1、November 2011 Translation by DIN-Sprachendienst.English price group 7No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).IC
2、S 11.040.70!$vT$“1834901www.din.deDDIN EN ISO 10943Ophthalmic instruments Indirect ophthalmoscopes (ISO 10943:2011)English translation of DIN EN ISO 10943:2011-11Ophthalmische Instrumente Indirekte Ophthalmoskope (ISO 10943:2011)Englische bersetzung von DIN EN ISO 10943:2011-11Instruments ophtalmiqu
3、es Ophtalmoscopes indirects (ISO 10943:2011)Traduction anglaise de DIN EN ISO 10943:2011-11SupersedesDIN EN ISO 10943:2006-08www.beuth.deIn case of doubt, the German-language original shall be considered authoritative.Document comprises 11 pages11.11 DIN EN ISO 10943:2011-11 2 A comma is used as the
4、 decimal marker. National foreword This standard has been prepared by Technical Committee ISO/TC 172 “Optics and photonics”, Subcommittee SC 7 “Ophthalmic optics and instruments” in collaboration with Technical Committee CEN/TC 170 “Ophthalmic optics” (both secretariats: DIN, Germany). The responsib
5、le German body involved in its preparation was the Normenausschuss Feinmechanik und Optik (Optics and Precision Mechanics Standards Committee). The DIN Standards corresponding to the International Standards referred to in Clause 2 of this document are as follows: ISO 15004-1 DIN EN ISO 15004-1 ISO 1
6、5004-2 DIN EN ISO 15004-2 IEC 60601-1 DIN EN 60601-1 In Germany, use of the symbol “dpt” for dioptre (expressed in m1) is legally required and this symbol is to be used rather than the symbol “D” used in other countries. Amendments This standard differs from DIN EN ISO 10943:2006-08 as follows: a) a
7、dditional information concerning the necessary use of a condensing lens when testing for compliance with light hazard requirements has been included in Subclause 4.4, second paragraph, and list item e) of Clause 6; b) the normative reference to DIN EN ISO 15004-2 has been updated; c) the revised sta
8、ndard EN ISO 10943:2011 has been adopted. Previous editions DIN EN ISO 10943: 1998-06, 2006-08 DIN EN ISO 10943:2011-11 3 National Annex NA (informative) Bibliography DIN EN 60601-1 (VDE 0750-1), Medical electrical equipment Part 1: General requirements for basic safety and essential performance DIN
9、 EN ISO 15004-1, Ophthalmic instruments Fundamental requirements and test methods Part 1: General requirements applicable to all ophthalmic instruments DIN EN ISO 15004-2, Ophthalmic instruments Fundamental requirements and test methods Part 2: Light hazard protection DIN EN ISO 10943:2011-11 4 This
10、 page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 10943 August 2011 ICS 11.040.70 Supersedes EN ISO 10943:2006English Version Ophthalmic instruments - Indirect ophthalmoscopes (ISO 10943:2011) Instruments ophtalmiques - Ophtalmoscopes indirects (ISO 10943:2011) Op
11、hthalmische Instrumente - Indirekte Ophthalmoskope (ISO 10943:2011) This European Standard was approved by CEN on 14 August 2011. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standa
12、rd without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application 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
13、 other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Repub
14、lic, 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 STANDARDIZATION COMIT EUROPEN DE
15、NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2011 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 10943:2011: EEN ISO 10943:2011 (E) 2 Contents PageForeword31 Scope 42 Normat
16、ive references 43 Terms and definitions .44 Requirements.54.1 General54.2 Optical and dimensional requirements .54.3 Construction and function64.4 Optical radiation hazard with indirect ophthalmoscopes .65 Test methods: Optical, mechanical and functional requirements76 Accompanying documents.77 Mark
17、ing .7DIN EN ISO 10943:2011-11 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 CEN/TC 170 “Ophthalmic optics”, the secretariat of which is held by DIN. This Europea
18、n 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 the latest by February 2012. Attention is drawn to the possibility that some of the elem
19、ents 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 the CEN/CENELEC Internal Regulations, the national standards organizations of the follow
20、ing 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, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovak
21、ia, 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. DIN EN ISO 10943:2011-11 EN ISO 10943:2011 (E) 4 1 Scope This International Standard, together with ISO 15004-1 and
22、 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 ISO 15004-2, if differences exist. This International
23、 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 ophthalmoscopes primarily intended for image capture and/or
24、 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 references, the latest edition of the referenced document
25、(including any amendments) applies. ISO 15004-1, Ophthalmic instruments Fundamental requirements and test methods Part 1: General requirements applicable to all ophthalmic instruments ISO 15004-2:2007, Ophthalmic instruments Fundamental requirements and test methods Part 2: Light hazard protection I
26、EC 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 instrument used to examine the external and internal
27、parts of the eye, particularly the media and the fundus 3.2 indirect ophthalmoscope optical instrument, 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 ima
28、ge that is viewed by an observer NOTE Indirect ophthalmoscopes may be monocular or binocular. DIN EN ISO 10943:2011-11 EN ISO 10943:2011 (E) 5 3.3 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
29、 Requirements 4.1 General The indirect ophthalmoscope shall conform to the requirements specified 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
30、 requirements The requirements specified in Table 1, Table 2 and Table 3 shall apply. Table 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 viewa
31、b100 mm Diameter of largest illuminated spota45 mm Range of adjustment of headband circumference, 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
32、systems Criterion Requirement Distance of focal point from end of instrument 15 mm to 20 mm 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 DIN EN ISO 10943:2011-11 EN ISO 10943:2011 (E) 6 Table 3 Requirements for opt
33、ical accuracy for binocular indirect ophthalmoscopes Criterion Tolerance 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
34、optical systems horizontal convergence in parallel systems; in convergent 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
35、 minimum adjustable range of the light 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 wit
36、hin 1 vertically. 4.3.4 For binocular 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 op
37、hthalmoscopes This clause replaces 10.4, 10.5, 10.6 and 10.7 of IEC 60601-1:2005. 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 instrumen
38、t. This lens shall be positioned from the reflecting surface of the indirect 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.
39、The applicable clauses of ISO 15004-2:2007 for indirect ophthalmoscopes are 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 requi
40、rements; 3) if status is determined not to be Group 1, the additional requirements 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. DIN EN ISO 10943:2011-11 EN ISO 10943:2011 (E) 7 5
41、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
42、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 us
43、e. In particular this information shall contain: a) name 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
44、 60601-1:2005; d) a reference to this International Standard (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 manufacturer or supplier; b) name and model of indirect ophthalmoscope; c) marking as required by IEC 60601-1. DIN EN ISO 10943:2011-11
