EN IEC 60601-2-83:2020

SLOVENSKI STANDARD
01-junij-2020
Medicinska električna oprema - 2-83. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti opreme za svetlobno terapijo na domu (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 (IEC 60601-2-83:2019)
Medizinische elektrische Geräte - Teil 2-83: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Heim-Lichttherapiegeräten (IEC
60601-2-83:2019)
Medizinische elektrische Geräte - Teil 2-83: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Heim-Lichttherapiegeräten (IEC
60601-2-83:2019)
Ta slovenski standard je istoveten z: EN IEC 60601-2-83:2020
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

NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2020
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)
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) Lichttherapiegeräten
(IEC 60601-2-83:2019)
This European Standard was approved by CENELEC on 2020-01-01. CENELEC members are bound to comply with the CEN/CENELEC
Internal Regulations which stipulate the conditions for giving this European Standard 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 European Standard 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,
Turkey 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
© 2020 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 E

European foreword
The text of document 62D/1682/FDIS, future edition 1 of IEC 60601-2-83, prepared by SC 62D
"Electromedical equipment" of IEC/TC 62 "Electrical equipment in medical practice" was submitted to
the IEC-CENELEC parallel vote and approved by CENELEC as EN IEC 60601-2-83:2020.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2020-10-03
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2023-04-03
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 mandate given to CENELEC by the European
Commission and the European Free Trade Association.
Endorsement notice
The text of the International Standard IEC 60601-2-83:2019 was approved by CENELEC as a
European Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards
indicated:
IEC 60335-2-113 NOTE Harmonized as FprEN 60335-2-113 to be published
IEC 60601-2-57:2011 NOTE Harmonized as EN 60601-2-57:2011 (not modified)
IEC 60601-1-10 NOTE Harmonized as EN 60601-1-10
IEC 60601-1-12 NOTE Harmonized as EN 60601-1-12

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.cenelec.eu.
The Annex ZA of EN 60601-1:2006 is applicable, except as follows:
Publication Year Title EN/HD Year
Replace
IEC 60601-1-2 2014 Medical electrical equipment - Part 1-2: EN 60601-1-2 2015
General requirements for basic safety and
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
essential performance - Collateral
standard: Usability
ISO 15223-1 2016 Medical devices – Symbols to be used with EN ISO 15223-1 2016
medical device labels, labelling and
information to be supplied – Part 1:
General requirements
+prA1
Addition
IEC 60601-1 2005 Medical electrical equipment - Part 1: EN 60601-1 2006
General requirements for basic safety and
essential performance
+A12 2014
+EN 60601-2010
1:2006/corrigendum
Mar. 2010
+AC 2014
+A11 2011
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 (mod) 2006 Photobiological safety of lamps and lamp EN 62471 2008
systems
Publication Year Title EN/HD Year
ISO 3864-1 2011 Graphical symbols - Safety colours and - -
safety signs - Part 1: Design principles for
safety signs and safety markings

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

IEC 60601-2-83:2019 © IEC 2019 – 3 –
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
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 commit
...