EN ISO 10341:2009

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Oftalmološki instrumenti - Glave refraktorjev (ISO 10341:2009)Ophthalmische Instrumente - Phoropter (ISO 10341:2009)Instruments ophtalmiques - Têtes de réfracteurs (ISO 10341:2009)Ophthalmic instruments - Refractor heads (ISO 10341:2009)11.040.70Oftalmološka opremaOphthalmic equipmentICS:Ta slovenski standard je istoveten z:EN ISO 10341:2009SIST EN ISO 10341:2009en01-oktober-2009SIST EN ISO 10341:2009SLOVENSKI
STANDARDSIST EN ISO 10341:20001DGRPHãþD

EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN ISO 10341July 2009ICS 11.040.70Supersedes EN ISO 10341:1999
English VersionOphthalmic instruments - Refractor heads (ISO 10341:2009)Instruments ophtalmiques - Têtes de réfracteurs (ISO10341:2009)Ophthalmische Instrumente - Phoropter (ISO 10341:2009)This European Standard was approved by CEN on 27 June 2009.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards 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 made by translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial versions.CEN members are the national standards 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 United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre:
Avenue Marnix 17,
B-1000 Brussels© 2009 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 10341:2009: ESIST EN ISO 10341:2009

Reference numberISO 10341:2009(E)© ISO 2009
INTERNATIONAL STANDARD ISO10341Second edition2009-07-01Ophthalmic instruments — Refractor heads Instruments ophtalmiques — Têtes de réfracteurs
ISO 10341:2009(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
©
ISO 2009 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO's member body in the country of the requester. ISO copyright office Case postale 56 • CH-1211 Geneva 20 Tel.
+ 41 22 749 01 11 Fax
+ 41 22 749 09 47 E-mail
copyright@iso.org Web
www.iso.org Published in Switzerland
ii © ISO 2009 – All rights reserved
ISO 10341:2009(E) © ISO 2009 – All rights reserved iiiForeword ISO (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 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-governmental, 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. 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 vote. 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 10341 was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 7, Ophthalmic optics and instruments. This second edition cancels and replaces the first edition (ISO 10341:1997), which has undergone minor revision in order to update normative references.
INTERNATIONAL STANDARD ISO 10341:2009(E) © ISO 2009 – All rights reserved 1Ophthalmic instruments — Refractor heads 1 Scope This International Standard specifies requirements and test methods for refractor heads used for the 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 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 document (including any amendments) applies. ISO 7944, Optics and optical instruments — Reference wavelengths ISO 8429, Optics and optical instruments — Ophthalmology — Graduated dial scale ISO 13666, Ophthalmic optics — Spectacle lenses — Vocabulary ISO 15004-1:2006, Ophthalmic instruments — Fundamental requirements and test methods — Part 1: General requirements applicable to all ophthalmic instruments IEC 60601-1, Medical electrical equipment — Part 1: General requirements for basic safety and essential performance 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 13666 and the following apply. 3.1 refractor head instrument providing a means of positioning spherical and cylindrical lenses, prisms and other optical devices in front of a subject’s eyes for the purpose of determining refractive error and binocular functions 3.2 reference plane plane at which the readings and the power tolerances of the refractor head apply 3.3 reference distance distance between the reference plane of the refractor head and the corneal vertex SIST EN ISO 10341:2009

ISO 10341:2009(E) 2 © ISO 2009 – All rights reserved 4 Requirements 4.1 General The refractor head shall conform to the requirements specified in ISO 15004-1. 4.2 Measuring ranges The requirements specified in Table 1 for refractor heads shall apply. Table 1 — Measuring ranges for refractor heads Criterion Minimum measuring ranges for each side Spherical power 0 D to +15 D in steps of 0,25 D
0 D to −15 D in steps of 0,25 D Astigmatic power 0 D to 5 D in steps of 0,25 D in plus or minus cylinder form Cylinder axis a 0° to 180° indicated in 5° steps; in addition, readings or estimates to 1° shall be possible Prismatic power b 0 ∆ to 10 ∆ in steps of 1 ∆, or continuously Prism base a 0° to 360° indicated in 5° steps; in addition, readings or estimates t
...