DIN EN ISO 10343-2014 Ophthalmic instruments - Ophthalmometers (ISO 10343 2014) German version EN ISO 10343 2014《眼科器械 折射头(ISO 10343 2014) 德文版本EN ISO 10343 2014》.pdf

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1、October 2014Translation 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

2、11.040.70!%;w%“2248402www.din.deDDIN EN ISO 10343Ophthalmic instruments Ophthalmometers (ISO 10343:2014);English version EN ISO 10343:2014,English translation of DIN EN ISO 10343:2014-10Ophthalmische Instrumente Ophthalmometer (ISO 10343:2014);Englische Fassung EN ISO 10343:2014,Englische bersetzung

3、 von DIN EN ISO 10343:2014-10Instruments ophtalmiques Ophtalmomtres (ISO 10343:2014);Version anglaise EN ISO 10343:2014,Traduction anglaise de DIN EN ISO 10343:2014-10SupersedesDIN EN ISO 10343:2009-10www.beuth.deIn case of doubt, the German-language original shall be considered authoritative.Docume

4、nt comprises 14 pages09.14 DIN EN ISO 10343:2014-10 2 A comma is used as the decimal marker. National foreword This document (EN ISO 10343:2014) has been prepared by Technical Committee ISO/TC 172 “Optics and photonics”, Subcommittee SC 7 “Ophthalmic optics and instruments” in collaboration with Tec

5、hnical Commit-tee CEN/TC 170 “Ophthalmic optics” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the DIN-Normenausschuss Feinmechanik und Optik (DIN Standards Committee Optics and Precision Mechanics), Working Committee NA 027-01-08 AA Augenoptik, Working Gro

6、up Ophthalmische Instrumente. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 8429 DIN EN ISO 8429 ISO 15004-1 DIN EN ISO 15004-1 ISO 18369-3 DIN EN ISO 18369-3 ISO 19980 DIN EN ISO 19980 IEC 60601-1 DIN EN 60601-1 (VDE 0750-1) In Germa

7、ny, use of 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 10343:2009-10 as follows: a) the ophthalmometers are divided into two types, “Type A” and “

8、Type B”: Type B ophthalmometers are those having a resolution and measuring range (as in Table 1) that allow the measurement of the radius of curvature and curvature of human corneas only. Type A ophthalmometers are those having a resolution and measuring range (as in Table 2) that allow the measure

9、ment of the radius of curvature and curvature not only of human corneas, but of contact lenses as well; b) requirements are not only expressed in radii of curvature, in mm (as previously), but also (new) as curvatures, in keratometric dioptres (KD); c) the revised text of the International Standard

10、has been adopted in its entirety. Previous editions DIN EN ISO 10343: 1999-07, 2009-10 DIN EN ISO 10343:2014-10 3 National Annex NA (informative) Bibliography DIN EN 60601-1 (VDE 0750-1), Medical electrical equipment Part 1: General requirements for basic safety and essential performance DIN EN ISO

11、8429, Optics and optical instruments Ophthalmology Graduated dial scale DIN EN ISO 15004-1, Ophthalmic instruments Fundamental requirements and test methods Part 1: General requirements applicable to all ophthalmic instruments DIN EN ISO 18369-3, Ophthalmic optics Contact lenses Part 3: Measurement

12、methods DIN EN ISO 19980, Ophthalmic instruments Corneal topographers DIN EN ISO 10343:2014-10 4 This page is intentionally blank EN ISO 10343 July 2014 ICS 11.040.70 Supersedes EN ISO 10343:2009English Version Ophthalmic instruments - Ophthalmometers (ISO 10343:2014) Instruments ophtalmiques - Opht

13、almomtres(ISO 10343:2014)Ophthalmische Instrumente - Ophthalmometer(ISO 10343:2014)This European Standard was approved by CEN on 24 April 2014. 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 n

14、ational 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 to any CEN member. This European Standard exists in three official versions (English, French, German). A

15、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 official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cypru

16、s, Czech Republic, Denmark, 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 United King

17、dom. CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2014 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 10343:2014 EEUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR N

18、ORMUNGEUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORM2DIN EN ISO 10343:2014-10 EN ISO 10343:2014 (E) Contents Page Foreword 3 1 Scope 4 2 Normative references .4 3 Terms and definitions 4 4 Requirements .5 4.1 General 5 4.2 Radius of curvature measurements 5 4.3 Measurement of direction of principal

19、 meridians 6 4.4 Eyepiece adjustment (if applicable) 6 5 Test methods 6 5.1 General 6 5.2 Checking optical requirements .6 6 Accompanying documents 7 7 Marking, labelling and packaging7 Annex A (informative) Test devices and test configuration for checking meridional axesand ophthalmometer position

20、8 Bibliography 10 Foreword This document (EN ISO 10343:2014) 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 o

21、f a national standard, either by publication of an identical text or by endorsement, at the latest by January 2015, and conflicting national standards shall be withdrawn at the latest by January 2015. Attention is drawn to the possibility that some of the elements of this document may be the subject

22、 of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 10343:2009. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement thi

23、s European Standard: 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, Norway, Poland, Portugal, Romania, Slovaki

24、a, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement noticeThe text of ISO 10343:2014 has been approved by CEN as EN ISO 10343:2014 without any modification. 3DIN EN ISO 10343:2014-10EN ISO 10343:2014 (E)1 ScopeThis International Standard, together with ISO 15004-1, sp

25、ecifies requirements and test methods for continuously or digitally indicating ophthalmometers. Certain types of ophthalmometer have sufficient resolution and range (see Table 2) to adequately measure the radii of curvature of contact lenses complying with ISO 18369-3:2006, 4.1.3, and Clause 5. It i

26、s assumed that the local corneal front surface and both contact lens surfaces are spherical or toroidal.This International Standard takes priority over ISO 15004-1, if differences exist.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document an

27、d are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 8429, Optics and optical instruments Ophthalmology Graduated dial scaleISO 15004-1:2006, Ophthal

28、mic 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 document, th

29、e following terms and definitions apply.3.1ophthalmometerinstrument designed to measure and indicate the radii of curvature and principal meridians of the human corneas central area and of contact lenses3.2distance-dependent ophthalmometerophthalmometer in which the result of measurement is influenc

30、ed by the distance between the instrument and the surface to be measured3.3toroidal surfacesurface having two orthogonal, circular “principal meridians”, one maximum and one minimum, and generated by a circular arc rotating about an axis which is in the same plane as the arc but which does not pass

31、through its centre of curvature3.4principal curvature directiondirection in which the radius of curvature of the reflecting surface to be measured is at its minimum or maximum4DIN EN ISO 10343:2014-10 EN ISO 10343:2014 (E) 3.5keratometric constantconversion value equal to 337,5 used to convert corne

32、al curvature from inverse millimetres (mm1) to keratometric dioptresSOURCE: ISO 19980:2012, 3.113.6keratometric dioptresKDvalue of curvature, expressed in inverse millimetres (mm1), multiplied by the keratometric constant 337,5SOURCE: ISO 19980:2012, 3.124 Requirements4.1 GeneralThe ophthalmometer s

33、hall conform to the requirements specified in ISO 15004-1.4.2 Radius of curvature measurementsThe ophthalmometer shall conform to requirements given in Table 1 or Table 2. Conformity shall be verified as described in 5.2. If the instrument conforms to the requirement of Table 1 it is a “Type B” opht

34、halmometer. If the instrument conforms to the requirements of Table 2 it is a “Type A” ophthalmometer. Type A and Type B ophthalmometers have sufficient resolution and range to adequately measure human corneas. Type A ophthalmometers have sufficient resolution and range (see Table 2) to adequately m

35、easure the radii of curvature of contact lenses complying with ISO 18369-3:2006, 4.1.3, and Clause 5. It is assumed that the local corneal front surface and both contact lens surfaces are spherical or toroidal.Table 1 Requirements for measurement of radius of curvature and curvature for Type B ophth

36、almometers (applicable to human corneas only)Criterion RequirementMeasuring range 6,5 mm to 9,4 mm (52,0 KD to 36,0 KD)Indications given in terms of radii of curvaturecontinuously indicating instrumentsscale interval of 0,1 mm (0,25 KD)digitally indicating instru-mentsincrement 0,02 mm (0,125 KD)Mea

37、surement accuracy (twice the standard deviation, i.e. 2)0,05 mm5DIN EN ISO 10343:2014-10EN ISO 10343:2014 (E)Table 2 Requirements for measurement of radius of curvature and curvature for Type A ophthalmometers (applicable to contact lenses and human corneas)Criterion RequirementMeasuring range 6,5 m

38、m to 9,4 mm (52,0 KD to 36,0 KD)Indications given in terms of radii of curvaturecontinuously indicating instrumentsscale interval of 0,02 mm (0,125 KD)digitally indicating instru-mentsincrement 0,02 mm (0,125 KD)Measurement accuracy (twice the standard deviation, i.e. 2)0,025 mm4.3 Measurement of di

39、rection of principal meridiansThe ophthalmometer shall conform to requirements given in Table 3. Conformity shall be verified as described in 5.2.Table 3 Requirements for measurement of direction of principal meridiansCriterion RequirementMeasuring range 0 to 180Meridian direction read-ingcontinuous

40、ly indicating scales scale interval 5digitally indicating scales increment 1Measurement accuracy using test device (twice the standard deviation, i.e. 2)for principal meridional dif-ferences in radii of curva-ture 0,3 mm4for principal meridional dif-ferences in radii of curva-ture 0,3 mm2Angular ind

41、ications shall be in accordance with ISO 8429.4.4 Eyepiece adjustment (if applicable)The dioptric adjustment range for distance-dependent instruments shall be a minimum of 4 D to +4 D, for which the scale from 3 D to +2 D shall be calibrated.5 Test methods5.1 GeneralAll tests described in this Inter

42、national Standard are type tests.5.2 Checking optical requirementsConformity to the requirements specified in 4.2 and 4.3 shall be verified by use of measuring devices the measuring error of which is less than 10 % of the smallest value to be determined.Test results shall be evaluated according to t

43、he general rules of statistics.6DIN EN ISO 10343:2014-10 EN ISO 10343:2014 (E) Conformity to the requirements of 4.2 shall be verified using three spherical test surfaces, one chosen from each of three radii ranges: 6,8 mm, 7,5 mm to 8,1 mm and 9,1 mm. These test surfaces shall have the following pr

44、operties:a) uncertainty of sphere radius of curvature 1 m;b) local departure from sphericity 0,5 m;c) surface roughness 0,05 m;d) diameter of effective surface 6 mm.Conformity to the requirements of 4.3 shall be verified with two test devices as described in Table 4. To fulfil the requirements of 4.

45、3, each test device shall be used to measure in four different orientations, namely 0, 45, 90 and 135. The orientation of the test devices shall be referenced to a local horizontal as established by a spirit level. One example of this test device is described in Annex A.Table 4 Parameters for test d

46、eviceType Maximum principal radius of curvatureDifference between principal radiiPrecision with which principal meridional axis is known1 8,0 mm 0,2 mm 0,2 mm 0,07 mm 12 8,0 mm 0,2 mm 0,4 mm 0,07 mm 0,56 Accompanying documentsThe ophthalmometer shall be accompanied by documents containing instructio

47、ns for use and any necessary precautions. In particular, these documents shall contain the following information:a) name and address of the manufacturer;b) instructions as to effective disinfection of the ophthalmometer with particular reference to instruments returned to the manufacturer for repair

48、 and maintenance;c) if appropriate, a statement that the ophthalmometer in its original packaging conforms to the transport conditions as specified in ISO 15004-1:2006, 5.3;d) any additional documents as specified in IEC 60601-1.7 Marking, labelling and packagingThe ophthalmometer shall be permanent

49、ly marked with at least the following information:a) name and address of manufacturer or supplier;b) name, model, serial number and type according to 4.2;c) additional marking as required by IEC 60601-1;d) a reference to this International Standard, i.e. ISO 10343:2014, if the manufacturer or supplier claims compliance with it.7DIN EN ISO 10343:2014-10EN ISO 10343:2014 (E)Annex A (informative) Test devices and t