EN ISO 12867-2010 en Ophthalmic instruments - Trial frames《眼科仪器 试验架》.pdf

1、BS EN ISO12867:2010ICS 11.040.70NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDOphthalmicinstruments Trial frames (ISO12867:2010)This British Standardwas published under theauthority of the StandardsPolicy and StrategyCommittee on 30 June2010 BSI 2010ISBN 978 0

2、 580 68837 9Amendments/corrigenda issued since publicationDate CommentsBS EN ISO 12867:2010National forewordThis British Standard is the UK implementation of EN ISO 12867:2010.It supersedes BS EN ISO 12867:1998 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalComm

3、ittee CH/172/6, Ophthalmic instruments.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisionsof a contract. Users are responsible for its correct application.Compliance with a British

4、Standard cannot confer immunityfrom legal obligations.EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 12867 June 2010 ICS 11.040.70 Supersedes EN ISO 12867:1998English Version Ophthalmic instruments - Trial frames (ISO 12867:2010) Instruments ophtalmiques - Montures dessai (ISO 12867:2010)

5、Ophthalmische Instrumente - Refraktionsbrillen (ISO 12867:2010) This European Standard was approved by CEN on 29 May 2010. 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 standard with

6、out any alteration. Up-to-date lists and bibliographical references concerning such national standards 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

7、 made by translation under the responsibility of a CEN member into its own language and notified to the CEN Management 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,

8、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 NORMALISATION EUROPISCH

9、ES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2010 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 12867:2010: EBS EN ISO 12867:2010EN ISO 12867:2010 (E) 3 Foreword This document (EN ISO 12867:2010)

10、 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 an identical

11、 text or by endorsement, at the latest by December 2010, and conflicting national standards shall be withdrawn at the latest by December 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 re

12、sponsible for identifying any or all such patent rights. This document supersedes EN ISO 12867:1998. 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, Croatia,

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 IS

14、O 12867:2010 has been approved by CEN as a EN ISO 12867:2010 without any modification. BS EN ISO 12867:2010ISO 12867:2010(E) ISO 2010 All rights reserved iiiForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). T

15、he 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-go

16、vernmental, 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 2.

17、 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 v

18、ote. 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 12867 was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC

19、7, Ophthalmic optics and instruments. This second edition cancels and replaces the first edition (ISO 12867:1998), which has undergone minor revision to update the normative references. BS EN ISO 12867:2010BS EN ISO 12867:2010INTERNATIONAL STANDARD ISO 12867:2010(E) ISO 2010 All rights reserved 1Oph

20、thalmic instruments Trial frames 1 Scope This International Standard, together with ISO 15004-1, specifies minimum requirements and test methods for trial frames for holding trial case lenses, complying with ISO 9801, in front of a subjects eyes in order to assess visual acuity and facilitate optica

21、l correction of vision. This International Standard is applicable to lens holders mounted on headbands, bracket-mounted frames and frames mounted in the manner of spectacles with supports on the ears and the bridge of the nose. It is applicable to all types of trial frame, including half-eye and rot

22、ating lens holders. This International Standard is not applicable to refractor heads (see ISO 10341). 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.

23、 For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 8429, Optics and optical instruments Ophthalmology Graduated dial scale ISO 9801, Ophthalmic instruments Trial case lenses ISO 15004-1:

24、2006, Ophthalmic instruments Fundamental requirements and test methods Part 1: General requirements applicable to all ophthalmic instruments 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 trial frame frame consisting of two interconnected le

25、ns holders and means for holding them in a required position in front of the subjects eyes 3.2 reduced-aperture trial frame trial frame designed to hold reduced-aperture trial lenses 3.3 full-aperture trial frame trial frame designed to hold both full-aperture trial lenses and reduced-aperture trial

26、 lenses BS EN ISO 12867:2010ISO 12867:2010(E) 2 ISO 2010 All rights reserved3.4 half-eye trial frame trial frame whose lens holders consist of the lower half-segment only and which are designed to hold full- or reduced-aperture trial lenses 3.5 lens holder unit designed to hold a number of trial cas

27、e lenses in front of one eye 3.6 bridge piece part of the mounting which supports the trial frame on, and part of which is in contact with, the subjects nose 3.7 side part of the trial frame which uses the subjects ear to retain the frame against the face 4 Requirements 4.1 General The trial frame s

28、hall conform to the requirements specified in ISO 15004-1:2006, except Clauses 5 and 6. 4.2 Mechanical requirements 4.2.1 General The trial frame shall conform to the requirements specified in 4.2.2 to 4.2.10. These requirements are verified as specified in Clause 5. 4.2.2 Lens holders The trial fra

29、me shall have the means of positioning each of two lens holders, one before each eye of the subject. Each lens holder shall have the means of retaining in position a combination of at least three lenses, each in a separate compartment spaced along the geometrical axis of the lens holder. 4.2.3 Inter

30、pupillary distance The spacing of the centres of the lens holders shall be adjustable to coincide with the interpupillary distance, and to maintain the lenses in position. 4.2.4 Lens rotation It shall be possible to rotate one lens in each holder smoothly about its optical axis (see Table 1). 4.2.5

31、Sides The sides, if not adjustable, shall be parallel in a vertical direction. 4.2.6 Bridge piece adjustment The bridge piece shall be so constructed as to enable the vertex distance to be varied, and the centre of the lenses to be raised or lowered with respect to the interpupillary line. BS EN ISO

32、 12867:2010ISO 12867:2010(E) ISO 2010 All rights reserved 34.2.7 Axis scale The trial frame shall have a scale indicating cylinder axis and prism base for each lens holder. It shall extend to at least 180. The scale direction shall increase from the horizontal, anticlockwise, in accordance with ISO

33、8429. The scale divisions shall be no greater than 5. 4.2.8 Lens holder alignment The geometrical axes of the lens holders shall be parallel to within 2; the relative axial displacement of the lens holders shall be no more than 0,5 mm. 4.2.9 Dimensions and tolerances Table 1 gives the interpupillary

34、 range, minimum aperture and lens rotation for lens holders. Table 1 Range and minimum aperture Parameter Full and reduced apertures Half-eye Interpupillary distance range 55 mm to 75 mm 59 mm to 67 mm Minimum clear aperture 20 mm 20 mm Minimum lens rotation 180 180 NOTE Interpupillary distance rang

35、e for childrens trial frames is not included. The lens holders shall be so arranged that when trial lenses in accordance with ISO 9801 are placed in them, the lens axes shall be parallel within 2,5 and shall coincide within a tolerance circle of 1 mm diameter. The lenses shall not be able to move la

36、terally or axially within 0,2 mm of their central position. 4.2.10 Construction The trial frame shall contain no surfaces, sharp edges or corners which could cause injury to the subject under normal conditions of use. 4.3 Materials Components of the trial frame which are designed to come into direct

37、 contact with the skin of the patient or user shall be made of materials that are neither toxic nor known to create significant allergic reactions, when used as intended by the manufacturer. Materials used in the construction shall be of noncorrosive composition or suitably surface-treated to render

38、 them noncorrosive in clinical atmospheric conditions. 5 Test methods 5.1 General All tests described in this International Standard are type tests. 5.2 Checking of mechanical requirements The requirements of 4.2.2 to 4.2.7 and 4.2.10 shall be checked by observation. BS EN ISO 12867:2010ISO 12867:20

39、10(E) 4 ISO 2010 All rights reserved5.3 Checking of parallelism of geometrical axes of lens holders Any suitable method capable of measuring the parallelism of the geometrical axes to an accuracy of 0,5 or better may be used. Examples are given in Annex A. 5.4 Checking of coincidence of lens holder

40、planes Any suitable method capable of measuring the distance between the lens holders planes to an accuracy of 0,1 mm or better may be used. A suitable method of carrying out the test is, for example, to fit one of the discs (see Figure A.1) with an arm (A) parallel to, and at a known distance from,

41、 the discs plane, and long enough to reach the geometrical axis of the lens holder. Measure the distance between the arm and the disc in the other lens holder using a calliper with an accuracy of 0,1 mm or better. 6 Accompanying documents The trial frame shall be accompanied by documents containing

42、instructions for use. In particular, this information shall include: a) name and address of the manufacturer; b) instructions for effective disinfection of the trial frame, with particular reference to the disinfection of trial frames returned to the manufacturer for repair and maintenance; c) model

43、 of trial frame, if applicable; d) a reference to this International Standard, i.e. ISO 12867:2010, if the manufacturer claims compliance with it. 7 Marking The trial frame shall be permanently marked with at least the name of the manufacturer or supplier. BS EN ISO 12867:2010ISO 12867:2010(E) ISO 2

44、010 All rights reserved 5Annex A (informative) Examples of test methods for checking parallelism of geometrical axes of lens holders A.1 Method 1: checking parallelism of geometrical axes with a collimated telescope Insert a plane mirror (M) (e.g. of diameter 38 mm) into each lens holder (LH) (see F

45、igure A.1). Use an autocollimation telescope (AT) mounted on a slide in order to move it perpendicular to the geometrical axis of one lens holder. Align the telescope when directed towards the first mirrored disc, then move and direct it towards the second and measure the displacement of the light s

46、ources (LS) image in the cross-hair (CH) plane of the telescope. From this displacement, calculate the angular deviation from parallel. (In Figure A.1, “A” indicates an arm serving as an auxiliary means to determine the relative and actual displacement of the lens holders.) Key A arm M plane mirror

47、LH lens holder AT autocollimation telescope LS light source CH cross-hair Figure A.1 Test configuration for checking parallelism of holders BS EN ISO 12867:2010ISO 12867:2010(E) 6 ISO 2010 All rights reservedA.2 Method 2: checking parallelism of geometrical axes using a laser NOTE Precautions should

48、 be taken when using the laser. Insert plane mirrors (M) (e.g. of diameter 38 mm) into each lens holder (LH) (see Figure A.2). Arrange an optical laser (L) (e.g. HeNe) so that its beam impinges at an incident angle of 30 on to the mirror in one lens holder. Attach to the laser a screen (S) 1,15 m aw

49、ay from the laser axis (LA), as shown in Figure A.2. Mount the laser and screen on a slide in order for it to be able to travel perpendicularly to the geometrical axis of the first lens holder. Ensure that the screen is 1 m from the plane mirror. Adjust the screen (see Figure A.3) so that the reflected beam shines on the centre of the cross. Now move the laser and screen on its slide so that the beam impinges on the second mirror. Check that the reflected beam falls within the 25,6 mm diameter circle, i.e. that the plane