1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 10341:2012Ophthalmic instruments Refractor headsBS EN ISO 10341:2012 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 10341:201
2、2. It supersedes BS EN ISO 10341:2009 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/172/6, Ophthalmic instruments.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport t
3、o include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2013. Published by BSI Standards Limited 2013ISBN 978 0 580 78872 7 ICS 11.040.70 Compliance with a British Standard cannot confer immunity from legal obligation
4、s.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 January 2013.Amendments issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 10341 December 2012 ICS 11.040.70 Supersedes EN ISO 1034
5、1:2009English 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
6、 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-CENELEC Management
7、 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-CENELEC Management Centre has the same status a
8、s the official 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, Ne
9、therlands, Norway, 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 ex
10、ploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 10341:2012: EBS EN ISO 10341:2012BS EN ISO 10341:2012EN ISO 10341:2012 (E) 3 Foreword This document (EN ISO 10341:2012) has been prepared by Technical Committee ISO/TC 172 “Optics andphotonics“ in co
11、llaboration with Technical Committee CEN/TC 170 “Ophthalmic optics” the secretariat of whichis held by DIN. This European Standard shall be given the status of a national standard, either by publication of an identicaltext or by endorsement, at the latest by June 2013, and conflicting national stand
12、ards shall be withdrawn atthe latest by June 2013. Attention is drawn to the possibility that some of the elements of this document may be the subject of patentrights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 1034
13、1:2009. According to the CEN/CENELEC Internal Regulations, the national standards organisations of the followingcountries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, CzechRepublic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, Franc
14、e, 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 notice The text of ISO 10341:2012 has been approved by CEN as a EN ISO
15、10341:2012 without any modification. BS EN ISO 10341:2012 ISO 10341:2012(E)ForewordISO (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 te
16、chnical committees. Each member body interested 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 close
17、ly with the International Electrotechnical Commission (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 I
18、nternational Standards adopted by the technical 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
19、may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights.ISO 10341 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
20、 edition (ISO 10341:2009), of which Tables 2, 3 and 4 have been technically revised. ISO 2012 All rights reserved iiiBS EN ISO 10341:2012BS EN ISO 10341:2012Ophthalmic instruments Refractor heads1 ScopeThis International Standard specifies requirements and test methods for refractor heads used for t
21、he determination of refractive errors and 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
22、 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 wavelengthsISO 8429, Optics and optical instruments Ophthalmology Graduated dial scaleISO 13666, Ophthalmic optics S
23、pectacle lenses VocabularyISO 15004-1:2006, 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 a
24、nd definitionsFor the purposes of this document, 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 determi
25、ning refractive error and binocular functions3.2reference 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 confo
26、rm to the requirements specified in ISO 15004-1.4.2 Measuring rangesThe requirements specified in Table 1 for refractor heads shall apply.INTERNATIONAL STANDARD ISO 10341:2012(E) ISO 2012 All rights reserved 1BS EN ISO 10341:2012ISO 10341:2012(E)Table 1 Measuring ranges for refractor headsCriterion
27、Minimum measuring ranges for each sideSpherical power 0 D to +15 D in steps of 0,25 D 0 D to 15 D in steps 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 possiblePris
28、matic power b0 to 10 in steps of 1 , or continuouslyPrism base a0 to 360 indicated in 5 steps; in addition, 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 ind
29、icated according to ISO 8429.bThe combined prismatic powers of both sides shall be at least 30 .4.3 Optical 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 indi
30、cated in Tables 2, 3 and 5 shall be referenced 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 spherical power are given in Table 2.Table
31、 2 Tolerances on spherical powerIndicated spherical power (absolute)Tolerance onmean power residual astigmatismSS122+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 t
32、he principal meridians.The requirements for cylindrical power are given in Table 3.2 ISO 2012 All rights reservedBS EN ISO 10341:2012ISO 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
33、,25The requirements on centration of lens combinations are given in Table 4.Table 4 Tolerances of prismatic effect of spherical and cylindrical lenses relative to the centre point of the aperture in the combined optical mechanical system (not including crossed cylinders)Indicated power (absolute)DTo
34、lerance 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 in 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
35、 optical system.The requirements for axis and base direction are given in Table 6.Table 6 Tolerances on cylinder axis and 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
36、3 10 2NOTE Zero direction for cylinder axis and prism base is defined as the line connecting the aperture centres when the 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 calibra
37、tion accuracy are given in Table 7. ISO 2012 All rights reserved 3BS EN ISO 10341:2012ISO 10341:2012(E)Table 7 Tolerances on reference and pupillary distance valuesCriterion Tolerance mmScale for reference distance 0,5Scale for pupillary distance 0,54.4 Construction and functionThese requirements sh
38、all 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 with 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
39、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 and dissociation. A Jackson crossed cylinder shall be installed on each side.d) The interpupillary distance shall be continuously adjustable in a minimum rang
40、e 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 constructed 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 pa
41、tient when viewing the target.h) The instrument shall be designed and constructed so that when the lenses and accessories are positioned in front of the viewing aperture, they shall be positively aligned and centred.5 Test methods5.1 GeneralAll tests specified in this International Standard are type
42、 tests.5.2 Checking optical requirementsConformance to the requirements specified in 4.3 shall be tested by using a device that 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 set
43、ting. Measurement shall be made at the aperture centre, and referred to the reference plane.NOTE An example is given in Annex A.Test results 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
44、 checked by observation.4 ISO 2012 All rights reservedBS EN ISO 10341:2012ISO 10341:2012(E)6 Information supplied by the manufacturer6.1 Accompanying documentsThe refractor head shall be accompanied by documents containing instructions for use and any necessary precautions. In particular, this infor
45、mation shall contain:a) name and address of the manufacturer;b) instructions for effective disinfection of the refractor head with particular reference to instruments returned to the manufacturer for repair and maintenance;c) if appropriate, a statement that the refractor head in its original packag
46、ing 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 OccluderFL Fr
47、osted lensCL or Cross lineRF Red filterGF Green filterPF Polarization filterOA Open apertureRL Retinoscopic lens6.3 Identification of the refractor headThe refractor head shall be permanently marked with at least the following information:a) name and address of manufacturer or supplier;b) name, mode
48、l and serial number of instrument;c) if appropriate, reference wavelength used;d) additional markings as required by IEC 60601-1;e) a reference to this International Standard, i.e. ISO 10341:2012, if the manufacturer or supplier claims compliance with it. ISO 2012 All rights reserved 5BS EN ISO 1034
49、1:2012ISO 10341:2012(E)Annex A (informative) Example of test device for checking accuracy of refractor head elementsA.1 Determination of spherical and cylindrical powerFor testing and determining the tolerances of spherical and cylindrical elements of the refractor head, 5.2 states that the uncertainty of the testing device is not to exceed 20 % of the given tolerance of the optical elements. A simplified design of a device for testing these elements is shown in Figu
