DIN EN ISO 12867-2010 Ophthalmic instruments - Trial frames (ISO 12867 2010) German version EN ISO 12867 2010《眼科仪器 试镜架(ISO 12867-2010) 德文版本EN ISO 12867-2010》.pdf

1、November 2010 Translation by DIN-Sprachendienst.English price group 8No 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!$l1“1731499www.din.deDDIN EN ISO 12867Ophthalmic instruments Trial frames (ISO 12867:2010)English translation of DIN EN ISO 12867:2010-11Ophthalmische Instrumente Refraktionsbrillen (ISO 12867:2010)Englische bersetzung von DIN EN ISO 12867:2010-11Instruments ophtalmiques Montures dessai

3、(ISO 12867:2010)Traduction anglaise de DIN EN ISO 12867:2010-11SupersedesDIN EN ISO 12867:1998-08www.beuth.deDocument comprises pagesIn case of doubt, the German-language original shall be considered authoritative.1211.10 DIN EN ISO 12867:2010-11 2 A comma is used as the decimal marker. National for

4、eword This standard has been prepared by Technical Committee ISO/TC 172 “Optics and photonics”, Subcommittee SC 7 “Ophthalmic optics and instruments” (Secretariat: DIN, Germany) in collaboration with Technical Committee CEN/TC 170 “Ophthalmic optics” (Secretariat: DIN, Germany). The responsible Germ

5、an 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 NA 027-01-08-06 AK Ophthalmische Instrumente. The DIN Standards corresponding to the International Stan

6、dards referred to in Clause 2 of this document are as follows: ISO 8429 DIN EN ISO 8429 ISO 9801 DIN EN ISO 9801 ISO 15004-1 DIN EN ISO 15004-1 Amendments This standard differs from DIN EN ISO 12867:1998-08 as follows: a) normative references have been updated; b) the text of ISO 12867:2010 has been

7、 adopted in its entirety. Previous editions DIN EN ISO 12867: 1998-08 National Annex NA (informative) Bibliography DIN EN ISO 8429, Optics and optical instruments Ophthalmology Graduated dial scale DIN EN ISO 9801, Ophthalmic instruments Trial case lenses DIN EN ISO 15004-1, Ophthalmic instruments F

8、undamental requirements and test methods Part 1: General requirements applicable to all ophthalmic instruments 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) Ins

9、truments ophtalmiques - Montures dessai (ISO 12867:2010) 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

10、 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 to the CEN Management Centre or to any CEN member. This European Standard exists in three official versions (

11、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 Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulg

12、aria, Croatia, 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 United Kingdom. EUROPEAN COMMITTEE FOR

13、 STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES 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: EContents EN ISO 12867:2010 (E

14、) DIN EN ISO 12867:2010-11 2 Page Foreword3 1 Scope 4 2 Normative references 4 3 Terms and definitions .4 4 Requirements.5 4.1 General5 4.2 Mechanical requirements5 4.2.1 General5 4.2.2 Lens holders.5 4.2.3 Interpupillary distance 5 4.2.4 Lens rotation 5 4.2.5 Sides .5 4.2.6 Bridge piece adjustment

15、.5 4.2.7 Axis scale .6 4.2.8 Lens holder alignment 6 4.2.9 Dimensions and tolerances 6 4.2.10 Construction.6 4.3 Materials .6 5 Test methods6 5.1 General6 5.2 Checking of mechanical requirements6 5.3 Checking of parallelism of geometrical axes of lens holders.7 5.4 Checking of coincidence of lens ho

16、lder planes .7 6 Accompanying documents.7 7 Marking .7 Annex A (informative) Examples of test methods for checking parallelism of geometrical axes of lens holders8 A.1 Method 1: checking parallelism of geometrical axes with a collimated telescope.8 A.2 Method 2: checking parallelism of geometrical a

17、xes using a laser .9 Bibliography 10 Foreword This document (EN ISO 12867:2010) 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

18、 given the status of a national standard, either by publication of an identical 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 docume

19、nt 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 12867:1998. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are b

20、ound 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, Slovakia, Slovenia, Spain

21、, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 12867:2010 has been approved by CEN as a EN ISO 12867:2010 without any modification. EN ISO 12867:2010 (E) DIN EN ISO 12867:2010-11 3 1 Scope This International Standard, together with ISO 15004-1, specifies minimum req

22、uirements 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 optical correction of vision. This International Standard is applicable to lens holders mounted on headbands, bracket-mounte

23、d 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 rotating lens holders. This International Standard is not applicable to refractor heads (see ISO 10341). This Internation

24、al 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, only the edition cited applies. For undated references, the latest edition of the referenced do

25、cument (including any amendments) applies. ISO 8429, Optics and optical instruments Ophthalmology Graduated dial scale ISO 9801, Ophthalmic instruments Trial case lenses ISO 15004-1:2006, Ophthalmic instruments Fundamental requirements and test methods Part 1: General requirements applicable to all

26、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 lens holders and means for holding them in a required position in front of the subjects eyes 3.2 reduced-aperture trial

27、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 lenses EN ISO 12867:2010 (E) DIN EN ISO 12867:2010-11 4 3.4 half-eye trial frame trial frame whose lens holders consi

28、st 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 case 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 wit

29、h, 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 shall conform to the requirements specified in ISO 15004-1:2006, except Clauses 5 and 6. 4.2 Mechanical requirements 4.2.1 General The tri

30、al 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 frame shall have the means of positioning each of two lens holders, one before each eye of the subject. Each lens holder shall have the mean

31、s 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 Interpupillary distance The spacing of the centres of the lens holders shall be adjustable to coincide with the interpupillary distance, and t

32、o 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 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

33、 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. EN ISO 12867:2010 (E) DIN EN ISO 12867:2010-11 5 4.2.7 Axis scale The trial frame shall have a scale indicating cylinder axis and prism base for e

34、ach lens holder. It shall extend to at least 180. The scale direction shall increase from the horizontal, anticlockwise, in accordance with ISO 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; th

35、e 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 range, minimum aperture and lens rotation for lens holders. Table 1 Range and minimum aperture Parameter Full and reduced apertures Half-eye Interpupillary

36、 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 range 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, t

37、he 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 laterally 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 coul

38、d 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 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 use

39、d as intended by the manufacturer. Materials used in the construction shall be of noncorrosive composition or suitably surface-treated to render them noncorrosive in clinical atmospheric conditions. 5 Test methods 5.1 General All tests described in this International Standard are type tests. 5.2 Che

40、cking of mechanical requirements The requirements of 4.2.2 to 4.2.7 and 4.2.10 shall be checked by observation. EN ISO 12867:2010 (E) DIN EN ISO 12867:2010-11 6 5.3 Checking of parallelism of geometrical axes of lens holders Any suitable method capable of measuring the parallelism of the geometrical

41、 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 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

42、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, 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

43、 with an accuracy of 0,1 mm or better. 6 Accompanying documents The trial frame shall be accompanied by documents containing 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, wi

44、th particular reference to the disinfection of trial frames returned to the manufacturer for repair and maintenance; c) model 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 sh

45、all be permanently marked with at least the name of the manufacturer or supplier. EN ISO 12867:2010 (E) DIN EN ISO 12867:2010-11 7 Annex 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

46、 collimated telescope Insert a plane mirror (M) (e.g. of diameter 38 mm) into each lens holder (LH) (see Figure 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 f

47、irst mirrored disc, then move and direct it towards the second and measure the displacement of the light sources (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 auxilia

48、ry means to determine the relative and actual displacement of the lens holders.) Key A arm M plane mirror LH lens holder AT autocollimation telescope LS light source CH cross-hair Figure A.1 Test configuration for checking parallelism of holders EN ISO 12867:2010 (E) DIN EN ISO 12867:2010-11 8 A.2 M

49、ethod 2: checking parallelism of geometrical axes using a laser NOTE Precautions should 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 away 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