1、January 2010DEUTSCHE NORM English price group 8No part of this standard 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).ICS 11.040.70!$Mc“1564264ww
2、w.din.deDDIN EN ISO 10944Ophthalmic instruments Synoptophores (ISO 10944:2009)English version of DIN EN ISO 10944:2010-01Ophthalmische Instrumente Synoptophore (ISO 10944:2009)Englische Fassung DIN EN ISO 10944:2010-01SupersedesDIN EN ISO 10944:1998-06www.beuth.deDocument comprises 11 pagesDIN EN IS
3、O 10944:2010-01 2 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” (Secretariat: DIN, Germany). The responsible Ge
4、rman body involved in its preparation was the Normenausschuss Feinmechanik und Optik (Optics and Precision Mechanics Standards Committee), Working Committee NA 027-01-08 AA Augenoptik, Working Group Ophthalmische Instrumente. The DIN Standards corresponding to the International Standards referred to
5、 in this document are as follows: ISO 15004-1 DIN EN ISO 15004-1 IEC 60601-1 DIN EN 60601-1 Amendments This standard differs from DIN EN ISO 10944:1998-06 as follows: a) Normative references have been updated. b) The standard has been editorially revised. c) The revised International Standard ISO 10
6、944:2009 has been adopted. Previous editions DIN EN ISO 10944: 1998-06 National Annex NA (informative) Bibliography DIN EN 60601-1, Medical electrical equipment Part 1: General requirements for basic safety and essential performance DIN EN ISO 9801, Ophthalmic instruments Trial case lenses DIN EN IS
7、O 15004-1, Ophthalmic instruments Fundamental requirements and test methods Part 1: General requirements applicable to all ophthalmic instruments 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 othe
8、r countries. EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 10944August 2009ICS 11.040.70 Supersedes EN ISO 10944:1998 English VersionOphthalmic instruments - Synoptophores (ISO 10944:2009)Instruments ophtalmiques - Synoptophores (ISO10944:2009)Ophthalmische Instrumente - Synoptophore (ISO109
9、44:2009)This European Standard was approved by CEN on 31 July 2009.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 alteration. Up-to-date lists and bibliographical
10、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 translationunder the responsibility of a CEN membe
11、r 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, Greece, Hungary, Iceland, Ireland, Italy, Latv
12、ia, 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 NORMUNGManagement Centre: Avenue Marnix 17, B-1000 Brussels 20
13、09 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 10944:2009: EContents Page Foreword .3 1 Scope4 2 Normative references4 3 Terms and definitions .4 4 Requirements.5 4.1 General .5 4.2 Optical and mechanical requirements 5 4.3 C
14、onstruction and functional requirements.6 5 Test methods .6 5.1 General .6 5.2 Checking the optical, mechanical and functional requirements6 5.3 Checking the interpupillary distance 7 5.4 Checking the axes alignment7 5.5 Checking the chin-rest height8 6 Accompanying documents 8 7 Marking.8 Bibliogra
15、phy9 2 DIN EN ISO 10944:2010-01 EN ISO 10944:2009 (E) Foreword 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 2010, and conflicting national standards shall be with
16、drawn at the latest by February 2010. 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 10944:1998. Acco
17、rding to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latv
18、ia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 10944:2009 has been approved by CEN as a EN ISO 10944:2009 without any modification. 3 DIN EN ISO 10944:2010-01
19、EN ISO 10944:2009 (E) This document (EN ISO 10944:2009) 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 1 Scope This International Standard, together with ISO 15004-1, specifies mi
20、nimum requirements and test methods for synoptophores (also called major amblyoscopes or synoptometers) used to test, measure, train and develop the patients binocular vision and to measure horizontal, vertical and cyclo deviation in different positions of gaze. This International Standard takes pre
21、cedence over ISO 15004-1, if differences exist. 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
22、 amendments) applies. ISO 15004-1:2006, Ophthalmic instruments Fundamental requirements and test methods Part 1: General requirements applicable to all ophthalmic instruments IEC 60601-1:2005, Medical electrical equipment Part 1: General requirements for basic safety and essential performance 3 Term
23、s and definitions For the purposes of this document, the following terms and definitions apply. 3.1 synoptophore instrument designed to present interchangeable targets to each eye and with the ability to move targets independently in order to present them at different versional and vergence position
24、s NOTE Target configuration and location along with other instrument features are used to test, measure and train binocular vision. 3.2 visual targets for simultaneous perception targets used to form two different images, one on each retina, which cannot be fused into a single image 3.3 visual targe
25、ts for fusion targets used to form two similar images, one on each retina, which are capable of being fused, and in which control points are often incorporated in order to assess if either eye is suppressing the relevant image 3.4 visual targets for stereoscopic vision targets used to test and/or me
26、asure stereoscopic acuity in which image pairs, having common reference points, are fused in vision to give a stereoscopic effect 4 DIN EN ISO 10944:2010-01 EN ISO 10944:2009 (E) 3.5 arm rotatable structural member of the synoptophore intended to carry the ocular systems, targets and illumination sy
27、stem 4 Requirements 4.1 General The synoptophore shall conform to the requirements specified in ISO 15004-1. The synoptophore shall conform to the specific requirements described in 4.2 and 4.3. These requirements shall be verified as described in Clause 5. 4.2 Optical and mechanical requirements Th
28、e requirements specified in Table 1 and Table 2 shall apply. Table 1 Requirements for adjustment ranges and graduation of scales Criterion Requirement adjustable range 45 mm to 75 mm Interpupillary distance graduation 1 mm outwardly 40 inwardlyHorizontal movement of each arm independently graduation
29、 1 or 2aangle of elevation 15 Vertical rotation of each arm independently angle of depression 20 clockwise range 20 anti-clockwise range 20 Torsional movement of visual targets (cyclo-) graduation 1 Chin-rest height adjustable range from chin-rest top to eyepiece centres 75 mm to 125 mm a = prism di
30、optre equivalent correction at the patients eye. The actual linear tolerance will depend on the optical path length of the ocular arms. Table 2 Adjustment tolerances Interpupillary distance setting 0,5 mm Lateral alignment of targets at zero setting 0,5 or 1aVertical alignment of targets at zero set
31、ting 0,125 or 0,25aTorsional alignment of targets at zero setting 0,5 vertically 10 laterally 0,5 Alignment of targets throughout the horizontal movement range with both arms locked together torsionally 10 aThe tolerances given are expressed in degrees when the scale is graduated in degrees, and in
32、prism dioptres when graduated in prism dioptres. 5 DIN EN ISO 10944:2010-01 EN ISO 10944:2009 (E) 4.3 Construction and functional requirements 4.3.1 The synoptophore shall be constructed so that it is possible to compensate for the patients refractive error. If designed to be used with trial case le
33、nses (see ISO 9801), the lens holder shall enable the trial case lens to be positioned with an error of not more than 0,5 mm relative to the optical axis of the eyepiece. 4.3.2 The synoptophore shall allow easy location of visual targets in both left and right ocular systems. The targets shall be ca
34、pable of quick insertion and removal. 4.3.3 The visual targets shall be clearly marked with their identity and orientation. 4.3.4 The luminance of the diffusing screen shall be even and uniform and shall not vary by more than 25 % over the area of the targets. 4.3.5 At maximum illumination settings
35、the average luminance of the right and left diffusing screens shall not differ by more than 20 %. 4.3.6 Each ocular illumination system shall be provided with a variable control to reduce the luminance of the target to 10 % or less of its maximum. 4.3.7 The equipment shall be provided with a means f
36、or switching off either illumination system independently. 4.3.8 The equipment shall be so constructed that the ocular systems together or individually (when not locked) can easily be horizontally rotated, without allowing the arms to move of their own accord. The movement shall be smooth and even.
37、4.3.9 The arms shall be capable of being locked together at a pre-set angle and of being moved together from side to side. 4.3.10 The arms shall be capable of smooth operation independently of one another over the designed range, without affecting the position of the other. 4.3.11 Sets of visual tar
38、gets (slides) shall be available for the execution of tests involving simultaneous perception, fusion and stereoscopic vision (see 3.2 to 3.4). 4.3.12 There shall be no noticeable contrast differences in the visual targets caused by internal reflections or scattered light. 5 Test methods 5.1 General
39、 All tests prescribed in this International Standard are type tests. 5.2 Checking the optical, mechanical and functional requirements 5.2.1 The requirements specified in 4.2 and 4.3 shall be verified by the use of measuring devices with accuracy better than 10 % of the smallest value to be determine
40、d. 5.2.2 For measuring the respective scales for precision, an angle scale measuring instrument (with a measuring precision of 5 or better) shall be used. 5.2.3 The requirements described in 4.3, with the exception of 4.3.4, 4.3.5 and 4.3.6, shall be checked by observation. 6 DIN EN ISO 10944:2010-0
41、1 EN ISO 10944:2009 (E) 5.3 Checking the interpupillary distance Set the axes of the eyepieces parallel. Measure A and B shown in Figure 1, using vernier callipers (having a precision of 0,1 mm or better) and calculate the interpupillary distance, IPD, using the equation: IPD2A B+= Key 1 eyepieces F
42、igure 1 Test configuration for measuring the interpupillary distance 5.4 Checking the axes alignment Insert a pair of cross-wire targets into the instrument. Set the left and right ocular systems at 0 for horizontal, vertical and torsional deviations. Mount +1,00 D test lenses before both eyepieces
43、so that the crosses are projected on to a screen at a distance of 1 m. Vertical or torsional deviations are present if the projected targets cannot be brought to coincidence by converging the tubes. To measure a horizontal deviation, set the two arms parallel (0), and measure the separation of the t
44、wo crosses on the screen. Check that the separation is the same as the interpupillary distance of the synoptophore. See Figure 2. Distances in centimetres Key 1 slides 3 lenses 2 synoptophore arms 4 screen Figure 2 Test configuration for measuring the axes alignment 7 DIN EN ISO 10944:2010-01 EN ISO
45、 10944:2009 (E) 5.5 Checking the chin-rest height Measure the distance from the chin-rest top to the horizontal line through the eyepieces centres, using a calliper with a measuring precision of 0,1 mm or better. 6 Accompanying documents The synoptophore shall be accompanied by documents containing
46、instructions for use. In particular this information shall contain the following: a) name and address of the manufacturer; b) instructions for effective disinfection of the synoptophore with particular reference to the disinfection of instruments returned to the manufacturer for repair and maintenan
47、ce; c) if appropriate, a statement that the synoptophore in its original packaging conforms to the transport conditions as specified in 5.3 of ISO 15004-1:2006; d) any additional documents as specified in 7.9 of IEC 60601-1:2005. 7 Marking The synoptophore shall be permanently marked with at least t
48、he following information: a) name of manufacturer or supplier; b) name and model of synoptophore; c) marking as required by IEC 60601-1; d) a reference to this International Standard, i.e. ISO 10944:2009, if the manufacturer or supplier claims compliance with it. 8 DIN EN ISO 10944:2010-01 EN ISO 10944:2009 (E) Bibliography 1 ISO 9801, Ophthalmic instruments Trial case lenses 9 DIN EN ISO 10944:2010-01 EN ISO 10944:2009 (E)
