EN IEC 60601-2-50:2021/prA1:2022

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

Medicinska električna oprema - 2-50. del: Posebne zahteve za osnovno varnost in bistvene lastnosti za otroško fototerapevtsko opremo - Dopolnilo A1

General Information

• Status: Not Published
• Publication Date: 26-May-2024
• ICS: 11.040.60 - Therapy equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62D - IEC_SC_62D
• Current Stage: 4060 - Enquiry results established and sent to TC, SR, BTTF - Enquiry
• Start Date: 27-Jan-2023
• Completion Date: 27-Jan-2023
• Ref Project: SIST EN IEC 60601-2-50:2021/oprA1:2023 - Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment - Amendment 1

Relations

• Amends: EN IEC 60601-2-50:2021 - Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
• Effective Date: 26-Jul-2021

Standards Content (Sample)

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

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.

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.

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.
23 _____________
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 administrative/technical changes to most 62D standards after completion of the

28 amendment projects within the IEC 60601-1 series. Those projects were all completed and the

29 amendments published in 2020.

30 The full list of IEC SC 62D documents that will be amended or revised may be found within the

31 IEC document 62D/1792/DC. The results and comments on the DC may be found within

32 62D1808/INF. The review report for this amendment is 62D/1814/RR.
33 _____________
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