EN ISO 15004-2:2024
(Main)Ophthalmic instruments - Fundamental requirements and test methods - Part 2: Light hazard protection (ISO 15004-2:2024)
Ophthalmic instruments - Fundamental requirements and test methods - Part 2: Light hazard protection (ISO 15004-2:2024)
This document specifies fundamental requirements for optical radiation safety for ophthalmic instruments and is applicable to all ophthalmic instruments that direct optical radiation into or at the eye. It is also applicable to all new and emerging ophthalmic instruments that direct optical radiation into or at the eye, as well as to those portions of therapeutic or surgical systems that direct optical radiation into or at the eye for diagnostic, illumination, measurement, imaging or alignment purposes.
NOTE For the purpose of this document, optical radiation relates to the wavelength range of 250 nm to 2 500 nm.
This document does not apply to therapeutic radiation. However, in the case of the treatment beams of therapeutic devices, when conducting risk assessments for non-target tissues, the limits given in this document may be applied to those parts of the treatment beam that strike non-target tissue.
Where vertical (instrument-specific) International Standards contain specific light hazard requirements different from those given in ISO 15004-2, then those in the vertical International Standard take precedence.
This document classifies ophthalmic instruments into either Group 1 or Group 2 to distinguish instruments that are non-hazardous from those that are potentially hazardous.
Ophthalmische Instrumente - Grundlegende Anforderungen und Prüfverfahren - Teil 2: Schutz gegen Gefährdung durch Licht (ISO 15004-2:2024)
Instruments ophtalmiques - Exigences fondamentales et méthodes d'essai - Partie 2: Protection contre les dangers de la lumière (ISO 15004-2:2024)
Le présent document spécifie des exigences fondamentales relatives à la sécurité liée au rayonnement optique et est applicable à tous les instruments ophtalmiques qui émettent un rayonnement optique dans ou en direction de l’œil. Il s’applique également à tout futur ou nouvel instrument ophtalmique qui dirige le rayonnement optique dans ou vers l’œil, ainsi qu’aux parties des systèmes thérapeutiques ou chirurgicaux qui dirigent le rayonnement optique dans ou vers l’œil à des fins de diagnostic, d’éclairement, de mesurage, d’imagerie ou d’alignement.
NOTE Pour les besoins du présent document, le rayonnement optique concerne la plage de longueur d’onde de 250 nm à 2 500 nm.
Le présent document ne s’applique pas au rayonnement thérapeutique. Cependant, dans le cas des faisceaux de traitement des dispositifs thérapeutiques, les limites données dans le présent document peuvent être appliquées aux parties du faisceau de traitement qui touche des tissus non cibles.
Si des Normes internationales verticales (spécifiques aux instruments) contiennent des exigences spécifiques vis-à-vis des dangers de la lumière différentes de celles données dans l’ISO 15004-2, celles indiquées dans la Norme internationale verticale prévalent.
Le présent document classe les instruments ophtalmiques soit dans le Groupe 1, soit dans le Groupe 2, afin de distinguer les instruments sans danger de ceux potentiellement dangereux.
Oftalmični instrumenti - Osnovne zahteve in preskusne metode - 2. del: Zaščita pred nevarno svetlobo (ISO 15004-2:2024)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-februar-2025
Nadomešča:
SIST EN ISO 15004-2:2007
Oftalmični instrumenti - Osnovne zahteve in preskusne metode - 2. del: Zaščita
pred nevarno svetlobo (ISO 15004-2:2024)
Ophthalmic instruments - Fundamental requirements and test methods - Part 2: Light
hazard protection (ISO 15004-2:2024)
Ophthalmische Instrumente - Grundlegende Anforderungen und Prüfverfahren - Teil 2:
Schutz gegen Gefährdung durch Licht (ISO 15004-2:2024)
Instruments ophtalmiques - Exigences fondamentales et méthodes d'essai - Partie 2:
Protection contre les dangers de la lumière (ISO 15004-2:2024)
Ta slovenski standard je istoveten z: EN ISO 15004-2:2024
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 15004-2
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2024
EUROPÄISCHE NORM
ICS 11.040.70 Supersedes EN ISO 15004-2:2007
English Version
Ophthalmic instruments - Fundamental requirements and
test methods - Part 2: Light hazard protection (ISO 15004-
2:2024)
Instruments ophtalmiques - Exigences fondamentales Ophthalmische Instrumente - Grundlegende
et méthodes d'essai - Partie 2: Protection contre les Anforderungen und Prüfverfahren - Teil 2: Schutz
dangers de la lumière (ISO 15004-2:2024) gegen Gefährdung durch Licht (ISO 15004-2:2024)
This European Standard was approved by CEN on 18 November 2024.
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
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15004-2:2024 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 15004-2:2024) 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 June 2025, and conflicting national standards shall be
withdrawn at the latest by June 2025.
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 15004-2:2007.
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 15004-2:2024 has been approved by CEN as EN ISO 15004-2:2024 without any
modification.
International
Standard
ISO 15004-2
Second edition
Ophthalmic instruments —
2024-12
Fundamental requirements and test
methods —
Part 2:
Light hazard protection
Instruments ophtalmiques — Exigences fondamentales et
méthodes d'essai —
Partie 2: Protection contre les dangers de la lumière
Reference number
ISO 15004-2:2024(en) © ISO 2024
ISO 15004-2:2024(en)
© ISO 2024
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
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Published in Switzerland
ii
ISO 15004-2:2024(en)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification principles . 7
4.1 General .7
4.2 Group 1 instruments .9
4.3 Group 2 instruments .9
5 Requirements for classification . 9
5.1 General .9
5.2 Requirements for classification as a Group 1 instrument .9
5.3 Requirements for classification as a Group 2 instrument .10
5.4 Exposure limits for Group 1 classification .10
5.4.1 Continuous wave instruments .10
5.4.2 Pulsed instruments . .10
5.4.3 Time-limited instruments .11
5.4.4 Dose limited instruments . .11
5.4.5 Scanning instruments .11
5.4.6 Instruments with multiple sources . 12
5.4.7 Instruments for long-term repetitive daily use . 12
5.5 Recommended maximum exposure (RME) values for Group 2 instruments . 12
5.5.1 Continuous wave instruments . 12
5.5.2 Pulsed instruments . . 12
5.5.3 Time-limited instruments . 13
5.5.4 Scanning instruments . 13
5.5.5 Instruments with multiple sources . 13
5.5.6 Instruments for long-term repetitive daily use .14
5.6 Exposure limits and maximum recommended exposure values .14
6 Test methods . 19
6.1 General .19
6.2 Classification of instruments into Group 1 or Group 2 .19
6.3 Spectral measurements . 20
6.4 Group 2 instruments: determination of time and number of pulses to reach
recommended maximum exposure . 20
6.4.1 Determination of time t to reach the recommended maximum exposure for
max
weighted corneal and lenticular ultraviolet radiation radiant exposure, H . 20
S-CL
6.4.2 Determination of time t to reach the recommended maximum exposure for
max
photochemical aphakic retinal radiant exposure . 20
6.4.3 Determination of the number of pulses necessary to reach the recommended
maximum exposure for photochemical aphakic retinal exposure, n (for
max
pulsed instruments) .21
7 Information supplied by the manufacturer .21
7.1 Information provided on request .21
7.2 Accompanying documents .21
7.2.1 General .21
7.2.2 Dose-limited instruments .21
7.2.3 Cautionary statements .21
7.3 Mar
...
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