EN IEC 60601-2-21:2021/A1:2023

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

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

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 (IEC 60601-2-21:2020/AMD1:2023)

General Information

• Status: Published
• Publication Date: 14-Dec-2023
• 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: 6060 - Document made available - Publishing
• Start Date: 15-Dec-2023
• Due Date: 30-Jun-2022
• Completion Date: 15-Dec-2023
• Ref Project: SIST EN IEC 60601-2-21:2021/A1:2024 - Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers (IEC 60601-2-21:2020/AMD1:2023)

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

Overview

The EN IEC 60601-2-21:2021/A1:2023 standard establishes particular requirements for the basic safety and essential performance of infant radiant warmers-medical electrical equipment designed to provide controlled thermal care to newborns, including premature and neonate babies. This amendment updates and refines the existing EN IEC 60601-2-21:2021 standard, ensuring compliance with the latest international safety directives and technical advancements.

Published and approved by CENELEC in December 2023, this standard aligns with IEC 60601 series standards concerning medical electrical equipment, with specific focus on the safe operation, electromagnetic compatibility, alarm systems, and temperature control relevant to infant radiant warmers.

Key Topics

• Safety and Performance Requirements
  The standard defines essential safety parameters and performance criteria that infant radiant warmers must meet. This includes reliable heating outputs, robust alarm systems with specified audible sound levels (minimum 57 dBA for high and medium priority alarms), and safety notices related to operational modes.

• Temperature Measurement and Control
  Specific guidelines emphasize the difference between infant skin temperature and core temperature. As newborns, particularly premature infants, cannot self-regulate temperature effectively, the skin temperature primarily reflects the environment rather than the infant’s core physiology. The standard clarifies that BABY CONTROLLED RADIANT WARMERS relying on skin temperature do not constitute physiological closed-loop controllers.

• Electromagnetic Compatibility (EMC)
  EN IEC 60601-2-21:2021/A1:2023 directs compliance with IEC 60601-1-2:2014 and its amendments concerning electromagnetic disturbances, specifying tests to guarantee safe operation of infant radiant warmers in medical environments. Notably, these devices are excluded from home healthcare EMC requirements.

• Alarm and Safety Notices
  The standard mandates alarm thresholds, response procedures, and clear manufacturer disclosures about prewarm mode operation-highlighting the necessity of manual mode activation when an infant is placed in the warmer to ensure patient safety.

• Normative References and Related Standards
  This amendment references crucial foundational standards such as IEC 60601-1 (general safety) and IEC 60601-1-10 (particular requirements for physiological closed-loop controllers), ensuring the harmonization of infant radiant warmer regulations with broader medical device safety frameworks.

Applications

The EN IEC 60601-2-21:2021/A1:2023 standard applies primarily to manufacturers, testing bodies, and healthcare providers involved with infant radiant warmers, including:

• Neonatal Intensive Care Units (NICUs) where precise thermal maintenance is critical for preterm and newborn infants’ survival and recovery.
• Medical Device Manufacturers designing and producing infant radiant warmers to meet the international safety and performance criteria.
• Regulatory Authorities and Certification Bodies tasked with evaluating conformity to updated medical electrical equipment standards.
• Clinical Engineers and Biomedical Technicians who operate and maintain infant radiant warmers to ensure compliance with safety alarms, temperature control, and electromagnetic safety.

By following this standard, stakeholders ensure that infant radiant warmers provide safe, effective, and reliable thermal protection essential to neonatal care.

Related Standards

• IEC 60601-1:2005 and Amendments (A1:2012, A2:2020) – General requirements for basic safety and essential performance of medical electrical equipment.
• IEC 60601-1-2:2014 and Amendment 1 (2020) – Collateral standard on electromagnetic disturbances requirements and testing.
• IEC 60601-1-10:2007 and Amendments – Application of physiological closed-loop controllers in medical electrical equipment.
• IEC 80601-2-49 – Particular requirements for the safety and essential performance of physiological monitoring equipment when integrated with infant radiant warmers.

Keywords

Infant radiant warmers, medical electrical equipment, EN IEC 60601-2-21, CENELEC, neonatal care standards, safety requirements, essential performance, electromagnetic compatibility, medical device alarms, temperature control, neonatal intensive care, physiological closed-loop controllers, medical device certification.

Standards Content (Sample)

SLOVENSKI STANDARD
01-februar-2024
Medicinska električna oprema - 2-21. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti otroških sevalnih ogrevalnikov - Dopolnilo A1 (IEC 60601-2-
21:2020/AMD1:2023)
Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and
essential performance of infant radiant warmers (IEC 60601-2-21:2020/AMD1:2023)
Medizinische elektrische Geräte - Teil 2-21: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Säuglingswärmestrahlern (IEC
60601-2-21:2020/AMD1:2023)
Amendement 1 - Appareils électromédicaux - Partie 2-21: Exigences particulières pour la
sécurité de base et les performances essentielles des incubateurs radiants pour
nouveau-nés (IEC 60601-2-21:2020/AMD1:2023)
Ta slovenski standard je istoveten z: EN IEC 60601-2-21:2021/A1:2023
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN IEC 60601-2-21:2021/A1

NORME EUROPÉENNE
EUROPÄISCHE NORM December 2023
ICS 11.040.10
English Version
Medical electrical equipment - Part 2-21: Particular requirements
for the basic safety and essential performance of infant radiant
warmers
(IEC 60601-2-21:2020/AMD1:2023)
Appareils électromédicaux - Partie 2-21: Exigences Medizinische elektrische Geräte - Teil 2-21: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des incubateurs radiants pour nouveau-nés wesentlichen Leistungsmerkmale von
(IEC 60601-2-21:2020/AMD1:2023) Säuglingswärmestrahlern
(IEC 60601-2-21:2020/AMD1:2023)
This amendment A1 modifies the European Standard EN IEC 60601-2-21:2021; it was approved by CENELEC on 2023-12-08. 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 60601-2-21:2021/A1:2023 E

European foreword
The text of document 62D/2077/FDIS, future IEC 60601-2-21/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 60601-2-21:2021/A1:2023.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2024-09-08
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2026-12-08
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 60601-2-21:2020/AMD1:2023 was approved by CENELEC
as a European Standard without any modification.
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments)
applies.
NOTE 1 Where an International Publication has been modified by common modifications, indicated by (mod), the
relevant EN/HD applies.
NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available
here: www.cencenelec.eu.
The Annex ZA of EN IEC 60601-2-21 applies with the following changes:
Publication Year Title EN/HD Year

Replace the existing references to IEC 60601-1 and IEC 60601-1-2 with the following new references:

IEC 60601-1 2005 Medical electrical equipment - Part 1: EN 60601-1 2006
General requirements for basic safety and
essential performance
- -  + corrigendum Mar. 2010
+ A1 2012  + A1 2013
- -  + A12 2014
+ A2 2020  + A2 2021
IEC 60601-1-2 2014 Medical electrical equipment - Part 1-2: EN 60601-1-2 2015
General requirements for basic safety and
essential performance - Collateral
Standard: Electromagnetic disturbances -
Requirements and tests
+ A1 2020  + A1 2021
IEC 60601-2-21 ®
Edition 3.0 2023-11
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
A MENDMENT 1
AM ENDEMENT 1
Medical electrical equipment –

Part 2-21: Particular requirements for the basic safety and essential performance

of infant radiant warmers
Appareils électromédicaux –
Partie 2-21: Exigences particulières pour la sécurité de base et les performances

essentielles des incubateurs radiants pour nouveau-nés

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.10  ISBN 978-2-8322-7702-7

– 2 – IEC 60601-2-21:2020/AMD1:2023
© IEC 2023
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-21: Particular requirements for the basic safety
and essential performance of infant radiant warmers

AMENDMENT 1
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international
co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and
in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports,
Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”). Their
preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with
may participate in this preparatory work. International, governmental and non-governmental organizations liaising
with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for
Standardization (ISO) in accordance with conditions determined by agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence between
any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) IEC draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). IEC takes no position concerning the evidence, validity or applicability of any claimed patent rights in
respect thereof. As of the date of publication of this document, IEC had not received notice of (a) patent(s), which
may be required to implement this document. However, implementers are cautioned that this may not represent
the latest information, which may be obtained from the patent database available at https://patents.iec.ch. IEC
shall not be held responsible for identifying any or all such patent rights.
Amendment 1 to IEC 60601-2-21:2020 has been prepared by subcommittee 62D: Particular
medical equipment, software, and systems, of IEC technical committee 62: Medical equipment,
software, and systems.
IEC 60601-2-21:2020/AMD1:2023 – 3 –
© IEC 2023
The text of this Amendment is based on the following documents:
Draft Report on voting
62D/2077/FDIS 62D/2095/RVD
Full information on the voting for its approval can be found in the report on voting indicated in
the above table.
The language used for the development of this Amendment is English.
This document was drafted in accordance with ISO/IEC Directives, Part 2, and developed in
accordance with ISO/IEC Directives, Part 1 and ISO/IEC Directives, IEC Supplement, available
at www.iec.ch/members_experts/refdocs. The main document types developed by IEC are
described in greater detail at www.iec.ch/publications/.
The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under webstore.iec.ch in the data related to the
specific document. At this date, the document will be
• reconfirmed,
• withdrawn, or
• revised.
NOTE The attention of users of this document is drawn to the fact that equipment manufacturers and testing
organizations may need a transitional period following publication of a new, amended or revised IEC or
ISO publication in which to make products in accordance with the new requirements and to equip themselves for
conducting new or revised tests. It is the recommendation of the committee that
...