prEN IEC 62471-6:2021
(Main)Photobiological Safety of Ultraviolet Lamp Products
Photobiological Safety of 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.
Sécurité photobiologique des appareils à lampes ultraviolettes
Fotobiološka varnost ultravijoličnih sijalk
General Information
Standards Content (sample)
SLOVENSKI STANDARD
oSIST prEN IEC 62471-6:2021
01-oktober-2021
Fotobiološka varnost ultravijoličnih sijalk
Photobiological Safety of Ultraviolet Lamp Products
Sécurité photobiologique des appareils à lampes ultraviolettes
Ta slovenski standard je istoveten z: prEN IEC 62471-6:2021
ICS:
29.140.01 Žarnice na splošno Lamps in general
oSIST prEN IEC 62471-6:2021 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------oSIST prEN IEC 62471-6:2021
---------------------- Page: 2 ----------------------
oSIST prEN IEC 62471-6:2021
76/680/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 62471-6 ED1
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2021-07-09 2021-10-01
SUPERSEDES DOCUMENTS:
76/652/CD, 76/659A/CC
IEC TC 76 : OPTICAL RADIATION SAFETY AND LASER EQUIPMENT
SECRETARIAT: SECRETARY:
United States of America Mr William Ertle
OF INTEREST TO THE FOLLOWING COMMITTEES: PROPOSED HORIZONTAL STANDARD:
TC 34,SC 62D
Other TC/SCs are requested to indicate their interest, if
any, in this CDV to the secretary.
FUNCTIONS CONCERNED:
EMC ENVIRONMENT QUALITY ASSURANCE SAFETY
SUBMITTED FOR CENELEC PARALLEL VOTING NOT SUBMITTED FOR CENELEC PARALLEL VOTING
Attention IEC-CENELEC parallel votingThe attention of IEC National Committees, members of
CENELEC, is drawn to the fact that this Committee Draft
for Vote (CDV) is submitted for parallel voting.
The CENELEC members are invited to vote through the
CENELEC online voting system.
This document is still under study and subject to change. It should not be used for reference purposes.
Recipients of this document are invited to submit, with their comments, notification of any relevant patent rights of
which they are aware and to provide supporting documentation.TITLE:
Photobiological Safety of Ultraviolet Lamp Products
PROPOSED STABILITY DATE: 2025
NOTE FROM TC/SC OFFICERS:
Copyright © 2021 International Electrotechnical Commission, IEC. All rights reserved. It is permitted to
download this electronic file, to make a copy and to print out the content for the sole purpose of preparing National
Committee positions. You may not copy or "mirror" the file or printed version of the document, or any part of it,
for any other purpose without permission in writing from IEC.---------------------- Page: 3 ----------------------
oSIST prEN IEC 62471-6:2021
IEC CDV 62471-6/ED1 IEC 2021 – 2 – 76/680/CDV
CONTENTSFOREWORD ........................................................................................................................... 5
INTRODUCTION ..................................................................................................................... 7
1 Scope .............................................................................................................................. 8
2 References ...................................................................................................................... 8
3 Terms and Definitions ...................................................................................................... 8
4 Risk Groups Applied for Ultraviolet Lamp-Product Safety Assessments ......................... 11
4.1 Basis for Optical Radiation Safety Risk Group Determination ................................ 11
4.2 Assessment Criteria (Background) for UV Lamp Products ..................................... 11
5 Measurements to determine applicable risk group ......................................................... 12
5.1 General ................................................................................................................. 12
5.2 Time-weighted averaged irradiance ...................................................................... 13
5.3 Risk Group Assessment Conditions ...................................................................... 13
5.3.1 Maximum Output conditioning ........................................................................ 13
5.3.2 Measurement and Assessment Distances for UV Lamp Products ................... 13
5.3.3 Risk-group assessment distance criteria ........................................................ 13
5.3.4 Products intended to expose the skin or eyes ................................................ 14
6 Engineering Requirements for Germicidal Ultraviolet Systems ....................................... 16
6.1 Protective Housing ................................................................................................ 16
6.1.1 General ......................................................................................................... 16
6.1.2 Openings, Panels and Doors ......................................................................... 17
6.2 Exemptions applicable to RG2 and RG3 products ................................................. 17
6.2.1 Proximity Sensor ........................................................................................... 17
6.2.2 Orientation Control ........................................................................................ 17
6.2.3 Upper-Room Germicidal UV Luminaire Alignment .......................................... 17
6.2.4 Delayed-ON Timer ......................................................................................... 18
6.2.5 Exposure Time Control / Auto-Shutoff ............................................................ 18
6.3 Emission Warning ................................................................................................. 18
6.4 Reliability .............................................................................................................. 18
6.5 Emission Controls ................................................................................................. 18
6.5.1 Emissions Stop .............................................................................................. 18
6.5.2 Key Control ................................................................................................... 18
6.6 Ozone Detection Warning ..................................................................................... 19
7 Guidelines for Manufacturer information on Safe Use Manufacturer’sRequirements ................................................................................................................ 19
7.1 User Information ................................................................................................... 19
7.2 Labeling on UV lamps ........................................................................................... 19
7.3 Labeling on UV lamp products .............................................................................. 20
7.3.1 RG 0 ultraviolet lamp products ....................................................................... 20
7.3.2 RG 1 ultraviolet lamp products ....................................................................... 20
7.3.3 RG2 ultraviolet lamp products ........................................................................ 20
7.3.4 RG3 ultraviolet lamp products ........................................................................ 20
7.4 User Manual ......................................................................................................... 21
7.4.1 Risk Reduction Measures .............................................................................. 21
7.4.2 Limited Use ................................................................................................... 21
7.5 Maintenance and Service ...................................................................................... 22
Annex A (informative) Typical applications of UV lamp products .......................................... 23
---------------------- Page: 4 ----------------------oSIST prEN IEC 62471-6:2021
IEC CDV 62471-6/ED1 IEC 2021 – 3 – 76/680/CDV
A.1 Background .......................................................................................................... 23
A.2 Applications of UV lamp products .......................................................................... 23
A.2.1 Near-UV (UV-A) “Black-Light” Sources to View Fluorescent Pigments ........... 23
A.2.2 Near-UV (UV-A) Insect Attractant Lamp Products .......................................... 23
A.2.3 UV Germicidal (UV-C) Lamp Products ........................................................... 24
A.2.4 UV Tanning Equipment (not in scope – provided for information only) ............ 24
A.2.5 UV Nail Curing and Treatment ....................................................................... 24
A.2.6 UV Medical and Dental Sources .................................................................... 25
Annex B (informative) Potentially hazardous biological effects ............................................. 26
B.1 Background .......................................................................................................... 26
B.2 Adverse acute biological effects from ultraviolet irradiation ................................... 26
B.2.1 Photokeratitis and Photoconjunctivitis ............................................................ 26
B.2.2 Erythema (“sunburn”) ..................................................................................... 27
B.3 Adverse biological effects from chronic exposure to ultraviolet irradiation ............. 28
B.3.1 Skin Cancer ................................................................................................... 28
B.3.2 Pterygium and Pinguecula ............................................................................. 29
B.3.3 Cataract ........................................................................................................ 30
B.3.4 Labrador Keratopathy .................................................................................... 30
B.3.5 Visual Effects from UV-A Exposure – Lens Fluorescence .............................. 31
B.3.6 Photoretinitis – or Photic Maculopathy (Blue-Light Hazard) ............................ 31
Annex C (informative) Measurement of Ultraviolet Lamp Products ....................................... 32
C.1 General ................................................................................................................. 32
C.2 Radiometers ......................................................................................................... 32
C.3 Spectroradiometers ............................................................................................... 32
C.4 Entrance Optic ...................................................................................................... 33
C.5 Spectroradiometer- radiometer approach .............................................................. 33
C.6 Measurement Distance vs. Assessment Distance .................................................. 34
Annex D (informative) Spectral Weighting Function S(λ) from 180 nm to 400 nm for
assessing actinic radiation hazard ........................................................................................ 36
Annex E (informative) Examples of risk group classification applying the concept of
TWA ..................................................................................................................................... 39
E.1 Spectral weighting to determine effective irradiance using S(λ) ............................. 39
E.2 Time Weighting of an Exposure ............................................................................ 39
E.3 Field Radiometric Measurements for Final Acceptance Testing of a UVGIinstallation ............................................................................................................ 42
Annex F (informative) Upper Room UVGI – Background and Rationale to AchieveSafety ................................................................................................................................... 43
F.1 Introduction ........................................................................................................... 43
F.2 Product Requirements .......................................................................................... 43
F.3 Product Test Measurement Conditions .................................................................. 43
F.3.1 Elevation Plane for Radiometric Measurements ............................................. 44
F.3.2 Test Grid for Measurements .......................................................................... 44
F.3.3 Detector Acceptance Angle (Field-of-View) .................................................... 44
F.3.4 Instrument Performance Specifications .......................................................... 44
F.4 UVGI Luminaires................................................................................................... 44
F.4.1 Adjustable Requirement for UV Luminaires .................................................... 44
F.4.2 Interlock safeguards on removable baffles ..................................................... 44
F.4.3 Labeling Requirements .................................................................................. 44
F.4.4 Efficacy and Information for the User ............................................................. 45
F.5 Acceptance Testing .............................................................................................. 45
---------------------- Page: 5 ----------------------oSIST prEN IEC 62471-6:2021
IEC CDV 62471-6/ED1 IEC 2021 – 4 – 76/680/CDV
F.5.1 Scope of the Installation Acceptance Testing ................................................. 45
F.5.2 Time-Weighted Averaging .............................................................................. 45
Bibliography .......................................................................................................................... 47
Figure 1 – Graphic 6040 of UV lamp inside triangle from IEC 60417 (2015-12-01 ................. 21
Figure 2 – Optional labels to provide added information for narrow-band UV lamps .............. 21
Figure B.1 – Figure title ........................................................................................................ 28
Figure B.2 – Figure title ........................................................................................................ 29
Figure C.1 – Geometry of irradiance/ spectral irradiance measurements ............................... 33
Figure E.1 – Example of how an occupational hygienist might determine differentzones of exposure by time-weighting .................................................................................... 40
Figure E.2 – Time-Weighted Averaging (TWA) ...................................................................... 41
Figure E.3 [to be redrawn] – Field UVGI Safety Meters ......................................................... 42
Table 1 – Emission Limits for risk groups for time-weighted irradiance .................................. 13
Table 2a – Risk group assessment distances for unrestricted-use products ........................ 14
Table 2b – Risk Group Assessment Distances for Restricted-Use Products intended to
be used by Instructed Persons .............................................................................................. 15
Table 2c – Risk Group Assessment Distances for Lamps or Lamp Products Intendedfor use by Professional, Competent Persons ......................................................................... 16
Table D.1 – Table title .......................................................................................................... 36
---------------------- Page: 6 ----------------------oSIST prEN IEC 62471-6:2021
IEC CDV 62471-6/ED1 IEC 2021 – 5 – 76/680/CDV
1 INTERNATIONAL ELECTROTECHNICAL COMMISSION2 ____________
4 PHOTOBIOLOGICAL SAFETY OF LAMPS AND LAMP SYSTEMS –
6 Part 6: Ultraviolet lamp products
8 FOREWORD
9 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
10 all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international
11 co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and
12 in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports,
13 Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”). Their
14 preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with
15 may participate in this preparatory work. International, governmental and non-governmental organizations liaising
16 with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for
17 Standardization (ISO) in accordance with conditions determined by agreement between the two organizations.
18 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
19 consensus of opinion on the relevant subjects since each technical committee has representation from all
20 interested IEC National Committees.21 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
22 Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
23 Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
24 misinterpretation by any end user.25 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
26 transparently to the maximum extent possible in their national and regional publications. Any divergence between
27 any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter.
28 5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
29 assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
30 services carried out by independent certification bodies.31 6) All users should ensure that they have the latest edition of this publication.
32 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
33 members of its technical committees and IEC National Committees for any personal injury, property damage or
34 other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
35 expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
36 Publications.37 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
38 indispensable for the correct application of this publication.39 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent
40 rights. IEC shall not be held responsible for identifying any or all such patent rights.
41 IEC 6XXXX has been prepared by subcommittee XX: TITLE, of IEC technical committee XX:
42 TITLE. It is an International Standard.43 This XXX edition cancels and replaces the XXX edition published in [publication_date],
44 Amendment 1:[publication_date] and Amendment 2:[publication_date]. This edition constitutes
45 a technical revision.46 This edition includes the following significant technical changes with respect to the previous
47 edition:48 a) ...;
49 b)
---------------------- Page: 7 ----------------------
oSIST prEN IEC 62471-6:2021
IEC CDV 62471-6/ED1 IEC 2021 – 6 – 76/680/CDV
50 The text of this International Standard is based on the following documents:FDIS Report on voting
XX/XX/FDIS XX/XX/RVD
52 Full information on the voting for its approval can be found in the report on voting indicated in
53 the above table.54 The language used for the development of this International Standard is English [change
55 language if necessary].56 This document was drafted in accordance with ISO/IEC Directives, Part 2, and developed in
57 accordance with ISO/IEC Directives, Part 1 and ISO/IEC Directives, IEC Supplement, available
58 at www.iec.ch/members_experts/refdocs. The main document types developed by IEC are
59 described in greater detail at www.iec.ch/standardsdev/publications.60 The committee has decided that the contents of this document will remain unchanged until the
61 stability date indicated on the IEC website under webstore.iec.ch in the data related to the
62 specific document. At this date, the document will be63 • reconfirmed,
64 • withdrawn,
65 • replaced by a revised edition, or
66 • 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.---------------------- Page: 8 ----------------------
oSIST prEN IEC 62471-6:2021
IEC CDV 62471-6/ED1 IEC 2021 – 7 – 76/680/CDV
70 INTRODUCTION71 Most lamps and lamp products are safe and do not pose photobiological risks except under
72 unusual exposure conditions; however, one group of products—ultraviolet lamp products—can
73 under some conditions pose optical hazards during use and require risk assessment for direct
74 and indirect exposure of the eyes and skin. Optical radiation hazards from all types of lamps or
75 other broadband light sources are assessed by the application of IEC62471/CIES009 Standard,
76 Edition 1, 2006, Photobiological Safety of Lamps and Lamp Systems. IEC 62471 covers LEDs,
77 incandescent, low- and high- pressure gas-discharge, arc and other lamps. It also covers lamps
78 which are designed primarily to emit ultraviolet radiant energy, such as ultraviolet sources
79 intended to excite fluorescence of irradiated materials, for insect light traps, for scientific studies,
80 mineral identification, for non-destructive testing, germicidal irradiation, and other purposes.
81 This vertical standard (IEC 62471-6) provides a risk group (RG) classification system for all
82 ultraviolet lamp products, and the assessment distances and measurement conditions for
83 different products. It includes manufacturing and user safety requirements that may be required
84 as a result of an ultraviolet lamp product being assigned to a particular risk group. The scope
85 is limited to products where the sole intent is to emit ultraviolet radiant energy. The advantage
86 of applying this standard, intended solely for ultraviolet lamp products, instead of the horizontal
87 IEC 62471 standard, is that the risks from visible and infrared optical radiation need not be
88 assessed using this document, as they are assumed to be insignificant for a lamp that emits
89 mainly UV. The assigned risk group of an ultraviolet lamp product using this standard also may
90 be used to assist with any needed risk assessments, e.g. for occupational exposure in
91 workplaces. National requirements may exist for the assessment of products or occupational
92 exposure or for the exclusion of certain RGs for use by the general public.---------------------- Page: 9 ----------------------
oSIST prEN IEC 62471-6:2021
IEC CDV 62471-6/ED1 IEC 2021 – 8 – 76/680/CDV
95 PHOTOBIOLOGICAL SAFETY OF LAMPS AND LAMP SYSTEMS –97 Part 6: Ultraviolet lamp products
100
101 1 Scope
102 This Standard provides the optical radiation safety requirements for ultraviolet lamp products,
103 including UV LED products.104 This standard provides requirements for:
105 • optical radiation safety assessment and ultraviolet-product risk groups;
106 • user information for safety measures;
107 • appropriate labelling of ultraviolet lamp products
108 This standard addresses those lamps and lamp products where the ultraviolet emission serves
109 the primary purpose of the product and where more than half of the optical radiation emitted
110 between 180 nm – 3 000 nm is in the spectral region 180 nm – 400 nm. If more than half of the
111 optical radiation emitted between 180 nm – 3 000 nm is outside of the spectral region 180 nm
112 – 400 nm, then the base standard IEC 62471-1 should be used. This standard covers medical
113 diagnostic devices/products that emit primarily UV radiation.114 Because photobiological effects from UV radiation are based on the total accumulated exposure
115 (dose) received, this standard relies on the concept of ‘Time-weighted Average’ exposures
116 where the assessment distance for determining the RG is chosen based on realistic exposure
117 distances and exposure durations. In other words, it is not expected that people will be exposed
118 at very close distances, e.g. 20 – 30 cm, for extended periods of time. This standard is needed
119 to provide assessment distances and specific guidance that are application-specific and
120 realistic rather than the more general values in IEC 62471 where the specific application is
121 unknown and time-weighted average exposures are not application-specific.122 This Standard does not provide requirements for:
123 • lamps which primarily emit visible and/or infrared radiant energy
124 • lamp products used for general lighting or infrared illumination or heating, which are treated
125 in separate standards.126 • fluorescent ultraviolet lamps for tanning (covered by IEC 60335-2-27 and IEC 61228).
127 • medical treatment devices/products (see IEC 60601-2-57), but covers UV medical
128 diagnostic products.129 2 References
130 The following documents are referred to in the text in such a way that some or all of their content
131 constitutes requirements of this document. For dated references, only the edition cited applies.
132 For undated references, the latest edition of the referenced document (including any
133 amendments) applies.134 IEC 62471/CIE S009, Photobiological safety of lamps and lamp systems
135 3 Terms and Definitions
136 To be completed by the project group as needed
---------------------- Page: 10 ----------------------
oSIST prEN IEC 62471-6:2021
IEC CDV 62471-6/ED1 IEC 2021 – 9 – 76/680/CDV
137 3.1138 actinic UV
139 capable of producing a photochemical effect. In the context of this standard, the biological
140 effects have a demonstrated action spectrum, S(λ), and refer most significantly to UV-B and
141 UV-C effects, e.g, UV erythema (skin reddening), UV photokeratitis ('welder's flash' or
142 'snowblindness'), etc. See Annex B143 3.2
144 assessment distance
145 distance used to determine the Risk Group Classification of a lamp or lamp product
146 3.3147 blue light hazard
148 potential for a photochemically induced retinal injury resulting from radiation exposure at
149 wavelengths primarily between 400 nm and 500 nm.150 Note 1 to entry: This damage mechanism normally dominates over thermal mechanisms for intense visible light for
151 viewing times exceeding 10 s, but is rarely of concern from UV lamps (unless the basic lamp is an arc lamp).
152 3.4153 competent person
154 a person who can demonstrate a combination of knowledge and skills to effectively, efficiently,
155 and safely carry out specific activities156 3.5
157 consumer
158 a person who purchases goods and services for personal use (also termed “ordinary person” in
159 IEC62368). Consumers include not only users of the ultraviolet lamp product, but also all
160 persons who may have access to the lamp product or who may be in the vicinity of the product
161 3.6162 controlled access location
163 location where an engineering and/or administrative control measure is established to restrict
164 access except to authorised personnel with appropriate safety training165 3.7
166 dose-limited product
167 a product where the emitted radiant exposure (dose) is limited by time or actual exposure
168 monitoring at the assessment distance to a set level during any day. The emission limit is
169 expressed in J/m170 3.7.1
171 emission Limit
172 a limit defined for each Risk Group, based upon reasonably foreseeable conditions of time-
173 weighted average (TWA) exposure174 Note 1 to entry: It incorporates both the concept of exposure duration and exposure distance and is derived from
175 exposure limits, however, the risk group assessment distance incorporates the TWA exposure.
176 3.8177 general lighting source (GLS)
178 a general term for lamps, nominally of “white” colour, intended for lighting spaces that are
179 typically occupied or viewed by people. See IEC 62471-1/2 (to be updated) for requirements
180 Note 1 to entry: This standard does not cover GLS lamps or lamp products.181 3.9
182 germicidal lamp product
183 any UV lamp product designed to disinfect by ultraviolet germicidal (UVG) irradiation to
184 inactivate microorganisms so they are no longer capable of replicating and causing
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.