DIN EN ISO 19980-2012 Ophthalmic instruments - Corneal topographers (ISO 19980 2012) German version EN ISO 19980 2012《眼科仪器 角膜外形素描系统 (ISO 19980-2012) 德文版本EN ISO 19980-2012》.pdf

1、July 2012 Translation by DIN-Sprachendienst.English price group 14No 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).ICS 1

2、1.040.70!$,p“1900977www.din.deDDIN EN ISO 19980Ophthalmic instruments Corneal topographers (ISO 19980:2012)English translation of DIN EN ISO 19980:2012-07Ophthalmische Instrumente Hornhauttopographen (ISO 19980:2012)Englische bersetzung von DIN EN ISO 19980:2012-07Instruments ophtalmiques Topographe

3、s de la corne (ISO 19980:2012)Traduction anglaise de DIN EN ISO 19980:2012-07SupersedesDIN EN ISO 19980:2005-11www.beuth.deIn case of doubt, the German-language original shall be considered authoritative.Document comprises 27 pages06.12 DIN EN ISO 19980:2012-07 2 A comma is used as the decimal marke

4、r. National foreword This standard has been prepared by Technical Committee ISO/TC 172 “Optics and photonics” in collaboration with Technical Committee CEN/TC 170 “Ophthalmic optics” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the Normenausschuss Feinmech

5、anik und Optik (Optics and Precision Mechanics Standards Committee), Working Committee NA 027-01-08 AA Augenoptik, Working Group Ophthalmische Instrumente. The DIN Standard corresponding to the International Standards referred to in Clause 2 of this document is as follows: IEC 60601-1 DIN EN 60601-1

6、 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 other countries. Amendments This standard differs from DIN EN ISO 19980:2005-11 as follows: a) the test surfaces for the type testing have been modi

7、fied (two further surfaces with spherical shape have been added, see Subclause 5.2.6 and Table 2; multicurves have been deleted from Annex A); b) the colour pallet recommended for the expanded interval scale in standardized curvature maps has been modified (see Subclause B.4);. c) normative referenc

8、es have been updated. d) the revised International Standard ISO 19980:2012 has been adopted. Previous editions DIN EN ISO 19980: 2005-11 National Annex NA (informative) Bibliography DIN EN 60601-1, Medical electrical equipment Part 1: General requirements for basic safety and essential performance D

9、IN EN ISO 8429, Optics and optical instruments Ophthalmology Graduated dial scale DIN EN ISO 15004-1, Ophthalmic instruments Fundamental requirements and test methods Part 1: General requirements applicable to all ophthalmic instruments DIN ISO 10110-12, Optics and photonics Preparation of drawings

10、for optical elements and systems Part 12: Aspheric surfaces EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 19980 April 2012 ICS 11.040.70 Supersedes EN ISO 19980:2005English Version Ophthalmic instruments - Corneal topographers Instruments ophtalmiques - Topographes de la corne Ophthalmisc

11、he Instrumente - Hornhauttopographen This European Standard was approved by CEN on 31 March 2012. 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 without any alteration. Up-to

12、-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC 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 translat

13、ion under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC 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, Finland,

14、France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. Management Centre: Avenue Marnix 17, B-1000 Brussels 2012 CEN All rights of expl

15、oitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 19980:2012: EEUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNG(ISO 19980:2012) (ISO 19980:2012) (ISO 19980:2012) Contents Page Foreword . 3 1 Scope . 4

16、2 Normative references 4 3 Terms and definitions 4 4 Requirements . 12 4.1 Area measured . 12 4.2 Measurement sample density . 12 4.3 Measurement and report of performance 12 4.4 Colour presentation of results 12 5 Test methods and test devices . 12 5.1 Tests 12 5.2 Test surfaces 12 5.3 Data collect

17、ion Test surfaces . 14 5.4 Analysis of the data . 14 6 Accompanying documents . 16 7 Marking 16 Annex A (informative) Test surfaces for corneal topographers (CTs) . 17 Annex B (normative) Standardized displays for corneal topographers (CTs) 19 Annex C (normative) Calculation of area-weighting values

18、 22 Annex D (normative) Test methods for measuring human corneas 24 Bibliography 25 2DIN EN ISO 19980:2012-07 EN ISO 19980:2012 (E) Foreword This document (EN ISO 19980:2012) has been prepared by Technical Committee ISO/TC 172 “Optics and photonics” in collaboration with Technical Committee CEN/TC 1

19、70 “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 October 2012, and conflicting national standards shall be withdrawn at the latest by

20、 October 2012. 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 19980:2005. According to the CEN/CENELE

21、C Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,

22、 Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 19980:2012 has been approved by CEN as a EN ISO 19980:2012 without any modification. 3DIN EN ISO 19980:2012-07 EN ISO

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26、OPRPHWHUV2 Normative references7KHIROORZLQJUHIHUHQFHGGRFXPHQWVDUHLQGLVSHQVDEOHIRUWKHDSSOLFDWLRQRIWKLVGRFXPHQW)RUGDWHGUHIHUHQFHVRQOWKHHGLWLRQFLWHGDSSOLHV)RUXQGDWHGUHIHUHQFHVWKHODWHVWHGLWLRQRIWKHUHIHUHQFHGGRFXPHQW LQFOXGLQJDQDPHQGPHQWV DSSOLHV,(&Medical electrical equipment Part 1: General requirement

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