EN IEC 60601-2-83:2020/A1:2025
(Amendment)Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment
Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment
2022-05-21-JO- to ensure continuity, HAS assessment should be prepared by Tony Wilkes
Medizinische elektrische Geräte - Teil 2-83: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Heim-Lichttherapiegeräten
Appareils électromédicaux - Partie 2-83: Exigences particulières pour la sécurité de base et les performances essentielles des appareils de luminothérapie à domicile
Medicinska električna oprema - 2-83. del: Posebne zahteve za osnovno varnost in bistvene lastnosti opreme za svetlobno terapijo na domu - Dopolnilo A1 (IEC 60601-2-83:2019/AMD1:2022)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2025
Medicinska električna oprema - 2-83. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti opreme za svetlobno terapijo na domu - Dopolnilo A1 (IEC
60601-2-83:2019/AMD1:2022)
Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and
essential performance of home light therapy equipment (IEC 60601-2-
83:2019/AMD1:2022)
Medizinische elektrische Geräte - Teil 2-83: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Heim-Lichttherapiegeräten (IEC
60601-2-83:2019/AMD1:2022)
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/AMD1:2022)
Ta slovenski standard je istoveten z: EN IEC 60601-2-83:2020/A1:2025
ICS:
11.040.60 Terapevtska oprema Therapy equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD EN IEC 60601-2-83:2020/A1
NORME EUROPÉENNE
EUROPÄISCHE NORM June 2025
ICS 11.040.60
English Version
Medical electrical equipment - Part 2-83: Particular requirements
for the basic safety and essential performance of home light
therapy equipment
(IEC 60601-2-83:2019/AMD1:2022)
Appareils électromédicaux - Partie 2-83: Exigences Medizinische elektrische Geräte - Teil 2-83: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des appareils de luminothérapie à domicile wesentlichen Leistungsmerkmale von Heim-
(IEC 60601-2-83:2019/AMD1:2022) Lichttherapiegeräten
(IEC 60601-2-83:2019/AMD1:2022)
This amendment A1 modifies the European Standard EN IEC 60601-2-83:2020; it was approved by CENELEC on 2025-03-26. CENELEC
members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this amendment the
status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
Management Centre or to any CENELEC member.
This amendment exists in three official versions (English, French, German). A version in any other language made by translation under the
responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the same status as
the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Türkiye and the United Kingdom.
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2025 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 60601-2-83:2020/A1:2025 E
European foreword
The text of document 62D/1931/CDV, future edition 1 of IEC 60601-2-83/AMD1, prepared by SC 62D
"Particular medical equipment, software, and systems" of IEC/TC 62 "Medical equipment, software,
and systems" was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as
The following dates are fixed:
• latest date by which this document has (dop) 2026-06-30
to be implemented at national level by
publication of an identical national
standard or by endorsement
• latest date by which the national (dow) 2028-06-30
standards conflicting with this document
have to be withdrawn
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
This document has been prepared under a standardization request addressed to CENELEC by the
European Commission. The Standing Committee of the EFTA States subsequently approves these
requests for its Member States.
For the relationship with EU Legislation, see informative Annex ZZ, which is an integral part of this
document.
Any feedback and questions on this document should be directed to the users’ national committee. A
complete listing of these bodies can be found on the CENELEC website.
Endorsement notice
The text of the International Standard IEC 60601-2-83:2019/AMD1:2022 was approved by CENELEC
as a European Standard without any modification.
Annex ZA
(normative)
Normative references to international publications with their
corresponding European publications
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments)
applies.
NOTE 1 Where an International Publication has been modified by common modifications, indicated by (mod),
the relevant EN/HD applies.
NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is
available here: www.cencenelec.eu.
Replace all references with the following:
Publication Year Title EN/HD Year
IEC 60601-1 2005 Medical electrical equipment – Part 1: General EN 60601-1 2006
requirements for basic safety and essential
+ A1 2012 + A1 2013
performance
+ A2 2020 + A2 2021
IEC 60601-1-2 2014 Medical electrical equipment – Part 1-2: EN 60601-1-2 2015
General requirements for basic safety and
+ A1 2020 + A1 2021
essential performance – Collateral Standard:
Electromagnetic disturbances – Requirements
and tests
IEC 60601-1-6 2010 Medical electrical equipment – Part 1-6: EN 60601-1-6 2010
General requirements for basic safety and
+ A1 2013 + A1 2015
essential performance – Collateral Standard:
+ A2 2020 + A2 2021
Usability
IEC 60601-1-11 2015 Medical electrical equipment – Part 1-11: EN 60601-11 2015
General requirements for basic safety and
+ A1 2020 + A1 2021
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 EN 62471 2008
systems
ISO 3864-1 - Graphical symbols – Safety colours and safety - -
signs – Part 1: Design principles for safety
signs and safety markings
ISO 15223-1 2021 Medical devices – Symbols to be used with EN ISO 15223-1 2021
information to be supplied by the manufacturer
– Part 1: General requirements
Annex ZZ
(informative)
Relationship between this European standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745
aimed to be covered
This European standard has been prepared under standardisation request M/575 given to CENELEC
by the European Commission to provide one voluntary means of conforming to the General Safety
and Performance Requirements of Regulation (EU) 2017/745 of 5 April 2017 concerning medical
devices [OJ L 117].
Once this standard is cited in the Official Journal of the European Union under that Regulation,
compliance with the normative clauses of this standard given in Table ZZ.1 confers, within the limits of
the scope of this standard, a presumption of conformity with the corresponding General Safety and
Performance Requirements of that Regulation, and associated EFTA regulations.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Regulation (EU) 2017/745. This means that risks have to
be ‘reduced as far as possible’, ‘reduced to the lowest possible level’, ‘reduced as far as possible and
appropriate’, ‘removed or reduced as far as possible’, ‘eliminated or reduced as far as possible’, ’removed or
minimized as far as possible’, or ‘minimized’, according to the wording of the corresponding General Safety and
Performance Requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with General
Safety and Performance Requirements 1, 2, 3, 4, 5, 8, 9, 10, 11, 14, 16, 17, 18, 19, 20, 21 and 22 of the
Regulation.
NOTE 3 When a General Safety and Performance Requirement does not appear in Table ZZ.1, it means that
it is not addressed by this European Standard.
Table ZZ.1 — Correspondence between this European standard and Annex I of Regulation (EU)
2017/745 [OJ L 117]
General Safety and Clause(s) / sub-clause(s) Remarks / Notes
Performance Requirements
of this EN
of Regulation (EU) 2017/745
1 201.6.101 Covered in respect of risks associated
with the intended purpose and related to
201.7.2
the design and manufacture of the
201.7.9.2
device, the emission of optical radiation,
201.7.9.2.17
and the use by lay operators in the home
201.10 healthcare environment.
211.8.3.1
4 201.6 Covered in respect of risks associated
with the intended purpose and related to
201.7
the design and manufacture of the
201.10
device, the emission of optical radiation,
201.15
and the use by lay operators in the home
healthcare environment.
General Safety and Clause(s) / sub-clause(s) Remarks / Notes
Performance Requirements
of this EN
of Regulation (EU) 2017/745
5 201.7.2.3 Covered in respect of risks associated
with the intended purpose of the device,
201.7.2.13
the emission of optical radiation, and the
201.7.2.13.101
use by lay operators in the home
201.7.9.2.2.101
healthcare environment.
201.7.9.2.17
201.10
211.8.3.1
8 201.6 Covered. The technical requirements in
the standard are conforming to the state
201.7
of the art and ensure that known and
201.10
foreseeable risks and undesirable side-
201.15
effects are minimized and outweighed by
the benefits to the patient/user.
10.1 (b) 201.7.2.13 Partly covered by a requirement to
indicate presence of natural rubber latex,
if applicable.
10.5 211.8.3.1 Covered in respect of ingress of water
and particulate matter.
14.2 (a) 201.5.9.2.1 Covered in respect of the risk of injury
related to accessible parts.
211.5
14.2 (b) 202.8.1.101 Covered concerning magnetic fields and
external electrical influences.
14.2 (e) 211.8.3.1 Covered.
16.1 (a) 201.6.101 Covered in respect of exposure of
patients, users and other persons to
201.10
optical radiation.
16.1 (b) 201.7.9.2.2.101 First sentence only.
201.7.9.2.17 Covered in respect of information as to
the nature of emitted optical radiation
201.10.106
and means of protection.
16.2 (a), first sentence only 201.10.105 Covered in respect of the control of
emissions according to the skin
pigmentation level.
16.3 201.6.101 Covered in respect of emission of
unintended, stray and scattered optical
201.10
radiation.
General Safety and Clause(s) / sub-clause(s) Remarks / Notes
Performance Requirements
of this EN
of Regulation (EU) 2017/745
22.1 201.6 Covered in respect of risks associated
with the intended purpose of the device,
201.7
the emission of optical radiation, and the
201.10
use by lay operators in the home
201.15
healthcare environment.
23.1, first paragraph 201.7.2.13 Covered for safety and performance
information appearing on the device
201.7.2.13.101
itself.
23.1, first paragraph 201.7.2.3 Covered for safety and performance
information appearing in the instructions
201.7.9.2.2.101
for use.
201.7.9.2.17
23.1 (a) 201.7.1.2 Covered in respect of warning
statements, symbols and safety signs on
201.7.2.3
the device label and in the instructions
201.7.2.13
for use.
201.7.2.13.101
201.7.9.2.2.101
201.7.9.2.17
23.1 (b) 201.7.2.3 Covered in respect of symbols and
safety signs on the device label.
201.7.2.13
201.7.2.13.101
23.1 (g) 201.7.2.3 Covered in respect of residual risks
related to the symbols, safety signs,
201.7.2.13
warnings, cautions and other information
201.7.2.13.101
on the device label and/or in the
201.7.9.2.2.101
instructions for use as required by the
indicated subclauses.
201.7.9.2.17
23.1 (h) 201.7.2.3 Covered in respect of symbols and
safety signs on the device label and/or in
201.7.2.13
the instructions for use applied in
201.7.2.13.101
accordance with the requirements of the
indicated subclauses.
23.2 (m) 201.7.2.3 Covered in respect of the symbols,
safety signs, warnings, cautions and
201.7.2.13
other information on the device label
201.7.2.13.101
and/or in the instructions for use as
201.7.9.2.2.101
required by the indicated subclauses.
201.7.9.2.17
211.8.3.1
23.4 (e) 201.7.9.2.17 (first Covered.
paragraph, items b, c, d)
23.4 (r) 201.7.9.2.17 (first Covered.
paragraph, items b, c, d)
201.10
General Safety and Clause(s) / sub-clause(s) Remarks / Notes
Performance Requirements
of this EN
of Regulation (EU) 2017/745
23.4 (s), sixth dash 201.7.2.13 Covered in respect of warnings as
regards the presence of natural rubber
latex.
WARNING 1 — Presumption of conformity stays valid only as long as a reference to this European
standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2 — Other Union legislation may be applicable to the product(s) falling within the scope of
this standard.
SIST EN IEC 60601-2-83:2020/A1:
...
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