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

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
22-Apr-2021
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
14-Apr-2021
Due Date
19-Jun-2021
Completion Date
23-Apr-2021

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SLOVENSKI STANDARD
SIST EN IEC 60601-2-83:2020/A11:2021
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
SIST EN IEC 60601-2-83:2020/A11:2021 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN IEC 60601-2-83:2020/A11:2021
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SIST EN IEC 60601-2-83:2020/A11:2021
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
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SIST EN IEC 60601-2-83:2020/A11:2021
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.
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SIST EN IEC 60601-2-83:2020/A11:2021
EN IEC 60601-2-83:2020/A11:2021 (E)
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
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SIST EN IEC 60601-2-83:2020/A11:2021
EN IEC 60601-2-83:2020/A11:2021 (E)
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.
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SIST EN IEC 60601-2-83:2020/A11:2021
EN IEC 60601-2-83:2020/A11:2021 (E)

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
...

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