1、 g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58The European Standard EN ISO 10942:2006 has the status of a British StandardICS 11.040.70Ophthalmic
2、 instruments Direct ophthalmoscopesBRITISH STANDARDBS EN ISO 10942:2006BS EN ISO 10942:2006This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 June 2006 BSI 2006ISBN 0 580 48578 1Cross-referencesThe British Standards which implement internatio
3、nal or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online.This publication does not purport to
4、 include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations.Summary of pagesThis document comprises a front cover, an inside front cover, the EN ISO title page, th
5、e EN ISO foreword page, the ISO title page, pages ii and iii, a blank page, pages 1 to 7 and a back cover.The BSI copyright notice displayed in this document indicates when the document was last issued.Amendments issued since publicationAmd. No. Date CommentsA list of organizations represented on th
6、is subcommittee can be obtained on request to its secretary. present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep UK interests informed; monitor related international and European developments and promulgate them in the UK
7、.National forewordThis British Standard is the official English language version of EN ISO 10942:2006. It is identical with ISO 10942:2006. It supersedes BS EN ISO 10942:1998 which is withdrawn.The UK participation in its preparation was entrusted by Technical Committee CH/172, Ophthalmic optics, to
8、 Subcommittee CH/172/6, Ophthalmic instruments, which has the responsibility to: aid enquirers to understand the text;EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 10942June 2006ICS 11.040.70 Supersedes EN ISO 10942:1998 English VersionOphthalmic instruments - Direct ophthalmoscopes (ISO1094
9、2:2006)Instruments ophtalmiques - Ophtalmoscopes directs (ISO10942:2006)Ophthalmische Instrumente - Direkte Ophthalmoskope(ISO 10942:2006)This European Standard was approved by CEN on 9 March 2006.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the condition
10、s for giving 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 Central Secretariat or to any CEN member.This European Standard exists in three officia
11、l versions (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 Central Secretariat has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgiu
12、m, 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 STANDARDIZATIO
13、NCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: rue de Stassart, 36 B-1050 Brussels 2006 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 10942:2006: EForeword This European Standard shall be given
14、the status of a national standard, either by publication of an identicalat the latest by December 2006. This document supersedes EN ISO 10942:1998. countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Luxembourg, Malta, Netherlands, Norway, Poland, Portu
15、gal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Endorsement notice The text of ISO 10942:2006 has been approved by CEN as EN ISO 10942:2006 without any modifications.This document (EN ISO 10942:2006) has been prepared by Technical Committee ISO/TC 172 “Optics and opt
16、ical instruments“ in collaboration with Technical Committee CEN/TC 170 “Ophthalmic optics“, the secretariat of which is held by DIN. text or by endorsement, at the latest by December 2006, and conflicting national standards shall be withdrawnDenmark, Estonia, Finland, France, Germany, Greece, Hungar
17、y, Iceland, Ireland, Italy, Latvia, Lithuania, According to the CEN/CENELEC Internal Regulations, the national standards organizations of the followingEN ISO 10942:2006Reference numberISO 10942:2006(E)INTERNATIONAL STANDARD ISO10942Second edition2006-06-01Ophthalmic instruments Direct ophthalmoscope
18、s Instruments ophtalmiques Ophtalmoscopes directs EN ISO 10942:2006ii 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 tec
19、hnical 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 closel
20、y 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 prepare International Standards. Draft
21、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 that some of the elements of this documen
22、t may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 10942 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 f
23、irst edition (ISO 10942:1998 and ISO 10942:1998/Cor.1:1998), which has been technically revised. EN ISO 10942:2006blank1Ophthalmic instruments Direct ophthalmoscopes 1 Scope This International Standard, together with ISO 15004-1 and ISO 15004-2, specifies minimum requirements and test methods for ha
24、nd-held direct ophthalmoscopes designed for directly observing the eye fundus. 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 document. For da
25、ted 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 ophthalmic instrument
26、s ISO 15004-2:1), 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 document, the fol
27、lowing terms and definitions apply. 3.1 ophthalmoscope optical instrument used to examine the external and internal parts of the eye, particularly the media and the fundus 3.2 direct ophthalmoscope ophthalmoscope which provides an illuminating system, an observation system and viewing lenses which a
28、llow the observer to visualize the patients eye directly, that is without the formation of an intermediate image 3.3 viewing lens lens which is positioned between the observers eye(s) and the eye to be examined in order to achieve optimum focus, i.e. to correct for patients and/or observers refracti
29、ve error and/or accommodation NOTE In direct ophthalmoscopes when a selection of such lenses is required, these are integrated with or mounted in a disc or other mechanical means by which the user may easily position the lens of choice centrally in the visual path. 1) To be published. EN ISO 10942:2
30、0062 3.4 auxiliary lens additional viewing lens to facilitate access to higher refractive powers without requiring an excessive number of lenses NOTE Auxiliary lenses are normally integral with or mounted on a separate disc or other mechanical means and when required are used in conjunction with the
31、 viewing lenses. 3.5 ophthalmoscope graticule pattern or target or graticule which can be optionally positioned in the illuminating light path within the instrument and which will be imaged on the retina for diagnostic, measurement or therapeutic purposes NOTE These can be fixed or focusable. 3.6 il
32、luminating system light source and associated lenses, mirrors and/or prism which serve to provide and project light into or onto the patients eye 3.7 viewing system lenses and apertures which enable the observer to examine the patients eye 3.8 field of view angular field which is visible when the en
33、trance pupil is 12 mm behind the back surface of the ophthalmoscope, measured from the centre of the entrance pupil NOTE See 6.2.3 and Figure 1. 3.9 field of illumination angular field which is illuminated and which is measured with its apex positioned at the image of the light source 4 Classificati
34、on Direct ophthalmoscopes shall be classified as follows. a) Group A: Direct ophthalmoscopes that comply with all the requirements of this International Standard. b) Group B: Direct ophthalmoscopes that comply with the reduced requirements specified in Table 1 and all other requirements specified in
35、 this International Standard except those in 5.4.2 and 5.4.3. 5 Requirements 5.1 General The direct ophthalmoscope shall conform to the requirements specified in ISO 15004-1. The direct ophthalmoscope shall conform to the specific requirements specified in 5.2 to 5.5. These requirements shall be ver
36、ified as specified in Clause 6. EN ISO 10942:200635.2 Optical requirements The requirements specified in Table 1 and Table 2 shall apply. Table 1 Requirements for optical specifications Requirements Criterion Group A Group B Steps for the powers, in dioptres, of viewing lenses 0, +1, +2, +3, +4, +6,
37、 +8, +10, +15, +20 1, 2, 3, 4, 6, 8, 10, 15, 20 10 steps in the range +10 to 0 to 10 Angle of field of view, W 3 W 2,5 Angle of field of illumination at maximum aperture W 9 W 7 Diameter of the viewing system W 3 mm W 2,5 mm Table 2 Requirements for optical accuracy Criterion Combined refractive pow
38、er Tolerance 0 D to +3 D 0 D to 3 D 0,37 D +3 D to +10 D +10 D to +15 D +15 D +10 D 10 D 0,5 mm 5.3 Construction and function of the viewing system 5.3.1 The viewing lenses shall be arranged so that, as viewed from the observers side: a) increments of positive power, indicated by black or green figu
39、res, increase when the disc is turned clockwise; b) increments of negative power, indicated by red figures, increase when the disc is turned anticlockwise. 5.3.2 The viewing lens control shall be provided with indexing stops for each lens power. 5.3.3 Left-hand and right-hand operation of the viewin
40、g lens control shall be possible. EN ISO 10942:20064 5.4 Construction and function of the illumination system 5.4.1 The defocused illumination beam shall be homogeneous and achromatic as determined by visual inspection. 5.4.2 The minimum adjustment range of the luminous flux from the illuminating sy
41、stem of Group A direct ophthalmoscopes shall be from the maximum to 10 % of the maximum. 5.4.3 Group A direct ophthalmoscopes shall have a minimum of two aperture stops in the illuminating system. These shall be a full aperture and a reduced aperture. Additionally a red-free filter shall be included
42、. NOTE Other filters, apertures, graticules, slits or half-circles are optional. 5.5 Optical radiation hazard with direct ophthalmoscopes This clause replaces 10.4, 10.5, 10.6 and 10.7 of IEC 60601-1:2005. Light hazard protection requirements and test methods are given in ISO 15004-2:. The applicabl
43、e clauses of ISO 15004-2: for direct ophthalmoscopes are as follows: a) classified in accordance with ISO 15004-2:, Clause 4; b) for Group 1 direct ophthalmoscopes: 1) applicable clauses of ISO 15004-2: are 5.1, 5.2, 5.4.1, 6.1, 6.2 and 6.4; 2) if status is determined to be Group 1, there are no fur
44、ther requirements; 3) if status is determined not to be Group 1, the additional requirements given in c) are applicable; c) for Group 2 direct ophthalmoscopes: 1) applicable clauses of ISO 15004-2: are 5.5.1, 6.3, 6.4, 6.5 and Clause 7, and 2) additionally 5.3 of ISO 15004-2: for instruments with va
45、riable light intensity. 6 Test methods 6.1 General All tests described in this International Standard are type tests. 6.2 Checking the optical and functional requirements 6.2.1 The requirements specified in 5.2 shall be verified by the use of measuring devices with accuracy better than 10 % of the s
46、mallest value to be determined. Measurements shall be carried out according to general rules of statistical evaluation. For measuring the refractive power according to Table 2, the use of a focimeter as specified in ISO 8598 is recommended. 6.2.2 For measuring the field of view, place the direct oph
47、thalmoscope so that the back surface of the instrument is 12 mm in front of a pin-hole illuminated by a non-collimated light source. 6.2.3 The requirements described in 5.3 and 5.4.1 shall be checked by observation. EN ISO 10942:20065It is essential that the divergent angle of the light source excee
48、d the minimum angle of field of view specified in Table 1. Project the light patch onto a screen at a distance l (expressed in millimetres) from the pin-hole (see Figure 1). Measure the diameter d (expressed in millimetres) of the fully illuminated, central core of the patch, disregarding the penumb
49、ra rim. For the purposes of this measurement, use a 0,2 mm diameter pin-hole and calculate the angle of field of view, , from the expression: ()12 tan 0,2 / 2dl=where d is the diameter, expressed in millimetres, of the fully illuminated, central core of the patch, disregarding the penumbra rim; l is the distance, expressed in millimetres, from the pin-hole to the screen. If the projected light patch has a shape other than circular, the diameter d of the smallest circle which w
