Ophthalmic instruments - Slit-lamp microscopes (ISO 10939:2017)

ISO 10939:2017, together with ISO 15004‑1 and ISO 15004‑2, specifies requirements and test methods for slit-lamp microscopes to provide slit illumination and observation under magnification of the eye and its adnexa.
ISO 10939:2017 is not applicable to microscope accessories, e.g. photographic equipment and lasers.
ISO 10939:2017 takes precedence over ISO 15004‑1 and ISO 15004‑2, if differences exist.

Ophthalmische Instrumente - Spaltleuchten (ISO 10939:2017)

Instruments ophtalmiques - Microscopes avec lampe à fente (ISO 10939:2017)

ISO 10939:2017 spécifie, conjointement à l'ISO 15004‑1 et à l'ISO 15004‑2, les exigences et les méthodes d'essai relatives aux microscopes avec lampe à fente, produisant un éclairage lumineux en forme de fente et permettant l'observation, sous grossissement, de l'?il et de ses tissus annexes.
ISO 10939:2017 ne s'applique pas aux accessoires de microscopes tels que les appareils photographiques et les lasers.
ISO 10939:2017 prévaut sur l'ISO 15004‑1 et sur l'ISO 15004‑2 en cas de différences.

Oftalmični instrumenti - Špranjske svetilke (ISO 10939:2017)

Ta dokument skupaj s standardoma ISO 15004-1 in ISO 15004-2 določa zahteve in preskusne metode za špranjske svetilke za špranjsko osvetlitev in opazovanje pod povečavo očesa ter njegovih adneksov.
Ta dokument se ne uporablja za dodatno opremo za mikroskope, npr. fotografsko opremo in laserje. V primeru razlik ima ta dokument prednost pred standardoma ISO 15004-1 in ISO 15004-2.

General Information

Status
Published
Publication Date
06-Jun-2017
Withdrawal Date
30-Dec-2017
Technical Committee
CEN/TC 170 - Ophthalmic optics
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
07-Jun-2017
Completion Date
07-Jun-2017

Relations

Effective Date
20-Jul-2016

Overview

EN ISO 10939:2017 - Ophthalmic instruments: Slit‑lamp microscopes specifies requirements and test methods for slit‑lamp microscopes used to provide slit illumination and magnified observation of the eye and adnexa. Published by CEN/ISO, this standard is intended for the design, testing and conformity assessment of slit‑lamp microscopes (excluding accessories such as photographic equipment and lasers). Where differences exist, EN ISO 10939:2017 takes precedence over ISO 15004‑1 and ISO 15004‑2.

Key topics and technical requirements

  • Scope and precedence: Applies together with ISO 15004‑1 (general ophthalmic instrument requirements) and ISO 15004‑2 (light hazard protection); EN ISO 10939:2017 overrides those where conflicts exist.
  • Optical requirements (Table 1): includes numerical tolerances such as:
    • Magnification tolerance: ±5%
    • Left/right magnification difference: ≤3%
    • Interpupillary adjustment range: 55 mm to 72 mm
    • Slit image: minimum width 0.2 mm, minimum length 8.0 mm, with strict parallelism and shape criteria
    • Focus and alignment tolerances: axial and lateral focus tolerances (e.g., axial Δa ≈ ±0.5 mm; lateral ≈ ±0.35 mm), and permissible shift in object plane ≤0.4 mm
    • Dioptre scale calibration error: ±0.25 D at zero; typical adjustment ranges (e.g., −5.00 D to +5.00 D; −4.00 D to +2.00 D for high‑eye‑point eyepieces)
    • Exit pupil difference between left and right systems: ≤1.5 mm
  • High eye point eyepiece: if claimed, exit pupil clearance must be ≥17 mm to allow spectacles.
  • Construction and performance: requirements for slit edge quality, even illumination, absence of stray light/contrast loss, and minimum resolving power at high magnification.
  • Optical radiation / light hazard: classification into Group 1 or Group 2 per ISO 15004‑2 with specific test methods and exposure limits; additional measures required if used with supplementary lenses (e.g., 90 D Volk lens).
  • Test and measurement rules: type testing; measurement devices must have errors smaller than 10% of the smallest value to be determined; results evaluated statistically.

Applications and users

  • Medical device manufacturers designing and producing slit‑lamp microscopes for ophthalmology.
  • Test laboratories and conformity assessment bodies performing type testing and verification to EN ISO 10939:2017.
  • Regulatory and procurement specialists ensuring devices meet optical safety and performance criteria.
  • Clinical engineers and optometrists/ophthalmologists involved in device selection, maintenance and safety checks.

Related standards

  • ISO 15004‑1 - Fundamental requirements and test methods (general ophthalmic instruments)
  • ISO 15004‑2 - Light hazard protection for ophthalmic instruments
  • IEC 60601‑1:2005 + AMD1:2012 - referenced for medical electrical equipment safety where applicable

Keywords: EN ISO 10939:2017, slit‑lamp microscopes, ophthalmic instruments, optical requirements, light hazard protection, ISO 15004‑2, high eye point eyepiece, dioptre calibration.

Frequently Asked Questions

EN ISO 10939:2017 is a standard published by the European Committee for Standardization (CEN). Its full title is "Ophthalmic instruments - Slit-lamp microscopes (ISO 10939:2017)". This standard covers: ISO 10939:2017, together with ISO 15004‑1 and ISO 15004‑2, specifies requirements and test methods for slit-lamp microscopes to provide slit illumination and observation under magnification of the eye and its adnexa. ISO 10939:2017 is not applicable to microscope accessories, e.g. photographic equipment and lasers. ISO 10939:2017 takes precedence over ISO 15004‑1 and ISO 15004‑2, if differences exist.

ISO 10939:2017, together with ISO 15004‑1 and ISO 15004‑2, specifies requirements and test methods for slit-lamp microscopes to provide slit illumination and observation under magnification of the eye and its adnexa. ISO 10939:2017 is not applicable to microscope accessories, e.g. photographic equipment and lasers. ISO 10939:2017 takes precedence over ISO 15004‑1 and ISO 15004‑2, if differences exist.

EN ISO 10939:2017 is classified under the following ICS (International Classification for Standards) categories: 11.040.70 - Ophthalmic equipment. The ICS classification helps identify the subject area and facilitates finding related standards.

EN ISO 10939:2017 has the following relationships with other standards: It is inter standard links to EN ISO 10939:2007. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.

EN ISO 10939:2017 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.

Standards Content (Sample)


SLOVENSKI STANDARD
01-september-2017
1DGRPHãþD
SIST EN ISO 10939:2007
2IWDOPLþQLLQVWUXPHQWLâSUDQMVNHVYHWLONH ,62
Ophthalmic instruments - Slit-lamp microscopes (ISO 10939:2017)
Ophthalmische Instrumente - Spaltleuchten (ISO 10939:2017)
Instruments ophtalmiques - Microscopes avec lampe à fente (ISO 10939:2017)
Ta slovenski standard je istoveten z: EN ISO 10939:2017
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 10939
EUROPEAN STANDARD
NORME EUROPÉENNE
June 2017
EUROPÄISCHE NORM
ICS 11.040.70 Supersedes EN ISO 10939:2007
English Version
Ophthalmic instruments - Slit-lamp microscopes (ISO
10939:2017)
Instruments ophtalmiques - Microscopes avec lampe à Ophthalmische Instrumente - Spaltleuchten (ISO
fente (ISO 10939:2017) 10939:2017)
This European Standard was approved by CEN on 5 March 2017.

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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10939:2017 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 10939:2017) 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 December 2017, and conflicting national standards
shall be withdrawn at the latest by December 2017.
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 10939:2007.
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, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 10939:2017 has been approved by CEN as EN ISO 10939:2017 without any modification.

INTERNATIONAL ISO
STANDARD 10939
Third edition
2017-05
Ophthalmic instruments — Slit-lamp
microscopes
Instruments ophtalmiques — Microscopes avec lampe à fente
Reference number
ISO 10939:2017(E)
©
ISO 2017
ISO 10939:2017(E)
© ISO 2017, Published in Switzerland
All rights reserved. Unless otherwise specified, 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
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CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2017 – All rights reserved

ISO 10939:2017(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 requirements . 2
4.3 Construction and function . 4
4.3.1 General. 4
4.3.2 High eye point eyepiece . 4
4.4 Optical radiation hazard with slit-lamp microscopes . 4
5 Accompanying documents . 5
6 Marking . 5
Bibliography . 6
ISO 10939:2017(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
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electrotechnical standardization.
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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).
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This document was prepared by Technical Committ
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