IEC 60601-2-83:2019/AMD1:2022

Amendment 1 - Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment

Amendement 1 - Appareils électromédicaux - Partie 2-83: Exigences particulières pour la sécurité de base et les performances essentielles des appareils de luminothérapie à domicile

General Information

• Status: Published
• Publication Date: 14-Dec-2022
• ICS: 11.040.60 - Therapy equipment
• Technical Committee: SC 62D - Particular medical equipment, software, and systems
• Drafting Committee: MT 39 - TC 62/SC 62D/MT 39
• Current Stage: PPUB - Publication issued
• Start Date: 09-Jan-2023
• Completion Date: 15-Dec-2022

Relations

• Amends: IEC 60601-2-83:2019 - Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment
• Effective Date: 05-Sep-2023

Standards Content (Sample)

IEC 60601-2-83
®

Edition 1.0 2022-12
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
A MENDMENT 1
AM ENDEMENT 1

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

IEC 60601-2-83:2019-05/AMD1:2022-12(en-fr)

---------------------- Page: 1 ----------------------
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IEC 60601-2-83

®


Edition 1.0 2022-12




INTERNATIONAL



STANDARD




NORME



INTERNATIONALE




A MENDMENT 1

AM ENDEMENT 1





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 978-2-8322-6215-3




Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale

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– 2 – IEC 60601-2-83:2019/AMD1:2022
© IEC 2022
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________

MEDICAL ELECTRICAL EQUIPMENT –

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

AMENDMENT 1

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
with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for
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
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence between
any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
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
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
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 document may be the subject of patent
rights. IEC shall not be held responsible for identifying any or all such patent rights.
Amendment 1 to IEC 60601-2-83:2019 has been prepared by subcommittee 62D: Particular
medical equipment, software, and systems, of IEC technical committee 62: Medical equipment,
software, and systems.
The text of this Amendment is based on the following documents:
Draft Report on voting
62D/1931/CDV 62D/1962/RVC

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 Amendment is English.

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IEC 60601-2-83:2019/AMD1:2022 – 3 –
© IEC 2022
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/.
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.

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 or ISO
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 mandatory implementation nationally not earlier than 3 years from the date of publication.

___________

INTRODUCTION TO AMENDMENT 1
The first edition of IEC 60601-2-83 was published in May 2019. Since the publication of
IEC 60601-2-83:2019, the IEC Subcommittee (SC) 62A has published amendments to the
general and collateral standards, thus requiring amendments to the particular standards for
alignment as discussed at the IEC SC 62D meeting in Shanghai, China, in October 2019.
Because this is an amendment to IEC 60601-2-83:2019, the style in force at the time of
publication of IEC 60601-2-83 has been applied to this amendment. The style specified in
ISO/IEC Directives Part 2:2021 has only been applied when implementing the new style
guidance would not result in additional editorial changes.
Users of this document should note that when constructing the dated references to specific
elements in a standard, such as definitions, amendments are only referenced if they modified
the text being cited. For example, if a reference is made to a definition that has not been
modified by an amendment, then the reference to the amendment is not included in the dated
reference.

INTRODUCTION
Replace the existing last paragraph with:
This document is aligned with:
– IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020;
– IEC 60601-1-2:2014 and IEC 60601-1-2:2014/AMD1:2020;
– IEC 60601-1-6:2010, IEC 60601-1-6:2010/AMD1:2013 and
IEC 60601-1-6:2010/AMD2:2020; and

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– 4 – IEC 60601-2-83:2019/AMD1:2022
© IEC 2022
– IEC 60601-1-11:2015 and IEC 60601-1-11:2015/AMD1:2020.
201.1 Scope, object and related standards
Replace the existing footnote 2 with:
2 The general standard is 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.
201.1.3 Collateral standards
Replace the first sentence of the second paragraph with:
IEC 60601-1-2:2014 and IEC 60601-1-2:2014/AMD1:2020, IEC 60601-1-6:2010,
IEC 60601-1-6:2010/AMD1:2013 and IEC 60601-1-6:2010/AMD2:2020, and
IEC 60601-1-11:2015 and IEC 60601-1-11:2015/AMD1:2020 apply as modified in Clauses 202,
206 and 211, respectively.
201.1.4 Particular standards
Replace the first sentence of the third paragraph with:
For brevity, IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 are referred to in this particular standard as the general
standard.
201.2 Normative references
Replace the existing references to IEC 60601-1-2, IEC 60601-1-6 and ISO 15223-1 with the
following new references:
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
IEC 60601-1-2:2014/AMD1:2020
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
IEC 60601-1-6:2010/AMD2:2020
ISO 15223-1:2021, Medical devices – Symbols to be used with information to be supplied by
the manufacturer – Part 1: General requirements
Replace the existing references to IEC 60601-1 and IEC 60601-1-11 with the following new
references:
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety
and essential performance
IEC 60601-1:2005/AMD1:2012
IEC 60601-1:2005/AMD2:2020
IEC 60601-1-11:2015, Medical electrical equipment – Part 1-11: General requirements for basic
Collateral Standard: Requirements for medical electrical
safety and essential performance –
equipment and medical electrical systems used in the home healthcare environment
IEC 60601-1-11:2015/AMD1:2020

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IEC 60601-2-83:2019/AMD1:2022 – 5 –
© IEC 2022
201.7.2.3 Consult ACCOMPANYING DOCUMENTS
SAFETY SIGN".
Replace, in the existing first paragraph, "safety sign" in two places with "
Replace, in the existing NOTE, "safety signs" with "SAFETY SIGNS".
201.7.2.13 Physiological effects (safety signs and warning statements)
Replace, in the title, "safety signs" with "SAFETY SIGNS".
Replace the reference to “ISO 15223-1:2016” with “ISO 15223-1:2021”.
201.7.2.13.101 * Markings and symbols for HOME LIGHT THERAPY EQUIPMENT
Replace, in the existing first paragraph, "safety sign" in two places with "SAFETY SIGN".
Replace the existing second paragraph with:
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
SAFETY SIGN 101 or SAFETY SIGN 102 of Table 201.D.2.
marked with
Replace the existing third paragraph with:
HOME LIGHT THERAPY EQUIPMENT for which the emitted OPTICAL RADIATION exceeds the EMISSION
LIMIT for the Exempt Group for the retinal thermal HAZARD and/or the corneal/lens IR HAZARD,
shall be marked with SAFETY SIGN 101 or SAFETY SIGN 103 of Table 201.D.2.
Replace, in the existing fourth paragraph, "safety sign" with "SAFETY SIGN".
SAFETY SIGNS".
Replace, in the existing NOTE, "safety signs" with "
201.10.104 Skin detection feedback
Replace, in the existing first and second paragraphs and in the existing NOTE, "signal" with
"INFORMATION SIGNAL" (3 occurrences).
201.10.105 Means to assess the skin pigmentation level
Add, after the existing first paragraph, the following note:
NOTE 1 HOME LIGHT THERAPY EQUIPMENT emitting INTENSE PULSED LIGHT can also emit a part of its spectral output
at wavelengths above 1 200 nm. The absorption of that part of the OPTICAL RADIATION by the skin becomes
independent of the skin pigmentation level and is included in the EXPOSURE LIMIT for the thermal HAZARD for the skin.
Replace the existing second paragraph with:
The assessment of the skin pigmentation level shall be at or adjacent to the area of skin
irradiation. There shall be continuous full skin contact between the moment of assessment of
the skin pigmentation level and the emission of OPTICAL RADIATION.
NOTE 2 The purpose of these requirements is to prevent irradiation of skin with a different pigmentation level than
the skin that was assessed.
A colour chart may be used additionally to advise the user on adjustment of the output of
OPTICAL RADIATION.

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– 6 – IEC 60601-2-83:2019/AMD1:2022
© IEC 2022
201.10.106 Protection measures
SAFETY SIGN".
Replace, in the existing second paragraph, "safety sign" in two places with "
202 Electromagnetic disturbances – Requirements and tests
Replace the existing first paragraph with:
IEC 60601-1-2:2014 and IEC 60601-1-2:2014/AMD1:2020 apply, except as follows:
206 Usability
Replace the existing first paragraph with:
IEC 60601-1-6:2010, IEC 60601-1-6:2010/AMD1:2013, and IEC 60601-1-6:2010/AMD2:2020
apply, except as follows:
211 Requirements for MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL
SYSTEMS used in the HOME HEALTHCARE ENVIRONMENT
Replace the existing first paragraph with:
IEC 60601-1-11:2015 and IEC 60601-1-11:2015/AMD1:2020 apply, except as follows:
ME EQUIPMENT
211.8.3.1 * Ingress of water or particulate matter into
Replace the existing second paragraph with:
ENCLOSURE of HOME LIGHT THERAPY EQUIPMENT that is not BODY-WORN, shall either:
The
a) maintain BASIC SAFETY and ESSENTIAL PERFORMANCE after undergoing the test of IEC 60529
for at least IP21; or
b) be marked with SAFETY SIGN ISO 7010-W001:2011-05 (see IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, Table D.2, SAFETY
SIGN 2) as well as with
1) the text "KEEP DRY" or
2) symbol 5.3.4 of ISO 15223-1:2021 (see Table 201.D.1, symbol 102).
Add, after the existing second paragraph, the following new paragraph:
If some or all of the protection against the ingress of water or particulate matter is provided by
HOME LIGHT THERAPY EQUIPMENT shall be tested while inside the
a carrying case, then the
carrying case.
Annex C – Guide to marking and labelling requirements for ME EQUIPMENT and ME
SYSTEMS
201.C.1 Marking on the outside of ME EQUIPMENT, ME SYSTEMS or their parts
Replace, in the second and third sentences of the existing first paragraph, "safety signs" with
"SAFETY SIGNS".

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IEC 60601-2-83:2019/AMD1:2022 – 7 –
© IEC 2022
Add, after the existing first paragraph, the following note:
NOTE The requirements in 201.7.2.13.101 allow the use of SAFETY SIGN 101 of Table 201.D.2 as alternative for
SAFETY SIGN 102 or SAFETY SIGN 103 of Table 201.D
...