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1、BRITISH STANDARD BS EN ISO 10943:2006 Ophthalmic instruments Indirect ophthalmoscopes The European Standard EN ISO 10943:2006 has the status of a British Standard ICS 11.040.70 ? Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 15:07:12 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 1094
2、3:2006 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 June 2006 BSI 2006 ISBN 0 580 48579 X National foreword This British Standard is the official English language version of EN ISO 10943:2006. It is identical with ISO 10943:2006. It sup
3、ersedes BS EN ISO 10943:1998 which is withdrawn.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, which has the responsibility to: A list of organizations represented on this subcommittee can be
4、obtained on request to its secretary. Cross-references The British Standards which implement international 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” facil
5、ity of the BSI Electronic Catalogue or of British Standards Online. 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 does not of itself confer immunity from legal obligations
6、. aid enquirers to understand the text; 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. Summary of pages Th
7、is document comprises a front cover, an inside front cover, the EN ISO title page, the EN ISO foreword page, the ISO title page, pages ii and iii, a blank page, pages 1 to 4, an inside back cover and a back cover. The BSI copyright notice displayed in this document indicates when the document was la
8、st issued. Amendments issued since publication Amd. No. DateComments Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 15:07:12 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 10943 June 2006 ICS 11.040.70Supersedes EN ISO 10943:1998 English V
9、ersion Ophthalmic instruments - Indirect ophthalmoscopes (ISO 10943:2006) Instruments ophtalmiques - Ophtalmoscopes indirects (ISO 10943:2006) Ophthalmische Instrumente - Indirekte Ophthalmoskope (ISO 10943:2006) This European Standard was approved by CEN on 9 March 2006. CEN members are bound to co
10、mply 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 application to the Central S
11、ecretariat 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 same status as the o
12、fficial versions. CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia,
13、 Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2006 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN natio
14、nal Members. Ref. No. EN ISO 10943:2006: E Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 15:07:12 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Foreword This document (EN ISO 10943:2006) has been prepared by Technical Committee ISO/TC 172 “Optics and optical instruments“ in collaboration with
15、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 December 2006, and conflicting national standards shall
16、 be withdrawn at the latest by December 2006. This document supersedes EN ISO 10943:1998. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmar
17、k, 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 of ISO 10943:2006 has been approved by
18、CEN as EN ISO 10943:2006 without any modifications. EN ISO 10943:2006 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 15:07:12 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Reference number ISO 10943:2006(E) INTERNATIONAL STANDARD ISO 10943 Second edition 2006-06-01 Ophthalmic instruments Indire
19、ct ophthalmoscopes Instruments ophtalmiques Ophtalmoscopes indirects EN ISO 10943:2006 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 15:07:12 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ii Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 15:07:12 GMT+00:00 2006, Uncontrolled Copy, (c)
20、BSI iii 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 technical committees. Each member body interested in a subject for w
21、hich 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 (IEC) on all
22、 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 committees are c
23、irculated 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 held resp
24、onsible for identifying any or all such patent rights. ISO 10943 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 10943:1998) which has been technically revised.
25、 EN ISO 10943:2006 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 15:07:12 GMT+00:00 2006, Uncontrolled Copy, (c) BSI blank Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 15:07:12 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 1 Ophthalmic instruments Indirect ophthalmoscopes 1 Scope Thi
26、s International Standard, together with ISO 15004-1 and ISO 15004-2 specifies minimum requirements and test methods for hand-held, spectacle-type, and head-worn indirect ophthalmoscopes for observing indirect images of the eye fundus. This International Standard takes precedence over ISO 15004-1 and
27、 ISO 15004-2, if differences exist. This International Standard is not applicable to condensing lenses used for indirect ophthalmoscopy or to accessories. This International Standard is not applicable to table-mounted instruments such as Gullstrand ophthalmoscopes and their derivatives, nor to ophth
28、almoscopes primarily intended for image capture and/or processing such as those based on scanning laser techniques. 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 refe
29、rences, 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 instruments ISO 15004-2:1), Ophthalmic instruments Fundamental requirement
30、s 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 following terms and definitions apply. 3.1 ophthalmoscope optical i
31、nstrument used to examine the external and internal parts of the eye, particularly the media and the fundus 1) To be published. EN ISO 10943:2006 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 15:07:12 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 2 3.2 indirect ophthalmoscope optical instrumen
32、t, which provides an illumination system and which is used with a condensing lens (hand- held or integral) to direct appropriately focused light into an eye in order to produce a real intermediate image that is viewed by an observer NOTE Indirect ophthalmoscopes may be monocular or binocular. 3.3 co
33、ndensing lens plus-power lens system used to focus the illuminating beam into an eye and to form a real inverted image of the retina thus illuminated 4 Requirements 4.1 General The indirect ophthalmoscope shall conform to the requirements specified in ISO 15004-1. The indirect ophthalmoscope shall c
34、onform to the specific requirements described in 4.2 to 4.4. These requirements shall be verified as described in Clause 5. 4.2 Optical and dimensional requirements The requirements specified in Table 1, Table 2 and Table 3 shall apply. Table 1 Optical and dimensional requirements where applicable f
35、or indirect ophthalmoscopes used with a hand-held condensing system Criterion Requirement Interpupillary distance range 55 mm to 72 mm Diameter 2 r of the field of viewa, b W 100 mm Diameter of largest illuminated spota W 45 mm Range of adjustment of headband circumference, if applicable 520 mm to 6
36、40 mm a At 500 mm distance from the light exit. b Definition of r for different fields of view: Table 2 Optical requirements for indirect ophthalmoscopes with integral condensing systems Criterion Requirement Distance of focal point from end of instrument 15 mm to 20 mm Diameter of beam at 500 mm fr
37、om focal point 125 mm to 225 mm Diameter of field of view at 500 mm from focal point 150 mm to 250 mm EN ISO 10943:2006 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 15:07:12 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 3 Table 3 Requirements for optical accuracy for binocular indirect ophtha
38、lmoscopes Criterion Tolerance interpupillary distance between 60 mm and 66 mm u 10 vertical interpupillary distance between 55 mm and 60 mm and between 66 mm and 72 mm u 15 divergence in parallel systems u 10 Difference in axes orientation between left and right optical systems horizontal convergenc
39、e in parallel systems; in convergent systems deviation from the indicated angle u 45 Difference in magnification between left and right systems, where provided u 5 % Specified power of eyepieces or lenses where provided 0,12 D 4.3 Construction and function 4.3.1 The minimum adjustable range of the l
40、ight output of the indirect ophthalmoscope shall be from maximum to 10 % of the maximum. 4.3.2 No reflections or scattered light shall be visible as determined by observation. 4.3.3 The illumination system shall be capable of alignment with the viewing system to within 1 vertically. 4.3.4 For binocu
41、lar systems, no difference in brightness or colour between the left and right optical system shall be visible. 4.3.5 The defocused illumination beam shall be homogeneous and achromatic as determined by visual inspection. 4.4 Optical radiation hazard with indirect ophthalmoscopes This clause replaces
42、 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 applicable clauses of ISO 15004-2: for indirect ophthalmoscopes are as follows: a) classified in accordance with ISO 15004-2:, Clause 4; b) for Group 1 indirect ophtha
43、lmoscopes: 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 further requirements; 3) if status is determined not to be Group 1, the additional requirements given in c) are applicable; c) for Group 2 indirect ophthalmo
44、scopes: 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 variable light intensity. EN ISO 10943:2006 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 15:07:12 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 4 5
45、 Test methods: Optical, mechanical and functional requirements 5.1 All tests described in this International Standard are type tests. 5.2 The requirements specified in 4.2, 4.3.1, 4.3.3 and 4.3.4 shall be verified by use of measuring devices with accuracy better than 10 % of the smallest value to be
46、 determined. Measurements shall be carried out according to general rules of statistical evaluation. 5.3 The requirements described in 4.3.2 and 4.3.5 shall be checked by observation. 6 Accompanying documents The indirect ophthalmoscope shall be accompanied by documents containing instructions for u
47、se. In particular this information shall contain: a) name and address of the manufacturer; b) if appropriate, a statement the indirect ophthalmoscope in its original packaging conforms to the transport conditions as specified in ISO 15004-1; c) any additional documents as specified in 7.9 of IEC 606
48、01-1:2005; d) a reference to this International Standard (ISO 10943:2006), if the manufacturer or supplier claims compliance with it. 7 Marking The indirect ophthalmoscope shall be permanently marked with at least the following information: a) name of manufacturer or supplier; b) name and model of i
49、ndirect ophthalmoscope; c) marking as required by IEC 60601-1. EN ISO 10943:2006 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 15:07:12 GMT+00:00 2006, Uncontrolled Copy, (c) BSI blank Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 15:07:12 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 10943:2006 BSI 389 Chiswick High Road London W4 4AL BSI British Standards Institution BSI is the independent national body responsible for preparing British S