EN IEC 60601-2-83:2020/A11:2021

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

2021-02.09 -JO - positive assessment for MDD (EN IEC 60601-2-83:2020 - PR= 64477) and the comments of the HAS consultant for MDR was resolved by the TC for EN IEC 60601-2-83:2020/prA11 - PR= 72969
This A11 introduces a revised Annex ZA & Annex ZZ  to EN IEC 60601-2-83:2020 in view of offering it for citation in OJEU under MDD (93/42/EEC) and MDR (2017/745)

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

No scope availble

Medicinska električna oprema - 2-83. del: Posebne zahteve za osnovno varnost in bistvene lastnosti opreme za svetlobno terapijo na domu - Dopolnilo A11

General Information

• Status: Published
• Publication Date: 01-Apr-2021
• ICS: 11.040.60 - Therapy equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: CLC/TC 62 - Electrical equipment in medical practice
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 02-Apr-2021
• Completion Date: 02-Apr-2021
• Directive: 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Mandate: M/565 - Medical devices and in vitro diagnostic medical devices in support of Regulation (EU) 2017/745 of the European Parliament and of the Council and Regulation (EU) 2017/746
• Mandate: M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
• Mandate: M/575 AMD 2 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medicial devices in support of Regulation (EU) 2017746
• Ref Project: SIST EN IEC 60601-2-83:2020/A11:2021 - Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment

Relations

• Amends: EN IEC 60601-2-83:2020 - Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment
• Effective Date: 10-Nov-2020

Overview

EN IEC 60601-2-83:2020/A11:2021 is a crucial European standard developed by CLC that specifies the particular requirements for the basic safety and essential performance of home light therapy equipment. This amendment (A11) revises Annex ZA and Annex ZZ of the original EN IEC 60601-2-83:2020 standard to ensure compliance and enable citation in the Official Journal of the European Union (OJEU) under the Medical Device Directive (MDD 93/42/EEC) and the Medical Device Regulation (MDR 2017/745). The standard supports device manufacturers and healthcare providers by establishing safety benchmarks and performance criteria tailored for light therapy devices intended for domestic use.

Key Topics

• Safety Requirements: Outlines essential safety measures for light therapy devices used at home, addressing risks associated with optical radiation, electrical safety, and user operation by non-professionals.
• Essential Performance: Defines performance standards to ensure light therapy devices deliver effective treatment without compromising user safety or device reliability.
• Risk Management: Requires rigorous risk evaluation and mitigation strategies aligned with the latest EU directives to minimize hazards related to device use.
• Electromagnetic Compatibility: Includes requirements concerning electromagnetic disturbances to ensure safe device operation within the home environment.
• Labeling and Instructions: Specifies necessary safety signs, symbols, warnings, and information on device labels and instructions to promote correct and safe use.
• Photobiological Safety: Addresses exposure limits and control mechanisms for optical radiation compliant with IEC 62471 to protect users from harmful effects.
• Testing and Compliance: Provides guidance for device testing, validation, and conformity assessment based on applicable international and European norms.

Applications

EN IEC 60601-2-83:2020/A11:2021 applies explicitly to home-use light therapy devices designed for therapeutic purposes, such as phototherapy for skin conditions, pain management, or circadian rhythm regulation. By following this standard, manufacturers can:

• Develop safe and high-performance home light therapy equipment.
• Ensure compliance with EU regulatory requirements (MDD and MDR) to facilitate market access.
• Enhance user confidence with clear labeling and usability instructions suited for lay operators.
• Support healthcare providers and patients in deploying home-based light therapy treatments effectively and safely.
• Reduce risks including injury, optical radiation hazards, and electrical malfunctions in non-clinical environments.

This standard is particularly relevant for medical device manufacturers, regulatory professionals, quality assurance teams, and certification bodies working within the electrotechnical medical equipment domain.

Related Standards

EN IEC 60601-2-83:2020/A11 references and aligns with several key international and European standards including:

• EN IEC 60601-1: General requirements for basic safety and essential performance of medical electrical equipment.
• EN IEC 60601-1-2: Requirements for electromagnetic compatibility.
• EN IEC 60601-1-6: Usability and human factors for medical electrical devices.
• EN IEC 60601-1-11: Requirements for medical electrical equipment used in the home healthcare environment.
• EN 62471: Photobiological safety of lamps and lamp systems.
• EN ISO 15223-1: Symbols for medical device labelling and information.
• ISO 3864-1: Safety colors and signs for graphical symbols.

Compliance with these standards ensures comprehensive safety, performance, and labeling of home light therapy devices.

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By adhering to EN IEC 60601-2-83:2020/A11:2021, stakeholders can ensure their home light therapy equipment meets the highest standards required for safety, regulatory compliance, and therapeutic effectiveness in the evolving medical device landscape. This contributes to enhancing patient safety and promoting the wider acceptance of light therapy solutions in home healthcare settings.

Standards Content (Sample)

SLOVENSKI STANDARD
01-junij-2021
Medicinska električna oprema - 2-83. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti opreme za svetlobno terapijo na domu - Dopolnilo A11
Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and
essential performance of home light therapy equipment
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
Ta slovenski standard je istoveten z: EN IEC 60601-2-83:2020/A11:2021
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/A11

NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2021
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
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-
Lichttherapiegeräten
This amendment A11 modifies the European Standard EN IEC 60601-2-83:2020; it was approved by CENELEC on 2020-11-03. 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,
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
© 2021 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/A11:2021 E

European foreword
This document (EN IEC 60601-2-83:2020/A11:2021) has been prepared by CLC/TC 62 "Electrical
equipment in medical practice".
The following dates are fixed:
• latest date by which this document has (dop) 2021-10-02
to be implemented at national level by
publication of an identical national
standard or by endorsement
• latest date by which the national (dow) 2023-11-03
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 mandate given to CENELEC by the European
Commission and the European Free Trade Association, and supports essential requirements of EU
Directive(s).
For the relationship with EU Directive(s) see informative Annexes ZZA and ZZB, which are an integral
part of this document.
Annex ZA
(normative)
Normative references to international publications with their
corresponding European publications
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
However, for any use of this standard “within the meaning of Annex ZZ”, the user must always check
that any referenced document has not been superseded and that its relevant contents can still be
considered the generally acknowledged state-of-art.
When the IEC or ISO standard is referred to in the IEC text standard, this must be understood as a
normative reference to the parallel EN standard, as outlined below, including the foreword and the
Annexes ZZ.
NOTE 1 The way in which referenced documents are cited in normative requirements determines the extent
(in whole or in part) to which they apply.
NOTE 2 When an international publication has been modified by common modifications, indicated by (mod),
the relevant EN/HD applies.
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
AMD1 2012 A1 2013
performance
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
AMD1 2013 A1 2015
essential performance – Collateral Standard:
Usability
IEC 60601-1-11 2015 Medical electrical equipment – Part 1-11: EN 60601-11 2015
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 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 2016 Medical devices – Symbols to be used with EN ISO 2016
medical device labels, labelling and information 15223-1
to be supplied – Part 1: General requirements

Annex ZZA
(informative)
Relationship between this European standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered
This European Standard has been prepared under a standardization request M/023 concerning the
development of European standards related to medical devices given to CENELEC by the European
Commission to provide a means of conforming to the Essential Requirements of Council Directive
93/42/EEC of 14 June 1993 concerning medical devices [OJ L 169].
Once this standard is cited in the Official Journal of the European Union under that Directive,
compliance with the normative clauses of this standard given in Table ZZA.1 confers, within the limits
of the scope of this standard, a presumption of conformity with the corresponding Essential
Requirements (ERs) of that Directive and associated EFTA regulations.
NOTE 1 The standard’s scope is limited to the specific uses, environments, contexts, objective situations
specifically indicated. It cannot provide for presumption of conformity in other conditions. Some clauses or
subclauses may be not applicable due to the specific type of equipment under consideration.
NOTE 2 Only requirements contained in the normative parts of the text are relevant to the presumption of
conformity of this standard. Informative parts may, however, support users to interpret such requirements
correctly.
NOTE 3 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 Directive 93/42/EEC. This means that risks have to be
reduced "as far as possible", "to a minimum", "to the lowest possible level", "minimized" or "removed", according
to the wording of the corresponding essential requirement which must be interpreted and applied in such a way
as to take account of technology and practice existing at the time of design and of technical and economical
considerations compatible with a high level of protection of health and safety.
NOTE 4 The manufacturer’s policy for determining acceptable risk must be in compliance with Essential
Requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive.
NOTE 5 For all parts of this standard that a) refer in their clauses to specific national legislation possibly
exempting manufacturers from the thorough application of relevant provisions of this standard or b) link the
completion of a relevant process/prescription to any discretional choice/power of manufacturers, the user of the
standard should check that such clauses are in compliance with Directive 93/42/EEC.
NOTE 6 This Annex ZZ is based on Normative References according to Annex ZA, replacing the references
in the core text.
WARNING 1: Other requirements and other EU Directives and Regulations may be applicable to the
product(s) falling within the scope of this standard.
WARNING 2: 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.
Table ZZA.1 — Correspondence between the Essential Requirements of Directive 93/42/EEC
and Clauses and Sub-clauses of this European standard
Essential Requirements of Clause(s) / sub-clause(s) Remarks / Notes
Directive 93/42/EEC
of this EN
1 201.6.101 Covered in respect of risks
associated with the intended
201.7.2
purpose and related to the
201.7.9.2
construction of the device, the
201.10
emission o
...