SIST EN 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

• Status: Published
• Public Enquiry End Date: 27-Feb-2022
• Publication Date: 12-Apr-2023
• ICS: 11.040.70 - Ophthalmic equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 16-Mar-2023
• Due Date: 21-May-2023
• Completion Date: 13-Apr-2023
• Ref Project: EN ISO 10943:2023 - Ophthalmic instruments - Indirect ophthalmoscopes (ISO 10943:2023)

Relations

• Replaces: SIST EN ISO 10943:2011 - Ophthalmic instruments - Indirect ophthalmoscopes (ISO 10943:2011)
• Effective Date: 01-May-2023

Overview

The SIST EN ISO 10943:2023 standard, titled Ophthalmic instruments - Indirect ophthalmoscopes (ISO 10943:2023), issued by CEN, defines minimum requirements and test methods for indirect ophthalmoscopes. This international standard applies specifically to hand-held, spectacle-type, and head-worn indirect ophthalmoscopes used for observing indirect images of the eye fundus. It supersedes the previous EN ISO 10943:2011 edition and takes precedence over ISO 15004-1 and ISO 15004-2 in case of conflicting provisions.

This standard excludes condensing lenses, accessories, table-mounted instruments (e.g., Gullstrand ophthalmoscopes), and ophthalmoscopes primarily designed for image capture or advanced scanning laser techniques.

Key Topics

Scope and Applicability

• Covers indirect ophthalmoscopes including hand-held, spectacle-type, and head-worn models.
• Excludes condensing lenses and accessories.
• Does not apply to table-mounted devices or image-capturing ophthalmoscopes.

Optical and Dimensional Requirements

• Specifies parameters such as:
  • Interpupillary distance range: 55 mm to 72 mm
  • Diameter of field of view: ≥100 mm for hand-held use; 150 mm to 250 mm for integral condensing systems
  • Diameter of illumination spot: ≥45 mm for hand-held systems
• Defines tolerances on binocular indirect ophthalmoscopes for interpupillary distance, optical axis orientation, and magnification differences (max ±5%).

Construction and Functional Requirements

• Light output must be adjustable between maximum and 10% of maximum level.
• Free from visible reflections or scattered light.
• Illumination alignment to viewing system within 1° vertically.
• Homogeneous and achromatic light beam.
• Matching brightness and colour for binocular systems.

Safety and Light Hazard Protection

• Strict evaluation of optical radiation hazards in accordance with ISO 15004-2.
• Testing performed with manufacturer-specified condensing lenses representing the worst-case scenario for light safety.
• Ensures ophthalmic safety compliance for light exposure during eye examination.

Test Methods

• Includes type tests for optical, mechanical, and functional criteria.
• Measurements require high-accuracy instruments with less than 10% relative error.
• Applies statistical evaluation methods per ISO/IEC guidelines on measurement uncertainty.

Documentation and Marking

• Accompanying documents must provide:
  • Manufacturer’s name and address
  • Usage instructions referencing SIST EN ISO 10943:2023 compliance
  • Specification of compatible condensing lenses
• Permanent marking on devices with manufacturer details, model, and IEC 60601-1 required symbols.

Applications

The SIST EN ISO 10943:2023 standard is essential for manufacturers, designers, and quality assurance professionals involved in the development and production of indirect ophthalmoscopes used in:

• Clinical ophthalmology and optometry practices
• Eye fundus examination procedures
• Diagnostic imaging where indirect visualization of retina and internal eye structures is required
• Ensuring medical device compliance for ophthalmic instruments used worldwide

Medical device manufacturers utilize this standard to align their product specifications with global safety, optical precision, and performance criteria, facilitating regulatory approvals and market access.

Related Standards

• ISO 15004-1 - General requirements and test methods for all ophthalmic instruments.
• ISO 15004-2 - Requirements and test methods for light hazard protection in ophthalmic instruments.
• IEC 60601-1 - General requirements for basic safety and essential performance of medical electrical equipment.
• ISO/IEC Guide 98-3 - Guide to expression of measurement uncertainty, important for validating test precision.

Compliance with SIST EN ISO 10943:2023 ensures that indirect ophthalmoscopes meet harmonized European and international safety, functionality, and optical quality standards, supporting consistent clinical outcomes and patient safety in ophthalmic diagnostics.

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Keywords: SIST EN ISO 10943:2023, indirect ophthalmoscopes standard, ophthalmic instruments, eye fundus examination, optical safety, medical device standards, binocular indirect ophthalmoscopes, ophthalmic optics, light hazard protection, ophthalmic equipment compliance.

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.
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
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
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 identif
...