SIST EN ISO 15004-2:2025

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

• Status: Not Published
• Public Enquiry End Date: 10-Dec-2023
• ICS: 11.040.70 - Ophthalmic equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 19-Dec-2024
• Due Date: 23-Feb-2025
• Ref Project: EN ISO 15004-2:2024 - Ophthalmic instruments - Fundamental requirements and test methods - Part 2: Light hazard protection (ISO 15004-2:2024)

Relations

• Replaces: SIST EN ISO 15004-2:2007 - Ophthalmic instruments - Fundamental requirements and test methods - Part 2: Light hazard protection (ISO 15004-2:2007)
• Effective Date: 01-Feb-2025

Standards Content (Sample)

SLOVENSKI STANDARD
oSIST prEN ISO 15004-2:2023
01-december-2023
Nadomešča:
SIST EN ISO 15004-2:2007
Oftalmični instrumenti - Osnovne zahteve in preskusne metode - 2. del: Zaščita
pred nevarno svetlobo (ISO/DIS 15004-2:2023)
Ophthalmic instruments - Fundamental requirements and test methods - Part 2: Light
hazard protection (ISO/DIS 15004-2:2023)
Ophthalmische Instrumente - Grundlegende Anforderungen und Prüfverfahren - Teil 2:
Schutz gegen Gefährdung durch Licht (ISO/DIS 15004-2:2023)
Instruments ophtalmiques - Exigences fondamentales et méthodes d'essai - Partie 2:
Protection contre les dangers de la lumière (ISO/DIS 15004-2:2023)
Ta slovenski standard je istoveten z: prEN ISO 15004-2
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
oSIST prEN ISO 15004-2:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

oSIST prEN ISO 15004-2:2023
oSIST prEN ISO 15004-2:2023
DRAFT INTERNATIONAL STANDARD
ISO/DIS 15004-2
ISO/TC 172/SC 7 Secretariat: DIN
Voting begins on: Voting terminates on:
2023-09-11 2023-12-04
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
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 15004-2:2023(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 2023

oSIST prEN ISO 15004-2:2023
ISO/DIS 15004-2:2023(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 15004-2
ISO/TC 172/SC 7 Secretariat: DIN
Voting begins on: Voting terminates on:

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
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 2023
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
NOT BE REFERRED TO AS AN INTERNATIONAL
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on STANDARD UNTIL PUBLISHED AS SUCH.
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
IN ADDITION TO THEIR EVALUATION AS
or ISO’s member body in the country of the requester. BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
ISO copyright office
USER PURPOSES, DRAFT INTERNATIONAL
CP 401 • Ch. de Blandonnet 8
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
CH-1214 Vernier, Geneva
POTENTIAL TO BECOME STANDARDS TO
Phone: [phone]
WHICH REFERENCE MAY BE MADE IN
Reference number
Email: [e-mail]
NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 15004-2:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
Published in Switzerland
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
ii
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023

oSIST prEN ISO 15004-2:2023
ISO/DIS 15004-2:2023(E)
Contents Page
Foreword .v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification principles . 7
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 . 11
5.4.1 Continuous wave instruments . 11
5.4.2 Pulsed instruments . . 11
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 .13
6 Test methods .19
6.1 General . 19
6.2 Classification of instruments into Group 1 or Group 2 . 19
6.3 Spectral Measurements . 19
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
max
for 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
max
for unweighted corneal and lenticular ultraviolet radiation radiant
exposure, H . .20
UV-CL
6.4.3 Determination of time t to reach the recommended maximum exposure
max
for photochemical aphakic retinal radiant exposure . 20
6.4.4 Determination of the number of pulses necessary to reach the
recommended maximum exposure for photochemical aphakic retinal
exposure, n (for pulsed instruments) . 21
max
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 . 24
7.3.1 Radiation output . 24
7.3.2 Consult accompanying documents. 24
7.3.3 Safety information for optical radiation . 24
iii
oSIST prEN ISO 15004-2:2023
ISO/DIS 15004-2:2023(E)
Annex A (normative) Spectral weighting functions .26
Annex B (informative) Ophthalmic instruments with product-related International
Standards that contain a specific light hazard section.33
Annex D (informative) Measurement methods for radiance/irradiance.37
Annex E (informative) Guidance on the direct measurement of irradiance.42
Annex G (informative) Safety signs .55
Annex ZA (informative) Relationship between this European Standard and theGeneral
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered .56
Bibliography .58
iv
oSIST prEN ISO 15004-2:2023
ISO/DIS 15004-2:2023(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,
...