EN IEC 60601-2-83:2020/prA1:2022
(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
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Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN IEC 60601-2-83:2020/oprA1:2022
01-april-2022
Medicinska električna oprema - 2-83. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti opreme za svetlobno terapijo na domu - Dopolnilo A1
Amendment 1 - 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/prA1:2022
ICS:
11.040.60 Terapevtska oprema Therapy equipment
SIST EN IEC 60601-2- en
83:2020/oprA1:2022
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/oprA1:2022
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SIST EN IEC 60601-2-83:2020/oprA1:2022
62D/1931/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 60601-2-83/AMD1 ED1
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2022-01-28 2022-04-22
SUPERSEDES DOCUMENTS:
62D/1857/CD, 62D/1927/CC
IEC SC 62D : ELECTROMEDICAL EQUIPMENT
SECRETARIAT: SECRETARY:
United States of America Ms Ladan Bulookbashi
OF INTEREST TO THE FOLLOWING COMMITTEES: PROPOSED HORIZONTAL STANDARD:
Other TC/SCs are requested to indicate their interest, if
any, in this CDV to the secretary.
FUNCTIONS CONCERNED:
EMC ENVIRONMENT QUALITY ASSURANCE SAFETY
SUBMITTED FOR CENELEC PARALLEL VOTING NOT SUBMITTED FOR CENELEC PARALLEL VOTING
Attention IEC-CENELEC parallel voting
The attention of IEC National Committees, members of
CENELEC, is drawn to the fact that this Committee Draft for
Vote (CDV) is submitted for parallel voting.
The CENELEC members are invited to vote through the
CENELEC online voting system.
This document is still under study and subject to change. It should not be used for reference purposes.
Recipients of this document are invited to submit, with their comments, notification of any relevant patent rights of which
they are aware and to provide supporting documentation.
TITLE:
Amendment 1 - Medical electrical equipment - Part 2-83: Particular requirements for the basic safety
and essential performance of home light therapy equipment
PROPOSED STABILITY DATE: 2027
NOTE FROM TC/SC OFFICERS:
This document is circulated as the Committee Draft for Vote (CDV). This standard is amended in order to align
with the published IEC 60601-1 series Amendment projects.
Copyright © 2021 International Electrotechnical Commission, IEC. All rights reserved. It is permitted to download
this electronic file, to make a copy and to print out the content for the sole purpose of preparing National Committee
positions. You may not copy or "mirror" the file or printed version of the document, or any part of it, for any other purpose
without permission in writing from IEC.
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SIST EN IEC 60601-2-83:2020/oprA1:2022
62D/1931/CDV – 2 – IEC CDV 60601-2-83:2019/AMD1
© IEC:2022
1 FOREWORD
2 This amendment has been prepared by subcommittee 62D: Electromedical equipment, of IEC
3 technical committee 62: Electrical equipment in medical practice.
4 The text of this amendment is based on the following documents:
Draft Report on voting
62D/xxxx/FDIS 62D/xxxx/RVD
5
6 Full information on the voting for the approval of this amendment can be found in the report on
7 voting indicated in the above table.
8 The committee has decided that the contents of this amendment and the base publication will
9 remain unchanged until the stability date indicated on the IEC website under
10 “http://webstore.iec.ch” in the data related to the specific document. At this date, the document
11 will be
12 • reconfirmed,
13 • withdrawn,
14 • replaced by a revised edition, or
15 • amended.
16
17 NOTE The attention of users of this document is drawn to the fact that equipment manufacturers
18 and testing organizations may need a transitional period following publication of a new, amended or
19 revised IEC or ISO publication in which to make products in accordance with the new requirements and
20 to equip themselves for conducting new or revised tests. It is the recommendation of the committee that
21 the content of this publication be adopted for mandatory implementation nationally not earlier than 3
22 years from the date of publication.
23 _____________
24
25 INTRODUCTION TO AMENDMENT 1
26 The first edition of IEC 60601-2-83 was published in May 2019. Since the publication of IEC
27 60601-2-83:2019, the IEC Subcommittee (SC) 62A has published amendments to the general
...
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