EN ISO 10944-2009 en Ophthalmic instruments - Synoptophores《眼科器械 斜视诊疗器》.pdf

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1、BS EN ISO10944:2009ICS 11.040.70NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDOphthalmicinstruments Synoptophores (ISO10944:2009)This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 August 2009 BSI 2009IS

2、BN 978 0 580 65286 8Amendments/corrigenda issued since publicationDate CommentsBS EN ISO 10944:2009National forewordThis British Standard is the UK implementation of EN ISO 10944:2009. It is identical to ISO 10944:2009. It supersedes BS EN ISO 10944:1998 which is withdrawn.The UK participation in it

3、s preparation was entrusted to Technical Committee CH/172/6, Ophthalmic instruments.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its

4、 correct application.Compliance with a British Standard cannot confer immunity from legal obligations.EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 10944August 2009ICS 11.040.70 Supersedes EN ISO 10944:1998 English VersionOphthalmic instruments - Synoptophores (ISO 10944:2009)Instruments oph

5、talmiques - Synoptophores (ISO10944:2009)Ophthalmische Instrumente - Synoptophore (ISO10944:2009)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 st

6、atus of a national standard without any alteration. Up-to-date lists and bibliographical 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

7、 version in any other language made by translationunder the responsibility of a CEN member 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,

8、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 STANDARDIZATIONCOMIT EUROPEN DE NORMALISA

9、TIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 10944:2009: EBS EN ISO 10944:2009EN ISO 10944:2009 (E) 3 Foreword This document (EN ISO 1

10、0944:2009) 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 which is held by DIN. This European Standard shall be given the status of a national standard, either by publication of a

11、n identical text or by endorsement, at the latest by February 2010, and conflicting national standards shall be withdrawn 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

12、 be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 10944:1998. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria

13、, 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 the United Kingdom. Endorsement notice The text of

14、ISO 10944:2009 has been approved by CEN as a EN ISO 10944:2009 without any modification. BS EN ISO 10944:2009ISO 10944:2009(E) ISO 2009 All rights reserved iiiForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies).

15、 The work of preparing International Standards is normally carried out through ISO technical 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-

16、governmental, in liaison with ISO, also take part in the work. ISO collaborates closely 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

17、2. The main task of technical committees is to prepare International Standards. Draft 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

18、 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 responsible for identifying any or all such patent rights. ISO 10944 was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee S

19、C 7, Ophthalmic optics and instruments. This second edition cancels and replaces the first edition (ISO 10944:1998), which has undergone minor revision in order to update normative references. BS EN ISO 10944:2009BS EN ISO 10944:2009INTERNATIONAL STANDARD ISO 10944:2009(E) ISO 2009 All rights reserv

20、ed 1Ophthalmic instruments Synoptophores 1 Scope This International Standard, together with ISO 15004-1, specifies minimum 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 m

21、easure horizontal, vertical and cyclo deviation in different positions of gaze. This International Standard takes precedence 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,

22、 only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 15004-1:2006, Ophthalmic instruments Fundamental requirements and test methods Part 1: General requirements applicable to all ophthalmic instruments IEC 6060

23、1-1:2005, 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 synoptophore instrument designed to present interchangeable targets to each eye and

24、 with the ability to move targets independently in order to present them at different versional and vergence positions 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 targ

25、ets used to form two different images, one on each retina, which cannot be fused into a single image 3.3 visual targets 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 e

26、ither eye is suppressing the relevant image 3.4 visual targets for stereoscopic vision targets used to test and/or measure stereoscopic acuity in which image pairs, having common reference points, are fused in vision to give a stereoscopic effect BS EN ISO 10944:2009ISO 10944:2009(E) 2 ISO 2009 All

27、rights reserved3.5 arm rotatable structural member of the synoptophore intended to carry the ocular systems, targets and illumination system 4 Requirements 4.1 General The synoptophore shall conform to the requirements specified in ISO 15004-1. The synoptophore shall conform to the specific requirem

28、ents described in 4.2 and 4.3. These requirements shall be verified as described in Clause 5. 4.2 Optical and mechanical requirements The requirements specified in Table 1 and Table 2 shall apply. Table 1 Requirements for adjustment ranges and graduation of scales Criterion Requirement adjustable ra

29、nge 45 mm to 75 mm Interpupillary distance graduation 1 mm outwardly 40 inwardly 40 Horizontal movement of each arm independently graduation 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 o

30、f visual targets (cyclo-) graduation 1 Chin-rest height adjustable range from chin-rest top to eyepiece centres 75 mm to 125 mm a = prism dioptre equivalent correction at the patients eye. The actual linear tolerance will depend on the optical path length of the ocular arms. Table 2 Adjustment toler

31、ances Interpupillary distance setting 0,5 mm Lateral alignment of targets at zero setting 0,5 or 1aVertical alignment of targets at zero setting 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

32、with both arms locked together torsionally 10 aThe tolerances given are expressed in degrees when the scale is graduated in degrees, and in prism dioptres when graduated in prism dioptres. BS EN ISO 10944:2009ISO 10944:2009(E) ISO 2009 All rights reserved 34.3 Construction and functional requirement

33、s 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 lenses (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

34、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 capable of quick insertion and removal. 4.3.3 The visual targets shall be clearly marked with their identity and orientation. 4.3.4 The luminan

35、ce 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 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

36、 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 for switching off either illumination system independently. 4.3.8 The equipment shall be so constructed that the ocular systems together or in

37、dividually (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. 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 sh

38、all 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 targets (slides) shall be available for the execution of tests involving simultaneous perception, fusion and stereoscopic vision (see 3.2 to 3.4

39、). 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 All tests prescribed in this International Standard are type tests. 5.2 Checking the optical, mechanical and functional requirements 5.2.1 T

40、he 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 determined. 5.2.2 For measuring the respective scales for precision, an angle scale measuring instrument (with a measuring precision of 5 or better) s

41、hall 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. BS EN ISO 10944:2009ISO 10944:2009(E) 4 ISO 2009 All rights reserved5.3 Checking the interpupillary distance Set the axes of the eyepieces parallel. Measure A and B s

42、hown 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 Figure 1 Test configuration for measuring the interpupillary distance 5.4 Checking the axes alignment Insert a pair of cros

43、s-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 so that the crosses are projected on to a screen at a distance of 1 m. Vertical or torsional deviations are present if the

44、 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 two crosses on the screen. Check that the separation is the same as the interpupillary distance of the synoptophore. See Fi

45、gure 2. Distances in centimetres Key 1 slides 3 lenses 2 synoptophore arms 4 screen Figure 2 Test configuration for measuring the axes alignment BS EN ISO 10944:2009ISO 10944:2009(E) ISO 2009 All rights reserved 55.5 Checking the chin-rest height Measure the distance from the chin-rest top to the ho

46、rizontal 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 instructions for use. In particular this information shall contain the following: a) name and address o

47、f 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 maintenance; c) if appropriate, a statement that the synoptophore in its original packaging conforms to the tran

48、sport 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 the following information: a) name of manufacturer or supplier; b) name and model of synoptophore; c) ma

49、rking 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. BS EN ISO 10944:2009ISO 10944:2009(E) 6 ISO 2009 All rights reservedBibliography 1 ISO 9801, Ophthalmic instruments Trial case lenses BS EN ISO 10944:2009BS EN ISO10944:2009BSI GroupHeadquarters 389Chiswick High Road,London, W4 4AL, UKTel +44 (0)20 8996 9001Fax +44 (0)20 8996 - British Standards