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1、BRITISH STANDARD BS EN ISO 10940:1998 Ophthalmic instruments Fundus cameras The European Standard EN ISO 10940:1998 has the status of a British Standard ICS 11.040.70 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:54:42 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 10940:1998 This
2、British Standard, having been prepared under the direction of the Health and Environment Sector Board, was published under the authority of the Standards Board and comes into effect on 15 July 1998 BSI 04-1999 ISBN 0 580 29901 5 National foreword This British Standard is the English language version
3、 of EN ISO 10940:1998. It is identical with ISO 10940:1998. The UK participation in its preparation was entrusted by Technical Committee CH/78, Ophthalmic optics, to Subcommittee CH/78/6, Ophthalmic instruments, which has the responsibility to: aid enquirers to understand the text; present to the re
4、sponsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. A list of organizations represented on this subcommittee can be obtained
5、 on request to its secretary. Cross-references Attention is drawn to the fact that CEN and CENELEC standards normally include an annex which lists normative references to international publications with their corresponding European publications. The British Standards which implement international or
6、 European publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include all the
7、 necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, pages i and ii,
8、the EN ISO title page, page 2, the ISO title page, page ii, pages 1 to 10 and a back cover. This standard has been updated (see copyright date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover. Amendments issued since publication Amd.
9、No.DateComments Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:54:42 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 10940:1998 BSI 04-1999i Contents Page National forewordInside front cover Foreword2 Forewordii Text of ISO 109401 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 1
10、5 12:54:42 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ii blank Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:54:42 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 10940 May 1998 ICS 11.040.70 Descriptors: See ISO document English versio
11、n Ophthalmic instruments Fundus cameras (ISO 10940:1998) Instruments ophtalmiques Appareils photographiques du fond de loeil (ISO 10940:1998) Ophthalmische Instrumente Funduskameras (ISO 10940:1998) This European Standard was approved by CEN on 9 March 1998. CEN members are bound to comply with the
12、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 Central Secretariat or
13、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 Central Secretariat has the same status as the official versio
14、ns. CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. CEN European Committee for Standardization Comit Europe
15、n de Normalisation Europisches Komitee fr Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1998 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 10940:1998 E Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15
16、 12:54:42 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 10940:1998 BSI 04-1999 2 Foreword The text of the International Standard ISO 10940:1998 has been prepared by Technical Committee ISO/TC 172 “Optics and optical instruments” in collaboration with Technical Committee CEN/TC 170 “Ophthalmic op
17、tics”, the secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by November 1998, and conflicting national standards shall be withdrawn at the latest by November 1998.
18、 According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Po
19、rtugal, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of the International Standard ISO 10940:1998 was approved by CEN as a European Standard without any modification. NOTENormative references to International Standards are listed in Annex ZA (normative). A-deviation
20、s are given in Annex ZB (informative). Contents Page Foreword2 1Scope1 2Normative references1 3Definitions1 4Requirements1 5Test methods4 6Accompanying documents5 7Marking5 Annex A (normative) Optical radiation hazard6 Annex B (informative) Photometric measures8 Annex C (informative) Information to
21、be provided on the avoidance of over-exposure to potentially hazardous optical radiation9 Annex ZA (normative) Normative references to international publications with their relevant European publications10 Annex ZB (informative) A-deviations10 Figure 1 Meaning of dimension r for various formats2 Fig
22、ure 2 Test target for checking the resolving power4 Figure B.1 Solid angle 7 subtended by a light source8 Table 1 Requirements for optical properties2 Table A.17 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:54:42 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Licensed Copy: sheffieldun shef
23、fieldun, na, Wed Nov 15 12:54:42 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 10940:1998 ii BSI 04-1999 Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is
24、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 part
25、in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standar
26、d requires approval by at least 75 % of the member bodies casting a vote. International Standard ISO 10940 was prepared by Techncial Committee ISO/TC 172, Optics and optical instruments, Subcommittee SC 7, Ophthalmic optics and instruments. Annex A forms an integral part of this International Standa
27、rd. Annex B and Annex C are for information only. Descriptors: Optics, optical equipment, ophthalmic equipment, cameras, specifications, optical properties, safety requirements, tests, type testing (tests), performance tests, marking, instructions. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov
28、 15 12:54:42 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 10940:1998 BSI 04-19991 1 Scope This International Standard, together with ISO 15004, specifies requirements and test methods for fundus cameras operating exclusively for photography of the fundus of the human eye. This International Sta
29、ndard is based upon techniques involving the direct effects of an optical image on a photographic emulsion. This International Standard is not applicable to the following types of fundus camera: those designed to produce simultaneous stereoscopic photography; those using infrared radiation as a sour
30、ce of illumination for the observing system. This International Standard takes precedence over ISO 15004, if differences exist. 2 Normative references The following standards contain provisions which, through reference in this text, constitute provisions of this International Standard. At the time o
31、f publication, the editions indicated were valid. All standards are subject to revision, and parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent editions of the standards indicated below. Members of IEC and ISO maintain
32、 registers of currently valid International Standards. ISO 15004:1997, Ophthalmic instruments Fundamental requirements and test methods. IEC 60601-1:1988, Medical electrical equipment Part 1: General requirements for safety. 3 Definitions For the purposes of this International Standard, the followin
33、g definitions apply. 3.1 resolving power of the fundus camera minimum separation allowing recognition of two adjacent lines on the fundus, expressed as line pairs per millimetre (lp/mm) 3.2 field of view photographic angular field of view angle subtended at the exit pupil of the eye by the maximum d
34、imension 2r see Figure 1 3.3 magnification of photography ratio of the size of the image on the photosensitive target to that of the fundus at the centre of the photographic field, assuming that the eye is emmetropic and that it has a focal length of 17 mm in air 3.4 high eye point eyepiece eyepiece
35、 in which the exit pupil is of sufficient clearance from the eyepiece to allow spectacles to be worn 4 Requirements 4.1 General The fundus camera shall conform to the requirements specified in ISO 15004. 4.2 Optical requirements The fundus camera shall conform to the requirements given in Table 1. T
36、hese requirements are verified as described in 5.1. NOTEIt is recommended that an oblique astigmatism compensator is provided for observation and photography of the periphery of the retina when using a fundus camera with an angular field-of-view of 30 or less. Licensed Copy: sheffieldun sheffieldun,
37、 na, Wed Nov 15 12:54:42 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 10940:1998 2 BSI 04-1999 Table 1 Requirements for optical properties 4.3 Construction and function 4.3.1 General The instrument shall be designed in a way that there is no reflection nor stray light which is detrimental to th
38、e photography. 4.3.2 High eye point eyepiece If the manufacturer states that the eyepiece is a high eye point eyepiece, the clearance shall be a minimum of 17 mm, as measured from that part of the eyepiece nearest the examiners eye to the exit pupil of the instrument. Figure 1 Meaning of dimension r
39、 for various formats CriterionMinimum requirement centre80 lp/mm # 30middle (r/2)60 lp/mm Resolving power forperiphery (r)40 lp/mm camera withcentre60 lp/mm field of view 30middle (r/2)40 lp/mm periphery (r)25 lp/mm Tolerance of field of view 7 % Tolerance of magnification of photography 7 % Range o
40、f dioptre adjustment of the optical finder 5 D to + 5 D 4 D to + 2 D for high eye point eyepieces Range of focus adjustment for compensation of patients refractive error 15 D to + 15 D Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:54:42 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 1
41、0940:1998 BSI 04-19993 4.4 Optical radiation hazard with fundus cameras 4.4.1 General This clause replaces clauses 32, 33 and 34 of IEC 60601-1:1988. The limit values given in items a) and b) of 4.4.2 shall apply to the radiation emerging from the fundus camera used to illuminate and view the human
42、eye with visible light (380 nm to 700 nm) and in which the full beam homogeneously illuminates an 8 mm circular pupil (see notes 1 and 2 of 4.4.2). NOTEThe limit values given in 4.4.2 are considered acceptable with respect to the risks when weighted against the performances intended. 4.4.2 Limit val
43、ues a) Short wavelength limit: The amount of radiant power exiting the fundus camera in the portion of the spectrum from 305 nm to 400 nm shall have an irradiance no greater than 0,05 mW/cm2 as measured in the corneal plane when the instrument is operating at maximum intensity1) and, if the aperture
44、 can be varied, at maximum aperture. b) Long wavelength limit: The amount of energy exiting the fundus camera in the wavelength range 700 nm to 1 100 nm shall not exceed 100 mW/cm2 nor shall it exceed the amount of energy exiting the fundus camera in the range between 380 nm and 700 nm. The energy s
45、hall be measured in the corneal plane when the fundus camera is operating at maximum intensity and maximum aperture. NOTE 1If due to stops or other obstructions of the beam, a circular pupil of less than 8 mm diameter is illuminated, the limit values may be increased by the ratio of the area of an 8
46、 mm diameter pupil divided by the true area illuminated. NOTE 2It is recommended that the energy in the range of the spectrum below 420 nm be attenuated as much as possible. NOTE 3For fundus cameras, when operated with non-pulsed radiation (in particular when using the alignment illumination), the a
47、ssumptions used to set the limit value for radiation of wavelength shorter than 400 nm are based on considerations of the typical spectral distribution of a 3 000 K standard black-body source, an illuminating solid angle at the corneal plane of 0,031 sr, a maximum exposure time of 5 min and the weig
48、hting factors for LA (see Annex A). The limit is set to ensure that the fraction of the photochemical hazard dose due to radiation of wavelength shorter than 400 nm is no greater than 1/8 of the total photochemical hazard dose over all wavelengths when that total dose is at the threshold limit for a
49、n 8 mm diameter pupil. Using the American Conference of Governmental Industrial Hygienists (ACGIH) guidelines, that threshold limit is 14 J/(cm2 sr). To convert from photochemical hazard weighted radiance to irradiance, over the designated spectral range 305 nm to 400 nm, the conversion factor 0,276 is used. Thus the limit is then found by the formula 14 J/(cm2 sr) (0,031 sr) 0,276/(300s 8) = 0,05 mW/cm2 NOTE 4For fundus cameras, when operated with pulsed radiation, the limit is a total dose expressed in J/cm2,