IEC 60601-2-57:2023
(Main)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
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
IEC 60601-2-57:2023 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 photobiological effects in humans for therapeutic, diagnostic, monitoring, and cosmetic or aesthetic applications; hereafter referred to as light source equipment (ls equipment).
Appareils électromédicaux - Partie 2-57: Exigences particulières pour la sécurité de base et les performances essentielles des appareils à source de lumière non laser destinés à des usages thérapeutiques, de diagnostic, de surveillance, cosmétiques et esthétiques
IEC 60601-2-57:2023 s'applique à la sécurité de base et aux performances essentielles des équipements incorporant une ou plusieurs sources de rayonnement optique dans la gamme de longueurs d'onde comprises entre 200 nm et 3 000 nm, à l'exception du rayonnement laser, et destinés à créer des effets photobiologiques chez l'homme pour des applications thérapeutiques, diagnostiques, de surveillance et cosmétiques ou esthétiques; Ci-après dénommés équipements d'origine lumineuse (équipements LS).
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IEC 60601-2-57
®
Edition 2.0 2023-07
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, cosmetic and 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 destinés à des usages
thérapeutiques, de diagnostic, de surveillance, cosmétiques et esthétiques
IEC 60601-2-57:2023-07(en-fr)
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IEC 60601-2-57
®
Edition 2.0 2023-07
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, cosmetic and 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 destinés
à des usages thérapeutiques, de diagnostic, de surveillance, cosmétiques et
esthétiques
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.50, 11.040.60 ISBN 978-2-8322-7296-1
Warning! Make sure that you obtained this publication from an authorized distributor.
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® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale
---------------------- Page: 3 ----------------------
– 2 – IEC 60601-2-57:2023 © IEC 2023
CONTENTS
FOREWORD . 3
INTRODUCTION . 6
201.1 Scope, object and related standards . 7
201.2 Normative references . 9
201.3 Terms and definitions . 9
201.4 General requirements . 12
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 . 13
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 17
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 18
201.10 Protection against unwanted and excessive radiation HAZARDS . 18
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 for ME EQUIPMENT . 22
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 22
201.15 Construction of ME EQUIPMENT . 22
201.16 ME SYSTEMS . 22
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 22
Annexes . 23
Annex AA (informative) Particular guidance and rationale . 24
Annex BB (informative) Summary of MANUFACTURER’S requirements . 26
Annex CC (informative) Symbols on marking . 27
Bibliography . 28
Index of defined terms used in this document . 29
Figure 201.101 – Example of explanatory label for a device with multiple hazard
spectral regions . 14
Figure 201.102 – Example of explanatory label . 14
Figure 201.103 – Reproduction of the OPTICAL RADIATION warning symbol
(ISO 7010:W027:2011-05) . 15
Table 201.104 – Requirements for marking of LS EQUIPMENT according to risk group
classification . 14
Table BB.1 – Summary of MANUFACTURER’s requirements . 26
Table CC.1 – Symbols, references and descriptions . 27
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IEC 60601-2-57:2023 © IEC 2023 – 3 –
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, cosmetic and 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 international
co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and
in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports,
Publicly Available Specifications (PAS) and Guides (hereafter referred to as "IEC Publication(s)"). Their
preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with
may participate in this preparatory work. International, governmental and non-governmental organizations liaising
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Standardization (ISO) in accordance with conditions determined by agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
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3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
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6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
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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) IEC draws attention to the possibility that the implementation of this document may involve the use of
(a) patent(s). IEC takes no position concerning the evidence, validity or applicability of any claimed patent rights
in respect thereof. As of the date of publication of this document, IEC had not received notice of (a) patent(s),
which may be required to implement this document. However, implementers are cautioned that this may not
represent the latest information, which may be obtained from the patent database available at
https://patents.iec.ch. IEC shall not be held responsible for identifying any or all such patent rights.
IEC 60601-2-57 has been prepared by IEC technical committee 76: Optical radiation safety and
laser equipment. It is an International Standard.
This second edition cancels and replaces the first edition published in 2011. This edition
constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous
edition:
a) This edition constitutes a major review of the previous edition and covers the recent
development of LS EQUIPMENT. It now includes the RISK GROUP 1C (RG-1C). LS EQUIPMENT
of RG-1C incorporates technical means which inhibit emission into free space when the
APPLICATOR is not in GOOD CONTACT with the target tissue.
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– 4 – IEC 60601-2-57:2023 © IEC 2023
b) It now excludes LS EQUIPMENT of RG-1 and RG-2 as these are assumed to represent no
hazard. RG-1C is only included if the incorporated light source is of RG-3.
c) It clarifies its relation to the concept of Risk Groups (RGs), as introduced in IEC 62471.
d) Although the previous edition was applicable to LS EQUIPMENT containing UV sources, more
emphasis is given to UV applications of the equipment in this edition.
e) This edition excludes LS EQUIPMENT which is intended to be used on animals.
The text of this International Standard is based on the following documents:
Draft Report on voting
76/734/FDIS 76/737/RVD
Full information on the voting for its approval can be found in the report on voting indicated in
the above table.
The language used for the development of this International Standard is English.
This document was drafted in accordance with ISO/IEC Directives, Part 2, and developed in
accordance with ISO/IEC Directives, Part 1 and ISO/IEC Directives, IEC Supplement, available
at www.iec.ch/members_experts/refdocs. The main document types developed by IEC are
described in greater detail at www.iec.ch/publications.
In this document, the following print types are used:
– 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 IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020, in this document 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 document 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 2:2021. 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.
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IEC 60601-2-57:2023 © IEC 2023 – 5 –
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 webstore.iec.ch in the data related to the
specific document. At this date, the document will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
IMPORTANT – The "colour inside" logo on the cover page of this document indicates
that it contains colours which are considered to be useful for the correct understanding
of its contents. Users should therefore print this document using a colour printer.
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– 6 – IEC 60601-2-57:2023 © IEC 2023
INTRODUCTION
This document amends and supplements IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012
and IEC 60601-1:2005/AMD2:2020, Medical electrical equipment – Part 1: General
requirements for basic safety and essential performance.
The requirements of this document 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 or
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
document and be of use in any revision that may be necessitated by changes in clinical practice
or as a result of developments in technology.
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IEC 60601-2-57:2023 © IEC 2023 – 7 –
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
201.1 Scope, object and related standards
Clause 1 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 applies, except as follows:
201.1.1 *Scope
Replacement:
This part of IEC 60601-2 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 photobiological effects
in humans for therapeutic, diagnostic, monitoring, and cosmetic or aesthetic applications;
hereafter referred to as light source equipment (LS EQUIPMENT).
This document applies to LS EQUIPMENT of RISK GROUP 1C if the incorporated source of OPTICAL
RADIATION is of RG-3, and of Risk Group 3.
NOTE 1 For classification rules for Risk Groups, see 201.6.1.102.
This document does not apply to equipment for sun tanning such as sunlamp products, for
ophthalmic instruments, for lighting purposes in medical or cosmetic environments, for
photography/video, for equipment which produces visual or non-visual effects such as circadian
entrainment, or for infant phototherapy and infant radiant warmers. This document does not
apply to sterilization equipment.
This document does not apply to home-use appliances. It does not apply to home light therapy
equipment, such as equipment which is intended to be used in the HOME HEALTHCARE
ENVIRONMENT and is typically used by a LAY OPERATOR.
1
NOTE 2 Home-use appliances are covered by IEC 60335-2-113:2016 [1] . Appliances for skin exposure to OPTICAL
RADIATION, such as sunlamp products, are covered by IEC 60335-2-27 [2]. Home light therapy equipment providing
light therapy by means of eye-mediated photobiological effects, which can be visual or non-visual, and skin-mediated
photobiological effects, possible applications including pain relief, psoriasis treatment, and treatment of winter
depression (SAD), are also covered by IEC 60601-2-83:2019 [3].
NOTE 3 Safety requirements in this document are intended to address only HAZARDS to the eye and superficial
tissues including skin or mucosa. As OPTICAL RADIATION does not penetrate more than a few millimetres in tissue,
HAZARDS to underlying tissues are not considered.
___________
1
Numbers in square brackets refer to the Bibliography.
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201.1.2 Object
Replacement:
The objects of this document are:
– to establish the risk from OPTICAL RADIATION, specify 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 risks associated with accessible OPTICAL RADIATION from
LS EQUIPMENT through signs, labels and instructions;
– to reduce the possibility of adverse effects and injuries by minimizing unnecessary
accessible OPTICAL RADIATION; to provide means of improved control of the HAZARDS related
to OPTICAL RADIATION through engineering controls;
– to specify requirements for protection against other HAZARDS resulting from the operation
and use of LS EQUIPMENT.
201.1.3 Collateral standards
Addition:
This document refers to the applicable collateral standards that are listed in Clause 2 of
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020.
All collateral standards apply, except IEC 60601-1-11.
201.1.4 Particular standards
Replacement:
In the IEC 60601 series, particular standards may modify, replace or delete requirements
contained in IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601 1:2005/AMD2:2020 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 IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020.
The numbering of clauses and subclauses of this document corresponds to that of
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 with the
prefix "201" (e.g. 201.1 in this document addresses the content of Clause 1 of
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020) 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 document addresses the content of Clause 4 of
the IEC 60601-1-2 collateral standard, 203.4 in this document addresses the content of Clause
4 of the IEC 60601-1-3 collateral standard, etc.). The changes to the text of IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 are specified by the use of
the following words:
"Replacement" means that the clause or subclause of IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or applicable collateral
standard is replaced completely by the text of this document.
"Addition" means that the text of this document is additional to the requirements of
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or
applicable collateral standard.
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IEC 60601-2-57:2023 © IEC 2023 – 9 –
"Amendment" means that the clause or subclause of IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or applicable collateral
standard is amended as indicated by the text of this document.
Subclauses, figures or tables which are additional to those of IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 are numbered starting from
201.101. However, due to the fact that definitions in IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 are numbered 3.1 through
3.139, 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 final digit(s) of the collateral standard document
number, 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 IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, any applicable collateral
standards and this document taken together.
Where there is no corresponding clause or subclause in this document, the clause or subclause
of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or
applicable collateral standard, although possibly not relevant, applies without modification;
where it is intended that any part of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 or applicable collateral standard, although possibly relevant, is
not to be applied, a statement to that effect is given in this document.
201.2 Normative references
NOTE Informative references are listed in the Bibliography.
Clause 2 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 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
Clause 3 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 applies, 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 nm to 700 nm and 10 s for all other wavelengths
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– 10 – IEC 60601-2-57:2023 © IEC 2023
201.3.73
OPERATOR
person handling the LS EQUIPMENT
Note 1 to entry: In general, the OPERATOR controls the delivery of optical radiation. The OPERATOR can appoint one
or more other persons who assist with the selection and/or setting of the parameters. The more general term "user"
is interpreted in its generic meaning. The meaning of "user" may include the definition of "OPERATOR".
201.3.76
PATIENT
person undergoing the treatment or diagnostic procedure
Addition:
201.3.201
APPLICATOR
mechanical or optical means of transferring OPTICAL RADIATION from the source to the human
tissue
201.3.202
EMERGENCY STOP
device intended to stop the LS EQUIPMENT OUTPUT immediately in case of emergency
201.3.203
EMISSION APERTURE
opening or window through which the OPTICAL RADIATION is emitted
201.3.204
EXPOSURE DURATION
duration of a PULSE, or series, or train of PULSES or of continuous emission of OPTICAL RADIATION
LS EQUIPMENT
incident upon the human body during operation, maintenance or servicing of
Note 1 to entry: For a single PULSE, this is the duration between the half-peak power point of the leading edge and
the corresponding point on the trailing edge. For a train of PULSES (or subsections of a train o
...
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