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

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

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

General Information

• Status: Published
• Publication Date: 02-Nov-2023
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: SC 62D - Particular medical equipment, software, and systems
• Drafting Committee: MT 21 - TC 62/SC 62D/MT 21
• Current Stage: PPUB - Publication issued
• Start Date: 03-Nov-2023
• Completion Date: 24-Nov-2023

Relations

• Amends: IEC 60601-2-21:2020 - Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
• Effective Date: 05-Sep-2023

Standards Content (Sample)

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

IEC 60601-2-21:2020-09/AMD1:2023-11 (en-fr)

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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
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6) All users should ensure that they have the latest edition of this publication.
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expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
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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 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 the content of this publication be
adopted for mandatory implementation nationally not earlier than 3 years from the date of publication.

___________
INTRODUCTION to Amendment 1
At the October 2019 meeting of IEC SC 62D in Shanghai, China, the subcommittee discussed
the need for administrative/technical changes to most 62D standards after completion of the
amendment projects within the IEC 60601-1 series. Those projects were all completed and the
amendments published in 2020.
The full list of IEC SC 62D documents that will be amended or revised can be found within the
IEC document 62D/1792/DC. The results and comments on the DC can be found within
62D/1808/INF. The review report for this amendment is 62D/1816/RR.

___________
– 4 – IEC 60601-2-21:2020/AMD1:2023
© IEC 2023
201.1 Scope, object and related standards
Replace the existing footnote 1 with the following new footnote:
The general standard is IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601‑1:2005/AMD2:2020, Medical electrical equipment – Part 1: General requirements
for basic safety and essential performance.
201.1.3 Collateral standards
Add an asterisk (*) at the beginning of the subclause title.
Replace, in the existing second paragraph, "IEC 60601-1-2:2014 applies" with:
"IEC 60601‑1‑2:2014 and IEC 60601-1-2:2014/AMD1:2020 apply".
Add, after the existing second paragraph, the following new paragraph:
If a BABY CONTROLLED RADIANT WARMER is based on a temperature measurement which is
substantially influenced by the INFANT'S core or body temperature IEC 60601-1-10:2007,
IEC 60601-1-10:2007/AMD1:2013 and IEC 60601-1-10:2007/AMD2:2020 apply. Examples for
temperature measurements stipulating applicability of IEC 60601-1-10:2007,
IEC 60601‑1‑10:2007/AMD1:2013 and IEC 60601-1-10:2007/AMD2:2020 are provided in
Annex AA.
201.1.4 Particular standards
Replace, in the existing third paragraph, "IEC 60601-1 and IEC 60601-1:2005/AMD1:2012" with
"IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020".
Add, after the existing last paragraph, the following new paragraph:
If an INFANT RADIANT WARMER is supplied with dedicated physiological monitoring, then
IEC 80601-2-49 [34] applies. Measured parameters related to the inherent function of an INFANT
RADIANT WARMER i.e. the SKIN TEMPERATURE, are not considered to be a physiological monitoring
unit as per IEC 80601-2-49 [34].
201.2 Normative references
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: General requirements for basic safety
and essential performance
IEC 60601-1:2005/AMD1:2012
IEC 60601-1:2005/AMD2:2020
IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral standard: Electromagnetic disturbances –
Requirements and tests
IEC 60601-1-2:2014/AMD1:2020
201.3 Terms and definitions
Replace, in the existing first paragraph, "IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012"
with "IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020".

© IEC 2023
201.3.203
INFANT
Add, after the existing definition, the following new note to entry:
Note 1 to entry: INFANT includes premature/pre-born baby and neonate baby/newborn baby.
Table 201.101 – Additional ESSENTIAL PERFORMANCE requirements
Replace the existing table with the following new table:
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
201.7.9.2.2 Warning and safety notices
Replace the existing item q) with the following new item:
q) a statement that the INFANT RADIANT WARMER does not adjust for PATIENT temperature in
PREWARM MODE and that the mode shall be changed to MANUAL MODE or BABY CONTROLLED
RADIANT WARMER (baby mode) immediately when the PATIENT is placed on the device. The
MANUFACTURER shall disclose the level of heat in mW/cm or in % of the maximum heater
output when operating in PREWARM MODE.
*
Audible alarms sound level
201.9.6.2.1.101
Replace the entire text with the following new text:
The audible HIGH PRIORITY and MEDIUM PRIORITY ALARM SIGNALS shall have a sound level of at
least 57 dBA. The auditory alarm may be adjusted by the OPERATOR to a minimum lower level
of 42 dBA.
Compliance is checked by inspection and measurement of the audible alarm level as specified
in 6.3.3.2 of IEC 60601-1-8:2006, IEC 60601-1-8:2006/AMD1:2012 and
IEC 60601‑1‑8:2006/AMD2:2020.
202 Electromagnetic disturbances – Requirements and tests
Add an asterisk (*) at the beginning of the clause title.
Replace the entire text, including 202.8.9, with the following new text:
IEC 60601-1-2:2014 and IEC 60601-1-2:2014/AMD1:2020 apply.
NOTE An INFANT RADIANT WARMER is not considered to be used in a HOME HEALTHCARE ENVIRONMENT.

– 6 – IEC 60601-2-21:2020/AMD1:2023
© IEC 2023
AA.2 Particular guidance
Subclause 201.1.1 – Scope
Add, after the existing first paragraph, the following new paragraph:
See also the rationale for Subclause 201.1.3.
Add, before the existing subclause 201.3.207, the following new subclause:
Subclause 201.1.3 – Collateral standards
Self-thermoregulation of newborns, especially of preterm newborns, is immature and cannot
compensate for thermal changes in their direct vicinity. Hence, the skin temperature of such
infants is rather determined by the thermal conditions in the infant's vicinity than by the infant's
physiology. Consequently, the skin temperature is only a very weak surrogate for the (clinically
relevant) core or body temperature while it is a strong surrogate for the incoming irradiance.
Moreover, there are some dedicated physiological situations such as fever or shock that
additionally may impair the weak correlation between skin and core temperature. Therefore,
such a closed loop controller cannot fulfill the requirements for a reliable physiological closed
BABY CONTROLLED RADIANT WARMER is not considered to be a
loop controller. Henceforth, the
physiological closed loop controller.
Provided, however, in future applications the temperature control of an INFANT RADIANT WARMER
is based on temperature measurements being substantially influenced by the core or body
temperature of the INFANT the corresponding control is considered to be a physiological closed
loop controller. Examples for such temperature measurement are core or body temperature
sensors like rectal probes, oral probes or probes measuring the core or body temperature via
heat fluxes e.g. on the forehead. Axillary sensors may also be considered substantially
influenced by the core or body temperature of the INFANT and henceforth the corresponding
control is considered to be a physiological closed loop controller.
Subclause 201.9.6.2.1.101 – Audible alarms sound level
Replace the last three paragraphs with:
Previous editions of this particular standard specified that the alarm sound volume shall be
measured in a reflecting room, as such rooms represent a more realistic acoustic situation in
an intensive care nursery. Reflecting rooms, however, are not well defined and deliver less
reproducible values due to their variable size and geometry. The experts henceforth decided to
specify measurements subsequently to be performed in non-reflecting or semi-anechoic rooms.
For transfer of the alarm sound volume limits a reflecting room with typical acoustical
characteristics was assumed.
For legacy devices it is still permissible to provide objective evidence of compliance with the
old test:
Compliance is checked with the microphone of a sound level meter complying with the
requirements of IEC 61672-1 placed 1,5 m above the floor and 3 m from the front of the infant
radiant warmer.
Compliance of the maximum level is checked with each alarm sound means activated, the sound
level being measured at a point 5 cm above the centre of the MATTRESS.
Ensure that the background sound pressure level is at least 10 dBA below the measured levels.

© IEC 2023
In this case auditory ALARM SIGNALS shall have a sound level of at least 65 dBA at a distance of
3 m perpendicular to the front of the INFANT RADIANT WARMER in a reflecting room. The auditory
alarm may be adjusted by the OPERATOR to a minimum lower level of 50 dBA.
Add, after the existing subclause 201.15.4.1.101, the following new clause:
Clause 202 – Electromagnetic disturbances – Requirements and tests
Thermal processes in warming therapy devices are mainly slow and the SKIN TEMPERATURE or
the temperature of the TEST DEVICES can be too slow to indicate disturbances that are induced
by the EMC IMMUNITY tests in adequate time or at all. Hence, it is recommended to monitor not
only the SKIN TEMPERATURE but also other technical signals of the device such as sensor or
actuator signals in the tests. Those signals can indicate the consequences of electromagnetic
emission on the device during immunity tests much faster.
As an example, during the fast transient/burst IMMUNITY tests the heating actuator of the device
can be affected by the disturbance immediately while temperature of a TEST DEVICE as being
dampened by heat transfer processes can react only with a delay.

– 8 – IEC 60601-2-21:2020/AMD1:2023
© IEC 2023
Bibliography
Replace the existing references [31] and [32] with the following new references:
[31] IEC 60601-1-10:2007, Medical electrical equipment – Part 1-10: General requirements
for basic safety and essential performance – Collateral Standard: Requirements for the
development of physiologic closed-loop controllers
IEC 60601-1-10:2007/AMD1:2013
IEC 60601-1-10:2007/AMD2:2020
[32] IEC 60601-1-8:2006, Medical electrical equipment – Part 1-8: General requirements for
basic safety and essential performance – Collateral Standard: General requirements,
tests and guidance for alarm systems in medical electrical equipment and medical
electrical systems
IEC 60601-1-8:2006/AMD1:2012
IEC 60601-1-8:2006/AMD2:2020
Add the following new reference to the end of the Bibliography:
[34] IEC 80601-2-49:2018, Medical electrical equipment – Part 2-49: Particular requirements
for the basic safety and essential performance of multifunction patient monitoring
equipment
© IEC 2023
Index of defined terms used in this particular standard
Add the following new terms:
ELECTROMAGNETIC COMPATIBILITY (EMC) .IEC 60601-1-2:2014, 3.2
HIGH PRIORITY . IEC 60601-1-8:2006, IEC 60601-1-8:2006/AMD1:2012
...............................................
...