kSIST FprEN ISO 10943:2022

Ophthalmic instruments - Indirect ophthalmoscopes (ISO/FDIS 10943:2022)

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/FDIS 10943:2022)

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/FDIS 10943:2022)

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/FDIS 10943:2022)

General Information

• Status: Not Published
• Public Enquiry End Date: 27-Feb-2022
• ICS: 11.040.70 - Ophthalmic equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 5020 - Formal vote (FV) (Adopted Project)
• Start Date: 29-Nov-2022
• Due Date: 17-Jan-2023
• Completion Date: 19-Dec-2022
• Ref Project: FprEN ISO 10943 - Ophthalmic instruments - Indirect ophthalmoscopes (ISO/FDIS 10943:2022)

Relations

• Revised: SIST EN ISO 10943:2011 - Ophthalmic instruments - Indirect ophthalmoscopes (ISO 10943:2011)
• Effective Date: 29-Sep-2021
• Revised: SIST EN ISO 10943:2011 - Ophthalmic instruments - Indirect ophthalmoscopes (ISO 10943:2011)
• Effective Date: 18-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
oSIST prEN ISO 10943:2022
01-februar-2022
Oftalmični instrumenti - Indirektni oftalmoskopi (ISO/DIS 10943:2021)
Ophthalmic instruments - Indirect ophthalmoscopes (ISO/DIS 10943:2021)
Ophthalmische Instrumente - Indirekte Ophthalmoskope (ISO/DIS 10943:2021)
Instruments ophtalmiques - Ophtalmoscopes indirects (ISO/DIS 10943:2021)
Ta slovenski standard je istoveten z: prEN ISO 10943
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
oSIST prEN ISO 10943:2022 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN ISO 10943:2022
---------------------- Page: 2 ----------------------
oSIST prEN ISO 10943:2022
DRAFT INTERNATIONAL STANDARD
ISO/DIS 10943
ISO/TC 172/SC 7 Secretariat: DIN
Voting begins on: Voting terminates on:
2021-12-29 2022-03-23
Ophthalmic instruments — Indirect ophthalmoscopes
Instruments ophtalmiques — Ophtalmoscopes indirects
ICS: 11.040.70
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
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
Reference number
NATIONAL REGULATIONS.
ISO/DIS 10943:2021(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2021
---------------------- Page: 3 ----------------------
oSIST prEN ISO 10943:2022
ISO/DIS 10943:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021

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.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
© ISO 2021 – All rights reserved
---------------------- Page: 4 ----------------------
oSIST prEN ISO 10943:2022
ISO/DIS 10943:2021(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

iii
© ISO 2021 – All rights reserved
---------------------- Page: 5 ----------------------
oSIST prEN ISO 10943:2022
ISO/DIS 10943:2021(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.

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 identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www.iso.org/patents).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO's adherence to

the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see

www.iso.org/iso/foreword.html.

This document was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee

SC 7, Ophthalmic optics and instruments.

This fourth edition cancels and replaces the third edition (ISO 10943:2011), which has been technically

revised.
The main changes are as follows:
— Revision of the dated references;
— Editorial update of the whole document.

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www.iso.org/members.html.
© ISO 2021 – All rights reserved
---------------------- Page: 6 ----------------------
oSIST prEN ISO 10943:2022
DRAFT INTERNATIONAL STANDARD ISO/DIS 10943:2021(E)
Ophthalmic instruments — Indirect ophthalmoscopes
1 Scope
This d
...