1、January 2010DEUTSCHE NORM English price group 11No 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!$t“1568156ww
2、w.din.deDDIN EN ISO 10940Ophthalmic instruments Fundus cameras (ISO 10940:2009)English version of DIN EN ISO 10940:2010-01Ophthalmische Instrumente Funduskameras (ISO 10940:2009)Englische Fassung DIN EN ISO 10940:2010-01SupersedesDIN EN ISO 10940:1998-06See start of validitywww.beuth.deDocument comp
3、rises pages19DIN EN ISO 10940:2010-01 Start of validity This standard takes effect on 1 January 2010. DIN EN ISO 10940:1998-06 may be used in parallel until 31 December 2011. National foreword This standard has been prepared by Technical Committee ISO/TC 172 “Optics and photonics”, Subcommittee SC 7
4、 “Ophthalmic optics and instruments” (Secretariat: DIN, Germany) in collaboration 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 Mechanic
5、s Standards Committee). The DIN Standards corresponding to the International Standards referred to in clause 2 of this document are as follows: ISO 15004-1 DIN EN ISO 15004-1 ISO 15004-2 DIN EN ISO 15004-2 IEC 60601-1 DIN EN 60601-1 In Germany, use of the symbol “dpt” for dioptre (expressed in m1; s
6、ee Table 1) 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 10940:1998-06 as follows: a) The scope has been extended: The standard now applies to all types of fundus cameras operating for observing
7、, photographing or recording electronic images. Instruments that contact the eye and those using scanning laser sources are not within the scope of this standard. b) The fundamental requirements for ophthalmic instruments have been revised on the basis of the amended ISO 15004:1998 (now: ISO 15004-1
8、). c) The requirements and test methods for fundus cameras have been revised on the basis of the amended ISO 15004:1998 (now: ISO 15004-2). Further, the information to be supplied by the manufacturer about potential optical radiation hazards associated with the use of the fundus camera has been modi
9、fied. d) The term “pixel pitch on the fundus” as well as the associated requirements and the test method have been included. e) The method used for the determination of the field of view has been rendered more precise. f) The method used for the determination of the resolving power has been rendered
10、 more precise. g) Additional requirements relating to the information to be supplied by the manufacturer of the fundus camera have been included. h) The revised version of the International Standard ISO 10940:2009 has been adopted. Previous editions DIN EN ISO 10940: 1998-06 2 DIN EN ISO 10940:2010-
11、01 National Annex NA (informative) Bibliography DIN EN ISO 15004-1, Ophthalmic instruments Fundamental requirements and test methods Part 1: General requirements applicable to all ophthalmic instruments DIN EN ISO 15004-2, Ophthalmic instruments Fundamental requirements and test methods Part 2: Ligh
12、t hazard protection DIN EN 60601-1, Medical electrical equipment Part 1: General requirements for basic safety and essential performance 3 DIN EN ISO 10940:2010-01 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 10940 August 2009 ICS 11.040.70 Supersedes E
13、N ISO 10940:1998English Version Ophthalmic instruments Fundus cameras (ISO 10940:2009) Instruments ophtalmiques Appareils photographiques du fond de loeil (ISO 10940:2009) Ophthalmische Instrumente Funduskameras (ISO 10940:2009) This European Standard was approved by CEN on 31 July 2009. CEN members
14、 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 references concerning such national standards may be obtained on application
15、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 translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the s
16、ame status as theofficial versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, R
17、omania, 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-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reserv
18、ed worldwide for CEN national Members. Ref. No. EN ISO 10940:2009: EContents Page Foreword. 3 1 Scope . 4 2 Normative references . 4 3 Terms and definitions. 4 4 Requirements 5 4.1 General. 5 4.2 Optical properties . 5 4.3 Construction and function. 6 4.4 Optical radiation hazard with fundus cameras
19、 6 5 Test methods for checking the optical properties 7 5.1 General. 7 5.2 Test target arrangement. 7 5.3 Checking the resolving power of the fundus camera optics . 8 5.4 Checking the angular field of view 8 5.5 Checking the magnification of the image. 8 5.6 Checking the pixel pitch of a sensor on t
20、he fundus . 9 6 Accompanying documents 9 7 Marking 9 Annex A (normative) Guidance for the measurement and calculation of the light hazard related values. 10 Annex B (informative) Guidance for safe use of the fundus camera 15 EN ISO 10940:2009 (E) DIN EN ISO 10940:2010-01 2Foreword This document (EN
21、ISO 10940:2009) 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, either by publication o
22、f an identical text or by endorsement, at the latest by February 2010, and conflicting national standards shall be withdrawn at the latest by December 2011. 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
23、not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 10940:1998. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulga
24、ria, 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. Endorsement notice The text
25、of ISO 10940:2009 has been approved by CEN as a EN ISO 10940:2009 without any modification. “”EN ISO 10940:2009 (E) DIN EN ISO 10940:2010-01 31 Scope This International Standard, together with ISO 15004-1 and ISO 15004-2, specifies requirements and test methods for fundus cameras operating for obser
26、ving, photographing or recording electronic images of the fundus of the human eye in order to provide the image information for diagnosis. This International Standard is not applicable to the following instruments: those that contact the eye during the examination; those using scanning laser sources
27、. This International Standard takes precedence over ISO 15004-1 and ISO 15004-2, if differences exist. 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 references, the l
28、atest edition of the referenced document (including any amendments) applies. ISO 15004-1, Ophthalmic instruments Fundamental requirements and test methods Part 1: General requirements applicable to all ophthalmic instruments ISO 15004-2:2007, Ophthalmic instruments Fundamental requirements and test
29、methods Part 2: Light hazard protection IEC 60601-1:2005, Medical electrical equipment Part 1: General requirements for basic safety and essential performance 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 resolving power of the fundus camer
30、a optics on the fundus minimum separation allowing recognition of two adjacent lines on the fundus, expressed as number of line pairs per millimetre (lp/mm) 3.2 angular field of view FOV maximum image size displayed on the image plane, expressed as the angle subtended at the exit pupil of the eye by
31、 the maximum dimension 2r See Figure 1. EN ISO 10940:2009 (E) DIN EN ISO 10940:2010-01 43.3 magnification of image ratio of the size of an object at the centre on the image plane to that of the fundus, assuming that the eye is emmetropic and that it has a focal length of 17 mm in air 3.4 pixel pitch
32、 on the fundus distance between two pixels (from centre to centre) of a digital image sensor theoretically projected on to the fundus, expressed in micrometres (m), assuming that the eye is emmetropic and that it has a focal length of 17 mm in air 3.5 high eye point eyepiece eyepiece in which the ex
33、it pupil is of sufficient clearance from the eyepiece to allow spectacles to be worn Key 1 angular field of view 2 entrance pupil of instrument/exit pupil of eye Figure 1 Meaning of dimension r for various formats 4 Requirements 4.1 General The fundus camera shall conform to the requirements specifi
34、ed in ISO 15004-1 and ISO 15004-2. 4.2 Optical properties The fundus camera shall conform to the requirements given in Table 1. When using near infrared light (NIR) for imaging (e.g. ICG application), the given limits for resolving power shall be reduced by a factor of 1,6. It is recommended that an
35、 oblique astigmatism compensator be provided for observation and recording images of the periphery of the retina when using a fundus camera with an optical angular field u 30. EN ISO 10940:2009 (E) DIN EN ISO 10940:2010-01 5Table 1 Requirements for optical properties Criterion Requirement centre W 8
36、0 lp/mm middle (r/2) W 60 lp/mm Field of view u 30 periphery (r) W 40 lp/mm centre W 60 lp/mm middle (r/2) W 40 lp/mm Resolvingapower on the fundus for fundus camera optics Field of view 30 periphery (r) W 25 lp/mm Tolerance of angular field of view 5 % Tolerance of magnification of imageb 7 % Toler
37、ance of pixel pitch on fundusc 7 % 5 D to + 5 D Range of dioptre adjustment of the optical finder (when an optical finder is attached) 4 D to + 4 D for high eye point eyepieces Range of focus adjustment for compensation of patients refractive error 15 D to + 15 D aTo achieve the resolving power acco
38、rding this table, optical means are recommended. In the case of recording images, it is necessary to choose an appropriate medium (film or digital sensor). bOnly for fundus cameras recording on film. cOnly for fundus cameras recording on a digital sensor. 4.3 Construction and function 4.3.1 General
39、The instrument shall be designed in such a way that neither reflection nor stray light degrades the image. 4.3.2 High eye point eyepiece If the manufacturer states that the eyepiece is a high eye point eyepiece, the clearance shall be W 17 mm, as measured from that part of the eyepiece nearest the e
40、xaminers eye to the exit pupil of the instrument. 4.4 Optical radiation hazard with fundus cameras This clause replaces 10.5, 10.6 and 10.7 of IEC 60601-1:2005. Fundus cameras shall comply with the light hazard protection requirements that are given in ISO 15004-2 in consideration of the following m
41、odality. (For guidance, see Annex A.) It shall first be determined if the fundus camera is classified as a group 1 or group 2 instrument in accordance with ISO 15004-2:2007, Clause 4. The applicable clauses of ISO 15004-2:2007 for fundus cameras are as follows. a) For group 1 fundus cameras: 1) appl
42、icable requirements of ISO 15004-2:2007 are 5.1, 5.2 and 5.4 (except 5.4.3). For cameras with multiple sources designed to direct optical radiation on to the same point(s) of the eye at the same time, the following shall apply: i) the optical radiation emissions shall be below all applicable limits
43、for each light source alone; ii) the resulting or combined radiation of the multiple sources shall be below all applicable limits of ISO 15004-2:2007, Table 2 or Table 3; EN ISO 10940:2009 (E) DIN EN ISO 10940:2010-01 62) applicable test methods are given in ISO 15004-2:2007, 6.1, 6.2 and 6.4. If st
44、atus is determined to be group 1, there are no further requirements. If status is determined not to be group 1, the additional requirements given in b) are applicable. b) For group 2 fundus cameras: 1) applicable requirements of ISO 15004-2:2007 are 5.1, 5.3, 5.5 (except 5.5.3). For cameras with mul
45、tiple sources designed to direct optical radiation on to the same point(s) of the eye at the same time the following shall apply: i) the optical radiation emissions shall be below all applicable limits for each light source alone; ii) the resulting or combined radiation of the multiple sources shall
46、 be below all applicable limits or guideline values of ISO 15004-2:2007, Tables 4, 5 and 6; iii) for intended consecutive and/or simultaneous use of pulsed and continuous light sources within an 8 h period, the sum of the ratios of the optical radiation emitted over the specified wavelength range ac
47、cording ISO 15004-2:2007, Tables 4, 5 and 6 to the applicable limit or guideline value shall be less than one. Only ratios of the same kind, i.e. related to the same hazard (e.g. photochemical, thermal or aphakic), shall be considered; 2) applicable test methods are given in ISO 15004-2:2007, 6.1, 6
48、.2, 6.3, 6.4 and 6.5; 3) ISO 15004-2:2007, Clause 7. If a fundus camera is capable of emitting more radiation in the visible or infrared wavelength range than specified for group 2 instruments, the manufacturer shall inform the user in the user manual about the potential hazard. See Annex B. 5 Test
49、methods for checking the optical properties 5.1 General All tests described in this International Standard are type tests. The requirements specified in 4.2 shall be verified by use of measuring devices, the measuring errors of which are less than 10 % of the smallest value to be determined. 5.2 Test target arrangement 5.2.1 Test target distance The resolving power, the angular field of view, the magnification of image and the pixel pitch shall be checked using a test target in front of the fundus camera. The test targ
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