EN ISO 10943:2023
(Main)Ophthalmic instruments - Indirect ophthalmoscopes (ISO 10943:2023)
Ophthalmic instruments - Indirect ophthalmoscopes (ISO 10943:2023)
This document, 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 document takes precedence over ISO 15004-1 and ISO 15004-2, if differences exist.
This document is not applicable to condensing lenses used for indirect ophthalmoscopy or to accessories.
This document 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 10943:2023)
Dieses Dokument 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 dieses Dokument Vorrang vor ISO 15004 1 und ISO 15004 2.
Dieses Dokument ist nicht anzuwenden für Ophthalmoskopierlinsen und Zubehör.
Dieses Dokument ist nicht anzuwenden für Tischgeräte wie Gullstrand‘sche Ophthalmoskope und ihre Ab-wand¬lungen und auch nicht für Ophthalmoskope, die hauptsächlich zur Bildaufnahme und/oder verarbeitung bestimmt sind, wie solche, die auf der Laser-Scanning-Technik beruhen.
Instruments ophtalmiques - Ophtalmoscopes indirects (ISO 10943:2023)
Le présent document, conjointement avec les ISO 15004‑1 et ISO 15004‑2, spécifie les exigences minimales et les méthodes d’essai relatives aux ophtalmoscopes indirects à maniement manuel, de type binoculaire porté sur la tête, conçus pour l’observation indirecte des images du fond de l’œil.
Le présent document a la priorité sur l’ISO 15004‑1 et l’ISO 15004‑2 lorsque des différences existent.
Il ne s’applique pas aux lentilles convergentes utilisées en ophtalmoscopie indirecte, ni aux accessoires.
Le présent document 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 balayage laser.
Oftalmični instrumenti - Indirektni oftalmoskopi (ISO 10943:2023)
Ta dokument skupaj s standardoma ISO 15004-1 in ISO 15004-2 določa minimalne zahteve in preskusne metode za ročne oftalmoskope, oftalmoskope z očali in naglavne neposredne oftalmoskope za neposredno opazovanje očesnega ozadja.
V primeru razlik ima ta dokument prednost pred standardoma ISO 15004-1 in ISO 15004-2.
Ta dokument se ne uporablja za kondenzacijske leče, ki se uporabljajo v indirektni oftalmoskopiji ali za pripomočke.
Ta dokument se ne uporablja za namizne instrumente, kot je Gullstrandov oftalmoskop in njegove izvedbe, in oftalmoskope, ki se primarno uporabljajo za zajemanje slik in/ali obdelavo, npr. tisti, ki temeljijo na tehnikah laserskega skeniranja.
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
01-maj-2023
Nadomešča:
SIST EN ISO 10943:2011
Oftalmični instrumenti - Indirektni oftalmoskopi (ISO 10943:2023)
Ophthalmic instruments - Indirect ophthalmoscopes (ISO 10943:2023)
Ophthalmische Instrumente - Indirekte Ophthalmoskope (ISO 10943:2023)
Instruments ophtalmiques - Ophtalmoscopes indirects (ISO 10943:2023)
Ta slovenski standard je istoveten z: EN ISO 10943:2023
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 10943
EUROPEAN STANDARD
NORME EUROPÉENNE
January 2023
EUROPÄISCHE NORM
ICS 11.040.70 Supersedes EN ISO 10943:2011
English Version
Ophthalmic instruments - Indirect ophthalmoscopes (ISO
10943:2023)
Instruments ophtalmiques - Ophtalmoscopes indirects Ophthalmische Instrumente - Indirekte
(ISO 10943:2023) Ophthalmoskope (ISO 10943:2023)
This European Standard was approved by CEN on 6 January 2023.
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 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
translation 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10943:2023 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 10943:2023) has been prepared by Technical Committee ISO/TC 172 "Optics
and photonics" 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 July 2023, and conflicting national standards shall be
withdrawn at the latest by July 2023.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 10943:2011.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC 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, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 10943:2023 has been approved by CEN as EN ISO 10943:2023 without any modification.
INTERNATIONAL ISO
STANDARD 10943
Fourth edition
2023-01
Ophthalmic instruments — Indirect
ophthalmoscopes
Instruments ophtalmiques — Ophtalmoscopes indirects
Reference number
ISO 10943:2023(E)
ISO 10943:2023(E)
© ISO 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
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Phone: +41 22 749 01 11
Email: copyright@iso.org
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Published in Switzerland
ii
ISO 10943:2023(E)
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
5 Test methods: optical, mechanical and functional requirements .3
6 Accompanying documents . .4
7 Marking . . 4
Bibliography . 5
iii
ISO 10943:2023(E)
Foreword
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bodies (ISO member bodies). The work of preparing International Standards is normally carried out
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electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
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. Details of
any patent rights identif
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