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1、BRITISH STANDARD BS EN ISO 10939:1998 Ophthalmic instruments Slit-lamp microscopes The European Standard EN ISO 10939:1998 has the status of a British Standard ICS 11.040.70 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:54:55 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 10939:199
2、8 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 October 1998 BSI 05-1999 ISBN 0 580 29900 7 National foreword This British Standard is the English langua
3、ge version of EN ISO 10939:1998. It is identical with ISO 10939:1998. 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 these
6、international or European publications 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 necessary pr
7、ovisions 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, the EN ISO ti
8、tle 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 issued since publicati
9、on Amd. No.DateComments Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:54:55 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 10939:1998 BSI 05-1999i Contents Page National forewordInside front cover Foreword2 Forewordii Text of ISO 109391 Licensed Copy: sheffieldun sheffieldun, na, W
10、ed Nov 15 12:54:55 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ii blank Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:54:55 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 10939 July 1998 ICS 11.040.70 Descriptors: See ISO document Engli
11、sh version Ophthalmic instruments Slit-lamp microscopes (ISO 10939:1998) Instruments ophtalmiques Microscopes avec lampe fente (ISO 10939:1998) Ophthalmische Instrumente Spaltleuchten (ISO 10939:1998) This European Standard was approved by CEN on 9 March 1998. CEN members are bound to comply with th
12、e 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 o
13、r 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 vers
14、ions. 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 Euro
15、pen 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 10939:1998 E Licensed Copy: sheffieldun sheffieldun, na, Wed Nov
16、15 12:54:55 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 10939:1998 BSI 05-1999 2 Foreword The text of the International Standard ISO 10939:1998 has been prepared by Technical Committee ISO/TC 172 “Optics and optical instruments” in collaboration with Technical Committee CEN/TC 170 “Opthalmic o
17、ptics”, 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 January 1999, and conflicting national standards shall be withdrawn at the latest by January 1999.
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, Por
19、tugal, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of the International Standard ISO 10939:1998 was approved by CEN as a European Standard without any modification. NOTENormative references to International Standards are listed in Annex ZA (normative). A-deviations
20、 are given in Annex ZB (informative). Contents Page Forewordii 1Scope1 2Normative references1 3Definitions1 4Requirements1 5Test methods4 6Accompanying documents4 7Marking5 Annex A (normative) Optical radiation hazard6 Annex B (informative) Photometric measures7 Annex C (informative) Information to
21、be provided on the avoidance of over-exposure to potentially hazardous optical radiation8 Annex ZA (normative) Normative references to international publications with their corresponding European publicationsInside back cover Annex ZB (informative) A-deviationsInside back cover Figure 1 Explanation
22、to criterion No. 53 Figure B.1 Solid angle 7 subtended by a light source7 Table 1 Requirements for optical properties2 Table A.16 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:54:55 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:54:55
23、 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 10939:1998 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 preparing International Standards is normally carried out through ISO
24、 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 in the work. ISO collaborates cl
25、osely 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 Standard requires approval by at least
26、75 % of the member bodies casting a vote. International Standard ISO 10939 was prepared by Technical Committee ISO/TC 172, Optics and optical instruments, Subcommittee SC 7, Ophthalmic optics and instruments. Annex A forms an integral part of this International Standard. Annex B and Annex C are for
27、information only. Descriptors: Optics, optical equipment, ophthalmic equipment, microscopes, optical microscopes, specifications, optical properties, safety requirements, tests, type testing (tests), performance tests, marking, instructions. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:
28、54:55 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 10939:1998 BSI 05-19991 1 Scope This International Standard, together with ISO 15004, specifies requirements and test methods for slit-lamp microscopes to provide slit illumination and observation under magnification of the eye and its adnexa.
29、This International Standard is not applicable to microscope accessories, e.g. photographic equipment and lasers. 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,
30、 constitute provisions of this International Standard. 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 the possibility of applying the most recent editio
31、ns of the standards indicated below. Members of IEC and ISO maintain registers of currently valid International Standards. ISO 7944:1998, Optics and optical instruments Reference wavelengths. ISO 15004:1997, Ophthalmic instruments Fundamental requirements and test methods. IEC 60601-1:1988, Medical
32、electrical equipment Part 1: General requirements for safety. 3 Definitions For the purposes of this International Standard, the following definitions apply. 3.1 slit-lamp microscope instrument consisting of a microscope and a swivelling illumination system providing a slit image 3.2 magnification r
33、atio of the viewing angle of an object when observed through a magnifying system with the image at infinity to that of the object when observed by the naked eye at a reference viewing distance of 250 mm NOTE 1The magnification, , can be calculated using the following equation: NOTE 2The magnificatio
34、n of the microscope comprises the magnifications of the complete system. 3.3 high eye point eyepiece eyepiece in which the exit pupil is of sufficient clearance from the eyepiece to allow spectacles to be worn 4 Requirements 4.1 General The slit-lamp microscope shall conform to the requirements spec
35、ified in ISO 15004. 4.2 Optical requirements The slit-lamp microscope shall conform to the requirements given in Table 1. These requirements are verified as described in 5.1. 4.3 Construction and function 4.3.1 General The following requirements shall apply: a) the parallel slit edges shall be smoot
36、h and free from any imperfections when observed using the highest magnification; b) the slit image shall be evenly illuminated; c) no contrast decrease in the slit image caused by reflections or scattered light shall be observed; d) the brightness and colour transmission of the left and right optica
37、l systems shall be identical; e) at the highest magnification, the resolving power in the centre of the field shall be at least 1 800 N line pairs/mm. Compliance with these requirements is checked by observation. where 9 is the angle at which an object is seen through the microscope; is the angle at
38、 which the same object is seen without any instrument at a viewing distance of 250 mm. + tan B tanB - -= Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:54:55 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 10939:1998 2 BSI 05-1999 Table 1 Requirements for optical properties No.Criterion
39、Requirement 1Permissible tolerance of microscope magnification (see 3.2) 5 % 2Difference in magnification between left and right observation systems# 3 % 3 Difference in axis between left and right optical systemsa Interpupillary distance between 60 mm and 66 mm # 109 VerticalInterpupillary distance
40、 between 55 mm and 66 mm and 72 mm # 159 HorizontalConvergenceb# 459 Divergence# 109 4Shift in the object plane by change in magnification# 0,4 mm 5Focus tolerance for illumination system withAxialc%a = 0,5 mm respect to the mechanical rotation axisc Lateralc(%a)! = 0,35 mm 6Tolerance for foci plane
41、s of left and right observation systems (%R, %L) including all magnifications with respect to the focus of illumination system (slit image) in any position %R, %L # x dd x = 2e 7Focus difference between the left and right observation systems%(R, L) # x dd x = 2e Calibration error of dioptre scale 0,
42、25 D at zero on the dioptre scale Range for interpupillary distance adjustment55 mm to 72 mm 5,00 D to + 5,00 D 8EyepieceAdjustment range (minimum) 4,00 D to + 2,00 D for high eye point eyepieces Difference in axial positions of the exit pupils between left and right observation systems # 1,5 mm Min
43、imum width# 0,2 mm Minimum length# 8,0 mm 9Slit imageParallelism of the sides (for a slit image 0,2 mm 0,8 mm) # 0,5 Maximum widthEqual to slit length a With the eyepiece for which the slit-lamp microscope is designed. b This requirement does not apply to those slit-lamp microscopes where, due to th
44、e design, the mechanical axes of the eyepieces are not parallel to each other. c Explanation to criterion No. 5 (see also Figure 1). (%a)a = %a sin for a rotational angle range up to = 45 OSis the observation system; ISis the illumination system; RCis the rotational centre of OS and IS; %ais the axi
45、al focus tolerance. d Depth of field, expressed in millimetres where: Nis the numerical aperture; is the total magnification of the microscope (see 3.2); is the reference wavelength according to ISO 7944, expressed in nanometres. e x is a weighting factor. d 2 2N2 - - 10 6 1 7+ N - -+= Licensed Copy
46、: sheffieldun sheffieldun, na, Wed Nov 15 12:54:55 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 10939:1998 BSI 05-19993 4.3.2 High eye point eyepiece If the manufacturer states that the eyepiece is a high eye point eyepiece, the distance between the exit pupil of the observation system and the
47、nearest part of the eyepiece shall be not less than 17 mm. 4.4 Optical radiation hazard with slit-lamp microscopes 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 slit-lamp
48、 microscope used to illuminate and view the human eye with visible light (380 nm to 700 nm) and in which the full beam homogeneously illuminates a circular pupil of 8 mm diameter (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 whe
49、n weighted against the performances intended. 4.4.2 Limit values a) Short wavelength limit: The amount of radiant power exiting the slit-lamp microscope in the portion of the spectrum from 305 nm to 400 nm shall have an irradiance no greater than 0,22 mW/cm2 as measured in the corneal plane when the slit-lamp microscope is operating at maximum intensity1) and, if the aperture can be varied, at maximum aperture. b) Long wavelength limit: The amount of energy exiting the slit-