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1、BRITISH STANDARD BS EN ISO 10943:1998 Ophthalmic instruments Indirect ophthalmoscopes The European Standard EN ISO 10943:1998 has the status of a British Standard ICS 11.040.70 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:54:58 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 10943:
2、1998 This 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 05-1999 ISBN 0 580 29898 1 National foreword This British Standard is the English langua
3、ge version of EN ISO 10943:1998. It is identical with ISO 10943:1998. 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
4、 to the responsible 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 b
5、e obtained 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 intern
6、ational or 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 inclu
7、de all the 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
8、i and ii, the EN ISO title page, page 2, the ISO title page, page ii, pages 1 to 8, an inside back cover 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
9、 issued since publication Amd. No.DateComments Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:54:58 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 10943:1998 BSI 05-1999i Contents Page National forewordInside front cover Foreword2 Forewordii Text of ISO 109431 Licensed Copy: sheffie
10、ldun sheffieldun, na, Wed Nov 15 12:54:58 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ii blank Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:54:58 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 10943 May 1998 ICS 11.040.70 Descriptors:
11、See ISO document English version Ophthalmic instruments Indirect ophthalmoscopes (ISO 10943:1998) Instruments ophtalmiques Ophtalmoscopes indirects (ISO 10943:1998) Ophthalmische Instrumente Indirekte Ophthalmoskope (ISO 10943:1998) This European Standard was approved by CEN on 9 March 1998. CEN mem
12、bers 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 applicat
13、ion to the Central Secretariat or 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
14、same status as the official versions. 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 Committe
15、e for Standardization Comit Europen 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 10943:1998 E Licensed Copy: sheff
16、ieldun sheffieldun, na, Wed Nov 15 12:54:58 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 10943:1998 BSI 05-1999 2 Foreword The text of the International Standard ISO 10943:1998 has been prepared by Technical Committee ISO/TC 172 “Optics and optical instruments” in collaboration with Technical C
17、ommittee 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 of an identical text or by endorsement, at the latest by November 1998, and conflicting national standards shall be withdra
18、wn at the latest by November 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, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, L
19、uxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of the International Standard ISO 10943:1998 was approved by CEN as a European Standard without any modification. NOTENormative references to International Standards are listed in
20、 Annex ZA (normative). A-deviations are given in Annex ZB (informative). Contents Page Foreword2 1Scope1 2Normative references1 3Dfinitions1 4Requirements1 5Test methods3 6Accompanying documents4 7Marking4 Annex A (normative) Optical radiation hazard5 Annex B (informative) Photometric measures7 Anne
21、x C (informative) Information to be provided on the avoidance of over-exposure to potentially hazardous optical radiation8 Annex ZA (normative) Normative references to international publications with their relevant European publicationsInside back cover Annex ZB (informative) A-deviationsInside back
22、 cover Figure B.1 Solid angle 7 subtended by a light source7 Table 1 Optical and dimensional requirements where applicable2 Table 2 Requirements for optical accuracy where applicable2 Table A.16 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:54:58 GMT+00:00 2006, Uncontrolled Copy, (c) BS
23、I Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:54:58 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 10943:1998 ii BSI 05-1999 Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of prep
24、aring International Standards 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
25、liaison with ISO, also take part 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. Public
26、ation as an International Standard requires approval by at least 75 % of the member bodies casting a vote. International Standard ISO 10943 was prepared by Techncial Committee ISO/TC 172, Optics and optical instruments, Subcommittee SC 7, Ophthalmic optics and instruments. Annex A forms an integral
27、part of this International Standard. Annex B and Annex C are for information only. Descriptors: Optics, optical equipment, ophthalmic equipment, ophthalmoscopes, specifications, optical properties, safety requirements, tests, type testing (tests), performance tests, marking, technical data sheets, i
28、nstructions. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:54:58 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 10943:1998 BSI 05-19991 1 Scope This International Standard, together with ISO 15004, specifies minimum requirements and test methods for hand-held, spectacle-type, and head
29、-worn indirect ophthalmoscopes for observing indirect images of the eye fundus. This International Standard takes precedence over ISO 15004, if differences exist. This International Standard is not applicable to condensing lenses used for indirect ophthalmoscopy or to accessories. This International
30、 Standard is not applicable to table-mounted instruments such as Gullstrand ophthalmoscopes and their derivatives, nor to ophthalmoscopes primarily intended for image capture and/or processing such as those based on scanning laser techniques. 2 Normative references The following standards contain pr
31、ovisions which, through reference in this text, constitute provisions of this International Standards. At the time of 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 th
32、e possibility of applying the most recent editions of the standards indicated below. Members of IEC and ISO maintain registers of currently valid International Standards. ISO 15004:1997, Ophthalmic instruments Fundamental requirements and test methods. IEC 60601-1:1988, Medical electrical equipment
33、Part 1: General requirements for safety. 3 Dfinitions For the purposes of this International Standard, the following definitions apply. 3.1 indirect ophthalmoscope optical instrument used with a condensing lens (hand-held or integral) to examine the eye, particularly the media and the fundus, by pro
34、ducing a real intermediate image which is viewed by the observer 3.2 monocular indirect ophthalmoscope monocular ophthalmoscope which provides an illumination system and which is used with a condensing lens (hand-held or integral) in order to direct appropriately focused light into the patients eye
35、NOTESuch instruments may include corrective lenses or eyepieces to aid focusing by the observer of the real intermediate image produced by the condensing lens. 3.3 binocular indirect ophthalmoscope binocular ophthalmoscope which provides an illumination system and which is used with a condensing len
36、s in order to direct appropriately focused light into the patients eye NOTE 1Such instruments also include a viewing system which allows the observer to examine the patients retina by binocularly viewing the real intermediate image produced by the condensing lens. NOTE 2Such instruments may include
37、corrective lenses or eyepieces to aid focusing of this image which is viewed by the observer. 3.4 condensing lens plus-power lens used to condense the illuminating beam into the patients eye and to form a real inverted image of the retina thus illuminated 4 Requirements 4.1 General The indirect opht
38、halmoscope shall conform to the requirements specified in ISO 15004. The indirect ophthalmoscope shall conform to the specific requirements described in 4.2 to 4.4. These requirements are verified as described in clause 5. 4.2 Optical and dimensional requirements The requirements specified in Table
39、1 and Table 2 shall apply. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:54:58 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 10943:1998 2 BSI 05-1999 Table 1 Optical and dimensional requirements where applicable Table 2 Requirements for optical accuracy where applicable 4.3 Construct
40、ion and function 4.3.1 The light output of the indirect ophthalmoscope shall be at least adjustable between the maximum and 10 % of the maximum. 4.3.2 The illuminance without a condensing lens and without filters at 500 mm distance from the exit aperture of the indirect ophthalmoscope shall be not l
41、ess than 200 lx. Instruments with an integral condensing lens shall have equivalent illuminance. 4.3.3 No reflections or scattered light shall be visible. 4.3.4 The illumination system shall be capable of alignment with the viewing system to within 1 vertically. 4.3.5 No difference in brightness or
42、colour between the left and right optical system shall be visible. 4.4 Optical radiation hazard with indirect ophthalmoscopes 4.4.1 General This clause replaces clauses 32, 33 and 34 of IEC 60601-1:1988. 4.4.2 Limit values The limit values given in items a) and b) shall apply to the radiation emergi
43、ng from the indirect ophthalmoscope used to illuminate and view the human eye with light from 380 nm to 700 nm and in which the full beam homogeneously illuminates a circular pupil of 8 mm (see notes 2 and 5). NOTE 1The limit values are considered acceptable with respect to the risks when weighted a
44、gainst the performances intended. a) Short wavelength limit: The amount of radiant power exiting the indirect ophthalmoscope 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
45、maximum intensity1) and, if the aperture can be varied, at maximum aperture. CriterionRequirement Interpupillary distance range55 mm to 72 mm Diameter 2r of the field of viewab$ 100 mm Diameter of largest illuminated spota# 45 mm Range of adjustment of headband size520 mm to 640 mm a At 500 mm dista
46、nce from the light exit. b CriterionTolerance VerticalInterpupillary distance between 60 mm and 66 mm # 109 Difference in axes orientation between left and right optical systems Interpupillary distance between 55 mm and 60 mm and between 66 mm and 72 mm # 159 HorizontalDivergence in parallel systems
47、# 109 Convergence in parallel systems; in convergent systems deviation from the indicated angle # 459 Difference in magnification between left and right systems, where provided# 5 % Specified power of eyepieces or lenses where provided 0,09 D 1) Maximum intensity is the highest brightness the indire
48、ct ophthalmoscope is capable of delivering, including the highest brightness achievable if overvoltage is provided. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:54:58 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 10943:1998 BSI 05-19993 b) Long wavelength limit: The amount of energy
49、 exiting the indirect ophthalmoscope 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 indirect ophthalmoscope in the range between 380 nm and 700 nm. The energy shall be measured in the corneal plane when the instrument is operating at maximum intensity and maximum aperture. NOTE 2If, 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 mm d