IEC 60601-2-57:2011

Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use

IEC 60601-2-57:2011 applies to basic safety and essential performance of equipment incorporating one or more sources of optical radiation in the wavelength range 200 nm to 3 000 nm, with the exception of laser radiation, and intended to create non-visual photo-biological effects in humans or animals for therapeutic, diagnostic, monitoring, cosmetic/aesthetic or veterinary applications; hereafter referred to as light source equipment. IEC 60601-2-57:2011 does not apply to equipment for sun tanning, for ophthalmic instruments or for infant phototherapy. Light source equipment may consist of a single or multiple sources of optical radiation, with or without power supply, or may be incorporated into a complex system that includes optical, electricalor mechanical systems or sources of other radiation.

Appareils électromédicaux - Partie 2-57: Exigences particulières pour la sécurité de base et les performances essentielles des appareils à source de lumière non-laser prévus pour des utilisations thérapeutiques, de diagnostic, de surveillance et de cosmétique/esthétique

La CEI 60601-2-57:2011 s'applique à la sécurité de base et aux performances essentielles des appareils intégrant une ou plusieurs sources de rayonnement optique dans la gamme des longueurs d'onde de 200 nm à 3 000 nm, à l'exception du rayonnement laser, et prévus pour créer des effets photobiologiques non visibles sur les humains ou sur les animaux, pour applications thérapeutiques, de diagnostic, de surveillance, cosmétiques/esthétiques ou vétérinaires, dénommés ci-après appareils à source de lumière. La CEI 60601-2-57:2011 n'est pas applicable aux appareils de bronzage, aux appareils ophtalmiques ou de photothérapie pour nourrissons. Les appareils à source de lumière peuvent consister en une unique ou en de multiples sources de rayonnement optique, avec ou sans alimentation électrique, ou bien peuvent être intégrés à un système complexe incluant des systèmes optiques, électriques ou mécaniques, ou des sources d'autres rayonnements.

General Information

• Status: Published
• Publication Date: 30-Jan-2011
• ICS: 11.040.50 - Radiographic equipment
• ICS: 11.040.60 - Therapy equipment
• Technical Committee: TC 76 - Optical radiation safety and laser equipment
• Drafting Committee: WG 4 - TC 76/WG 4
• Current Stage: DELPUB - Deleted Publication
• Start Date: 27-Jul-2023
• Completion Date: 23-Dec-2021

Relations

• Revised: IEC 60601-2-57:2023 - Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring, cosmetic and aesthetic use
• Effective Date: 05-Sep-2023

Standards Content (Sample)

IEC 60601-2-57 ®
Edition 1.0 2011-01
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 2-57: Particular requirements for the basic safety and essential performance
of non-laser light source equipment intended for therapeutic, diagnostic,
monitoring and cosmetic/aesthetic use

Appareils électromédicaux –
Partie 2-57: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils à source de lumière non-laser prévus pour des
utilisations thérapeutiques, de diagnostic, de surveillance et de
cosmétique/esthétique
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IEC 60601-2-57 ®
Edition 1.0 2011-01
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 2-57: Particular requirements for the basic safety and essential performance
of non-laser light source equipment intended for therapeutic, diagnostic,
monitoring and cosmetic/aesthetic use

Appareils électromédicaux –
Partie 2-57: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils à source de lumière non-laser prévus pour des
utilisations thérapeutiques, de diagnostic, de surveillance et de
cosmétique/esthétique
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX V
ICS 11.040.50; 11.040.60 ISBN 978-2-88912-344-5
– 2 – 60601-2-57  IEC:2011
CONTENTS
FOREWORD . 4
INTRODUCTION . 7
201.1 Scope, object and related standards. 8
201.2 Normative references . 10
201.3 Terms and definitions . 10
201.4 General requirements . 13
201.5 General requirements for testing ME EQUIPMENT . 13
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 13
201.7 ME EQUIPMENT identification, marking and documents . 15
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 19
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 20
201.10 Protection against unwanted and excessive radiation HAZARDS . 20
201.11 Protection against excessive temperatures and other HAZARDS . 21
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 21
201.13 HAZARDOUS SITUATIONS and fault conditions . 22
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 23
201.15 Construction of ME EQUIPMENT . 23
201.16 ME SYSTEMS. 23
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 23
Annexes . 23
Annex AA (informative) Particular guidance and rationale . 24
Annex BB (informative) Exposure limit values . 26
Annex CC (informative) Protective eyewear for LS EQUIPMENT . 30
Annex DD (informative) Summary of MANUFACTURER’S requirements . 31
Annex EE (informative) Symbols on marking . 32
Bibliography . 33
Index of defined terms used in this particular standard. 34

Figure 201.101 – Example of explanatory label for a device with multiple HAZARD

spectral regions . 18
Figure 201.102 – Warning label – HAZARD symbol . 19

Table 201.101 – EMISSION LIMITS for risk groups of LS EQUIPMENT . 14
Table 201.102 – Risk group time base criteria for classification of LS EQUIPMENT . 15
Table 201.103 – Applicable ANGLE OF ACCEPTANCE for the assessment of accessible
emission from LS EQUIPMENT . 15
Table 201.104 – Requirements for labelling of LS EQUIPMENT according to risk group
classification . 17
Table BB.1 – EXPOSURE LIMIT values for non-coherent OPTICAL RADIATION . 26
Table BB.2 – S(λ) [dimensionless], 200 nm to 400 nm . 28
Table BB.3 – B (λ), R (λ) [dimensionless], 300 nm to 1 400 nm . 29

60601-2-57  IEC:2011 – 3 –
Table DD.1 – Summary of MANUFACTURER’S requirements . 31
Table EE.1 – Symbols, references and descriptions . 32

– 4 – 60601-2-57  IEC:2011
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-57: Particular requirements for the basic safety and essential
performance of non-laser light source equipment intended for therapeutic,
diagnostic, monitoring and cosmetic/aesthetic use

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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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 60601-2-57 has been prepared by IEC technical committee TC 76:
Optical radiation safety and laser equipment
The text of this standard is based on the following documents:
FDIS Report on voting
76/438/FDIS 76/441/RVD
Full information on the voting for the approval of this standard can be found in the report on
voting indicated in the above table.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this standard, the following print types are used:

60601-2-57  IEC:2011 – 5 –
– Requirements and definitions: roman type.
– 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 standard, 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 standard are preceded by the term “Clause” followed by the
clause number. References to subclauses within this particular standard are by number only.
In this standard, 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 standard conform to usage described in Annex H of the ISO/IEC
Directives, Part 2. For the purposes of this standard, the auxiliary verb:
– “shall” means that compliance with a requirement or a test is mandatory for compliance
with this standard;
– “should” means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this standard;
– “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.

– 6 – 60601-2-57  IEC:2011
The committee has decided that the contents of this publication will remain unchanged until
the stability date indicated on the IEC web site under "http://webstore.iec.ch" in the data
related to the specific publication. At this date, the publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
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.
60601-2-57  IEC:2011 – 7 –
INTRODUCTION
This particular standard amends and supplements IEC 60601-1:2005 (third edition): Medical
Electrical Equipment – Part 1: General requirements for basic safety and essential
performance.
The requirements of this particular standard should be taken as the minimum to comply with,
in order to achieve a reasonable level of safety and reliability during operation and application
of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and
cosmetic/aesthetic use.
An asterisk (*) notes clauses for which there is rationale comment in Annex AA. It is
considered that knowledge of the reasons for these requirements will facilitate the proper
application of this particular standard and be of use in any revision that may be necessitated
by changes in clinical practice or as a result of developments in technology.

– 8 – 60601-2-57  IEC:2011
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-57: Particular requirements for the basic safety and essential
performance of non-laser light source equipment intended for therapeutic,
diagnostic, monitoring and cosmetic/aesthetic use

201.1 Scope, object and related standards

1)
Clause 1 of the general standard applies, except as follows:
201.1.1 Scope
Replacement:
BASIC SAFETY and ESSENTIAL PERFORMANCE of equipment
This International Standard applies to
incorporating one or more sources of OPTICAL RADIATION in the wavelength range 200 nm to
3 000 nm, with the exception of laser radiation, and intended to create non-visual photo-
biological effects in humans or animals for therapeutic, diagnostic, monitoring,
cosmetic/aesthetic or veterinary applications; hereafter referred to as light source equipment
(LS EQUIPMENT).
This particular standard does not apply to equipment for sun tanning, for ophthalmic
instruments or for infant phototherapy.
NOTE Safety requirements in this particular standard are intended to address only HAZARDS to the eye and skin;
hazards to internal tissues are not included in its scope.
LS EQUIPMENT may consist of a single or multiple sources of OPTICAL RADIATION, with or without
power supply, or may be incorporated into a complex system that includes optical, electrical
or mechanical systems or sources of other radiation.
NOTE Annexes AA to EE have been included for purposes of general guidance and to illustrate many typical
cases. However, the annexes should not be regarded as definitive or exhaustive.
201.1.2 Object
Replacement:
The objects of this particular standard are:
– to establish optical radiation safety, basic safety and essential performance requirements
for LS EQUIPMENT;
– to specify requirements for the MANUFACTURER to supply information and establish
procedures so that proper precautions can be adopted;
– to provide warning to individuals of HAZARDS associated with accessible OPTICAL RADIATION
from LS EQUIPMENT through signs, labels and instructions;
– to reduce the possibility of injury by minimizing unnecessary accessible OPTICAL RADIATION;
to provide means of improved control of the HAZARDS related to OPTICAL RADIATION through
protective features and to assist safe use of LS EQUIPMENT;
___________
1)
The general standard is IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for
basic safety and essential performance.

60601-2-57  IEC:2011 – 9 –
– to protect persons against other HAZARDS resulting from the operation and use of
LS 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 in Clause 201.2 of this particular standard.
All published collateral standards in the IEC 60601 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 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 is 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 particular standard 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 3.1 through 3.139, additional definitions in this particular standard 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 standard" is used to make reference to the general standard, any applicable
collateral standards and this particular standard taken together.

– 10 – 60601-2-57  IEC:2011
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 on page 33.
Clause 2 of the general standard applies, except as follows:
Addition:
IEC 60947-3, Low voltage switchgear and controlgear – Part 3: Switches, disconnectors,
switch-disconnectors and fuse-combination units
IEC 62471, Photobiological safety of lamps and lamp systems
ISO 3864-2, Graphical symbols – Safety colours and safety signs – Part 2: Design principles
for product safety labels.
201.3 Terms and definitions
NOTE An index of defined terms used in this document is found beginning on page 34.
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005,
apply, except as follows:
Replacement:
201.3.18
CONTINUOUS OPERATION
operation with a continuous OPTICAL RADIATION output for a duration equal to or greater than
0,25 s for wavelengths in the range 400 to 700 nm and 10 s for all other wavelengths
Addition:
201.3.201
ANGLE OF ACCEPTANCE
γ
plane angle within which a detector responds to OPTICAL RADIATION
NOTE 1 THE ANGLE OF ACCEPTANCE may be controlled by apertures or optical elements.
NOTE 2 The ANGLE OF ACCEPTANCE is sometimes referred to as the field-of-view.
SI Unit: radian (rad)
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 In this particular standard subtended angles are denoted by the full included angle, not the half angle.

60601-2-57  IEC:2011 – 11 –
SI Unit: radian (rad)
201.3.203
EMERGENCY STOP
device intended to stop the LS EQUIPMENT OUTPUT immediately in case of emergency
201.3.204
EMISSION APERTURE
opening or window through which the OPTICAL RADIATION is emitted
201.3.205
EMISSION LIMIT
maximum accessible emission permitted for a particular risk group
201.3.206
EXPOSURE LIMIT
maximum level of exposure of the eye or skin that is not expected to result in adverse
biological effects
NOTE EXPOSURE LIMITS are shown in Table BB.1
201.3.207
EXPOSURE TIME
PULSE DURATION (for a single pulse), duration of a pulse train or of a continuous emission of
optical radiation incident upon the human or animal body during operation, maintenance or
servicing of LS EQUIPMENT
SI Unit: second (s)
201.3.208
LS EQUIPMENT
ME EQUIPMENT which incorporates one or more sources of optical radiation in the wavelength
range 200 nm to 3 000 nm, with the exception of laser radiation, and which is intended to
create non-visual photo-biological effects in humans or animals for therapeutic, diagnostic,
monitoring, cosmetic/aesthetic or veterinary applications
201.3.209
LS EQUIPMENT OUTPUT
either radiant power or radiant energy emitted by the LS EQUIPMENT
201.3.210
OCULAR HAZARD DISTANCE (OHD)
distance from an EMISSION APERTURE within which the projected radiant exposure or irradiance
for a given EXPOSURE TIME equals the applicable EXPOSURE LIMIT value for the eye
SI Unit: m
201.3.211
OPTICAL RADIATION
electromagnetic radiation with wavelengths between 100 nm and 1 mm
201.3.212
PULSE/PULSED
accessible emission with the duration shorter than 0,25 s in the range 400 nm to 700 nm and
shorter than 10 s at other wavelengths

– 12 – 60601-2-57  IEC:2011
201.3.213
PULSE DURATION
time increment measured between the half peak (50 %) power points at the leading and
trailing edges of a PULSE
SI Unit: second (s)
201.3.214
PULSE INTERVAL
time between the end of one PULSE and the onset of the following PULSE, measured at the
50 % trailing and leading edges respectively
SI Unit: second (s)
201.3.215
PULSE TRAIN
series of PULSES where the total on time of the PULSES in any series of PULSES in any single
exposure sequence does not exceed 0,25 s for wavelengths in the range 400 nm to 700 nm
and does not exceed 10 s for all other wavelengths
201.3.216
READY
ready condition: the LS EQUIPMENT is capable of emitting OPTICAL RADIATION when the control
switch is activated
201.3.217
READY INDICATOR
visible or audible signal that indicates when LS EQUIPMENT is in the ready condition; the
purpose of the ready indicator is to make all persons present in the vicinity aware of the need
to take precautions against hazardous optical radiation
201.3.218
SET VALUE
intended LS EQUIPMENT output incident on the treatment area, as set by the OPERATOR
201.3.219
SHORT WAVELENGTH BOUNDARY
wavelength at the 50 % point of the emission spectrum at its short wavelength edge
SI Unit: nm
201.3.220
SKIN HAZARD DISTANCE
distance from an EMISSION APERTURE within which the projected radiant exposure or irradiance
for a given EXPOSURE TIME equals the applicable EXPOSURE LIMIT value for the skin
201.3.221
STAND-BY
stand-by condition: the power supply (SUPPLY MAINS or battery) is connected and the SUPPLY
MAINS switch activated; the LS EQUIPMENT is not capable of emitting the OPTICAL RADIATION
even if the control switch is activated
201.3.222
USER
person, who controls the delivery of the LS EQUIPMENT OUTPUT to the treatment area

60601-2-57  IEC:2011 – 13 –
201.4 General requirements
Clause 4 of the general standard applies.
201.5 General requirements for testing ME EQUIPMENT
Clause 5 of the general standard applies.
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
Clause 6 of the general standard applies, except as follows:
201.6.1 General
Addition:
201.6.1.101 *Classification responsibilities
The MANUFACTURER shall provide the classification of LS EQUIPMENT.
The LS EQUIPMENT shall be classified on the basis of the emission of the accessible OPTICAL
RADIATION over the full range of capability during operation at any time after manufacture and
under every reasonably foreseeable single fault condition.
NOTE Classification of LS EQUIPMENT provides the basis for the range of control measures which the USER should
take in order to minimize risk of excessive exposure to OPTICAL RADIATION.
201.6.1.102 *Classification rules
The classification is used to indicate the potential risk of adverse health effects.
For the purpose of classification rules, the following ranking of the risk groups, in order of
increasing risk at a distance of 200 mm from the EMISSION APERTURE, shall be used.
Assessment shall be made by the method specified in IEC 62471:
– Exempt Group – no photo-biological HAZARD;
– Risk Group 1 – low risk group; the risk is limited by normal behavioural limitations on
exposure;
– Risk Group 2 – moderate risk group; the risk is limited by the aversion response to very
bright light sources. However, such reflex responses do not occur universally;
– Risk Group 3 – high risk group; LS EQUIPMENT that may pose a risk even for momentary or
brief exposure.
NOTE Risk Groups are described in IEC 62471.
201.6.1.102.1 Classification of continuous operation LS EQUIPMENT
a) Exempt Risk Group
CONTINUOUS OPERATION LS EQUIPMENT shall be assigned to the Exempt Risk Group if its
accessible emission does not exceed the EMISSION LIMITS in any of the HAZARD spectral
regions of Table 201.101 when assessed for the time criteria of Table 201.102 and the
ANGLE OF ACCEPTANCE γ specified in Table 201.103.
b) Risk Group 1
CONTINUOUS OPERATION LS EQUIPMENT shall be assigned to Risk Group 1 if its accessible
emission exceeds one or more EMISSION LIMITS for the Exempt Group as defined in Table
EMISSION LIMITS of Risk Group 1 in any of the HAZARD
201.101 and does not exceed
– 14 – 60601-2-57  IEC:2011
spectral regions of Table 201.101 when assessed for the time criteria of Table 201.102
and the ANGLE OF ACCEPTANCE γ specified in Table 201.103.
c) Risk Group 2
CONTINUOUS OPERATION LS EQUIPMENT shall be assigned to Risk Group 2 if its accessible
emission exceeds one or more EMISSION LIMITS for Risk Group 1 as defined in Table
201.101 and does not exceed EMISSION LIMITS of Risk Group 2 in any of the HAZARD
spectral regions of Table 201.101 when assessed for the time criteria of Table 201.102
and the ANGLE OF ACCEPTANCE γ specified in Table 201.103.
d) Risk Group 3
CONTINUOUS OPERATION LS EQUIPMENT shall be assigned to Risk Group 3 if its accessible
emission exceeds one or more EMISSION LIMITS for Risk Group 2 as defined in Table
201.101.
Table 201.101 – EMISSION LIMITS for risk groups of LS EQUIPMENT
Wavelength Emission limits
range
HAZARD Symbol Units
Exempt Group Risk Group 1 Risk Group 2
nm
Actinic UV 180 – 400 E 0,001 0,003 0,03
W⋅m
s
Near UV
315 – 400 E 10 33 100 W⋅m
UVA
2 1
Blue light 300 – 700 L 100 10 000 4 000 000
W⋅m ⋅sr
B
a 2 1
Retinal thermal 380 – 1 400 L 28 000/α N/A 71 000/α W⋅m ⋅sr
R
Retinal thermal, weak visual
a a 2 1
780 – 1 400 L 6 000/α N/A N/A W⋅m ⋅sr
IR
stimulus
Corneal/lens IR
780 – 3 000 E 100 570 3 200 W⋅m
IR
NOTE 1 The list of the HAZARDS in Table 201.101 refers to eye damage and skin damage in the UV. Skin damage can
also occur in the visible and IR, e.g. erythema or burning.
NOTE 2 Retinal damage in the wavelength range 780 nm to 1400 nm may be affected by absence of aversion response
due to weak visual stimulus
a
The retinal thermal HAZARDS L L do not change with time for EXPOSURE TIMES longer than 10 s. A consequence of
R, IR
this is that if the EMISSION LIMIT of Exempt Risk Group is exceeded for EXPOSURE TIME up to 10 s, the LS EQUIPMENT
classified on the basis of the L HAZARD, should be allocated to Risk Group 3. Similarly, LS EQUIPMENT classified on
IR
the basis of the retinal thermal HAZARD (L ) should be allocated to Risk Group 2 or 3, as appropriate, if the EMISSION
R
LIMIT of the Exempt Risk Group is exceeded for EXPOSURE TIME up to 10 s.

201.6.1.102.2 Classification of PULSED LS EQUIPMENT
For PULSED LS EQUIPMENT, classification criteria shall apply to the most restrictive of the
requirements for a single PULSE, or any group of PULSEs within the time criteria of the
applicable HAZARD region given in Table 201.102. EMISSION LIMITS for PULSED LS EQUIPMENT
shall be calculated according to IEC 62471.
a) Exempt Risk Group
PULSED LS EQUIPMENT shall be assigned to the Exempt Risk Group if its accessible emission
does not exceed EMISSION LIMITS in any of the HAZARD spectral regions of Table 201.101 when
assessed for the time criteria of Table 201.102 and ANGLE OF ACCEPTANCE γ specified in Table
201.103.
b) Risk Group 1
PULSED LS EQUIPMENT shall be assigned to Risk Group 1 if its accessible emission exceeds
one or more EMISSION LIMITS for the Exempt Group as defined in Table 201.101 and does not
exceed the EMISSION LIMITS of Risk Group 1 in any of the HAZARD spectral regions of Table
201.101 when assessed for the time criteria of Table 202.102 and ANGLE OF ACCEPTANCE γ
specified in Table 201.103.
60601-2-57  IEC:2011 – 15 –
c) Risk Group 2
PULSED LS EQUIPMENT shall be assigned to Risk Group 2 if its accessible emission exceeds
one or more EMISSION LIMITS for Risk Group 1 as defined in Table 201.101 and does not
exceed the EMISSION LIMITS of Risk Group 2 in any of the HAZARD spectral regions of Table
201.101 when assessed for the time criteria of Table 201.102 and the ANGLE OF ACCEPTANCE γ
specified in Table 201.103.
d) Risk Group 3
PULSED LS EQUIPMENT shall be assigned to Risk Group 3 if its accessible emission exceeds
one or more EMISSION LIMITS for Risk Group 2 as defined in Table 201.101.
Table 201.102 – Risk group time base criteria for classification of LS EQUIPMENT
Time
HAZARD Wavelength range
s
nm
Exempt Group Risk Group 1 Risk Group 2
Actinic UV 180 – 400 30 000 10 000 1 000
Near UV 315 – 400 1 000 300 100
Blue-light 300 – 700 10 000 100 0,25
Retinal thermal 380 – 1 400 10 N/A 0,25
Retinal thermal, weak visual
780 – 1 400 10 N/A N/A
stimulus
Corneal/lens IR 780 –3 000 1 000 100 10

ANGLE OF ACCEPTANCE for the assessment of accessible
Table 201.103 – Applicable
emission from LS EQUIPMENT
Angle of acceptance γ
Wavelength range
rad
HAZARD
nm
Exempt
Risk Group 1 Risk Group 2
Risk Group
Actinic UV 180 – 400 1,4 1,4 1,4
Near UV 315 – 400 1,4 1,4 1,4
Blue-light 300 – 700 0,11 0,011 0,0017
Retinal Thermal 380 – 1 400 0,011 N/A 0,0017
Retinal Thermal, weak visual
780 – 1 400 0,011 N/A N/A
stimulus
Corneal/Lens IR 780 – 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:
201.7.9 ACCOMPANYING DOCUMENTS
201.7.9.1 General
Addition:
– 16 – 60601-2-57  IEC:2011
MANUFACTURERS of LS EQUIPMENT shall provide instructions for proper operation, including
clear warnings concerning precautions to avoid possible exposure to hazardous OPTICAL
RADIATION.
201.7.9.2 Instructions for use
201.7.9.2.13 Maintenance
Addition:
MANUFACTURERS of LS EQUIPMENT shall provide instructions for maintenance to be performed
by the USER, including warnings concerning precautions to avoid possible exposure to
hazardous OPTICAL RADIATION.
Additional subclauses:
201.7.9.2.101 Specific information for LS EQUIPMENT
201.7.9.2.101.1 Information on output
The MANUFACTURER of LS EQUIPMENT shall provide the following information for the USER:
– spectral irradiance or spectral radiant exposure for all intended configurations of
LS EQUIPMENT;
– maximum output of OPTICAL RADIATION for all intended configurations of LS EQUIPMENT,
measured at the treatment area. If the LS EQUIPMENT is designed for providing treatment in
different treatment areas, these parameters shall be specified for each of the treatment
areas;
– maximum variation of the output from the mean value across the treatment area for all
intended configurations of the equipment;
– OCULAR HAZARD DISTANCE and/or SKIN HAZARD DISTANCE, when the LS EQUIPMENT is
classified in excess of Risk Group 1.
For PULSED LS EQUIPMENT, for all intended operational settings of the equipment, the
MANUFACTURER shall provide an additional statement of:
– PULSE DURATION of individual pulses;
– duration of a PULSE TRAIN;
– pulse interval;
– repetition rate;
– number of PULSES in a PULSE TRAIN.
201.7.9.2.101.2 Safety information
MANUFACTURERS of LS EQUIPMENT shall provide the following safety information in the USER
instruction:
– instructions for installation, maintenance, check procedures and safe use, including clear
warnings concerning precautions to avoid possible exposure to hazardous radiation or risk
of fire;
– recommendations for training;
– legible reproductions (colour optional) of all required labels and HAZARD warnings affixed
to the LS EQUIPMENT;
– a clear indication of all locations of EMISSION APERTURES;

60601-2-57  IEC:2011 – 17 –
– a list of controls, adjustments and procedures for operation and maintenance by the USER,
including the warning "Caution – Use of controls or adjustments or performance of
procedures other than those specified herein may result in hazardous radiation exposure";
– a note, saying that LS EQUIPMENT should be protected against unauthorised use, for
example by removal of the key from the key switch;
– a recommendation for eye and skin protection for the USER and for the PATIENT/client.
NOTE The MANUFACTURER should provide a warning of risk of fire if the LS EQUIPMENT is used in the presence of
flammable materials, solutions or gases, or in an oxygen enriched environment. Some materials, e.g. darkly
coloured clothing or cotton wool, when saturated with oxygen, may be ignited by the high temperatures produced in
NORMAL USE of the LS EQUIPMENT.
Additional paragraphs:
201.7.101 Labelling of LS EQUIPMENT
201.7.101.1 Labelling requirements
The MANUFACTURER of LS EQUIPMENT shall provide product risk group marking. The label shall
include the risk group number and wording according to Table 201.104.
NOTE Wording that conveys an equivalent meaning is acceptable.
Table 201.104 – Requirements for labelling of LS EQUIPMENT
according to risk group classification
Exempt
Hazard Risk Group 1 Risk Group 2 Risk Group 3
Group
WARNING
CAUTION
CAUTION
UV emitted from this
UV emitted from this device
Actinic UV Not required device may be hazardous
UV emitted from this
Eye or skin irritation may
device
Avoid eye or skin
result
exposure
WARNING
CAUTION
CAUTION
UV emitted from this
Near UV Not required UV emitted from this device
UV emitted from this
device may be hazardous
device
Eye irritation may result
Avoid eye exposure
CAUTION
The light emitted may be
Blue-light Not required Not required harmful to the eyes
WARNING
Do not stare at the light
The light emitted may
source
result in eye injury
CAUTION
Do not look at the light
The light emitted may be
source
Retinal
Not required Not applicable harmful to the eyes
Thermal
Do not stare at the light
source
Retinal
Thermal,
Not required Not applicable Not applicable
weak visual
WARNING
stimulus
IR emitted from this
CAUTION CAUTION
device may cause eye
injury
IR emitted from this IR emitted from this device
Corneal/
Not required device may cause eye irritation
Avoid eye exposure
Lens IR
Do not stare at the Do not stare at the light
IR source source
– 18 – 60601-2-57  IEC:2011
When LS EQUIPMENT emits OPTICAL RADIATION in more than one HAZARD spectral region, it shall
be classified for the most restrictive case. If the OPTICAL RADIATION in other spectral regions
exceeds the EMISSION LIMITS for the Exempt Group, appropriate warning shall be included in
the product explanatory label.
NOTE For example, for the device classified as a Risk Group 3 product on the basis of a retinal IR HAZARD and
emitting UV to the level of Risk Group 2, the legend of the label should indicate Risk Group 3, with the appropriate
‘Warning’ text; and show the ‘Caution’ text for the Risk Group 2 for the UV, but should not mention Risk Group 2
explicitly, as illustrated in Figure 201.1.

RISK GROUP 3
WARNING IR emitted from this device may cause eye injury.
Avoid eye exposure
CAUTION UV emitted from this device. Eye irritation may result
IEC  173/11
Figure 201.101 – Example of explanatory label for a device with multiple
HAZARD spectral regions
201.7.101.2 Product label design and labelling information
LS EQUIPMENT classified in excess of the Exempt Group shall carry an explanatory label
(Fig. 201.101) and warning label (Fig. 201.102) in accordance with the requirements of this
standard and ISO 3864-2. The labels shall be durable, permanently affixed, legible, and
clearly visible during operation, maintenance or service, according to their purpose. They
shall be positioned so that they can be read without the necessity for human exposure to
OPTICAL RADIATION in excess of the EXPOSURE LIMITS. Text borders and symbols shall be black
on a yellow background.
If the size or design of the product makes labelling impractical, the label shall be included with
the USER information or on the package.
NOTE 1 Direct printing or engraving of equivalent labels on the LS EQUIPMENT or panels is acceptable.
NOTE 2 Explanatory label may be of any size necessary to contain the required lettering and border. The
minimum width of each border dimension should be 0,06 times the length of the shorter side of the label.

60601-2-57  IEC:2011 – 19 –
IEC  174/11
Figure 201.102 – Warning label – HAZARD symbol
201.7.101.3 EMISSION APERTURE label
Each LS EQUIPMENT classified in excess of Risk Group 1 shall have a label affixed close to
each EMISSION APERTURE. The label(s) shall bear the wo
...