EN ISO 10943:2011

Ophthalmic instruments - Indirect ophthalmoscopes (ISO 10943:2011)

ISO 10943:2011 specifies minimum requirements and test methods for hand-held, spectacle-type, and head-worn indirect ophthalmoscopes for observing indirect images of the eye fundus.
ISO 10943:2011 is not applicable to condensing lenses used for indirect ophthalmoscopy or to accessories.
ISO 10943:2011 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 10943:2011)

Diese Internationale Norm legt zusammen mit ISO 15004-1 und ISO 15004-2 Mindestanforderungen und
Prüfverfahren 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 Abwandlungen
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 10943:2011)

L'ISO 10943:2011 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 10943:2011 ne s'applique pas aux lentilles de champ, ni aux accessoires utilisés en ophtalmoscopie indirecte.
L'ISO 10943:2011 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 10943:2011)

Ta mednarodni standard skupaj z ISO 15004-1 in ISO 15004-2 določa minimalne zahteve in preskusne metode za ročne indirektne oftalmoskope v obliki očal, ki se nosijo na glavi, za opazovanje indirektnih slik očesnega ozadja. Ta mednarodni standard ima prednost pred ISO 15004-1 in ISO 1500-2, če so med njima razlike. Ta mednarodni standard ne velja za kondenzacijske leče, ki se uporabljajo za indirektno oftalmoskopijo, ali za dodatke. Ta mednarodni standard ne velja za instrumente, pritrjene na mizo, kot so Gullstrandovi oftalmoskopi in njihove izpeljanke, in ne za oftalmoskope, ki so predvsem namenjeni slikanju in/ali obdelavi, na primer oftalmoskope na osnovi laserskih tehnik slikanja.

General Information

• Status: Withdrawn
• Publication Date: 14-Aug-2011
• Withdrawal Date: 17-Jan-2023
• ICS: 11.040.70 - Ophthalmic equipment
• Technical Committee: CEN/TC 170 - Ophthalmic optics
• Drafting Committee: CEN/TC 170 - Ophthalmic optics
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 18-Jan-2023
• Ref Project: SIST EN ISO 10943:2011 - Ophthalmic instruments - Indirect ophthalmoscopes (ISO 10943:2011)

Relations

• Replaces: EN ISO 10943:2006 - Ophthalmic instruments - Indirect ophthalmoscopes (ISO 10943:2006)
• Effective Date: 20-Aug-2011
• Replaced By: EN ISO 10943:2023 - Ophthalmic instruments - Indirect ophthalmoscopes (ISO 10943:2023)
• Effective Date: 29-Sep-2021

Standards Content (Sample)

SLOVENSKI STANDARD
01-december-2011
1DGRPHãþD
SIST EN ISO 10943:2006
2IWDOPLþQLLQVWUXPHQWL,QGLUHNWQLRIWDOPRVNRSL,62
Ophthalmic instruments - Indirect ophthalmoscopes (ISO 10943:2011)
Ophthalmische Instrumente - Indirekte Ophthalmoskope (ISO 10943:2011)
Instruments ophtalmiques - Ophtalmoscopes indirects (ISO 10943:2011)
Ta slovenski standard je istoveten z: EN ISO 10943:2011
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 10943
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2011
ICS 11.040.70 Supersedes EN ISO 10943:2006
English Version
Ophthalmic instruments - Indirect ophthalmoscopes (ISO
10943:2011)
Instruments ophtalmiques - Ophtalmoscopes indirects (ISO Ophthalmische Instrumente - Indirekte Ophthalmoskope
10943:2011) (ISO 10943:2011)
This European Standard was approved by CEN on 14 August 2011.

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, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.

EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10943:2011: E
worldwide for CEN national Members.

Contents Page
Foreword .3

Foreword
This document (EN ISO 10943:2011) 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 February 2012, and conflicting national standards shall be withdrawn
at the latest by February 2012.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 10943:2006.
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, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 10943:2011 has been approved by CEN as a EN ISO 10943:2011 without any modification.

INTERNATIONAL ISO
STANDARD 10943
Third edition
2011-08-15
Ophthalmic instruments — Indirect
ophthalmoscopes
Instruments ophtalmiques — Ophtalmoscopes indirects

Reference number
ISO 10943:2011(E)
©
ISO 2011
ISO 10943:2011(E)
©  ISO 2011
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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ii © ISO 2011 – All rights reserved

ISO 10943:2011(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 third edition cancels and replaces the second edition (ISO 10943:2006), which has undergone a minor
revision to include:
⎯ updated normative references;
⎯ additional information concerning the necessary use of a condensing lens when testing for compliance
with light hazard requirements [second paragraph of 4.4 and list item e) of Clause 6].

INTERNATIONAL STANDARD ISO 10943:2011(E)

Ophthalmic instruments — Indirect ophthalmoscopes
1 Scope
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 ophthal
...