EN ISO 10341-2012 en Ophthalmic instruments - Refractor heads《眼科仪器 折射》.pdf
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1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 10341:2012Ophthalmic instruments Refractor headsBS EN ISO 10341:2012 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 10341:201
2、2. It supersedes BS EN ISO 10341:2009 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/172/6, Ophthalmic instruments.A list of organizations represented on this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 t
3、o include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2013. Published by BSI Standards Limited 2013ISBN 978 0 580 78872 7 ICS 11.040.70 Compliance with a British Standard cannot confer immunity from legal obligation
4、s.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 January 2013.Amendments issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 10341 December 2012 ICS 11.040.70 Supersedes EN ISO 1034
5、1:2009English Version Ophthalmic instruments - Refractor heads (ISO 10341:2012) Instruments ophtalmiques - Ttes de rfracteurs (ISO 10341:2012) Ophthalmische Instrumente - Phoropter (ISO 10341:2012)This European Standard was approved by CEN on 14 January 2013. CEN members are bound to comply with the
6、 CEN/CENELEC Internal Regulations 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 CEN-CENELEC Management
7、 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 translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status a
8、s the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Ne
9、therlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2012 CEN All rights of ex
10、ploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 10341:2012: EBS EN ISO 10341:2012BS EN ISO 10341:2012EN ISO 10341:2012 (E) 3 Foreword This document (EN ISO 10341:2012) has been prepared by Technical Committee ISO/TC 172 “Optics andphotonics“ in co
11、llaboration with Technical Committee CEN/TC 170 “Ophthalmic optics” the secretariat of whichis held by DIN. This European Standard shall be given the status of a national standard, either by publication of an identicaltext or by endorsement, at the latest by June 2013, and conflicting national stand
12、ards shall be withdrawn atthe latest by June 2013. Attention is drawn to the possibility that some of the elements of this document may be the subject of patentrights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 1034
13、1:2009. According to the CEN/CENELEC Internal Regulations, the national standards organisations of the followingcountries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, CzechRepublic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, Franc
14、e, Germany, Greece,Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 10341:2012 has been approved by CEN as a EN ISO
15、10341:2012 without any modification. BS EN ISO 10341:2012 ISO 10341:2012(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO te
16、chnical 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-governmental, in liaison with ISO, also take part in the work. ISO collaborates close
17、ly 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.The main task of technical committees is to prepare International Standards. Draft I
18、nternational 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 vote.Attention is drawn to the possibility that some of the elements of this document
19、may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights.ISO 10341 was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 7, Ophthalmic optics and instruments.This third edition cancels and replaces the second
20、 edition (ISO 10341:2009), of which Tables 2, 3 and 4 have been technically revised. ISO 2012 All rights reserved iiiBS EN ISO 10341:2012BS EN ISO 10341:2012Ophthalmic instruments Refractor heads1 ScopeThis International Standard specifies requirements and test methods for refractor heads used for t
21、he determination of refractive errors and binocular functions of the human eye.This International Standard takes priority over ISO 15004-1, if differences exist.2 Normative referencesThe following referenced documents are indispensable for the application of this document. For dated references, only
22、 the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 7944, Optics and optical instruments Reference wavelengthsISO 8429, Optics and optical instruments Ophthalmology Graduated dial scaleISO 13666, Ophthalmic optics S
23、pectacle lenses VocabularyISO 15004-1:2006, Ophthalmic instruments Fundamental requirements and test methods Part 1: General requirements applicable to all ophthalmic instrumentsIEC 60601-1, Medical electrical equipment Part 1: General requirements for basic safety and essential performance3 Terms a
24、nd definitionsFor the purposes of this document, the terms and definitions given in ISO 13666 and the following apply.3.1refractor headinstrument providing a means of positioning spherical and cylindrical lenses, prisms and other optical devices in front of a subjects eyes for the purpose of determi
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