ISO INTERNATIONAL STANDARD 12865 Second edition 2006-07-01 Ophthalmic instruments Retinoscopes Instruments ophtalmiques Skiascopes Reference number ISO 12865:2006(E) @ ISO 2006 ISO12865:2006(E) PDFdisclaimer 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 ?ISO2006 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
[email protected] Web www.iso.org Published in Switzerland @ ISO 2006 - All rights reserved ISO 12865:2006(E) Foreword 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 technicalcommittees.Eachmemberbodyinterestedinasubjectforwhichatechnicalcommitteehasbeen 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/lEc 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. rights. IsO shall not be held responsible for identifying any or all such patent rights. Ophthalmicopticsand instruments. This second edition cancels and replaces the first edition (IsO 12865:1998), which has been technically revised. anization for Stand ization'ghts reserved ili Copvriaht International Oraanization for Standardizatior INTERNATIONAL STANDARD ISO12865:2006(E) Ophthalmic instruments Retinoscopes 1 Scope This International Standard, together with IsO 15004-1, specifies minimum requirements and test methods for hand-held streak and spot retinoscopes for use in objective determination of the refractive errors of the eye This International Standard takes precedence over IsO 15004-1, if differences exist. Normative references document (including any amendments) applies. Iso 15004-1, Ophthalmic instruments Fundamental requirements and test methods — Part 1: General requirements applicable to all ophthalmic instruments IEC 60601-1:2005, Medical electrical equipment — Part 1: General requirements for basic safety and essential performance 3 Terms and definitions For the purposes of this document, the following terms and definitions apply 3.1 retinoscope ophthalmic instrument designed to assess objectively refractive errors of the eye by reflecting a beam of light into it from a mirror and observing the movement of the retinal reflex across the pupil NOTE either a semi-reflective or a perforated highly-reflective coating, a viewing system and a power supply for the light source. 3.2 streak retinoscope orientation 3.3 spot retinoscope retinoscope capable of producing a beam of light of approximately circular cross-section NOTE The spot image focus can be adjusta