EN IEC 62471-6:2023
(Main)Photobiological safety of lamps and lamp systems - Part 6: Ultraviolet lamp products
Photobiological safety of lamps and lamp systems - Part 6: Ultraviolet lamp products
This Standard provides the optical radiation safety requirements for ultraviolet lamp products, including UV LED products. This standard provides requirements for: - optical radiation safety assessment and ultraviolet-product risk groups; - user information for safety measures; - appropriate labelling of ultraviolet lamp products This standard addresses those lamps and lamp products where the ultraviolet emission serves the primary purpose of the product and where more than half of the optical radiation emitted between 180 nm - 3 000 nm is in the spectral region 180 nm - 400 nm. If more than half of the optical radiation emitted between 180 nm - 3 000 nm is outside of the spectral region 180 nm - 400 nm, then the base standard IEC 62471-1 should be used. This standard covers medical diagnostic devices/products that emit primarily UV radiation. Because photobiological effects from UV radiation are based on the total accumulated exposure (dose) received, this standard relies on the concept of ‘Time-weighted Average’ exposures where the assessment distance for determining the RG is chosen based on realistic exposure distances and exposure durations. In other words, it is not expected that people will be exposed at very close distances, e.g. 20 - 30 cm, for extended periods of time. This standard is needed to provide assessment distances and specific guidance that are application-specific and realistic rather than the more general values in IEC 62471 where the specific application is unknown and time-weighted average exposures are not application-specific. This Standard does not provide requirements for: - lamps which primarily emit visible and/or infrared radiant energy - lamp products used for general lighting or infrared illumination or heating, which are treated in separate standards. - fluorescent ultraviolet lamps for tanning (covered by IEC 60335-2-27 and IEC 61228). - medical treatment devices/products (see IEC 60601-2-57), but covers UV medical diagnostic products.
Photobiologische Sicherheit von Lampen und Lampensystemen - Teil 6: Produkte mit ultravioletter Strahlung
Sécurité photobiologique des lampes et des appareils utilisant des lampes - Partie 6: Appareils à lampes ultraviolettes
IEC 62471-6:2022 IEC 62471:2006/CIE S009:2002. La norme CEI 62471 couvre les diodes électroluminescentes (DEL), les lampes à incandescence, à décharge de gaz à basse et haute pression, les lampes à arc et autres. Il couvre également les lampes conçues principalement pour émettre de l’énergie rayonnante ultraviolette, telles que les sources ultraviolettes destinées à exciter la fluorescence des matériaux irradiés, pour les pièges à insectes, pour les études scientifiques, l’identification des minéraux, les essais non destructifs, l’irradiation germicide et à d’autres fins. La présente partie de la CEI 62471 fournit les exigences de sécurité contre le rayonnement optique pour les lampes ultraviolettes, y compris les lampes UV LED. Le présent document prévoit des exigences pour :
l’évaluation de la sûreté des rayonnements optiques et les groupes à risque de produits ultraviolets;
les renseignements sur l’utilisateur pour les mesures de sécurité;
l’étiquetage approprié des produits de lampes ultraviolettes. Le présent document traite des lampes et des produits de lampes dont l’émission ultraviolette sert l’objectif principal du produit et où plus de la moitié de la puissance rayonnante émise entre 180 nm et 3 000 nm se trouve dans la région spectrale de 180 nm à 400 nm. Si plus de la moitié du rayonnement optique émis entre 180 nm et 3 000 nm se trouve en dehors de la région spectrale de 180 nm à 400 nm, il convient d’utiliser la norme de base IEC 62471. Ce document couvre les dispositifs/produits de diagnostic médical et cosmétiques qui émettent principalement des rayons UV.
Fotobiološka varnost ultravijoličnih sijalk
Ta standard podaja zahteve v zvezi z varnostjo pri optičnem sevanju za ultravijolične sijalke, vključno z izdelki UV-LED.
Standard podaja zahteve za:
– oceno varnosti pri optičnem sevanju in tvegane skupine ultravijoličnih izdelkov;
– informacije za uporabnike o varnostnih ukrepih;
– ustrezno označevanje ultravijoličnih sijalk.
Ta standard obravnava sijalke in izdelke s sijalkami, pri katerih je ultravijolično sevanje prvotni namen izdelka in je več kot polovica optičnega sevanja, ki se oddaja v razponu od 180 nm do 3000 nm, v spektralnem območju od 180 nm do 400 nm. Če je več kot polovica optičnega sevanja, ki se oddaja v razponu od 180 nm do 3000 nm, zunaj spektralnega območja od 180 nm do 400 nm, je priporočljivo uporabiti osnovni standard IEC 62471-1. Ta standard obravnava diagnostične medicinske pripomočke/izdelke, ki oddajajo predvsem ultravijolično sevanje.
Fotobiološki učinki UV-sevanja temeljijo na skupni prejeti izpostavljenosti (odmerku), zato se ta standard navezuje na koncept »časovno obtežene povprečne« izpostavljenosti, pri katerem je ocenjevalna razdalja za določanje RG izbrana na podlagi realnih razdalj izpostavljenosti in njenega trajanja. Tako ni pričakovati, da bodo ljudje dlje časa izpostavljeni na zelo majhnih razdaljah (npr. 20–30 cm). Ta standard je potreben za zagotavljanje ocenjevalnih razdalj in posebnih smernic, ki so specifične za vrsto uporabe in realistične – za razliko od splošnejših vrednosti v standardu IEC 62471, pri katerih posebna vrsta uporabe ni znana in časovno obtežena povprečna izpostavljenost ni specifična za vrsto uporabe.
Standard ne podaja zahtev za:
– sijalke, ki oddajajo predvsem vidno in/ali infrardečo sevalno energijo;
– izdelke s sijalkami, ki se uporabljajo za splošno razsvetljavo, infrardečo osvetlitev ali ogrevanje (obravnavani so v ločenih standardih);
– fluorescenčne ultravijolične sijalke za umetno sončenje (zajete v standardih IEC 60335-2-27 in IEC 61228);
– medicinske pripomočke/izdelke za zdravljenje (glej standard IEC 60601-2-57), vendar zajema ultravijolične diagnostične medicinske izdelke.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2023
Fotobiološka varnost ultravijoličnih sijalk
Photobiological Safety of Ultraviolet Lamp Products
Photobiologische Sicherheit von Lampen und Lampensystemen - Teil 6: Produkte mit
ultravioletter Strahlung
Sécurité photobiologique des appareils à lampes ultraviolettes
Ta slovenski standard je istoveten z: EN IEC 62471-6:2023
ICS:
29.140.01 Žarnice na splošno Lamps in general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD EN IEC 62471-6
NORME EUROPÉENNE
EUROPÄISCHE NORM November 2023
ICS 29.140.01; 31.260
English Version
Photobiological safety of lamps and lamp systems - Part 6:
Ultraviolet lamp products
(IEC 62471-6:2022)
Sécurité photobiologique des lampes et des appareils Photobiologische Sicherheit von Lampen und
utilisant des lampes - Partie 6: Appareils à lampes Lampensystemen ) Teil 6: Produkte mit ultravioletter
ultraviolettes Strahlung
(IEC 62471-6:2022) (IEC 62471-6:2022)
This European Standard was approved by CENELEC on 2023-10-11. CENELEC 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 CENELEC 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 CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Türkiye and the United Kingdom.
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2023 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 62471-6:2023 E
European foreword
The text of document 76/714/FDIS, future edition 1 of IEC 62471-6, prepared by IEC/TC 76 "Optical
radiation safety and laser equipment" was submitted to the IEC-CENELEC parallel vote and approved
by CENELEC as EN IEC 62471-6:2023.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2024-07-11
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2026-10-11
document have to be withdrawn
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
This document has been prepared under a Standardization Request addressed to CENELEC by the
European Commission.
Any feedback and questions on this document should be directed to the users’ national committee. A
complete listing of these bodies can be found on the CENELEC website.
Endorsement notice
The text of the International Standard IEC 62471-6:2022 was approved by CENELEC as a European
Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standard indicated:
IEC 61010-2-040 NOTE Approved as EN IEC 61010-2-040
IEC 61228 NOTE Approved as EN IEC 61228
IEC 61508 (series) NOTE Approved as EN 61508 (series)
IEC 62035:2014 NOTE Approved as EN 62035:2014 (modified)
IEC 62061 NOTE Approved as EN IEC 62061
IEC 62368-1:2018 NOTE Approved as EN IEC 62368-1:2020 (not modified)
ISO 13849 (series) NOTE Approved as EN ISO 13849 (series)
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments)
applies.
NOTE 1 Where an International Publication has been modified by common modifications, indicated by (mod), the
relevant EN/HD applies.
NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available
here: www.cencenelec.eu.
Publication Year Title EN/HD Year
IEC 60335-2-27 - Household and similar electrical appliances EN 60335-2-27 -
- Safety - Part 2-27: Particular
requirements for appliances for skin
exposure to optical radiation
IEC 60417 2002 Graphical symbols for use on equipment - - -
12-month subscription to regularly updated
online database comprising all graphical
symbols published in IEC 60417
IEC 60601-2-57 - Medical electrical equipment - Part 2-57: EN 60601-2-57 -
Particular requirements for the basic safety
and essential performance of non-laser
light source equipment intended for
therapeutic, diagnostic, monitoring,
cosmetic and aesthetic use
IEC 61549 - Miscellaneous lamps EN 61549 -
IEC 62471 2006 Photobiological safety of lamps and lamp EN 62471 2008
/CIE S009 /2002 systems
ISO 7010 - Graphical symbols - Safety colours and - -
safety signs - Registered safety signs
ISO 15004-2 - Ophthalmic instruments - Fundamental EN ISO 15004-2 -
requirements and test methods - Part 2:
Light hazard protection
CIE 247 2021 Guide for the Gonioradiometric - -
Measurement of Upper Air Ultraviolet
Germicidal Irradiation Luminaires, ISBN
978-3-902842-19-0, Vienna
IEC 62471-6 ®
Edition 1.0 2022-10
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Photobiological safety of lamps and lamp systems –
Part 6: Ultraviolet lamp products
Sécurité photobiologique des lampes et des appareils utilisant des lampes –
Partie 6: Appareils à lampes ultraviolettes
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 29.140.01; 31.260 ISBN 978-2-8322-5828-6
– 2 – IEC 62471-6:2022 © IEC 2022
CONTENTS
FOREWORD . 5
INTRODUCTION . 7
1 Scope . 8
2 Normative references . 8
3 Terms and definitions . 9
4 Risk groups applied for ultraviolet lamp-product safety assessments . 12
4.1 Basis for optical radiation safety risk group determination . 12
4.2 Assessment criteria (background) for UV lamp products . 12
5 Measurements to determine applicable risk group . 13
5.1 General . 13
5.2 Time-weighted averaged irradiance . 14
5.3 Risk group assessment conditions . 14
5.3.1 Maximum output conditioning . 14
5.3.2 Measurement and assessment distances for UV lamp products . 15
5.3.3 Risk-group assessment distances . 15
5.3.4 Dose-limited products . 18
5.3.5 Products intended to expose the skin or eyes . 18
6 Engineering requirements for RG-2 and RG-3 ultraviolet systems . 18
6.1 General . 18
6.2 Protective housing . 19
6.2.1 General . 19
6.2.2 Enclosures . 19
6.2.3 Openings, panels and doors . 19
6.3 RG-2 and RG-3 products . 19
6.3.1 General . 19
6.3.2 Proximity sensor . 20
6.3.3 Orientation control . 20
6.3.4 Upper-room germicidal UV luminaire alignment . 20
6.3.5 Delayed-ON timer . 20
6.3.6 Exposure time control / auto-shutoff . 20
6.4 Emission warning . 20
6.5 Reliability . 21
6.6 Emission controls . 21
6.6.1 General . 21
6.6.2 Emissions stop . 21
6.6.3 Key control . 21
7 Information and Labelling – Manufacturer’s Requirements . 21
7.1 General . 21
7.2 User information . 22
7.3 Labelling on UV lamps . 22
7.4 Labelling on UV lamp products. 22
7.4.1 RG-0 UV lamp products . 22
7.4.2 RG-1 UV lamp products . 22
7.4.3 RG-2 UV lamp products . 22
7.4.4 RG-3 UV lamp products . 23
7.5 User manual . 23
IEC 62471-6:2022 © IEC 2022 – 3 –
7.5.1 General . 23
7.5.2 Risk reduction measures . 23
7.5.3 Limited use . 24
7.6 Maintenance and service . 24
Annex A (informative) Typical applications of UV lamp products . 25
A.1 Background. 25
A.2 Applications of UV lamp products . 25
A.2.1 Near-UV (UV-A) “black-light” sources to view fluorescent pigments . 25
A.2.2 Near-UV (UV-A) insect attractant lamp products . 25
A.2.3 UV germicidal (UV-C) lamp products . 26
A.2.4 UV nail curing and treatment . 26
A.2.5 UV medical and dental sources . 27
Annex B (informative) Potentially hazardous biological effects . 28
B.1 Background. 28
B.2 Adverse acute biological effects from ultraviolet irradiation . 28
B.2.1 Photokeratitis and photoconjunctivitis . 28
B.2.2 UV-Cornea reference documents . 29
B.2.3 Erythema (sunburn) . 29
B.2.4 Erythema reference documents . 29
B.3 Adverse biological effects from chronic exposure to ultraviolet irradiation . 30
B.3.1 Skin cancer . 30
B.3.2 Skin cancer reference documents . 31
B.3.3 Pterygium and pinguecula . 31
B.3.4 Pterygium and pinguecula reference documents . 31
B.3.5 Cataract . 32
B.3.6 Cataract reference documents . 32
B.3.7 Labrador keratopathy . 32
B.3.8 Corneal reference documents . 32
B.3.9 Visual effects from UV-A exposure – Lens fluorescence . 33
B.3.10 Photoretinitis – or photic maculopathy (blue light hazard) . 33
B.3.11 Retinal-photochemical biological effects reference documents . 34
Annex C (informative) Measurement of ultraviolet lamp products . 35
C.1 General . 35
C.2 Radiometers . 35
C.3 Spectroradiometers . 35
C.4 Entrance optic . 36
C.5 Spectroradiometer- radiometer approach . 37
C.6 Measurement distance versus assessment distance . 37
C.6.1 General . 37
C.6.2 Spectroradiometer approach . 37
C.6.3 Radiometer approach . 38
C.7 Reference documents . 38
Annex D (informative) Spectral weighting function S(λ) from 180 nm to 400 nm for
assessing actinic radiation hazard . 39
Annex E (informative) Examples of risk group classification applying the concept of
TWA of a spectrally-weighted emission . 42
E.1 Spectral weighting to determine effective irradiance using S(λ) . 42
E.2 Time weighting of an exposure . 42
– 4 – IEC 62471-6:2022 © IEC 2022
E.3 Field radiometric measurements for final acceptance testing of a GUV
installation . 45
Annex F (informative) Upper room GUV – Background and rationale to achieve safety . 46
F.1 General . 46
F.2 Product Goals . 46
F.3 Product test measurement conditions. 46
F.3.1 General . 46
F.3.2 Elevation plane for radiometric measurements . 47
F.3.3 Test grid for measurements . 47
F.3.4 Detector acceptance angle (field-of-view) . 47
F.3.5 Instrument performance specifications . 47
F.4 GUV luminaires . 47
F.4.1 Adjustable UV luminaires . 47
F.4.2 Interlock safeguards on removable baffles . 47
F.4.3 Labelling requirements . 48
F.4.4 Efficacy and information for the user . 48
F.5 Acceptance testing. 48
F.5.1 Scope of the installation acceptance testing . 48
F.5.2 Time-weighted averaging . 48
F.6 Reference documents. . 48
Bibliography . 50
Figure 1 – Based on Graphic 6040 of UV lamp inside triangle from IEC 60417 . 23
Figure 2 – Alternative labels to provide added information for narrow-band UV lamps . 23
Figure B.1 – CIE Standard Action Spectrum for NMSC . 30
Figure B.2 – Semi-logarithmic comparison of three action spectra (ICNIRP S(λ) – solid
line; McKinlay, Diffey erythema – dashed; NMSC – dots) . 31
Figure C.1 – Geometry of irradiance / spectral irradiance measurements . 36
Figure E.1 – Example of how an occupational hygienist might determine different
zones of exposure by time-weighting . 43
Figure E.2 – Time-weighted averaging (TWA) over an 8 h period . 44
Figure E.3 – Field GUV safety meter with 80° full field of view . 45
Table 1 – Emission limits for risk groups for time-weighted averaged irradiance . 14
a
Table 2 – Risk group assessment distances for unrestricted-use products . 16
Table 3 – Risk group assessment distances for restricted-use products intended to be
used by instructed persons . 17
Table 4 – Risk group assessment distances for lamps or lamp products intended for
use by professional, competent persons . 18
Table D.1 – Spectral weighting function S(λ) values at 1 nm intervals . 39
IEC 62471-6:2022 © IEC 2022 – 5 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
PHOTOBIOLOGICAL SAFETY OF LAMPS AND LAMP SYSTEMS –
Part 6: Ultraviolet lamp products
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international
co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and
in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports,
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preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with
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with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for
Standardization (ISO) in accordance with conditions determined by agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence between
any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent
rights. IEC shall not be held responsible for identifying any or all such patent rights.
IEC 62471-6 has been prepared by IEC technical committee 76: Optical radiation safety and
laser equipment. It is an International Standard.
The text of this International Standard is based on the following documents:
FDIS Report on voting
76/714/FDIS 76/718/RVD
Full information on the voting for its approval can be found in the report on voting indicated in
the above table.
The language used for the development of this International Standard is English.
This document was drafted in accordance with ISO/IEC Directives, Part 2, and developed in
accordance with ISO/IEC Directives, Part 1 and ISO/IEC Directives, IEC Supplement, available
at www.iec.ch/members_experts/refdocs. The main document types developed by IEC are
described in greater detail at www.iec.ch/standardsdev/publications.
– 6 – IEC 62471-6:2022 © IEC 2022
In this standard, the following print types are used:
conformity statements: in italic type.
A list of all parts in the IEC 62471 series, published under the general title Photobiological
safety of lamps and lamp systems, can be found on the IEC website.
The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under webstore.iec.ch in the data related to the
specific document. At this date, the document will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
IMPORTANT – The "colour inside" logo on the cover page of this document indicates that it
contains colours which are considered to be useful for the correct understanding of its
contents. Users should therefore print this document using a colour printer.
IEC 62471-6:2022 © IEC 2022 – 7 –
INTRODUCTION
Most lamps and lamp products are safe and do not pose photobiological risks except under
unusual exposure conditions; however, one group of products-ultraviolet lamp products-can
under some conditions pose optical hazards during use and require risk assessment for direct
and indirect exposure of the eyes and skin. Optical radiation hazards from all types of lamps or
other broadband light sources are assessed by the application of
IEC 62471:2006/CIE S009:2002. IEC 62471 covers light emitting diodes (LEDs), incandescent,
low- and high- pressure gas-discharge, arc and other lamps. It also covers lamps which are
designed primarily to emit ultraviolet radiant energy, such as ultraviolet sources intended to
excite fluorescence of irradiated materials, for insect light traps, for scientific studies, mineral
identification, for non-destructive testing, germicidal irradiation, and other purposes.
This document provides a risk group (RG) classification system for all ultraviolet lamp products,
and the assessment distances and measurement conditions for different products (Annex A and
Annex C). It includes manufacturing and user safety requirements that may be required as a
result of an ultraviolet lamp product being assigned to a particular risk group. The scope is
limited to products where the sole intent is to emit ultraviolet radiant energy. The advantage of
applying this document, intended solely for ultraviolet lamp products, instead of the horizontal
IEC 62471 standard, is that the risks from visible and infrared optical radiation need not be
assessed using this document, as they are assumed to be insignificant for a lamp that emits
mainly UV. The assigned risk group of an ultraviolet lamp product using this document may also
be used to assist with any needed risk assessments, e.g. for occupational exposure in
workplaces.
– 8 – IEC 62471-6:2022 © IEC 2022
PHOTOBIOLOGICAL SAFETY OF LAMPS AND LAMP SYSTEMS –
Part 6: Ultraviolet lamp products
1 Scope
This part of IEC 62471 provides the optical radiation safety requirements for ultraviolet lamp
products, including UV LED lamp products.
This document provides requirements for:
• optical radiation safety assessment and ultraviolet-product risk groups;
• user information for safety measures;
• appropriate labelling of ultraviolet lamp products.
This document addresses those lamps and lamp products where the ultraviolet emission serves
the primary purpose of the product and where more than half of the radiant power emitted
between 180 nm and 3 000 nm is in the spectral region 180 nm to 400 nm. If more than half of
the optical radiation emitted between 180 nm and 3 000 nm is outside of the spectral region
180 nm to 400 nm, then the base standard IEC 62471 should be used. This document covers
medical diagnostic and cosmetic devices/products that emit primarily UV radiation.
Because photobiological effects from UV radiation are based on the total accumulated exposure
(dose) received, this document relies on the concept of ‘time-weighted average’ exposures
where the assessment distance for determining the RG is chosen based on realistic exposure
distances and exposure durations. In other words, it is not expected that people will be exposed
at very close distances, e.g. 20 cm to 30 cm, for extended periods of time. This document
provides assessment distances and specific guidance that are application-specific and realistic
rather than the more general values in IEC 62471 where the specific application is unknown
and time-weighted average exposures are not application-specific.
This document does not provide requirements for:
• lamps which primarily emit visible (such as GLS – general lighting source) and/or infrared
radiant energy;
• lamp products used for general lighting or infrared illumination or heating, which are treated
in separate standards;
• fluorescent ultraviolet lamps for tanning (covered by IEC 60335-2-27 and IEC 61228);
• medical treatment devices/products (see IEC 60601-2-57), but covers UV medical
diagnostic products;
• non-optical hazards, e.g. ozone, mercury, etc.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies.
For undated references, the latest edition of the referenced document (including any
amendments) applies.
IEC 60335-2-27, Household and similar electrical appliances – Safety – Part 2-27: Particular
requirements for appliances for skin exposure to optical radiation
IEC 62471-6:2022 © IEC 2022 – 9 –
IEC 60417:2002, Graphical symbols for use on equipment – 12-month subscription to regularly
updated online database comprising all graphical symbols published in IEC 60417
IEC 60601-2-57, Medical electrical equipment – Part 2-57: Particular requirements for the basic
safety and essential performance of non-laser light source equipment intended for therapeutic,
diagnostic, monitoring and cosmetic/aesthetic use
IEC 61549, Miscellaneous lamps
IEC 62471:2006/CIE S009:2002, Photobiological safety of lamps and lamp systems
ISO 7010: Graphical symbols – Safety colours and safety signs – Registered safety signs
ISO 15004-2: Ophthalmic instruments – Fundamental requirements and test methods – Part 2:
Light hazard protection
CIE 247:2021, Guide for the Gonioradiometric Measurement of Upper Air Ultraviolet Germicidal
Irradiation Luminaires, ISBN 978-3-902842-19-0, Vienna
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following
addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
3.1
actinic UV
UV radiation capable of producing a photochemical effect
Note 1 to entry: In the context of this document, the biological effects have a demonstrated action spectrum, S(λ),
and refer most significantly to UV-B and UV-C effects, e.g, UV erythema (skin reddening), UV photokeratitis ('welder's
flash' or 'snowblindness'), etc. See also Annex B.
3.2
assessment distance
distance used to determine the risk group classification of a lamp or lamp product
Note 1 to entry: The risk group assessment distance takes account of the TWA exposure (variable irradiance,
exposure distances and durations).
Note 2 to entry: This is usually the distance from the closest point of human access to the emission, to the point of
assessment or measurement.
3.3
blue light hazard
potential for a photochemically induced retinal injury resulting from radiation exposure at
wavelengths primarily between 400 nm and 500 nm
Note 1 to entry: This damage mechanism normally dominates over thermal mechanisms for intense visible light for
viewing times exceeding 10 s, but is rarely of concern from UV lamps (unless the basic lamp is an arc lamp).
[SOURCE: IEC 60050-845:2020,845-26-055]
– 10 – IEC 62471-6:2022 © IEC 2022
3.4
competent person
person who can demonstrate a combination of knowledge and skills to effectively, efficiently,
and safely carry out specific activities
3.5
consumer
person who purchases or employs goods and services for personal use
Note 1 to entry: Consumers include not only users of the ultraviolet lamp product, but also all persons who may
have access to the lamp product or who may be in the vicinity of the product.
Note 2 to entry: Also termed “ordinary person” in IEC 62368-1.
3.6
controlled access location
location where an engineering and/or administrative control measure is established to restrict
access except to authorised personnel with appropriate safety training
3.7
dose-limited product
product where the emitted radiant exposure (dose) is limited by time or actual exposure
monitoring at the assessment distance to a set level during any day
2.
Note 1 to entry: The emission limit is expressed in J/m
3.8
emission limit
limit defined for each risk group, based upon reasonably foreseeable conditions of time-
weighted average (TWA) exposure
Note 1 to entry: The emission limit incorporates both the concept of exposure duration and variable exposure
distance and is derived from exposure limits, however, the risk group assessment distance incorporates the TWA
exposure.
3.9
general lighting source
GLS
general term for lamps, nominally of “white” colour, intended for lighting spaces that are typically
occupied or viewed by people
Note 1 to entry: See IEC 62471 for requirements.
Note 2 to entry: This document does not cover GLS lamps or lamp products.
3.10
germicidal lamp product
any UV lamp product designed to disinfect by ultraviolet germicidal (UVG) irradiation to
inactivate microorganisms so they are no longer capable of replicating and causing adverse
health effects
3.11
instructed person
person who has been instructed and trained by a competent person, or who is supervised by a
competent person, to identify ultraviolet sources that may cause pain or injury and to take
precautions to avoid unintentional exposure to those sources
[SOURCE: IEC 62368-1:2018, 0.2.3, modified to use competent instead of skilled person]
IEC 62471-6:2022 © IEC 2022 – 11 –
3.12
intended use
usage of a product, process or service in accordance with specifications, instructions and
information provided by the manufacturer or supplier
3.13
UV lamp
electric lamp or light emitting diode (LED) lamp that radiates especially strongly in the
ultraviolet, the visible radiation produced, if any, not being of direct interest
Note 1 to entry: There are several types of ultraviolet lamp used for photobiological, photochemical and biomedical
purposes.
[SOURCE: IEC 60050-845:2020, 845-27-091, modified, with Note 2 to entry omitted and with
LED lamp (845-27-054) addition]
3.14
UV lamp product
product incorporating a UV lamp or UV lamps, including fixtures, and possibly filters, where the
ultraviolet emission is the primary purpose of the lamp product and where more than half of the
optical radiation emitted between 180 nm and 3 000 nm is in the spectral region 180 nm to
400 nm
3.15
UV luminaire
apparatus which distributes, filters or transforms the ultraviolet radiant energy transmitted from
at least one source of optical radiation and which includes, except the sources themselves, all
the parts necessary for fixing and protecting the sources and, where necessary, circuit
auxiliaries together with the means for connecting them to the power supply
[SOURCE: IEC 60050-845:2020,845-30-001, modified for UV]
3.16
photocuring lamp product
lamp product that usually employs UV-A to photopolymerize liquid polymers to a solid state
Note 1 to entry: Examples include photopolymerization of liquid inks in printing or rapid curing of plastic products.
3.17
time-weighted average exposure
TWA exposure
averaged cumulative exposure dose over a given period of time (normally any 30 000 s to
approximately 8 h period) divided by the exposure duration to provide an effective irradiance
for both variable distances and durations
Note 1 to entry: The TWA is essential in considering lengthy exposures to ultraviolet hazards, since variable
exposure distances at different irradiances and durations determine the reasonably foreseeable worst-case
exposures (for photochemical hazards) which correspond therefore to the measured/calculated irradiance at a
specified distance for RG determination (analogous to the 500-lx assessment distance for GLS lamps). See Annex E.
3.18
ultraviolet radiation
optical radiation within the wavelength range from 100 nm to 400 nm
Note 1 to entry: The UV-C extends from 100 nm to 280 nm, UV-B from 280 nm to 315 nm, and UV-A from 315 nm
to 400 nm.
Note 2 to entry: Ultraviolet radiation at wavelengths less than 180 nm is considered vacuum ultraviolet radiation for
the purpose of this document and is not included in the scope.
[SOURCE: IEC 60050-845:2020, 845-21-008, modified: Notes 2 to 5 to entry omitted and new
Note 2.]
– 12 – IEC 62471-6:2022 © IEC 2022
3.19
ultraviolet-fluorescence illuminator
any UV-A lamp designed to illuminate and excite fluorescence to permit increased visualization
of the material
Note 1 to entry: Examples include “black-light” fluorescent illuminators, security-code reading UV-A lamps used for
counterfeit money detection, medical applications, etc.
4 Risk groups applied for ultraviolet lamp-product safety assessments
4.1 Basis for optical radiation safety risk group determination
IEC 62471/CIE S009 provides the fundamental method to determine the risk group of any
individual lamp and also the default measurement condition to determine the risk group of any
lamp or any product incorporating a lamp, unless a vertical (application-specific) standard exists
that includes measurement conditions for its specific application. The risk groups in IEC 62471
indicate the degree of risk from potential optical radiation hazards and minimize the need for
further measurements. The risk groups were developed based upon decades of lamp use
experience and the analysis of accidental injuries related to optical radiation emission (where
injuries were, generally, quite rare except from ultraviolet-emitting lamps or arc lamps). The risk
groups are also used in determining appropriate measures for risk management. There are four
basic risk groups:
• Exempt group (RG-0) where no optical hazard is considered reasonably foreseeable, even
for continuous, unrestricted use. Typical examples are small UV-A LED lamps and UV-A
fluorescent lamps used in ultraviolet fluorescence illuminators or in domestic insect light
traps;
• Risk group 1 (RG-1) products are safe for most use applications, except where prolonged
direct ocular exposures may be expected. An example of a risk group 1 lamp products are
some battery-operated UV-A torches (flashlights) or large, industrial insect light traps;
• Risk group 2 (RG-2) products generally do not pose a realistic optical hazard because of
either discomfort glare from lens fluorescence or where lengthy exposures are unrealistic;
examples include some UV-C germicidal fixtures;
• Risk group 3 (RG-3) products pose a potential hazard even for very brief exposures at close
distance, and product safety requirements are generally essential; examples include
sunlamp products (IEC 60335-2-27), Vitamin-D lamp products and unenclosed UV-C
germicidal lamp products.
IEC 62471 does not provide guidance on manufacturing requirements and control measures.
These issues are addressed in application-specific vertical standards such as this document.
Labelling requirements and user information for each UV-lamp-product risk group are provided
in this document (see 7.2 and 7.3).
4.2 Assessment criteria (background) for UV lamp products
The standard measurement conditions consider the emission spectrum and, for ultraviolet
radiation, the irradiance to determine risk to the eye and/or the skin. The measurement
conditions are intended to optimize the signal of trace amounts of UV-B and UV-C radiation that
are emitted from lamp products intended to emit largely in the UV-A spectral region. The risk-
group assessment distance is related to potentially hazardous exposure conditions and time-
weighted-average (TWA) effective assessment distances based upon reasonably foreseeable
worst-case exposure durations. This is built into the emission limits. The concept of a hazard
distance normally does not apply to photochemical hazards, since UV hazardous doses
accumulate, and the daily exposure determines the potential hazard. For time-varying sources,
the accumulated exposure (dose) determining the TWA exposure will be the same as a
continuous (CW) exposure for the same total duration. Optical sources are rarely at a fixed
distance from the eyes, nor does an individua
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