DIN EN ISO 15254-2009 Ophthalmic optics and instruments - Electro-optical devices for enhancing low vision (ISO 15254 2009) English version of DIN EN ISO 15254 2009-10《眼科光学技术和仪器 提高.pdf

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1、October 2009DEUTSCHE NORM English price group 8No part of this standard 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 11.040.70; 11.180.30!$Z

2、B8“1553121www.din.deDDIN EN ISO 15254Ophthalmic optics and instruments Electro-optical devices for enhancing low vision (ISO 15254:2009)English version of DIN EN ISO 15254:2009-10Augenoptik und ophthalmische Instrumente Elektrooptische Sehhilfen fr Sehbehinderte (ISO 15254:2009)Englische Fassung DIN

3、 EN ISO 15254:2009-10SupersedesDIN EN ISO 15254:2003-01www.beuth.deDocument comprises 12 pagesDIN EN ISO 15254:2009-10 2 National foreword This standard has been prepared by Technical Committee ISO/TC 172 “Optics and photonics”, Subcommittee SC 7 “Ophthalmic optics and instruments” in collaboration

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

5、oup Ophthalmische Instrumente. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 12870 DIN EN ISO 12870 ISO 15004-1 DIN EN ISO 15004-1 IEC 60601-1-1 DIN EN 60601-1-1 IEC 61000-4-2 DIN EN 61000-4-2 IEC 61000-4-3 DIN EN 61000-4-3 Amendments

6、 This standard differs from DIN EN ISO 15254:2003-01 as follows: a) Normative references have been updated. b) The standard has been editorially revised. c) The revised International Standard ISO 15254:2009 has been adopted. Previous editions DIN EN ISO 15254: 2003-01 National Annex NA (informative)

7、 Bibliography DIN EN ISO 12870, Ophthalmic optics Spectacle frames Requirements and test methods DIN EN ISO 15004-1, Ophthalmic instruments Fundamental requirements and test methods Part 1: General requirements applicable to all ophthalmic instruments DIN EN ISO 15253, Ophthalmic optics and instrume

8、nts Optical devices for enhancing low-vision DIN EN 60601-1-1, Medical electrical equipment Part 1-1: General requirements for safety; Collateral standard: Safety requirements for medical electrical systems DIN EN 61000-4-2, Electromagnetic compatibility (EMC) Part 4-2: Testing and measurement techn

9、iques Electrostatic discharge immunity test DIN EN 61000-4-3, Electromagnetic compatibility (EMC) Part 4-3: Testing and measurement techniques Radiated, radio-frequency, electromagnetic field immunity test EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 15254 July 2009 ICS 11.040.70; 11.180

10、.30 Supersedes EN ISO 15254:2002English Version Ophthalmic optics and instruments - Electro-optical devices for enhancing low vision (ISO 15254:2009) Optique et instruments ophtalmiques - Dispositifs lectro-optiques pour malvoyants (ISO 15254:2009) Augenoptik und ophthalmische Instrumente - Elektroo

11、ptische Sehhilfen fr Sehbehinderte (ISO 15254:2009) This European Standard was approved by CEN on 27 June 2009. 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 alt

12、eration. 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 language made by tr

13、anslation 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, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Ger

14、many, 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 EUROPISCHES KOMITEE FR NORMUN

15、G Management Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 15254:2009: EContents Page Foreword .3 1 Scope4 2 Normative references4 3 Terms and definitions .4 4 Classification, de

16、signation and coding.5 5 Requirements.5 5.1 General .5 5.2 Image characteristics6 5.3 Materials and construction.6 5.4 Electrical requirements.7 6 Environmental conditions of use.7 7 Test methods .7 7.1 General .7 7.2 Spatial resolution test.7 7.3 Display magnification test8 7.4 Lateral variation of

17、 magnification8 8 Marking and instructions for use.8 8.1 Marking.8 8.2 Documentation 8 Annex A (informative) Mechanical design9 Bibliography10 2 DIN EN ISO 15254:2009-10 EN ISO 15254:2009 (E) Foreword secretariat of which is held by DIN. This European Standard shall be given the status of a national

18、 standard, either by publication of an identical text or by endorsement, at the latest by January 2010, and conflicting national standards shall be withdrawn at the latest by January 2010. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent r

19、ights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 15254:2002. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European S

20、tandard: Austria, Belgium, Bulgaria, 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 Kingd

21、om. Endorsement notice The text of ISO 15254:2009 has been approved by CEN as a EN ISO 15254:2009 without any modification. 3 EN ISO 15254:2009 (E) DIN EN ISO 15254:2009-10 optical instruments” in collaboration with Technical Committee CEN/TC 170 “Ophthalmic optics” the This document (EN ISO 15254:2

22、009) has been prepared by Technical Committee ISO/TC 172 “Optics and 1 Scope This International Standard applies to electro-optical devices specified by the manufacturer for use by visually impaired persons, as low-vision aids. It specifies electro-optical and mechanical requirements and test method

23、s. This International Standard does not cover optical devices for enhancing low vision which are specified in ISO 15253. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated

24、 references, the latest edition of the referenced document (including any amendments) applies. ISO 12870, Ophthalmic optics Spectacle frames Requirements and test methods ISO 15004-1, Ophthalmic instruments Fundamental requirements and test methods Part 1: General requirements applicable to all opht

25、halmic instruments IEC 60601-1-1, Medical electrical equipment Part 1-1: General requirements for safety Collateral standard: Safety requirements for medical electrical systems IEC 61000-4-2, Electromagnetic compatibility (EMC) Part 4-2: Testing and measuring techniques Electrostatic discharge immun

26、ity test IEC 61000-4-3, Electromagnetic compatibility (EMC) Part 4-3: Testing and measurement techniques Radiated, radio-frequency, electromagnetic field immunity test EN 55022, Information technology equipment Radio disturbance characteristics Limits and methods of measurement (IEC/CISPR 22:2005, m

27、odified + A1:2005) 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 electro-optical low-vision device system intended for low vision that produces an image by electronic means 3.2 display size horizontal and vertical dimensions of the display

28、within which the image is visible 4 DIN EN ISO 15254:2009-10 EN ISO 15254:2009 (E) 3.3 display magnification ratio between any linear dimension of the displayed image and the corresponding dimension of the object 3.4 spatial resolution smallest separation between two details in the object at which a

29、 pair of points may be recognized as being separate under a given set of conditions 3.5 object speed limit maximum object speed which produces no discernible reduction in resolution 3.6 luminance ratio ratio of the difference between the maximum and minimum luminance of the image to the minimum lumi

30、nance (Lmax Lmin)/Lmin3.7 object table device used to support and position the object being viewed 3.8 free working distance electro-optical low-vision device accessible distance separating the camera or other image acquisition system and the object plane at a stated magnification 3.9 reverse polari

31、ty system system that is capable of changing the polarity of the image from positive to negative or vice-versa 3.10 portable system system that can be transported in its own package 4 Classification, designation and coding Electro-optical low-vision devices are classified according to the following

32、usage: a) hand-held; b) tabletop; c) portable system; d) head-mounted. 5 Requirements 5.1 General Where a device is not designed as a complete system, the manufacturer shall state which displays are suitable to meet the requirements of this International Standard. The manufacturer shall also state t

33、he recommended display size for which the range of magnification applies. 5 EN ISO 15254:2009 (E) DIN EN ISO 15254:2009-10 5.2 Image characteristics 5.2.1 Spatial resolution When tested in accordance with 7.2, using the level of illumination provided with the device or recommended by the manufacture

34、r and with the device used as specified by the manufacturer, the system shall resolve a target consisting of line pairs measuring not more than 0,233 mm per pair (0,116 mm per element) within the central 70 % of the display size as declared by the manufacturer. The manufacturer shall state the magni

35、fication for which this level of spatial resolution is achieved. 5.2.2 Display magnification When tested in accordance with 7.3, the display magnification over the central 20 % of the display shall be within 10 % of the value declared by the manufacturer. 5.2.3 Lateral variation of magnification Whe

36、n tested in accordance with 7.4, the uniformity of the display magnification within the central 70 % of the linear dimensions of the display size as declared by the manufacturer shall be equal to the magnification at the centre of the display within 5 %. 5.2.4 Object speed limit The system shall mee

37、t the spatial resolution requirements at a relative speed, between camera and object, of not less than 20 mm/s, and at the declared minimum magnification of the system. 5.2.5 Display luminance The maximum display luminance shall be declared by the manufacturer when the contrast is set to the maximum

38、 specified by the manufacturer. 5.2.6 Luminance ratio The luminance ratio shall be not less than 75 at the maximum display luminance. 5.3 Materials and construction 5.3.1 Object support Objects having the dimensions of 300 mm 220 mm, shall be accommodated by the display at its maximum magnification

39、without changing the position of the object relative to its support. 5.3.2 Free working distance Where the system is designed to have an accessible free working distance above the reading table, it shall, with the system set at maximum display magnification, be at least 100 mm. 5.3.3 Materials Mater

40、ials used in the construction, when used as intended by the manufacturer, shall, when applicable, conform to ISO 15004-1 and ISO 12870. 6 DIN EN ISO 15254:2009-10 EN ISO 15254:2009 (E) 5.4 Electrical requirements 5.4.1 General The system shall meet the fundamental requirements and test methods speci

41、fied in ISO 15004-1. 5.4.2 Radio frequency interference The electro-optical device shall comply with EN 55022 relative to radio interference. 5.4.3 Electrostatic discharge The electro-optical device shall comply with IEC 61000-4-2 relative to electrostatic discharge. 5.4.4 Electromagnetic field The

42、electro-optical device shall comply with IEC 61000-4-3 relative to electromagnetic fields. 6 Environmental conditions of use The electro-optical low-vision device shall, when in use, meet the fundamental environmental requirements and test conditions of ISO 15004-1. 7 Test methods 7.1 General All th

43、e methods described are type tests. Equivalent alternative methods are acceptable, but it is the responsibility of the manufacturer/tester to demonstrate the equivalence of the methods used. 7.2 Spatial resolution test 7.2.1 Test principle The following test arrangement shall be used to test the res

44、olving power of electro-optical low-vision devices. An appropriate optotype or a Ronchi ruling or equivalent, oriented in the directions 90, 180, 45 and 135, is used (see Figure 1 for an example). The criterion for assessing the resolution is the successful recognition of the optotype or the various

45、 directions of the ruling. The extent of the linear field of view in which the optotype can be resolved is measured. The observer shall have a visual acuity of at least 1,0. 7.2.2 Test procedure The observer shall wear any necessary corrective lenses for the viewing distance to the display. To perfo

46、rm the test, place the target at the object position. The illumination of the target shall be as recommended by the manufacturer for normal use. After alignment of the optotype, carry out the test at the maximum, mean and minimum values of the system magnification as declared by the manufacturer. 7

47、EN ISO 15254:2009 (E) DIN EN ISO 15254:2009-10 Key b = 0,116 mm Figure 1 Example of optotype for the spatial resolution test 7.3 Display magnification test 7.3.1 Equipment Two identical measuring scales. 7.3.2 Procedure Place one scale on the reading table and set the system at the minimum magnifica

48、tion. Then measure a length on that scale of 100 mm or some suitable value on the display with the other scale. The length on the scale on the display shall be the highest available to obtain the greatest accuracy. Repeat the procedure with the system set at maximum magnification. 7.4 Lateral variat

49、ion of magnification When the method of 7.3.2 is repeated anywhere within the central 70 % of the display dimensions, the requirement of 5.2.3 shall be met. 8 Marking and instructions for use 8.1 Marking Each device shall be marked with at least the following: a) identity of device and manufacturer, with model and serial number; b) product classification according to Clause 4; c) additional markings as required by IEC 60601-1-1, if applicable; d) manufacturers stated range of magnification. 8.2 Documentation Each dev