EN ISO 10939-2007 en Ophthalmic Instruments - Slit-Lamp Microscopes《眼科仪器 狭缝灯显微镜》.pdf

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1、BRITISH STANDARDBS EN ISO 10939:2007Ophthalmic instruments Slit-lamp microscopesThe European Standard EN ISO 10939:2007 has the status of a British StandardICS 11.040.70g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40

2、g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58BS EN ISO 10939:2007This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 May 2007 BSI 2007ISBN 978 0 580 50810 3National forewordThis British Standard was published by BSI. It

3、 is the UK implementation of EN ISO 10939:2007. It supersedes BS EN ISO 10939:1998 which is withdrawn.The UK participation in its preparation was entrusted by Technical Committee CH/172, Ophthalmic optics, to Subcommittee CH/172/6, Ophthalmic instruments.A list of organizations represented on this c

4、ommittee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunity from legal obligations.Amendments issued since pub

5、licationAmd. No. Date CommentsEUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 10939February 2007ICS 11.040.70 Supersedes EN ISO 10939:1998 English VersionOphthalmic instruments - Slit-lamp microscopes (ISO10939:2007)Instruments ophtalmiques - Microscopes avec lampe fente (ISO 10939:2007)Ophtha

6、lmische Instrumente - Spaltleuchten (ISO10939:2007)This European Standard was approved by CEN on 20 January 2007.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alt

7、eration. 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 (English, French, German). A version in any other language made by tran

8、slationunder 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, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,France, Germany,

9、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 STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagemen

10、t Centre: rue de Stassart, 36 B-1050 Brussels 2007 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 10939:2007: EForeword This document (EN ISO 10939:2007) has been prepared by Technical Committee ISO/TC 172 “Optics and optical in

11、struments“ 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 of an identical text or by endorsement, at the latest by August 2007, and confl

12、icting national standards shall be withdrawn at the latest by August 2007. This document supersedes EN ISO 10939:1998. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, B

13、ulgaria, 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. Endorsement notice The text

14、of ISO 10939:2007 has been approved by CEN as EN ISO 10939:2007 without any modifications. EN ISO 10939:2007Reference numberISO 10939:2007(E)INTERNATIONAL STANDARD ISO10939Second edition2007-02-01Ophthalmic instruments Slit-lamp microscopes Instruments ophtalmiques Microscopes avec lampe fente EN IS

15、O 10939:2007ii iiiForeword 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 technical committees. Each member body interested in a sub

16、ject 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 closely with the International Electrotechnical Commission (I

17、EC) 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 prepare International Standards. Draft International Standards adopted by the technical commit

18、tees 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 that some of the elements of this document may be the subject of patent rights. ISO shall not be

19、 held responsible for identifying any or all such patent rights. ISO 10939 was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 7, Ophthalmic optics and instruments. This second edition cancels and replaces the first edition (ISO 10939:1998), which has been technical

20、ly revised. It also incorporates the Technical Corrigendum ISO 10939:1998/Cor.1:2000. EN ISO 10939:2007blank1Ophthalmic instruments Slit-lamp microscopes 1 Scope This International Standard, together with ISO 15004-1 and ISO 15004-2, specifies requirements and test methods for slit-lamp microscopes

21、to provide slit illumination and observation under magnification of the eye and its adnexa. This International Standard is not applicable to microscope accessories, e.g. photographic equipment and lasers. This International Standard takes precedence over ISO 15004-1 and ISO 15004-2, if differences e

22、xist. 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 latest edition of the referenced document (including any amendments) applies. ISO 15004-1, Ophthal

23、mic 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 methods Part 2: Light hazard protection IEC 60601-1:2005, Medical electrical equipment Part 1: Ge

24、neral 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 slit-lamp microscope instrument consisting of a microscope and a swivelling illumination system providing a slit image 3.2 magnifica

25、tion ratio 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 1 The magnification, , can be calculated using the following equation: tan tan = EN

26、 ISO 10939:20072 where is the angle at which an object is seen through the microscope; is the angle at which the same object is seen without any instrument at a viewing distance of 250 mm. NOTE 2 The magnification of the microscope comprises the magnifications of the complete system. 3.3 high eye po

27、int 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 specified in ISO 15004-1 and ISO 15004-2. The slit-lamp microscope shall conform to the requ

28、irements specified in 4.2, 4.3 and 4.4. Compliance with these requirements is verified by type testing. 4.2 Optical requirements The slit-lamp microscope shall conform to the requirements given in Table 1. These requirements shall be verified by use of measuring devices whose measuring errors are sm

29、aller than 10 % of the smallest value to be determined. Test results shall be evaluated in accordance with general rules of statistics. EN ISO 10939:20073Table 1 Requirements for optical properties No. Criterion Requirement 1 Permissible tolerance of microscope magnification (see 3.2) 5 % 2 Differen

30、ce in magnification between left and right observation systems u 3 % Interpupillary distance between 60 mm and 66 mm u 10 Vertically Interpupillary distance between 55 mm and 66 mm and 72 mm u 15 Convergence bu 45 3 Angular difference in axis between left and right optical systems aHorizontally Dive

31、rgence u 10 4 Shift in the object plane by change in magnification u 0,4 mm Axial ca = 0,5 mm 5 Focus tolerance for illumination system with respect to the mechanical rotation axis cLateral c(a)= 0,35 mm 6 Tolerance for foci planes of left and right observation systems (R, L) including all magnifica

32、tions with respect to the focus of illumination system (slit image) in any position R, L u x d dx =2 e7 Focus difference between the left and right observation systems (R, L) u x d dx =2 eCalibration error of dioptre scale 0,25 D at zero on the dioptre scale Range for interpupillary distance adjustm

33、ent 55 mm to 72 mm 5,00 D to +5,00 D Adjustment range (minimum) 4,00 D to +2,00 D for high eye point eyepieces 8 Eyepiece Difference in axial positions of the exit pupils between left and right observation systems u 1,5 mm Minimum width u 0,2 mm Maximum length W 8,0 mm Parallelism of the sides (for

34、a slit image 0,2 mm 0,8 mm) u 0,5 9 Slit image Maximum width Equal to slit length aWith the eyepiece for which the slit-lamp microscope is designed. bThis requirement does not apply to those slit-lamp microscopes where, due to the design, the mechanical axes of the eyepieces are not parallel to each

35、 other. cFor explanation of criterion No. 5, see Figure 1. dDepth of field, expressed in millimetres: 6211072dNN=+where: N is the numerical aperture; is the total magnification of the microscope (see 3.2); is the reference wavelength in accordance with ISO 7944, expressed in nanometres. ex is a weig

36、hting factor. EN ISO 10939:20074 Key (a)= a sin for a rotational angle range up to = 45 OS observation system IS illumination system RC rotational centre of OS and IS a axial focus tolerance Figure 1 Explanation of criterion No. 5 4.3 Construction and function 4.3.1 General The following requirement

37、s shall apply: a) the parallel slit edges shall be smooth 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 brightn

38、ess and colour transmission of the left and right optical 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. Compliance with these requirements is checked by observation. 4.3.2 High eye point eyepiece If the manufact

39、urer states that the eyepiece is a high eye point eyepiece, the distance between the exit pupil of the observation system and the nearest part of the eyepiece shall be not less than 17 mm. 4.4 Optical radiation hazard with slit-lamp microscopes This subclause replaces IEC 60601-1:2005, 10.4, 10.5, 1

40、0.6 and 10.7. Slit-lamp microscopes shall comply with the light hazard protection requirements given in ISO 15004-2. EN ISO 10939:20075It shall first be determined if the slit-lamp microscope is classified as a Group 1 or Group 2 instrument in accordance with ISO 15004-2:2007, Clause 4. The applicab

41、le clauses of ISO 15004-2 for slit-lamp microscopes are as follows: a) for Group 1 slit-lamp microscopes: 1) applicable requirements of ISO 15004-2:2007 are 5.1, 5.2 and 5.4; 2) applicable test methods of ISO 15004-2:2007 are 6.1, 6.2, 6.4 and 6.5; 3) if status is determined to be Group 1, there are

42、 no further requirements; if status is determined not to be Group 1, the additional requirements given in b) are applicable; b) for Group 2 slit-lamp microscopes: 1) applicable requirements of ISO 15004-2:2007 are 5.1, 5.3 and 5.5; 2) applicable test methods of ISO 15004-2:2007 are 6.1, 6.2, 6.3, 6.

43、4, 6.5 and 6.6; 3) ISO 15004-2:2007, Clause 7, also applies. If the intended use of the slit-lamp microscope includes the use of supplementary 90 D lenses, an arrangement shall be made for measurement of corneal and lenticular related exposure values. The 90 D lens (e.g. Volk lens) shall be at a pos

44、ition 7 mm behind the focus plane of the slit lamp with the maximum illumination field. The exposure measurement then is to arrange 7 mm behind the 90 D lens on the spot of the minimum size of the illumination field. 5 Accompanying documents The slit-lamp microscope shall be accompanied by documents

45、 containing instructions for use. In particular, this information shall contain: a) the name and address of the manufacturer; b) if appropriate, a statement that the slit-lamp microscope in its original packaging conforms to the transport conditions as specified in ISO 15004-1; c) any additional doc

46、uments as specified in IEC 60601-1:2005, 7.9; d) a reference to this International Standard, i.e. ISO 10939:2007, if the manufacturer or supplier claims compliance with it. 6 Marking The slit-lamp microscope shall be permanently marked with at least the following information: a) the name and address

47、 of the manufacturer or supplier; b) the name and model of the slit-lamp microscope; c) marking as required by IEC 60601-1. EN ISO 10939:20076 Bibliography 1 ISO 7944, Optics and optical instruments Reference wavelengths EN ISO 10939:2007blankBS EN ISO 10939:2007BSI389 Chiswick High RoadLondonW4 4AL

48、BSI British Standards InstitutionBSI is the independent national body responsible for preparing British Standards. It presents the UK view on standards in Europe and at the international level. It is incorporated by Royal Charter.RevisionsBritish Standards are updated by amendment or revision. Users

49、 of British Standards should make sure that they possess the latest amendments or editions.It is the constant aim of BSI to improve the quality of our products and services. We would be grateful if anyone finding an inaccuracy or ambiguity while using this British Standard would inform the Secretary of the technical committee responsible, the identity of which can be found on the inside front cover. Tel: +44 (0)20 8996 9000. Fax: +44 (0)20 8996 7400.BSI offers members an individual updating serv