Op
32、tical requirementsThe requirements specified in Tables 2 to 7 shall apply. Powers shall be measured in the reference plane. Conformance shall be verified as described in 5.2.The dioptric powers indicated in Tables 2, 3 and 5 shall be referenced to the wavelength = 546,07 nm or alternatively = 587,56
33、 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 spherical power are given in Table 2.Table 2 Tolerances on spherical powerIndicated spherical power (absolute)Tolerance onmean power residual as
34、tigmatismSS122+DSS12 DD0,00 to 3,00 0,060,03 3,00 to 6,00 0,09 6,00 to 9,00 0,120,06 9,00 to 12,00 0,15 12,00 to 15,00 0,18 15,00 to 20,00 0,25 20,00 0,35NOTE S1and S2refer to the vertex powers in the principal meridians.The requirements for cylindrical power are given in Table 3.5DIN EN ISO 10341:2
35、013-04 EN ISO 10341:2012 (E) Table 3 Tolerances on cylindrical powerIndicated cylindrical power DTolerance D 0,50 0,06 0,50 to 1,00 0,09 1,00 to 3,00 0,12 3,00 to 6,00 0,18 6,00 0,25The requirements on centration of lens combinations are given in Table 4.Table 4 Tolerances of prismatic effect of sph
36、erical and cylindrical lenses relative to the centre point of the aperture in the combined optical mechanical system (not including crossed cylinders)Indicated power (absolute)DTolerance 0,00 0,12 0,00 to 6,00 0,25 6,00 to 12,00 0,37 12,00 0,62The requirements for rotary and fixed prisms are given i
37、n Table 5.Table 5 Tolerances on prismatic powerIndicated power Tolerance 5,00 0,25 5,00 5 %NOTE The indicated prismatic power refers to an incident ray parallel to the axis of the optical system.The requirements for axis and base direction are given in Table 6.Table 6 Tolerances on cylinder axis and
38、 prism base settingCriterion Indicated power (absolute)ToleranceCylinder axis a(excluding crossed cylinders) 0 D to 0,25 D 5 0,25 D to 1 D 3 1 D 2Prism base setting a 1 5 1 to 10 3 10 2NOTE Zero direction for cylinder axis and prism base is defined as the line connecting the aperture centres when th
39、e instrument is adjusted for zero height difference between both sides.aCylinder axis and prism base settings shall be indicated according to ISO 8429.The requirements for calibration accuracy are given in Table 7.6DIN EN ISO 10341:2013-04 EN ISO 10341:2012 (E) Table 7 Tolerances on reference and pu
40、pillary distance valuesCriterion Tolerance mmScale for reference distance 0,5Scale for pupillary distance 0,54.4 Construction and functionThese requirements shall be verified as described in 5.3.a) Minimum free aperture for all lenses within the refractor head shall be 16 mm; however, for prisms wit
41、h a power of 6 and more, the aperture may be reduced to a minimum of 11 mm.b) The manufacturer shall indicate the reference plane for the instrument and shall make provision for the measurement of the reference distance of each side.c) There shall be at least a device provided to allow for occlusion
42、 and dissociation. A Jackson crossed cylinder shall be installed on each side.d) The interpupillary distance shall be continuously adjustable in a minimum range from 50 mm to 75 mm.e) The adjustable range of the forehead rest shall be at least 10 mm.f) The instrument shall be designed and constructe
43、d to eliminate all detrimental internally reflected or stray light.g) The structures of the lens chamber shall not interfere with the visual function of the patient when viewing the target.h) The instrument shall be designed and constructed so that when the lenses and accessories are positioned in f
44、ront of the viewing aperture, they shall be positively aligned and centred.5 Test methods5.1 GeneralAll tests specified in this International Standard are type tests.5.2 Checking optical requirementsConformance to the requirements specified in 4.3 shall be tested by using a device that does not exce
45、ed 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. Measurement shall be made at the aperture centre, and referred to the reference plane.NOTE An example is given in Annex A.Test results
46、shall be evaluated according to the general rules of statistics.5.3 Checking construction and functionConformance to the requirements specified in 4.4 shall be checked by observation.7DIN EN ISO 10341:2013-04 EN ISO 10341:2012 (E) 6 Information supplied by the manufacturer6.1 Accompanying documentsT
47、he refractor head 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 effective disinfection of the refractor head with particular reference to instr
48、uments returned to the manufacturer for repair and maintenance;c) if appropriate, a statement that the refractor head 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 IEC 60601-1.6.2 Marking of the auxiliary wheelThe following letters or symbols shall be used, as appropriate:MR Maddox rodsSS or Stenopaic slitPH or PinholeBL or Occlu
