SIST EN ISO 10943:2006
(Main)Ophthalmic instruments - Indirect ophthalmoscopes (ISO 10943:2006)
Ophthalmic instruments - Indirect ophthalmoscopes (ISO 10943:2006)
This International Standard, together with ISO 15004-1 and ISO 15004-2 specifies minimum requirements and test methods for hand-held, spectacle-type, and head-worn indirect ophthalmoscopes for observing indirect images of the eye fundus. This International Standard takes precedence over ISO 15004-1 and ISO 15004-2, if differences exist. This International Standard is not applicable to condensing lenses used for indirect ophthalmoscopy or to accessories. This International Standard is not applicable to table-mounted instruments such as Gullstrand ophthalmoscopes and their derivatives, nor to ophthalmoscopes primarily intended for image capture and/or processing such as those based on scanning laser techniques.
Ophthalmische Instrumente - Indirekte Ophthalmoskope (ISO 10943:2006)
Diese Internationale Norm legt zusammen mit ISO 15004-1 und ISO 15004-2 Mindestanforderungen und Prüf¬verfahren für indirekte Ophthalmoskope in Form von Handgeräten, Geräten vom Brillentyp und am Kopf getragenen Geräten fest, die dazu dienen, indirekte Bilder des Augenhintergrundes zu beobachten.
Wenn Unterschiede vorliegen, hat diese Internationale Norm Vorrang vor ISO 15004-1 und ISO 15004-2.
Diese Internationale Norm gilt nicht für Ophthalmoskopierlinsen und Zubehör.
Diese Internationale Norm gilt nicht für Tischgeräte wie Gullstrand’sche Ophthalmoskope und ihre Ab¬wand¬lun¬gen und auch nicht für Ophthalmoskope, die hauptsächlich zur Bildaufnahme und/oder -verarbeitung be¬stimmt sind, wie solche, die auf der Laser-Scanning-Technik beruhen.
Instruments ophtalmiques - Ophtalmoscopes indirects (ISO 10943:2006)
L'ISO 10943:2006, conjointement à l'ISO 15004-1 et à l'ISO 15004-2, spécifie les exigences minimales et les méthodes d'essai relatives aux ophtalmoscopes indirects à maniement manuel, de type lunettes portées sur la tête, conçus pour l'observation indirecte des images du fond de l'oeil.
L'ISO 10943:2006 a la priorité sur l'ISO 15004-1 et l'ISO 15004-2 lorsque des différences existent.
L'ISO 10943:2006 ne s'applique pas aux lentilles de champ, ni aux accessoires utilisés en ophtalmoscopie indirecte.
L'ISO 10943:2006 ne s'applique pas aux instruments montés sur table tels que les ophtalmoscopes de Gullstrand, ni à leurs dérivés, ni encore aux ophtalmoscopes dont l'usage est principalement destiné à la saisie et/ou au traitement des images telles que celles obtenues avec les techniques de scannérisation au laser.
Oftalmični instrumenti – Indirektni oftalmoskopi (ISO 10943:2006)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 10943:2006
01-september-2006
1DGRPHãþD
SIST EN ISO 10943:2000
2IWDOPLþQLLQVWUXPHQWL±,QGLUHNWQLRIWDOPRVNRSL ,62
Ophthalmic instruments - Indirect ophthalmoscopes (ISO 10943:2006)
Ophthalmische Instrumente - Indirekte Ophthalmoskope (ISO 10943:2006)
Instruments ophtalmiques - Ophtalmoscopes indirects (ISO 10943:2006)
Ta slovenski standard je istoveten z: EN ISO 10943:2006
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN ISO 10943:2006 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 10943:2006
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SIST EN ISO 10943:2006
EUROPEAN STANDARD
EN ISO 10943
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2006
ICS 11.040.70 Supersedes EN ISO 10943:1998
English Version
Ophthalmic instruments - Indirect ophthalmoscopes (ISO
10943:2006)
Instruments ophtalmiques - Ophtalmoscopes indirects (ISO Ophthalmische Instrumente - Indirekte Ophthalmoskope
10943:2006) (ISO 10943:2006)
This European Standard was approved by CEN on 9 March 2006.
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-date lists and bibliographical references concerning such national
standards may be obtained on application to the Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, 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 STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10943:2006: E
worldwide for CEN national Members.
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SIST EN ISO 10943:2006
EN ISO 10943:2006 (E)
Foreword
This document (EN ISO 10943:2006) 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 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 2006, and conflicting national
standards shall be withdrawn at the latest by December 2006.
This document supersedes EN ISO 10943:1998.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium,
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.
Endorsement notice
The text of ISO 10943:2006 has been approved by CEN as EN ISO 10943:2006 without any
modifications.
2
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SIST EN ISO 10943:2006
INTERNATIONAL ISO
STANDARD 10943
Second edition
2006-06-01
Ophthalmic instruments — Indirect
ophthalmoscopes
Instruments ophtalmiques — Ophtalmoscopes indirects
Reference number
ISO 10943:2006(E)
©
ISO 2006
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SIST EN ISO 10943:2006
ISO 10943:2006(E)
PDF disclaimer
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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 2006
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.
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Published in Switzerland
ii © ISO 2006 – All rights reserved
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SIST EN ISO 10943:2006
ISO 10943:2006(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
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 10943 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 10943:1998) which has been technically
revised.
© ISO 2006 – All rights reserved iii
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SIST EN ISO 10943:2006
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SIST EN ISO 10943:200
...
EUROPEAN STANDARD
DRAFT
prEN ISO 10943
NORME EUROPÉENNE
EUROPÄISCHE NORM
February 2005
ICS Will supersede EN ISO 10943:1998
English version
Ophthalmic instruments - Indirect ophthalmoscopes (ISO/DIS
10943:2005)
Instruments ophtalmiques - Ophtalmoscopes indirects Ophthalmische Instrumente - Indirekte Ophthalmoskope
(ISO/DIS 10943:2005) (ISO/DIS 10943:2005)
This draft European Standard is submitted to CEN members for parallel enquiry. It has been drawn up by the Technical Committee
CEN/TC 170.
If this draft becomes a European Standard, 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.
This draft European Standard was established by CEN 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 standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,
Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2005 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN ISO 10943:2005: E
worldwide for CEN national Members.
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prEN ISO 10943:2005 (E)
Foreword
This document (prEN ISO 10943:2005) 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 of which is held by DIN.
This document is currently submitted to the parallel Enquiry.
This document will supersede EN ISO 10943:1998.
Endorsement notice
The text of ISO 10943:2005 has been approved by CEN as prEN ISO 10943:2005 without
any modifications.
2
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DRAFT INTERNATIONAL STANDARD ISO/DIS 10943
ISO/TC 172/SC 7 Secretariat: DIN
Voting begins on: Voting terminates on:
2005-02-03 2005-07-03
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION • МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ • ORGANISATION INTERNATIONALE DE NORMALISATION
Ophthalmic instruments — Indirect ophthalmoscopes
Instruments ophtalmiques — Ophtalmoscopes indirects
[Revision of first edition (ISO 10943:1998)]
ICS 11.040.70
ISO/CEN PARALLEL ENQUIRY
The CEN Secretary-General has advised the ISO Secretary-General that this ISO/DIS covers a subject
of interest to European standardization. In accordance with the ISO-lead mode of collaboration as
defined in the Vienna Agreement, consultation on this ISO/DIS has the same effect for CEN
members as would a CEN enquiry on a draft European Standard. Should this draft be accepted, a
final draft, established on the basis of comments received, will be submitted to a parallel two-month FDIS
vote in ISO and formal vote in CEN.
In accordance with the provisions of Council Resolution 15/1993 this document is circulated in
the English language only.
Conformément aux dispositions de la Résolution du Conseil 15/1993, ce document est distribué
en version anglaise seulement.
To expedite distribution, this document is circulated as received from the committee secretariat.
ISO Central Secretariat work of editing and text composition will be undertaken at publication
stage.
Pour accélérer la distribution, le présent document est distribué tel qu'il est parvenu du
secrétariat du comité. Le travail de rédaction et de composition de texte sera effectué au
Secrétariat central de l'ISO au stade de publication.
THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS THEREFORE SUBJECT TO CHANGE AND MAY NOT BE
REFERRED TO AS AN INTERNATIONAL STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS BEING ACCEPTABLE FOR INDUSTRIAL, TECHNOLOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN NATIONAL REGULATIONS.
© International Organization for Standardization, 2005
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ISO/DIS 10943
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.
Copyright notice
This ISO document is a Draft International Standard and is copyright-protected by ISO. Except as permitted
under the applicable laws of the user's country, neither this ISO draft nor any extract from it may be
reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic, photocopying,
recording or otherwise, without prior written permission being secured.
Requests for permission to reproduce should be addressed to either ISO at the address below or ISO's
member body in the country of the requester.
ISO copyright office
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Tel. + 41 22 749 01 11
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Web www.iso.org
Reproduction may be subject to royalty payments or a licensing agreement.
Violators may be prosecuted.
©
ii ISO 2005 – All rights reserved
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ISO/DIS 10943
Contents Page
Foreword. iv
1 Scope. 1
2 Normative references. 1
3 Terms and definitions. 1
4 Requirements. 2
4.1 General. 2
4.2 Optical and dimensional requirements . 2
4.3 Construction and function. 3
4.4 Optical radiation hazard with indirect ophthalmoscopes. 3
4.4.1 General. 3
4.4.2 Applicable clauses. 3
5 Test methods: Optical, mechanical and functional requirements. 4
6 Accompanying documents. 4
7 Marking. 4
© ISO 2004 – All rights reserved iii
DRAFT 2005
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ISO/DIS 10943
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of prepa
...
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