FprEN ISO 15004-2
(Main)Ophthalmic instruments - Fundamental requirements and test methods - Part 2: Light hazard protection (ISO/FDIS 15004-2:2024)
Ophthalmic instruments - Fundamental requirements and test methods - Part 2: Light hazard protection (ISO/FDIS 15004-2:2024)
Ophthalmische Instrumente - Grundlegende Anforderungen und Prüfverfahren - Teil 2: Schutz gegen Gefährdung durch Licht (ISO/FDIS 15004‑2:2024)
Instruments ophtalmiques - Exigences fondamentales et méthodes d'essai - Partie 2: Protection contre les dangers de la lumière (ISO/FDIS 15004-2:2024)
Oftalmični instrumenti - Osnovne zahteve in preskusne metode - 2. del: Zaščita pred nevarno svetlobo (ISO/FDIS 15004-2:2024)
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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
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NATIONAL REGULATIONS.
ISO/DIS 15004-2:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
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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
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NOT BE REFERRED TO AS AN INTERNATIONAL
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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,
...
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