IEC 60601-2-83:2019

IEC 60601-2-83 ®
Edition 1.0 2019-05
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 2-83: Particular requirements for the basic safety and essential performance
of home light therapy equipment

Appareils électromédicaux –
Partie 2-83: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils de luminothérapie à domicile

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IEC 60601-2-83 ®
Edition 1.0 2019-05
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –

Part 2-83: Particular requirements for the basic safety and essential

performance of home light therapy equipment

Appareils électromédicaux –
Partie 2-83: Exigences particulières pour la sécurité de base et les

performances essentielles des appareils de luminothérapie à domicile

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.60 ISBN 978-2-8322-6953-4

– 2 – IEC 60601-2-83:2019 © IEC 2019
CONTENTS
FOREWORD . 3
INTRODUCTION . 5
201.1 Scope, object and related standards . 6
201.2 Normative references . 7
201.3 Terms and definitions . 8
201.4 General requirements . 10
201.5 General requirements for testing ME EQUIPMENT . 10
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 10
201.7 ME EQUIPMENT identification, marking and documents . 12
201.8 Protection against electrical HAZARDS from ME EQUIPMENT. 15
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 15
201.10 Protection against unwanted and excessive radiation HAZARDS . 15
201.11 Protection against excessive temperatures and other HAZARDS . 17
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 18
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 18
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 18
201.15 Construction of ME EQUIPMENT . 18
201.16 ME SYSTEMS . 18
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 18
202 Electromagnetic disturbances – Requirements and tests . 18
206 Usability . 19
211 Requirements for MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS
used in the HOME HEALTHCARE ENVIRONMENT . 19
Annexes . 20
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS . 21
Annex D (informative) Symbols on marking . 24
Annex AA (informative) Particular guidance and rationale . 25
Annex BB (informative) Protective eyewear for HOME LIGHT THERAPY EQUIPMENT . 28
Bibliography . 29
Index of defined terms used in this particular standard . 30

Table 201.101 – EMISSION LIMITS for risk groups of HOME LIGHT THERAPY EQUIPMENT . 11
Table 201.102 – Time criteria for risk groups of HOME LIGHT THERAPY EQUIPMENT . 12
Table 201.103 – Applicable ANGLE OF ACCEPTANCE for the assessment of emitted
OPTICAL RADIATION from HOME LIGHT THERAPY EQUIPMENT . 12
Table 201.C.101 – Marking on the outside of ME EQUIPMENT, ME SYSTEMS or their parts . 21
Table 201.C.102 –Safety signs per HAZARD and per risk group . 22
Table 201.C.103 – ACCOMPANYING DOCUMENTS, instructions for use . 22
Table 201.C.104 –Caution statements per HAZARD and per risk group . 23
Table 201.D.1 – General symbols . 24
Table 201.D.2 – Safety signs . 24

INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-83: Particular requirements for the basic safety and
essential performance of home light therapy equipment

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
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6) All users should ensure that they have the latest edition of this publication.
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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.
International Standard IEC 60601-2-83 has been prepared by IEC subcommittee 62D:
Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
The text of this International Standard is based on the following documents:
FDIS Report on voting
62D/1682/FDIS 62D/1687/RVD
Full information on the voting for the approval of this International Standard can be found in
the report on voting indicated in the above table.
This document has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this document, the following print types are used:
– requirements and definitions: roman type;

– 4 – IEC 60601-2-83:2019 © IEC 2019
– test specifications: italic type;
– informative material appearing outside of tables, such as notes, examples and references: in smaller type.
Normative text of tables is also in a smaller type;
– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
NOTED: SMALL CAPITALS.
In referring to the structure of this document, the term
– "clause" means one of the seventeen numbered divisions within the table of contents,
inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
– "subclause" means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
subclauses of Clause 7).
References to clauses within this document are preceded by the term "Clause" followed by
the clause number. References to subclauses within this particular standard are by number
only.
In this document, the conjunctive "or" is used as an "inclusive or" so a statement is true if any
combination of the conditions is true.
The verbal forms used in this document conform to usage described in Clause 7 of the
ISO/IEC Directives, Part 2. For the purposes of this document, the auxiliary verb:
– "shall" means that compliance with a requirement or a test is mandatory for compliance
with this document;
– "should" means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this document;
– "may" is used to describe a permissible way to achieve compliance with a requirement or
test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
indicates that there is guidance or rationale related to that item in Annex AA.
A list of all parts of the IEC 60601 series, published under the general title Medical electrical
equipment, 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 "http://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.
NOTE The attention of users of this document is drawn to the fact that equipment manufacturers and testing
organizations may need a transitional period following publication of a new, amended or revised IEC publication in
which to make products in accordance with the new requirements and to equip themselves for conducting new or
revised tests. It is the recommendation of the committee that the content of this publication be adopted for
implementation nationally not earlier than 3 years from the date of publication.

IMPORTANT – The 'colour inside' logo on the cover page of this publication 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.
INTRODUCTION
This part of IEC 60601 has been prepared to provide safety requirements for HOME LIGHT
THERAPY EQUIPMENT, based on IEC 60601-1 and its collateral standards. This equipment is
intended to be used in the HOME HEALTHCARE ENVIRONMENT and is typically used by a LAY
OPERATOR, who is familiar with this environment and the specific characteristics of lamps.
Some requirements of IEC 60601-1-11 are amended to better suit this type of ME EQUIPMENT
and the environment in which it is used.
HOME LIGHT THERAPY EQUIPMENT provides light therapy by means of eye-mediated
photobiological effects (which can be visual or non-visual) and skin-mediated photobiological
effects (non-visual only). Possible applications include pain relief, psoriasis treatment, and
treatment of winter depression (seasonal affective disorder, SAD).
This document is developed because IEC 60601-2-57 [2] only covers light source equipment
providing light therapy by means of non-visual photobiological effects, which excludes an
important group of light source equipment creating visual photobiological effects. Further,
IEC 60601-2-57 focuses on radiation aspects and related markings but hardly provides any
product-specific safety requirements. IEC 60335-2-113 [1] provides such specific
requirements for household appliances with light sources for cosmetic and beauty care, but
does not apply to equipment with medical purposes. IEC 60601-2-83 addresses all safety
requirements for HOME LIGHT THERAPY EQUIPMENT and has taken over relevant requirements
from [1] and [2].
This document is the first edition of IEC 60601-2-83. It is aligned with IEC 60601-1:2005
and IEC 60601-1:2005/AMD1:2012, IEC 60601-1-2:2014, IEC 60601-1-6:2010 and
IEC 60601-1-6:2010/AMD1:2013, and IEC 60601-1-11:2015.

___________
Numbers in square brackets refer to the Bibliography.

– 6 – IEC 60601-2-83:2019 © IEC 2019
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-83: Particular requirements for the basic safety and
essential performance of home light therapy equipment

201.1 Scope, object and related standards
Clause 1 of the general standard applies, except as follows:
201.1.1 Scope
Replacement:
This part of IEC 60601 is applicable to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HOME
LIGHT THERAPY EQUIPMENT, intended for use in the HOME HEALTHCARE ENVIRONMENT. HOME
LIGHT THERAPY EQUIPMENT is typically used by a LAY OPERATOR.
The scope of this document includes all light sources except laser.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to
ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the
case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
201.1.2 Object
Replacement:
The object of this particular standard is to establish particular requirements for the BASIC
SAFETY and ESSENTIAL PERFORMANCE of HOME LIGHT THERAPY EQUIPMENT.
201.1.3 Collateral standards
Addition:
This particular standard refers to those applicable collateral standards that are listed in
Clause 2 of the general standard and Clause 201.2 of this particular standard.
IEC 60601-1-2:2014, IEC 60601-1-6:2010 and IEC 60601-1-6:2010/AMD1:2013 and
IEC 60601-1-11:2015 apply as modified in Clauses 202, 206 and 211, respectively.
IEC 60601-1-3, IEC 60601-1-8, IEC 60601-1-10 and IEC 60601-1-12 do not apply. All other
published collateral standards in the IEC 60601-1 series apply as published.
201.1.4 Particular standards
Replacement:
In the IEC 60601 series, particular standards may modify, replace or delete requirements
contained in the general standard and collateral standards as appropriate for the particular ME
___________
The general standard is IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, Medical electrical equipment –
Part 1: General requirements for basic safety and essential performance.

EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL PERFORMANCE
requirements.
A requirement of a particular standard takes priority over the general standard.
For brevity, IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 are referred to in this
particular standard as the general standard. Collateral standards are referred to by their
document number.
The numbering of clauses and subclauses of this particular standard corresponds to that of
the general standard with the prefix "201" (e.g. 201.1 in this document addresses the content
of Clause 1 of the general standard) or applicable collateral standard with the prefix "20x",
where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this
particular standard addresses the content of Clause 4 of the IEC 60601-1-2 collateral
standard, 203.4 in this particular standard addresses the content of Clause 4 of the
IEC 60601-1-3 collateral standard, etc.). The changes to the text of the general standard are
specified by the use of the following words:
"Replacement" means that the clause or subclause of the general standard or applicable
collateral standard is replaced completely by the text of this particular standard.
"Addition" means that the text of this particular standard is additional to the requirements of
the general standard or applicable collateral standard.
"Amendment" means that the clause or subclause of the general standard or applicable
collateral standard is amended as indicated by the text of this particular standard.
Subclauses, figures or tables which are additional to those of the general standard are
numbered starting from 201.101. However, due to the fact that definitions in the general
standard are numbered from 3.1 through 3.147, additional definitions in this document are
numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and
additional items aa), bb), etc.
Subclauses, figures or tables which are additional to those of a collateral standard are
numbered starting from 20x, where "x" is the number of the collateral standard, e.g. 202 for
IEC 60601-1-2, 203 for IEC 60601-1-3, etc.
The term "this document" is used to make reference to the general standard, any applicable
collateral standards and this particular standard taken together.
Where there is no corresponding clause or subclause in this particular standard, the clause or
subclause of the general standard or applicable collateral standard, although possibly not
relevant, applies without modification; where it is intended that any part of the general
standard or applicable collateral standard, although possibly relevant, is not to be applied, a
statement to that effect is given in this particular standard.
201.2 Normative references
NOTE Informative references are listed in the Bibliography.
Clause 2 of the general standard applies, except as follows:
Replacement:
IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral Standard: Electromagnetic disturbances –
Requirements and tests
– 8 – IEC 60601-2-83:2019 © IEC 2019
IEC 60601-1-6:2010, Medical electrical equipment – Part 1-6: General requirements for basic
safety and essential performance – Collateral standard: Usability
IEC 60601-1-6:2010/AMD1:2013
ISO 15223-1:2016, Medical devices – Symbols to be used with medical device labels,
labelling and information to be supplied – Part 1: General requirements
Addition:
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
IEC 60601-1:2005/AMD1:2012
IEC 60601-1-11:2015, Medical electrical equipment – Part 1-11: General requirements for
basic safety and essential performance – Collateral Standard: Requirements for medical
electrical equipment and medical electrical systems used in the home healthcare environment
IEC 62471:2006, Photobiological safety of lamps and lamp systems
ISO 3864-1:2011, Graphical symbols – Safety colours and safety signs – Part 1: Design
principles for safety signs and safety markings
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1,
IEC 60601-1-2, IEC 60601-1-6 and IEC 60601-1-11 and the following 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
NOTE An index of defined terms is found on page 30.
Addition:
201.3.201
* ANGLE OF ACCEPTANCE
γ
plane angle within which a detector responds to OPTICAL RADIATION
Note 1 to entry: The ANGLE OF ACCEPTANCE can be controlled by apertures or optical elements.
Note 2 to entry: The ANGLE OF ACCEPTANCE is sometimes referred to as the field-of-view.
[SOURCE: IEC 60601-2-57:2011, 201.3.201, modified – Unit deleted.]
201.3.202
* ANGULAR SUBTENSE
α
visual angle subtended by the source or apparent source at the eye of an observer or at the
point of measurement
Note 1 to entry: In this particular standard ANGULAR SUBTENSE is denoted by the full included angle, not the half
angle.
[SOURCE: IEC 60601-2-57:2011, 201.3.202, modified – Unit deleted.]

201.3.203
EMISSION APERTURE
opening or window through which the OPTICAL RADIATION is emitted
[SOURCE: IEC 60601-2-57:2011, 201.3.204]
201.3.204
EMISSION LIMIT
maximum accessible emission permitted for a particular RISK group
[SOURCE: IEC 60601-2-57:2011, 201.3.205]
201.3.205
EXPOSURE LIMIT
maximum level of exposure of the eye or skin that is not expected to result in adverse
biological effects
[SOURCE: IEC 60601-2-57:2011, 201.3.206, modified – Note deleted.]
201.3.206
EXPOSURE TIME
time period during which the human body is exposed to OPTICAL RADIATION emitted from the
HOME LIGHT THERAPY EQUIPMENT
201.3.207
* HOME LIGHT THERAPY EQUIPMENT
ME EQUIPMENT which incorporates one or more sources of OPTICAL RADIATION in the wavelength
range between 200 nm and 3 000 nm, with the exception of laser radiation, which is intended
to create photobiological effects for therapeutic or diagnostic applications, and which is
intended to be used in the HOME HEALTHCARE ENVIRONMENT
201.3.208
INTENSE PULSED LIGHT
periodically emitted non-coherent OPTICAL RADIATION in the wavelength range between 500 nm
and 1 200 nm intended to create thermal effects in the skin
Note 1 to entry: Periodic emission does not relate to high-frequency pulsed emission of OPTICAL RADIATION but to
periods with emission alternating with periods without emission, which are typically in the order of one to several
seconds.
201.3.209
OCULAR HAZARD DISTANCE
shortest distance from an EMISSION APERTURE at which the projected radiant exposure or
irradiance for a given EXPOSURE TIME equals the applicable EXPOSURE LIMIT value for the eye
[SOURCE: IEC 60601-2-57:2011, 201.3.210, modified – Abbreviated term "OHD" deleted,
word "shortest" inserted, word "within" replaced by "at", and unit deleted.]
201.3.210
OPTICAL RADIATION
electromagnetic radiation with wavelengths between 100 nm and 1 mm
[SOURCE: IEC 60601-2-57:2011, 201.3.211]
201.3.211
SKIN HAZARD DISTANCE
shortest distance from an EMISSION APERTURE at which the projected radiant exposure or
irradiance for a given EXPOSURE TIME equals the applicable EXPOSURE LIMIT value for the skin

– 10 – IEC 60601-2-83:2019 © IEC 2019
[SOURCE: IEC 60601-2-57:2011, 201.3.220, modified – Word "shortest" inserted and word
"within" replaced by "at".]
201.3.212
STRAY OPTICAL RADIATION
OPTICAL RADIATION that is unintentionally emitted from the EMISSION APERTURE or from the
target tissue, including scattered, reflected, and leakage radiation
201.4 General requirements
Clause 4 of the general standard applies, except as follows:
201.4.3 * ESSENTIAL PERFORMANCE
Addition:
For the purposes of this document, HOME LIGHT THERAPY EQUIPMENT is considered to have no
ESSENTIAL PERFORMANCE.
201.5 General requirements for testing ME EQUIPMENT
Clause 5 of the general standard applies, except as follows:
201.5.9 Determination of APPLIED PARTS and ACCESSIBLE PARTS
201.5.9.2 ACCESSIBLE PARTS
201.5.9.2.1 * Test finger
Addition, after the first paragraph, of the following sentence:
The test shall be performed with the lamp(s) mounted.
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
Clause 6 of the general standard applies, except as follows:
Additional subclause:
201.6.101 *Protection against OPTICAL RADIATION
HOME LIGHT THERAPY EQUIPMENT shall be classified on the basis of the emitted OPTICAL
RADIATION, including STRAY OPTICAL RADIATION, over the full range of its capability in NORMAL
CONDITION and SINGLE FAULT CONDITION.
HOME LIGHT THERAPY EQUIPMENT shall be assessed by the method specified in IEC 62471 at a
distance of 200 mm from the EMISSION APERTURE or from the apparent source.
If the HOME LIGHT THERAPY EQUIPMENT incorporates a skin detection device as specified in
201.10.103, the EMISSION LIMITS listed in Table 201.101 for actinic UV and near UV HAZARDS
shall apply with the skin detection device disabled, and the EMISSION LIMITS for blue light,
retinal thermal and corneal/lens IR HAZARDS shall apply with the skin detection device
enabled. Otherwise, the EMISSION LIMITS for all HAZARDS listed in Table 201.101 shall apply.
HOME LIGHT THERAPY EQUIPMENT shall be classified in the following groups:

– Exempt Group (no photobiological HAZARD), if the emitted OPTICAL RADIATION does not
exceed the EMISSION LIMITS for the Exempt Group specified in Table 201.101 for any
applicable HAZARD, when assessed under the conditions of the time criteria (EXPOSURE
TIMES) of Table 201.102 and the ANGLE OF ACCEPTANCE specified in Table 201.103;
– Risk Group 1 (low RISK), if the emitted OPTICAL RADIATION exceeds one or more EMISSION
LIMITS for the Exempt Group and does not exceed the EMISSION LIMITS for Risk Group 1
specified in Table 201.101 for any applicable HAZARD, when assessed under the conditions
of the time criteria (EXPOSURE TIMES) of Table 201.102 and the ANGLE OF ACCEPTANCE
specified in Table 201.103; or
– Risk Group 2 (moderate RISK), if the emitted OPTICAL RADIATION exceeds one or more
EMISSION LIMITS for Risk Group 1 and does not exceed the EMISSION LIMITS for Risk Group 2
specified in Table 201.101 for any applicable HAZARD, when assessed under the conditions
of the time criteria (EXPOSURE TIMES) of Table 201.102 and the ANGLE OF ACCEPTANCE
specified in Table 201.103.
NOTE 1 The time criteria are the maximum allowed EXPOSURE TIMES for the given wavelength ranges,
EMISSION LIMITS and risk groups.
NOTE 2 IEC 62471:2006 recognizes Risk Group 3, where no EMISSION LIMITS apply. Therefore, the RISKS
involved are considered too high for ME EQUIPMENT intended to be used in the HOME HEALTHCARE ENVIRONMENT.
Table 201.101 – EMISSION LIMITS for risk groups of HOME LIGHT THERAPY EQUIPMENT
Wavelength EMISSION LIMIT
range
a c
HAZARD Symbol Units
Exempt Risk Group Risk Group
nm Group 1 2
-2
Actinic UV E
180 to 400 0,001 0,003 0,03 W⋅m
S
-2
Near UV E
315 to 400 10 33 100
W⋅m
UVA
-2 -1
Blue light L
300 to 700 100 10 000 4 000 000 W⋅m ⋅sr
B
c d c -2 -1
Retinal thermal L
380 to 1 400
28 000/α N/A 71 000/α W⋅m ⋅sr
R
Retinal thermal, weak
c d d -2 -1
L
780 to 1 400 6 000/α N/A N/A W⋅m ⋅sr
IR
b
visual stimulus
-2
Corneal/lens IR E
780 to 3 000 100 570 3 200 W⋅m
IR
a
The EMISSION LIMITS are based on eye and skin damage in the ultraviolet (UV) ranges and on eye damage in
the visible and infrared (IR) ranges. Skin damage (such as erythema and burning) can also occur in the
visible and IR ranges, but skin damage in these ranges is not covered in this document.
b
Retinal damage in the wavelength range between 780 nm and 1 400 nm can be affected by absence of
aversion response due to weak visual stimulus.
c
The radiation quantities are defined in 4.3 of IEC 62471:2006. The ANGULAR SUBTENSE α is defined in
201.3.202.
d
Retinal thermal HAZARDS L and L do not change with time for EXPOSURE TIMES longer than 10 s. If the
IR
R
EMISSION LIMIT for L of the Exempt Group is exceeded (but not of Risk Group 2) for EXPOSURE TIMES up to
R
10 s, HOME LIGHT THERAPY EQUIPMENT is classified in Risk Group 2. If the EMISSION LIMIT for L of the Exempt
IR
Group is exceeded for EXPOSURE TIMES up to 10 s, HOME LIGHT THERAPY EQUIPMENT needs to incorporate a
skin detection device as specified in 201.10.103.

– 12 – IEC 60601-2-83:2019 © IEC 2019
Table 201.102 – Time criteria for risk groups of HOME LIGHT THERAPY EQUIPMENT
Time
Wavelength
range
HAZARD s
nm
Exempt Group Risk Group 1 Risk Group 2
Actinic UV 180 to 400 30 000 10 000 1 000
Near UV 315 to 400 1 000 300 100
Blue-light 300 to 700 10 000 100 0,25
Retinal thermal 380 to 1 400 10 N/A 0,25
Retinal thermal, weak visual stimulus 780 to 1 400 10 N/A N/A
Corneal/lens IR 780 to 3 000 1 000 100 10

Table 201.103 – Applicable ANGLE OF ACCEPTANCE for the assessment
of emitted OPTICAL RADIATION from HOME LIGHT THERAPY EQUIPMENT
ANGLE OF ACCEPTANCE γ
Wavelength
range
HAZARD rad
nm
Exempt Group Risk Group 1 Risk Group 2
Actinic UV 180 to 400 1,4 1,4 1,4
Near UV 315 to 400 1,4 1,4 1,4
Blue-light 300 to 700 0,11 0,011 0,001 7
Retinal thermal 380 to 1 400 0,011 N/A 0,001 7
Retinal thermal, weak visual stimulus 780 to 1 400 0,011 N/A N/A
Corneal/Lens IR 780 to 3 000 1,4 1,4 1,4

201.7 ME EQUIPMENT identification, marking and documents
Clause 7 of the general standard applies, except as follows:
201.7.1 General
201.7.1.2 *Legibility of markings
Replacement, at the end of the second sentence of the second paragraph of the compliance
statement, of "1 m" by "0,33 m".
201.7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts
201.7.2.3 Consult ACCOMPANYING DOCUMENTS
Addition:
HOME LIGHT THERAPY EQUIPMENT classified in Risk Group 2 and HOME LIGHT THERAPY
EQUIPMENT for which the emitted OPTICAL RADIATION exceeds the EMISSION LIMIT for the Exempt
Group for the actinic UV HAZARD, the near UV HAZARD and/or the corneal/lens IR HAZARD shall
be marked with safety sign ISO 7010-M002:2011-05 (see Table D.2, safety sign 10).
NOTE An overview of safety signs per HAZARD and per risk group is given in Table 201.C.102.
201.7.2.13 Physiological effects (safety signs and warning statements)
Addition:
HOME LIGHT THERAPY EQUIPMENT containing natural rubber latex shall be marked with symbol
5.4.5 of ISO 15223-1:2016 (see Table 201.D.1, symbol 101). The instructions for use shall
also disclose any component containing natural rubber latex.
Compliance is checked by inspection.
Additional subclause:
HOME LIGHT THERAPY EQUIPMENT
201.7.2.13.101 * Markings and symbols for
HOME LIGHT THERAPY EQUIPMENT for which the emitted OPTICAL RADIATION exceeds the EMISSION
for Risk Group 1 for the blue-light HAZARD shall be marked with safety sign ISO 7010-
LIMIT
W027:2011-05 (see Table 201.D.2, safety sign 101).
HOME LIGHT THERAPY EQUIPMENT for which the emitted OPTICAL RADIATION exceeds the EMISSION
LIMIT for the Exempt Group for the actinic UV HAZARD and/or the near UV HAZARD shall be
marked with safety sign 102 of Table 201.D.2.
HOME LIGHT THERAPY EQUIPMENT for which the emitted OPTICAL RADIATION exceeds the EMISSION
for the Exempt Group for the retinal thermal HAZARD and/or the corneal/lens IR HAZARD
LIMIT
shall be marked with safety sign 103 of Table 201.D.2.
HOME LIGHT THERAPY EQUIPMENT classified in Risk Group 2 and HOME LIGHT THERAPY
EQUIPMENT for which the emitted OPTICAL RADIATION exceeds the EMISSION LIMIT for the Exempt
Group for the corneal/lens IR HAZARD shall be marked with safety sign 104 of Table 201.D.2.
NOTE An overview of safety signs per HAZARD and per risk group is given in Table 201.C.102.
201.7.9 ACCOMPANYING DOCUMENTS
201.7.9.2 Instructions for use
201.7.9.2.2 Warnings and safety notices
Additional subclause:
201.7.9.2.2.101 * Additional warnings and safety notices
The instructions for use shall include
a) a warning statement to the effect: "WARNING: Do not leave the equipment unattended
when it is switched on to avoid the risk of fire or burns."
b) a warning statement to the effect: "WARNING: This equipment is not intended for use by
persons with reduced physical, sensory or mental capabilities, or lack of experience and
knowledge, unless they have been given supervision or instruction concerning use of the
equipment to avoid the risk of fire or burns."
c) a warning statement to the effect: "WARNING: This equipment is not intended for use by
children. Children should be supervised to ensure that they do not play with the equipment
to avoid the risk of fire and burns."
If applicable, the instructions for use shall include
a) a warning statement to the effect: "WARNING: If the mains cord is damaged, you shall
have it replaced by [place MANUFACTURER’S name here], a service centre authorised by
[place MANUFACTURER’S name here] or similarly qualified persons in order to avoid risk of
electrocution."
b) a warning statement to the effect: "WARNING: Water and electricity are a dangerous
combination! To avoid risk of electrocution,

– 14 – IEC 60601-2-83:2019 © IEC 2019
– do not use this equipment in wet surroundings (e.g. in the bathroom or near a shower
or swimming pool);
– do not let water run into the appliance."
c) a warning statement to the effect: "WARNING: Check if the voltage indicated on the
equipment corresponds to the local mains voltage before you connect the equipment to
avoid risk of electrocution or permanent damage to the equipment."
d) a warning statement to the effect: "WARNING: If the wall socket used to power the
equipment has poor connections, the plug of the equipment becomes hot. Make sure you
plug the equipment into a properly installed wall socket to avoid the risk of fire and burns."
e) a caution statement to the effect: "CAUTION: Do not subject the equipment to heavy
shocks to avoid risk of damage to the lamp."
f) a caution statement to the effect: "CAUTION: Always unplug the appliance after use and in
case of a power failure to avoid risk of damage to the equipment."
The instructions for use of HOME LIGHT THERAPY EQUIPMENT for which the emitted OPTICAL
RADIATION exceeds the EMISSION LIMIT for the Exempt Group for the actinic UV HAZARD and/or
HAZARD shall include a caution statement to the effect: "CAUTION: UV emitted
the near UV
from this device."
The instructions for use of HOME LIGHT THERAPY EQUIPMENT for which the emitted OPTICAL
RADIATION exceeds the EMISSION LIMIT for Risk Group 1 for the actinic UV HAZARD and/or the
near UV HAZARD shall include a caution statement to the effect: "CAUTION: UV emitted from
this device. Eye or skin irritation may result."
The instructions for use of HOME LIGHT THERAPY EQUIPMENT for which the emitted OPTICAL
RADIATION exceeds the EMISSION LIMIT for Risk Group 1 for the blue-light HAZARD and/or the
retinal thermal HAZARD shall include a caution statement to the effect: "CAUTION: The light
emitted from this device may be harmful to the eyes. Do not stare at the light source."
The instructions for use of HOME LIGHT THERAPY EQUIPMENT for which the emitted OPTICAL
RADIATION exceeds the EMISSION LIMIT for the Exempt Group for the corneal/lens IR HAZARD
shall include a caution statement to the effect: "CAUTION: IR emitted from this device. Do not
stare at the light source."
The instructions for use of HOME LIGHT THERAPY EQUIPMENT for which the emitted OPTICAL
RADIATION exceeds the EMISSION LIMIT for Risk Group 1 for the corneal/lens IR HAZARD shall
include a caution statement to the effect: "CAUTION: IR emitted from this device may cause
eye irritation. Do not stare at the light source."
NOTE An overview of cautions statement per HAZARD and per risk group is given in Table 201.C.104.
201.7.9.2.17 * ME EQUIPMENT emitting radiation
Replacement:
The instructions for use shall specify for all intended configurations:
a) the risk group classification (see 201.6.101);
b) the wavelength range (spectral range) of the emitted OPTICAL RADIATION;
c) the spectral irradiance or the spectral distribution of the radiant exposure;
d) the maximum output of OPTICAL RADIATION, measured at the treatment area – if the HOME
LIGHT THERAPY EQUIPMENT is designed for providing treatment in different treatment areas,
these parameters shall be specified for each of the treatment areas;
e) the OCULAR HAZARD DISTANCE and/or the SKIN HAZARD DISTANCE, when the HOME LIGHT
THERAPY EQUIPMENT is classified in Risk Group 2.
The MANUFACTURER shall provide the following safety information in the instructions for use:

– an indication of all locations of EMISSION APERTURES;
– a recommendation for eye and skin protection for the OPERATOR and for the PATIENT.
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
Clause 8 of the general standard applies.
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS
Clause 9 of the general standard applies.
201.10 Protection against unwanted and excessive radiation HAZARDS
Clause 10 of the general standard applies, except as follows:
Additional subclauses:
201.10.101 Skin HAZARDS
The MANUFACTURER shall address in the RISK MANAGEMENT PROCESS the HAZARDS related to
skin damage.
201.10.102 Limitation of OPTICAL RADIATION
If the OPTICAL RADIATION emitted from the EMISSION APERTURE exceeds one or more EMISSION
LIMITS for Risk Group 2 specified in Table 201.101, the HOME LIGHT THERAPY EQUIPMENT shall
...