EN IEC 60601-2-21:2021/prA1:2022

Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers - Amendment 1

Medizinische elektrische Geräte - Teil 2-21: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Säuglingswärmestrahlern

Amendement 1 - Appareils électromédicaux - Partie 2-21: Exigences particulières pour la sécurité de base et les performances essentielles des incubateurs radiants pour nouveau-nés

Medicinska električna oprema - 2-21. del: Posebne zahteve za osnovno varnost in bistvene lastnosti otroških sevalnih ogrevalnikov - Dopolnilo A1

General Information

• Status: Not Published
• Publication Date: 26-May-2024
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation 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 60601-2-21:2021/oprA1:2023 - Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers - Amendment 1

Relations

• Amends: EN IEC 60601-2-21:2021 - Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
• Effective Date: 26-Jul-2021

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN IEC 60601-2-21:2021/oprA1:2023
01-januar-2023
Medicinska električna oprema - 2-21. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti otroških sevalnih ogrevalnikov - Dopolnilo A1
Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and
essential performance of infant radiant warmers - Amendment 1
Medizinische elektrische Geräte - Teil 2-21: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Säuglingswärmestrahlern
Amendement 1 - Appareils électromédicaux - Partie 2-21: Exigences particulières pour la
sécurité de base et les performances essentielles des incubateurs radiants pour
nouveau-nés
Ta slovenski standard je istoveten z: EN IEC 60601-2-21:2021/prA1:2022
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN IEC 60601-2- en
21:2021/oprA1:2023
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN IEC 60601-2-21:2021/oprA1:2023

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SIST EN IEC 60601-2-21:2021/oprA1:2023
62D/1983/CDV

COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 60601-2-21/AMD1 ED3
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2022-11-04 2023-01-27
SUPERSEDES DOCUMENTS:
62D/1873/CD, 62D/1966/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 2-21: Particular requirements for the basic safety and
essential performance of infant radiant warmers

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
permission in writing from IEC.

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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
XX/XX/FDIS XX/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 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/1816/RR.
33 _____________
34

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35 Scope, object and related standards
36 Replace the existing footnote 1 with the following text:
37 The general standard is IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/
38 AMD2:2020, Medical electrical equipment – Part 1: General requirements for basic safety and essential
39 performance.
40 201.1.3 * Collateral standards
41 Add asterisk (*) at the beginning of the subclause title
42 Replace, in the existing second paragraph, “IEC 60601-1-2:2014 applies” with: “IEC 60601-1-2:2014
43 and IEC 60601-1-2:2014/AMD1:2020 apply”.
44 Add, after the existing second paragraph the following paragraph:
45 If a BABY CONTROLLED RADIANT WARMER is based on a temperature measurement which is substantially
46 influenced by the INFANT'S core or body temperature IEC 60601-1-10:2007, IEC 6060-1-
47 10:2007/AMD1:2013 and IEC 60601-1-10:2007/AMD2:2020 apply. Examples for temperature
48 measurements stipulating applicability of IEC 60601-1-10:2007, IEC 6060-1-10:2007/AMD1:2013 and
49 IEC 60601-1-10:2007/AMD2:2020 are provided in Annex AA.
50 201.1.4 * Particular standards
51 Replace, in the existing third paragraph, “IEC 60601-1 and IEC 60601-1:2005/AMD1:2012” with
52 ”IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020”.
53 Add, after the existing last paragraph, the following paragraph:
54 If an INFANT RADIANT WARMER is supplied with dedicated physiological monitoring, then IEC
55 80601-2-49 [34] applies. Measured parameters related to the inherent function of an INFANT
56 RADIANT WARMER i.e. the SKIN TEMPERATURE, are not considered to be a physiological monitoring
57 unit as per IEC 80601-2-49 [34].
58 201.2 Normative references
59 Replace the existing references to IEC 60601-1 and IEC 60601-1-2 with the following new references:
60 IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety
61 and essential performance
62 Amendment 1:2012
63 Amendment 2:2020
64 IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic
65 safety and essential performance – Collateral standard: Electromagnetic disturbances –
66 Requirements and tests
67 Amendment 1:2020
68 201.3 Terms and definitions
69 Replace, in the existing first paragraph, “IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012” with
70 “IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020”.
71 201.3.203
72 INFANT
73 Add, after the existing first paragraph, the following note:
74 Note 1 to entry: INFANT includes premature/pre-born baby and neonate baby/newborn baby.
75
76 Replace the existing Table 201.101 with:

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77 Table 201.101 – Additional ESSENTIAL PERFORMANCE requirements
Requirement Subclause
ESSENTIAL PERFORMANCE requirement 1 201.12.1.103, or
generation of a visual

and audible alarm in
compliance with
201.15.4.2.1
78
79 201.7.9.2.2 Warning and safety notices
80 Replace the existing list item q) with:
81 q) a statement that the INF
...