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

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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
Current Stage
6060 - Document made available - Publishing
Start Date
02-Apr-2021
Completion Date
02-Apr-2021

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Standards Content (Sample)

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.
2

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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 e
...

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