BS EN ISO 10940-2009 Ophthalmic instruments - Fundus cameras《眼科仪器 眼底检查镜》.pdf

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1、BS EN ISO10940:2009ICS 11.040.70NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDOphthalmicinstruments Fundus cameras (ISO10940:2009)This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 August 2009 BSI 2009I

2、SBN 978 0 580 55759 0Amendments/corrigenda issued since publicationDate CommentsBS EN ISO 10940:2009National forewordThis British Standard is the UK implementation of EN ISO 10940:2009.It is identical to ISO 10940:2009. It supersedes BS EN ISO 10940:1998 which is withdrawn.The UK participation in it

3、s preparation was entrusted to TechnicalCommittee CH/172/6, Ophthalmic instruments.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisionsof a contract. Users are responsible for its co

4、rrect application. Compliance with a British Standard cannot confer immunityfrom legal obligations.EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 10940August 2009ICS 11.040.70 Supersedes EN ISO 10940:1998 English VersionOphthalmic instruments - Fundus cameras (ISO 10940:2009)Instruments ophta

5、lmiques - Appareils photographiques dufond de loeil (ISO 10940:2009)Ophthalmische Instrumente - Funduskameras (ISO10940:2009)This European Standard was approved by CEN on 31 July 2009.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving

6、this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the CEN Management Centre or to any CEN member.This European Standard exists in three official versions

7、(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 same status as theofficial versions.CEN members are the national standards bodies of Austria, Belgium, Bulgar

8、ia, 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 United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATI

9、ONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 10940:2009: EBS EN ISO 10940:2009EN ISO 10940:2009 (E) 3 Fore

10、word This document (EN 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

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

12、CEN and/or CENELEC shall 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

13、: 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 Kingdom. End

14、orsement notice The text of ISO 10940:2009 has been approved by CEN as a EN ISO 10940:2009 without any modification. BS EN ISO 10940:2009ISO 10940:2009(E) ISO 2009 All rights reserved iiiContents Page Foreword iv 1 Scope . 1 2 Normative references . 1 3 Terms and definitions. 1 4 Requirements 2 4.1

15、General. 2 4.2 Optical properties . 2 4.3 Construction and function. 3 4.4 Optical radiation hazard with fundus cameras 3 5 Test methods for checking the optical properties 4 5.1 General. 4 5.2 Test target arrangement. 4 5.3 Checking the resolving power of the fundus camera optics . 5 5.4 Checking t

16、he angular field of view 5 5.5 Checking the magnification of the image. 5 5.6 Checking the pixel pitch of a sensor on the fundus . 6 6 Accompanying documents 6 7 Marking 6 Annex A (normative) Guidance for the measurement and calculation of the light hazard related values. 7 Annex B (informative) Gui

17、dance for safe use of the fundus camera 12 BS EN ISO 10940:2009ISO 10940:2009(E) iv ISO 2009 All rights reservedForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards

18、is normally carried out through ISO technical 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 pa

19、rt in the work. ISO collaborates closely 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

20、prepare International Standards. Draft International 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 th

21、at some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 10940 was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 7, Ophthalmic optics and instruments. This se

22、cond edition cancels and replaces the first edition (ISO 10940:1998) which has been technically revised. BS EN ISO 10940:2009INTERNATIONAL STANDARD ISO 10940:2009(E) ISO 2009 All rights reserved 1Ophthalmic instruments Fundus cameras 1 Scope This International Standard, together with ISO 15004-1 and

23、 ISO 15004-2, specifies requirements and test methods for fundus cameras operating for observing, 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 instru

24、ments: those that contact the eye during the examination; those using scanning laser sources. 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 d

25、ocument. For dated references, only the edition cited applies. For undated references, the latest 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 ophtha

26、lmic instruments ISO 15004-2:2007, Ophthalmic instruments Fundamental requirements and test 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

27、document, the following terms and definitions apply. 3.1 resolving power of the fundus camera 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 di

28、splayed on the image plane, expressed as the angle subtended at the exit pupil of the eye by the maximum dimension 2r See Figure 1. BS EN ISO 10940:2009ISO 10940:2009(E) 2 ISO 2009 All rights reserved3.3 magnification of image ratio of the size of an object at the centre on the image plane to that o

29、f the fundus, assuming that the eye is emmetropic and that it has a focal length of 17 mm in air 3.4 pixel pitch 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 i

30、s emmetropic and that it has a focal length of 17 mm in air 3.5 high eye point eyepiece eyepiece in which the exit 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 dimens

31、ion r for various formats 4 Requirements 4.1 General The fundus camera shall conform to the requirements specified 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 a

32、pplication), the given limits for resolving power shall be reduced by a factor of 1,6. It is recommended that an 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. BS EN ISO 10

33、940:2009ISO 10940:2009(E) ISO 2009 All rights reserved 3Table 1 Requirements for optical properties Criterion Requirement centre W 80 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 op

34、tics Field of view 30 periphery (r) W 25 lp/mm Tolerance of angular field of view 5 % Tolerance of magnification of imageb 7 % Tolerance 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 e

35、yepieces Range of focus adjustment for compensation of patients refractive error 15 D to + 15 D aTo achieve the resolving power according 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 fu

36、ndus cameras recording on film. cOnly for fundus cameras recording on a digital sensor. 4.3 Construction and function 4.3.1 General 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

37、 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 examiners 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

38、cameras shall comply with the light hazard protection requirements that are given in ISO 15004-2 in consideration of the following modality. (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:

39、2007, Clause 4. The applicable clauses of ISO 15004-2:2007 for fundus cameras are as follows. a) For group 1 fundus cameras: 1) applicable 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

40、(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 be below all applicable limits of ISO 15004-2:2007, Table 2 or Table

41、3; BS EN ISO 10940:2009ISO 10940:2009(E) 4 ISO 2009 All rights reserved2) applicable test methods are given in ISO 15004-2:2007, 6.1, 6.2 and 6.4. If status 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

42、 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 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 rad

43、iation emissions shall be below all applicable limits for each light source alone; ii) the resulting or combined radiation of the multiple sources shall 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

44、 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 according 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. re

45、lated 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, 6.2, 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

46、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 methods for checking the optical properties 5.1 General All tests described in this International Standard are type tests. The requirements specifie

47、d 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

48、 be checked using a test target in front of the fundus camera. The test target shall be used at a distance of 1 m from the entrance pupil of the fundus camera. The distance of 1 m shall be determined with a tolerance of u 5 mm. 5.2.2 Test target illumination The light source used to illuminate the t

49、est target may be the normal fundus camera light source or may be an external white light source. In either case, the light shall be filtered by a band-pass filter with peak transmission wavelength between 520 nm and 560 nm and a half-peak bandwidth of less than 80 nm. For NIR applications, the peak transmission wavelength shall be between 790 nm and 890 nm with a half-peak width of less than 120 nm. BS EN ISO 10940:2009ISO 10940:2009(E) ISO 2009 All rights reserved 55.2.3 Test target design The test target for resol