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

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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.

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oSIST prEN IEC 62471-6:2021
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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 voting
The 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.
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oSIST prEN IEC 62471-6:2021

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CONTENTS

FOREWORD ........................................................................................................................... 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’s

Requirements ................................................................................................................ 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

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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 UVGI

installation ............................................................................................................ 42

Annex F (informative) Upper Room UVGI – Background and Rationale to Achieve

Safety ................................................................................................................................... 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

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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 different

zones 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 Intended

for use by Professional, Competent Persons ......................................................................... 16

Table D.1 – Table title .......................................................................................................... 36

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1 INTERNATIONAL ELECTROTECHNICAL COMMISSION
2 ____________
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

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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)
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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 be
63 • 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.
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70 INTRODUCTION

71 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.
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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
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137 3.1
138 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 B
143 3.2
144 assessment distance

145 distance used to determine the Risk Group Classification of a lamp or lamp product

146 3.3
147 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 3.4
153 competent person

154 a person who can demonstrate a combination of knowledge and skills to effectively, efficiently,

155 and safely carry out specific activities
156 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 3.6
162 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 training
165 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/m
170 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) exposure

174 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 3.8
177 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

...

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