DIN EN ISO 12866-2009 Ophthalmic instruments - Perimeters (ISO 12866 1999+Amd1 2008) (includes Corrigendum AC 2000+Amendment A1 2008) English version of DIN EN ISO 12866 2009-03《眼科.pdf

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1、March 2009DEUTSCHE NORM English price group 11No 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!$VW%“1515202ww

2、w.din.deDDIN EN ISO 12866SupersedesDIN EN ISO 12866:2000-03www.beuth.deDocument comprises 18 pagesOphthalmic instruments Perimeters (ISO 12866:1999+Amd.1:2008) (includes Corrigendum AC:2000+Amendment A1:2008) English version of DIN EN ISO 12866:2009-03 Ophthalmische Instrumente Perimeter (ISO 12866:

3、1999+Amd.1:2008) (enthlt Berichtigung AC:2000+ nderung A1:2008) Englische Fassung DIN EN ISO 12866:2009-03 DIN EN ISO 12866:2009-03 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 c

4、ollaboration with Technical Committee CEN/TC 170 “Ophthalmic optics” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the Normenausschuss Feinmechanik und Optik (Optics and Precision Mechanics Standards Committee). This standard is the consolidated version of

5、ISO 12866:1999. It incorporates Amendment ISO 12866:1999/Amd.1:2008. The start and finish of text introduced or altered by amendment is indicated in the text by tags !“. The DIN Standards corresponding to the International Standards referred to in clause 2 of the EN are as follows: ISO 15004-1 DIN E

6、N ISO 15004-1 IEC 60601-1 DIN EN 60601-1 IEC 60601-1-1 DIN EN 60601-1-1 Amendments This standard differs from DIN EN ISO 12866:2000-03 as follows: a) Clause 2 “Normative references” has been updated. b) Subclauses 4.4.3 to 4.4.6 have been added. c) Clause 6 “Accompanying documents” has been revised.

7、 d) Annex C “Minimum requirements for a normative database” has been added. e) Amendment EN ISO 12866:1999/A1:2008 (ISO 12866:1999/Amd.1:2008) has been incorporated. Previous editions DIN EN ISO 12866: 2000-03 National Annex NA (informative) Bibliography DIN EN 60601-1, Medical electrical equipment

8、Part 1: General requirements for basic safety and essential performance DIN EN 60601-1-1, Medical electrical equipment Part 1: General requirements for safety; 1. collateral standard: Safety requirements for medical electrical systems DIN EN ISO 15004-1, Ophthalmic instruments Fundamental requiremen

9、ts and test methods Part 1: General requirements applicable to all ophthalmic instruments EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 12866 June 1999 +AC +A1 January 2000 November 2008 ICS 13.340.30 English version Ophthalmic instruments Perimeters (ISO 12866:1999+Amd.1:2008) Instrument

10、s ophtalmiques Primtres (ISO 12866:1999+Amd.1:2008) Ophthalmische Instrumente Perimeter (ISO 12866:1999+Amd.1:2008) EN ISO 12866 was approved by CEN on 1999-05-13, Corrigendum AC:2000 on 2000-01-20 and Amendment A1 on 2008-11-29. CEN members are bound to comply with the CEN/CENELEC Internal Regulati

11、ons which stipulate the conditions for giving this 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 Management Centre or to any CEN member. The European

12、 Standards exist in three official versions (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 Management Centre has the same status as the official versions. CEN members are the national s

13、tandards bodies of Austria, Belgium, Bulgaria, 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 Unite

14、d Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2008 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. A1:2008 ERef. No. EN ISO

15、 12866:1999+AC:2000+DIN EN ISO 12866:2009-03 EN ISO 12866:1999+AC:2000+A1:2008 (E) 2 Contents Page Foreword to EN ISO 12866:19993 !Foreword to EN ISO 12866:1999/A1:2008 . 3“ 1 Scope 4 2 Normative references 4 3 Terms and definitions .4 4 Requirements.7 4.1 General7 4.2 Specific requirements .7 4.3 K

16、inetic perimeters9 4.4 Static perimeters9 5 Test methods9 5.1 Checking the background luminance9 5.2 Checking stimulus luminance9 5.3 Checking the test stimulus location 9 5.4 Checking the test stimulus size 10 5.5 Checking the stimulus shape 10 5.6 Checking the stimulus duration 10 5.7 Type tests 1

17、0 5.7.1 Projection perimeters. 10 5.7.2 Fixed position stimulus perimeters 10 5.7.3 Checking the mechanical and functional requirements. 10 6 Accompanying documents 11 7 Marking 11 Annex A (informative) Goldmann test stimulus specifications. 12 A.1 Goldmann differential luminances 12 A.2 Goldmann te

18、st stimulus sizes. 12 Annex B (informative) Perimetric coordinate systems. 14 B.1 Reference system (polar coordinates) . 14 B.2 Cartesian coordinate system. 14 !Annex C (normative) Minimum requirements for a normative database. 15“ !Annex ZA (normative) Normative references to international publicat

19、ions with their relevant European publications 16“ DIN EN ISO 12866:2009-03 EN ISO 12866:1999+AC:2000+A1:2008 (E) 3 Foreword to EN ISO 12866:1999 The text of the International Standard ISO 12866:1999 has been prepared by Technical Committee ISO/TC 172 “Optics and optical instruments” in collaboratio

20、n 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 text or by endorsement, at the latest by December 1999, and conflicting national standard

21、s shall be withdrawn at the latest by December 1999. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland,

22、 Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of the International Standard ISO 12866:1999 was approved by CEN as a European Standard without any modification. NOTE: Normative references to International Sta

23、ndards are listed in annex ZA (normative). !Foreword to EN ISO 12866:1999/A1:2008 This document (EN ISO 12866:1999/A1:2008) has been prepared by Technical Committee ISO/TC 172 “Optics and optical instruments” in collaboration with Technical Committee CEN/TC 170 “Ophthalmic optics”, the secretariat o

24、f which is held by DIN. This Amendment to the European Standard EN ISO 12866:1999 shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by May 2009, and conflicting national standards shall be withdrawn at the latest by May 2009

25、. 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. According to the CEN/CENELEC Internal Regulations, the national standards organizati

26、ons 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, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania

27、, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 12866:1999/Amd.1:2008 has been approved by CEN as EN ISO 12866:1999/A1:2008 without any modification.“ DIN EN ISO 12866:2009-03 EN ISO 12866:1999+AC:2000+A1:2008 (E) 4 1 Scope This Internation

28、al Standard specifies requirements and test methods for instruments designed to assess differential light sensitivity in the visual field by the subjective detection of the presence of test stimuli on a defined background. It does not apply to clinical methodologies and other psychophysical tests of

29、 the visual field. This International Standard takes precedence over ISO 15004, if differences exist. 2 Normative references The following normative documents contain provisions which, through reference in this text, constitute provisions of this International Standard. For dated references, subsequ

30、ent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the l

31、atest edition of the normative document referred to applies. Members of ISO and IEC maintain registers of currently valid International Standards. !ISO 15004-1:2006, Ophthalmic instruments Fundamental requirements and test methods Part 1: General requirements applicable to all ophthalmic instruments

32、 IEC 60601-1:2005, Medical electrical equipment Part 1: General requirements for basic safety and essential performance “ IEC 60601-1-1:1992, Medical electrical systems Part 1: General requirements for safety. 1. Collateral standard: Safety requirements for medical electrical systems. 3 Terms and de

33、finitions For the purposes of this International Standard, the following terms and definitions apply. 3.1 visual field sum of all directions from which the eye may perceive visual stimulation at a defined moment in time and the performance of the perception of this stimulation 3.1.1 monocular field

34、visual field of an individual perceived with a single eye 3.1.2 binocular field visual field of an individual perceived with both eyes open 3.1.3 central field visual field in all directions extending up to 30 from fixation 3.1.4 peripheral field visual field in all directions beyond 30 from fixatio

35、n NOTE It is possible to discriminate between midperipheral and full-field. DIN EN ISO 12866:2009-03 EN ISO 12866:1999+AC:2000+A1:2008 (E) 5 3.2 perimeter instrument to assess differential light sensitivity in the visual field by detection of the presence of test stimuli on a defined background 3.2.

36、1 fixed-location stimulus perimeter perimeter which utilizes test stimuli that are at permanent locations on the background 3.2.2 projection perimeter perimeter which utilizes a projection system to create the test stimuli on the background 3.2.3 kinetic perimeter perimeter which utilizes moving tes

37、t stimuli 3.2.4 static perimeter perimeter which utilizes stationary test stimuli 3.3 test stimulus stimulus used to determine differential light sensitivity in each tested location of the visual field 3.3.1 Goldmann test stimulus set of sizes which can be used to specify test stimuli See annex A. 3

38、.3.2 stimulus duration time from the defined onset to the defined end of the stimulus 3.3.3 test stimulus pattern local distribution of a set of test stimuli 3.4 stimulus luminance LSluminance of the presented stimulus NOTE The stimulus luminance includes the background luminance. 3.5 threshold stim

39、ulus luminance LTluminance of the test stimulus which has a 50 % detection rate for a given set of test parameters 3.6 background luminance LBluminance of the surround within which the test stimuli are presented DIN EN ISO 12866:2009-03 EN ISO 12866:1999+AC:2000+A1:2008 (E) 6 3.7 differential lumina

40、nce L difference between stimulus luminance LSand the background luminance LBL = LS LB3.7.1 threshold differential luminance LTdifference between the threshold stimulus luminance LTand the background luminance LT= LT LB3.7.2 Goldmann differential luminances Set of luminance differentials which can b

41、e used to specify test stimulus differential luminance See annex A. 3.8 contrast ratio of the differential luminance L to background luminance LBLT/LB3.9 differential light sensitivity S ratio of the background luminance LBto the threshold differential luminance LTS = LB/LT3.10 perimeter decibel sca

42、le logarithmic scale used to express, in decibels, the differential light sensitivity, S, where the value of the background luminance, LB, is replaced within the formula by the defined maximum stimulus luminance of the specific instrument, Lmax, and where 0 dB represents this maximum stimulus lumina

43、nce S (in dB) = 10 log10Lmax/LT NOTE The same scale is used to express stimulus luminance, LS, by replacing the threshold differential luminance LTwithin the formula with the differential luminance L. 3.11 suprathreshold strategy supraliminal strategy examination strategy designed for screening purp

44、oses, in which stimulus luminances of a defined amount above the presumed threshold stimulus luminance are applied 3.12 threshold strategy examination strategy which is designed to quantify the sensitivity in each test location by estimation of the threshold stimulus luminance DIN EN ISO 12866:2009-

45、03 EN ISO 12866:1999+AC:2000+A1:2008 (E) 7 3.13 fixation direction in which the patient is required to look during the test 3.14 fixation target target used to locate the point where the patient should look during testing 3.15 eccentricity angle from fixation to a position in the visual field See an

46、nex B. 4 Requirements 4.1 General The requirements of this International Standard shall be verified through type testing. All tests described in this International Standard are type tests. The perimeter shall conform to the general requirements specified in ISO 15004. The perimeter shall conform to

47、the specific requirements described in 4.2 to 4.4. NOTE These requirements are verified as described in clause 5. 4.2 Specific requirements 4.2.1 The test stimuli shall be presented within the tolerances specified in Table 1. 4.2.2 The luminance of the background and test stimuli shall be specified

48、in candela per square metre (cd/m2), measured at the designated position of the centre of the entrance pupil of the patients eye. 4.2.3 The spectral distribution(s) of the background and the test stimuli shall be specified by the manufacturer. 4.2.4 The test stimulus size(s) and shape, including var

49、iation within the central visual field, shall be specified. 4.2.5 The viewing distance from the designated position of the centre of the entrance pupil of the eye to the fixation target shall be specified. 4.2.6 Provision for the optical correction of patients refractive error for the fixation-target viewing distance shall be made. 4.2.7 Provision for adequate head positioning within the instrument shall be made. 4.2.8 Means for monitoring fixation and eye position at the instrument shall be provided. This may be by operator obse