BS EN ISO 10943-2011 Ophthalmic instruments Indirect ophthalmoscopes《眼科仪器 间接检眼镜》.pdf

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1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 10943:2011Ophthalmic instruments Indirect ophthalmoscopes (ISO 10943:2011)BS EN ISO 10943:2011 BRITISH STANDARDNational forewordThis British Standard is the UK implemen

2、tation of EN ISO 10943:2011. It supersedes BS EN ISO 10943:2006, which is withdrawn.The UK participation in its preparation was entrusted to T e c h n i c a l C o m m i t t e e C H / 1 7 2 / 6 , O p h t h a l m i c i n s t r u m e n t s .A list of organizations represented on this committee can be o

3、btained 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. BSI 2011 ISBN 978 0 580 72697 2 ICS 11.040.70 Compliance with a British Standard cannot confer immunity from legal obligatio

4、ns.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 August 2011.Amendments issued since publicationDate T e x t a f f e c t e d EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 10943 August 2011 ICS 11.040.70 Supersedes EN ISO 10943

5、:2006English Version Ophthalmic instruments - Indirect ophthalmoscopes (ISO 10943:2011) Instruments ophtalmiques - Ophtalmoscopes indirects (ISO 10943:2011) Ophthalmische Instrumente - Indirekte Ophthalmoskope (ISO 10943:2011) This European Standard was approved by CEN on 14 August 2011. CEN members

6、 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 application

7、to the CEN-CENELEC 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 translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management

8、 Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands,

9、 Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2011 CEN All rights of exploitation in any

10、form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 10943:2011: EBS EN ISO 10943:2011 EN ISO 10943:2011 (E) 3 Foreword This document (EN ISO 10943:2011) has been prepared by Technical Committee ISO/TC 172 “Optics and photonics“ in collaboration with Technical Committee

11、 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 February 2012, and conflicting national standards shall be withdrawn at th

12、e latest by February 2012. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 10943:2006. According to th

13、e CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia

14、, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 10943:2011 has been approved by CEN as a EN ISO 10943:2011 without any modification. BS EN ISO 10943:2011ISO 10943

15、:2011(E) ISO 2011 All rights reserved 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 b

16、ody 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 closely with the International Electro

17、technical 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 International Standards adopted

18、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 document may be the subject of patent r

19、ights. ISO shall not be held responsible 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 third edition cancels and replaces the second edition (ISO 10943:2006), w

20、hich has undergone a minor revision to include: updated normative references; additional information concerning the necessary use of a condensing lens when testing for compliance with light hazard requirements second paragraph of 4.4 and list item e) of Clause 6. BS EN ISO 10943:2011BS EN ISO 10943:

21、2011INTERNATIONAL STANDARD ISO 10943:2011(E) ISO 2011 All rights reserved 1Ophthalmic instruments Indirect ophthalmoscopes 1 Scope This 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 indi

22、rect ophthalmoscopes for observing indirect images of the eye fundus. This International Standard takes precedence over ISO 15004-1 and ISO 15004-2, if differences exist. This International Standard is not applicable to condensing lenses used for indirect ophthalmoscopy or to accessories. This Inter

23、national 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 referenced d

24、ocuments 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, Ophthalmic instruments Fundamental requirements and test metho

25、ds 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: General requirements for basic safety and essential perfo

26、rmance 3 Terms and definitions For the purposes of this document, the following 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 indirect ophthalmoscope optical instrument, which p

27、rovides 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. BS EN ISO 10943:2

28、011ISO 10943:2011(E) 2 ISO 2011 All rights reserved3.3 condensing 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 spec

29、ified in ISO 15004-1. The indirect ophthalmoscope shall conform 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

30、1 Optical and dimensional requirements for indirect ophthalmoscopes used with a hand-held condensing system Criterion Requirement Interpupillary distance range 55 mm to 72 mm Diameter 2r of the field of viewab100 mm Diameter of largest illuminated spota45 mm Range of adjustment of headband circumfer

31、ence, if applicable 520 mm to 640 mm aAt 500 mm distance from the light exit. bDefinition 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

32、Diameter of beam at 500 mm from focal point 125 mm to 225 mm Diameter of field of view at 500 mm from focal point 150 mm to 250 mm BS EN ISO 10943:2011ISO 10943:2011(E) ISO 2011 All rights reserved 3Table 3 Requirements for optical accuracy for binocular indirect ophthalmoscopes Criterion Tolerance

33、interpupillary distance between 60 mm and 66 mm 10 vertical interpupillary distance between 55 mm and 60 mm and between 66 mm and 72 mm 15 divergence in parallel systems 10 Difference in axes orientation between left and right optical systems horizontal convergence in parallel systems; in convergent

34、 systems, deviation from the indicated angle 45 Difference in magnification between left and right systems, where provided 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 light output of the indirect ophthalmosc

35、ope 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 binocular systems, no difference in brightnes

36、s 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 10.4, 10.5, 10.6 and 10.7 of IEC 60601

37、-1:2005. Indirect ophthalmoscopes without an integral condensing system shall be evaluated and tested with a condensing lens of a design specified by the manufacturer of the indirect ophthalmoscope to be used with the instrument. This lens shall be positioned from the reflecting surface of the indir

38、ect ophthalmoscope at the position correct for it (in accordance with manufacturers instructions) to be placed when used to examine the human eye. Light hazard protection requirements and test methods are given in ISO 15004-2. The applicable clauses of ISO 15004-2:2007 for indirect ophthalmoscopes a

39、re as follows: a) classification in accordance with ISO 15004-2:2007, Clause 4; b) for Group 1 indirect ophthalmoscopes: 1) 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 req

40、uirements given in c) are applicable; c) for Group 2 indirect ophthalmoscopes: 1) 5.5.1, 6.3, 6.4, 6.5 and Clause 7, and 2) for instruments with variable light intensity, 5.3. BS EN ISO 10943:2011ISO 10943:2011(E) 4 ISO 2011 All rights reserved5 Test methods: Optical, mechanical and functional requi

41、rements 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 determined. Measurements shall be carried out accordin

42、g 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 use. In particular this information shall contain: a) na

43、me and address of the manufacturer; b) if appropriate, a statement that 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 60601-1:2005; d) a reference to this International St

44、andard (ISO 10943:2011), if the manufacturer or supplier claims compliance with it; e) the diameter and power of the condensing lens used for assessing optical radiation hazard. 7 Marking The indirect ophthalmoscope shall be permanently marked with at least the following information: a) name of manu

45、facturer or supplier; b) name and model of indirect ophthalmoscope; c) marking as required by IEC 60601-1. BS EN ISO 10943:2011This page deliberately left blankThis page deliberately left blankBSI is the independent national body responsible for preparing British Standardsand other standards-related

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