SIST EN IEC 60601-2-50:2021/A1:2024
(Amendment)Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment (IEC 60601-2-50:2020/AMD1:2023)
Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment (IEC 60601-2-50:2020/AMD1:2023)
Medizinische elektrische Geräte - Teil 2-50: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Säuglings-Phototherapiegeräten (IEC 60601-2-50:2020/AMD1:2023)
Appareils électromédicaux - Partie 2-50: Exigences particulières pour la sécurité de base et les performances essentielles des appareils de photothérapie pour nouveau-nés (IEC 60601-2-50:2020/AMD1:2023)
Medicinska električna oprema - 2-50. del: Posebne zahteve za osnovno varnost in bistvene lastnosti za otroško fototerapevtsko opremo - Dopolnilo A1 (IEC 60601-2-50:2020/AMD1:2023)
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN IEC 60601-2-50:2021/A1:2024
01-februar-2024
Medicinska električna oprema - 2-50. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti za otroško fototerapevtsko opremo - Dopolnilo A1 (IEC 60601-2-
50:2020/AMD1:2023)
Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and
essential performance of infant phototherapy equipment (IEC 60601-2-
50:2020/AMD1:2023)
Medizinische elektrische Geräte - Teil 2-50: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Säuglings-Phototherapiegeräten
(IEC 60601-2-50:2020/AMD1:2023)
Appareils électromédicaux - Partie 2-50: Exigences particulières pour la sécurité de base
et les performances essentielles des appareils de photothérapie pour nouveau-nés (IEC
60601-2-50:2020/AMD1:2023)
Ta slovenski standard je istoveten z: EN IEC 60601-2-50:2021/A1:2023
ICS:
11.040.60 Terapevtska oprema Therapy equipment
SIST EN IEC 60601-2-50:2021/A1:2024 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN IEC 60601-2-50:2021/A1:2024
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SIST EN IEC 60601-2-50:2021/A1:2024
EUROPEAN STANDARD EN IEC 60601-2-50:2021/A1
NORME EUROPÉENNE
EUROPÄISCHE NORM December 2023
ICS 11.040.60
English Version
Medical electrical equipment - Part 2-50: Particular requirements
for the basic safety and essential performance of infant
phototherapy equipment
(IEC 60601-2-50:2020/AMD1:2023)
Appareils électromédicaux - Partie 2-50: Exigences Medizinische elektrische Geräte - Teil 2-50: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des appareils de photothérapie pour nouveau- wesentlichen Leistungsmerkmale von Säuglings-
nés Phototherapiegeräten
(IEC 60601-2-50:2020/AMD1:2023) (IEC 60601-2-50:2020/AMD1:2023)
This amendment A1 modifies the European Standard EN IEC 60601-2-50:2021; it was approved by CENELEC on 2023-11-30. 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,
Türkiye 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
© 2023 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 60601-2-50:2021/A1:2023 E
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SIST EN IEC 60601-2-50:2021/A1:2024
EN IEC 60601-2-50:2021/A1:2023 (E)
European foreword
The text of document 62D/2069/FDIS, future IEC 60601-2-50/AMD1, 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 60601-2-50:2021/A1:2023.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2024-08-30
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2026-11-30
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.
Any feedback and questions on this document should be directed to the users’ national committee. A
complete listing of these bodies can be found on the CENELEC website.
Endorsement notice
The text of the International Standard IEC 60601-2-50:2020/AMD1:2023 was approved by CENELEC
as a European Standard without any modification.
2
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SIST EN IEC 60601-2
...
SLOVENSKI STANDARD
SIST EN IEC 60601-2-50:2021/oprA1:2023
01-januar-2023
Medicinska električna oprema - 2-50. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti za otroško fototerapevtsko opremo - Dopolnilo A1
Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and
essential performance of infant phototherapy equipment - Amendment 1
Medizinische elektrische Geräte - Teil 2-50: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Säuglings-Phototherapiegeräten
Amendement 1 - Appareils électromédicaux - Partie 2-50: Exigences particulières pour la
sécurité de base et les performances essentielles des appareils de photothérapie pour
nouveau-nés
Ta slovenski standard je istoveten z: EN IEC 60601-2-50:2021/prA1:2022
ICS:
11.040.60 Terapevtska oprema Therapy equipment
SIST EN IEC 60601-2- en
50:2021/oprA1:2023
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN IEC 60601-2-50:2021/oprA1:2023
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SIST EN IEC 60601-2-50:2021/oprA1:2023
62D/1981/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 60601-2-50/AMD1 ED3
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2022-11-04 2023-01-27
SUPERSEDES DOCUMENTS:
62D/1872/CD, 62D/1964/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 2-50: Particular requirements for the basic safety and
essential performance of infant phototherapy equipment
PROPOSED STABILITY DATE: 2028
NOTE FROM TC/SC OFFICERS:
Copyright © 2022 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 permis sion
in writing from IEC.
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SIST EN IEC 60601-2-50:2021/oprA1:2023
IEC CDV 60601-2-50:2020 AMD1:2022
© IEC:2022
– 2 –
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/XX/FDIS 62D/XX/RVD
5
6 Full information on the voting for its approval can be found in the report on voting indicated in
7 the above table.
8 The committee has decided that the contents of this document will remain unchanged until the
9 stability date indicated on the IEC website under "http://webstore.iec.ch" in the data related to
10 the specific document. At this date, the document will be
11 • reconfirmed,
12 • withdrawn,
13 • replaced by a revised edition, or
14 • amended.
15
16 NOTE The attention of users of this document is drawn to the fact that equipment manufacturers and testing
17 organizations may need a transitional period following publication of a new, amended or revised IEC or
18 ISO publication in which to make products in accordance with the new requirements and to equip themselves for
19 conducting new or revised tests. It is the recommendation of the committee that the content of this publication be
20 adopted for mandatory implementation nationally not earlier than 3 years from the date of publication.
21
IMPORTANT – The 'colour inside' logo on the cover page of this publication indicates that it
contains colours which are considered to be useful for the correct understanding of its
contents. Users should therefore print this document using a colour printer.
22
23 _____________
24
25 INTRODUCTION to Amendment 1
26 At the October 2019 meeting of IEC SC 62D in Shanghai, China, the subcommittee discussed
27 the need for administra
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