ISO 15004-2

Ophthalmic instruments — 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

General Information

• Status: Not Published
• ICS: 11.040.70 - Ophthalmic equipment
• Technical Committee: ISO/TC 172/SC 7 - Ophthalmic optics and instruments
• Drafting Committee: ISO/TC 172/SC 7/WG 6 - Ophthalmic instruments and test methods
• Current Stage: 6000 - International Standard under publication
• Completion Date: 18-Oct-2024

Relations

• Consolidates: ISO 8178-2:2021 - Reciprocating internal combustion engines — Exhaust emission measurement — Part 2: Measurement of gaseous and particulate exhaust emissions under field conditions
• Effective Date: 24-Aug-2024
• Consolidates: ISO 18527-3:2020 - Eye and face protection for sports use — Part 3: Requirements and test methods for eyewear intended to be used for surface swimming
• Effective Date: 06-Jun-2022
• Revises: ISO 15004-2:2007 - Ophthalmic instruments — Fundamental requirements and test methods — Part 2: Light hazard protection
• Effective Date: 23-Apr-2020

Standards Content (Sample)

FINAL DRAFT
International
Standard
ISO/FDIS 15004-2
ISO/TC 172/SC 7
Ophthalmic instruments —
Secretariat: DIN
Fundamental requirements and test
Voting begins on:
methods —
2024-08-22
Part 2:
Voting terminates on:
2024-10-17
Light hazard protection
Instruments ophtalmiques — Exigences fondamentales et
méthodes d'essai —
Partie 2: Protection contre les dangers de la lumière
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 SUPPOR TING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/CEN PARALLEL PROCESSING LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
ISO/FDIS 15004-2:2024(en) © ISO 2024

FINAL DRAFT
ISO/FDIS 15004-2:2024(en)
International
Standard
ISO/FDIS 15004-2
ISO/TC 172/SC 7
Ophthalmic instruments —
Secretariat: DIN
Fundamental requirements and test
Voting begins on:
methods —
Part 2:
Voting terminates on:
Light hazard protection
Instruments ophtalmiques — Exigences fondamentales et
méthodes d'essai —
Partie 2: Protection contre les dangers de la lumière
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 SUPPOR TING DOCUMENTATION.
© ISO 2024
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/CEN PARALLEL PROCESSING
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
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 Reference number
ISO/FDIS 15004-2:2024(en) © ISO 2024

ii
ISO/FDIS 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 Emission 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 . 13
5.5.1 Continuous wave instruments . 13
5.5.2 Pulsed instruments . . 13
5.5.3 Time-limited instruments . 13
5.5.4 Scanning instruments . 13
5.5.5 Instruments with multiple sources .14
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 . 20
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 Marking . 25
7.3.1 Radiation output . 25
7.3.2 Consult accompanying documents. 25
7.3.3 Safety information for optical radiation . 25

iii
ISO/FDIS 15004-2:2024(en)
Annex A (normative) Spectral weighting functions .26
Annex B (informative) Measurement instruments.33
Annex C (informative) Measurement methods for radiance/irradiance .37
Annex D (informative) Guidance on the direct measurement of irradiance .42
Annex E (informative) Examples of measurement methods for specific ophthalmic instruments .44
Annex F (informative) Safety signs .55
Bibliography .56

iv
ISO/FDIS 15004-2:2024(en)
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 document 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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available
...

ISO/FDIS 15004-2
ISO/TC 172/SC 7
Secretariat: DIN
Date: 2024-xx
Ophthalmic instruments — 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
FDIS stage
ISO/FDIS 15004-2:2024(en)
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: + 41 22 749 01 11
E-mail: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
ISO/FDIS 15004-2:2024(en)
Contents
Foreword . v
Introduction . vii
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 . 8
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 Emission 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. 12
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 . 13
5.5.1 Continuous wave instruments . 13
5.5.2 Pulsed instruments . 13
5.5.3 Time-limited instruments . 13
5.5.4 Scanning instruments. 14
5.5.5 Instruments with multiple sources . 14
5.5.6 Instruments for long-term repetitive daily use . 14
5.6 Exposure limits and maximum recommended exposure values . 14
6 Test methods . 22
6.1 General. 22
6.2 Classification of instruments into Group 1 or Group 2 . 22
6.3 Spectral measurements . 22
6.4 Group 2 instruments: determination of time and number of pulses to reach
recommended maximum exposure . 22
6.4.1 Determination of time t to reach the recommended maximum exposure for weighted
max
corneal and lenticular ultraviolet radiation radiant exposure, H . 22
S-CL
6.4.2 Determination of time t to reach the recommended maximum exposure for
max
photochemical aphakic retinal radiant exposure . 23
6.4.3 Determination of the number of pulses necessary to reach the recommended maximum
exposure for photochemical aphakic retinal exposure, n (for pulsed instruments) . 23
max
7 Information supplied by the manufacturer . 23
7.1 Information provided on request . 23
7.2 Accompanying documents . 23
7.2.1 General. 23
7.2.2 Dose-limited instruments . 24
7.2.3 Cautionary statements . 24
7.3 Marking . 27
iii
ISO/FDIS 15004-2:2024(en)
7.3.1 Radiation output . 27
7.3.2 Consult accompanying documents . 27
7.3.3 Safety information for optical radiation . 27
Annex A (normative) Spectral weighting functions. 29
Annex B (informative) Measurement instruments . 37
Annex C (informative) Measurement methods for radiance/irradiance . 41
Annex D (informative) Guidance on the direct measurement of irradiance . 46
Annex E (informative) Examples of measurement methods for specific ophthalmic instruments48
Annex F (informative) Safety signs . 59
Bibliography . 60

iv
ISO/FDIS 15004-2:2024(en)
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 document 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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent rights
in respect thereof. As of the date of publication of this document, ISO had not received notice of (a) patent(s)
which may be required to implement this document. However, implementers are cautioned that this may not
represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
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, in collaboration with the European Committee for Standardization (CEN)
Technical Committee CEN/TC 170, Ophthalmic optics, in accordance with the Agreement on technical
cooperation between ISO and CEN (Vienna Agreement).
This second edition cancels and replaces the first edition (ISO 15004-2:2007), which has been technically
revised.
The main changes are as follows:
— The terms and definitions include dose limited instruments and time limited instruments;
— The safe exposure limits have been reorganized into 4 tables (Tables 2 to 5), and the associated
measurement conditions have been reorganized into a companion table (Table 6);
— A number of Group 1 exposure limits and Group 2 recommended maximum exposures (RMEs) have been
updated to conform to recent research and relevant standards;
— The language has been clarified and simplified throughout the document, and a flowchart has been added
as a guide to make the standard more accessible to first-time users;
— Clauses and associated exposure limits have been added for long-term repetitive exposures, such as may
apply to extensive use of head-mounted displays by people with visual impairments;
— Provisions have been added to ensure that the exposure limits and RMEs applicable to specific devices are
easily accessible to end users.
v
ISO/FDIS 15004-2:2024(en)
A list of all parts in the ISO 15004 series can be found on the ISO website.
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.
vi
ISO/FDIS 15004-2:2024(en)
Introduction
Ophthalmic instruments are classified into two groups to distinguish instruments that can present a potential
hazard from those that cannot. The two groups are named Group 1 and Group 2. They are defined as follows:
Group 1 instruments: ophthalmic instruments for which no potential light hazard exists when used as
intended (see Clause 4).
Group 2 instruments: ophthalmic instruments for which a potential light hazard exists (see Clause 4).
Limits and guidelines for optical radiation exposure of the eye during ophthalmic examination can differ from
those of non-ophthalmic applications. They can be more restrictive because of pupils dilation or retinal image
stabilization, or less restrictive based on benefit/risk ratios. Furthermore, interruptions of exposure during
surgical procedures mitigate the risk.
All group 2 instruments pose a potential risk of injury at the upper emission values of the instrument. This is
true for both photochemical (where time is critical) and thermal, where transmission and absorption values
can vary. Clinical judgement of individual suscept
...

PROJET FINAL
Norme
internationale
ISO/FDIS 15004-2
ISO/TC 172/SC 7
Instruments ophtalmiques —
Secrétariat: DIN
Exigences fondamentales et
Début de vote:
méthodes d'essai —
2024-08-22
Partie 2:
Vote clos le:
2024-10-17
Protection contre les dangers de la
lumière
Ophthalmic instruments — Fundamental requirements and test
methods —
Part 2: Light hazard protection
LES DESTINATAIRES DU PRÉSENT PROJET SONT
INVITÉS À PRÉSENTER, AVEC LEURS OBSERVATIONS,
NOTIFICATION DES DROITS DE PROPRIÉTÉ DONT ILS
AURAIENT ÉVENTUELLEMENT CONNAISSANCE ET À
FOURNIR UNE DOCUMENTATION EXPLICATIVE.
OUTRE LE FAIT D’ÊTRE EXAMINÉS POUR
ÉTABLIR S’ILS SONT ACCEPTABLES À DES FINS
INDUSTRIELLES, TECHNOLOGIQUES ET COM-MERCIALES,
AINSI QUE DU POINT DE VUE DES UTILISATEURS, LES
PROJETS DE NORMES
TRAITEMENT PARALLÈLE ISO/CEN
INTERNATIONALES DOIVENT PARFOIS ÊTRE CONSIDÉRÉS
DU POINT DE VUE DE LEUR POSSI BILITÉ DE DEVENIR DES
NORMES POUVANT
SERVIR DE RÉFÉRENCE DANS LA RÉGLEMENTATION
NATIONALE.
Numéro de référence
ISO/FDIS 15004-2:2024(fr) © ISO 2024

PROJET FINAL
ISO/FDIS 15004-2:2024(fr)
Norme
internationale
ISO/FDIS 15004-2
ISO/TC 172/SC 7
Instruments ophtalmiques —
Secrétariat: DIN
Exigences fondamentales et
Début de vote:
méthodes d'essai —
2024-08-22
Partie 2:
Vote clos le:
2024-10-17
Protection contre les dangers de
la lumière
Ophthalmic instruments — Fundamental requirements and test
methods —
Part 2: Light hazard protection
LES DESTINATAIRES DU PRÉSENT PROJET SONT
INVITÉS À PRÉSENTER, AVEC LEURS OBSERVATIONS,
NOTIFICATION DES DROITS DE PROPRIÉTÉ DONT ILS
AURAIENT ÉVENTUELLEMENT CONNAISSANCE ET À
FOURNIR UNE DOCUMENTATION EXPLICATIVE.
DOCUMENT PROTÉGÉ PAR COPYRIGHT
OUTRE LE FAIT D’ÊTRE EXAMINÉS POUR
ÉTABLIR S’ILS SONT ACCEPTABLES À DES FINS
© ISO 2024 INDUSTRIELLES, TECHNOLOGIQUES ET COM-MERCIALES,
AINSI QUE DU POINT DE VUE DES UTILISATEURS, LES
Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en œuvre, aucune partie de cette
PROJETS DE NORMES
TRAITEMENT PARALLÈLE ISO/CEN
INTERNATIONALES DOIVENT PARFOIS ÊTRE CONSIDÉRÉS
publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,
DU POINT DE VUE DE LEUR POSSI BILITÉ DE DEVENIR DES
y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut
NORMES POUVANT
être demandée à l’ISO à l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.
SERVIR DE RÉFÉRENCE DANS LA RÉGLEMENTATION
NATIONALE.
ISO copyright office
Case postale 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Genève
Tél.: [phone]
E-mail: [e-mail]
Web: www.iso.org
Publié en Suisse Numéro de référence
ISO/FDIS 15004-2:2024(fr) © ISO 2024

ii
ISO/FDIS 15004-2:2024(fr)
Sommaire Page
Avant-propos .v
Introduction .vii
1 Domaine d’application . 1
2 Références normatives . 1
3 Termes et définitions . 1
4 Principes de classification . 8
4.1 Généralités .8
4.2 Instruments du Groupe 1 .9
4.3 Instruments du Groupe 2 .9
5 Exigences pour la classification . 9
5.1 Généralités .9
5.2 Exigences de classification en tant qu’instrument du Groupe 1 .10
5.3 Exigences de classification en tant qu’instrument du Groupe 2 .10
5.4 Limites d’émission pour une classification dans le Groupe 1 .11
5.4.1 Instruments à ondes entretenues .11
5.4.2 Instruments à impulsions .11
5.4.3 Instruments à durée limitée . 12
5.4.4 Instruments à dose limitée . 12
5.4.5 Instruments à balayage . 12
5.4.6 Instruments à sources multiples . 12
5.4.7 Instruments à usage quotidien répété sur le long terme . 13
5.5 Valeurs d’exposition maximale recommandée (EMR) pour les instruments du Groupe 2 . 13
5.5.1 Instruments à ondes entretenues . 13
5.5.2 Instruments à impulsions . 13
5.5.3 Instruments à durée limitée .14
5.5.4 Instruments à balayage .14
5.5.5 Instruments à sources multiples .14
5.5.6 Instruments à usage quotidien répété sur le long terme . 15
5.6 Limites d’exposition et valeurs d’exposition maximale recommandée . 15
6 Méthodes d’essai .21
6.1 Généralités .21
6.2 Classification des instruments dans le Groupe 1 ou le Groupe 2 .21
6.3 Mesurages spectraux .21
6.4 Instruments du Groupe 2: détermination du temps et du nombre d’impulsions
nécessaires pour atteindre l’exposition maximale recommandée . 22
6.4.1 Détermination du temps t nécessaire pour atteindre l’exposition maximale
max
recommandée pour l’exposition énergétique pondérée de la cornée et du
cristallin à un rayonnement ultraviolet, H . 22
S-CL
6.4.2 Détermination du temps t nécessaire pour atteindre l’exposition maximale
max
recommandée pour l’exposition énergétique photochimique de la rétine en cas
d’aphakie . . 22
6.4.3 Détermination du nombre d’impulsions nécessaire pour atteindre l’exposition
maximale recommandée pour l’exposition énergétique photochimique de la
rétine en cas d’aphakie, n (instruments à impulsions) . 23
max
7 Informations fournies par le fabricant .23
7.1 Informations fournies sur demande . 23
7.2 Documents d’accompagnement . 23
7.2.1 Généralités . 23
7.2.2 Instruments à dose limitée . 23
7.2.3 Mises en garde . 23
7.3 Marquage .27
7.3.1 Rayonnement émis .27

iii
ISO/FDIS 15004-2:2024(fr)
7.3.2 Consultation des documents d’accompagnement .27
7.3.3 Informations de sécurité relatives au rayonnement optique .27
Annexe A (normative) Fonctions de pondération spectrale .29
Annexe B (informative) Instruments de mesure .37
Annexe C (informative) Méthodes de mesure de la luminance énergétique/de l’éclairement
énergétique . 41
Annexe D (informative) Recommandations relatives au mesurage direct de l’éclairement
énergétique . 47
Annexe E (informative) Exemples de méthodes de mesure pour des instruments
ophtalmiques spécifiques .50
Annexe F (informative) Symboles de sécurité . 61
Bibliographie .62

iv
ISO/FDIS 15004-2:2024(fr)
Avant-propos
L’ISO (Organisation internationale de normalisation) est une fédération mondiale d’organismes nationaux
de normalisation (comités membres de l’ISO). L’élaboration des Normes internationales est en général
confiée aux comités techniques de l’ISO. Chaque comité membre intéressé par une étude a le droit de faire
partie du comité technique créé à cet effet. Les organisations internationales, gouvernementales et non
gouvernementales, en liaison avec l’ISO participent également aux travaux. L’ISO collabore étroitement avec
la Commission électrotechnique internationale (IEC) en ce qui concerne la normalisation électrotechnique.
Les procédures utilisées pour élaborer le présent document et celles destinées à sa mise à jour sont
décrites dans les Directives ISO/IEC, Partie 1. Il convient, en particulier, de prendre note des différents
critères d’approbation requis
...