IEC 60601-2-21:2009/AMD1:2016

IEC 60601-2-21 ®
Edition 2.0 2016-04
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
AM ENDMENT 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 60601-2-21:2009-02/AMD1:2016-04(en-fr)

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IEC 60601-2-21 ®
Edition 2.0 2016-04
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
AM ENDMENT 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 978-2-8322-3344-3

– 2 – IEC 60601-2-21:2009/AMD1:2016
© IEC 2016
FOREWORD
This amendment has been prepared by subcommittee 62D: Electromedical equipment of IEC
technical committee 62: Electrical equipment in medical practice.
The text of this amendment is based on the following documents:
FDIS Report on voting
62D/1326/FDIS 62D/1347/RVD
Full information on the voting for the approval of this amendment can be found in the report
on voting indicated in the above table.
The committee has decided that the contents of this amendment and the base publication will
remain unchanged until the stability date indicated on the IEC website under
"http://webstore.iec.ch" in the data related to the specific publication. At this date, the
publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
_____________
INTRODUCTION
Replace, in the second paragraph, “IEC 60601-1:2005” by “IEC 60601-1”.
201.1 Scope, object and related standards
Replace, in footnote 1), “IEC 60601-1:2005” by “IEC 60601-1”.
201.1.3 * Collateral standards
Delete the asterisk (*) from the title.
Replace the second paragraph by the following text:
IEC 60601-1-2 applies as modified in Clause 202. IEC 60601-1-3 and IEC 60601-1-10 do not
apply. All other published collateral standards in the IEC 60601-1 series apply as published.
201.1.4 Particular standards
Add an asterisk at the beginning of the title, as follows:
201.1.4 * Particular standards
Add the following paragraph at the end of this subclause:

© IEC 2016
SKIN TEMPERATURE SENSORS which are applied to operate a BABY CONTROLLED RADIANT WARMER
including the displayed value are considered to be not a CLINICAL THERMOMETER in the sense
of the particular standard ISO 80601-2-56.
201.2 Normative references
Replace “IEC 60601-1-2:2007” by “IEC 60601-1-2”.
Remove the reference to IEC 60601-1-10:2007.
201.3 Terms and definitions
201.3.201
BABY CONTROLLED RADIANT WARMER
Remove the note at the end of the entry.
202 Electromagnetic compatibility – Requirements and tests
Replace, in the first paragraph, “IEC 60601-1-2:2007” by “IEC 60601-1-2”.
202.6.2.3 Radiated RF electromagnetic fields
Replace the number, title and entire text by the following new subclause number, title and
text:
202.8.9 IMMUNITY TEST LEVELS
Addition:
For radiated radio-frequency electromagnetic fields, the INFANT RADIANT WARMER and/or
system shall
– continue to perform its intended function as specified by the MANUFACTURER at a level up
to 3 V/m for the frequency range stated in the collateral standard for EMC.
NOTE An INFANT RADIANT WARMER is not considered to be used in a HOME HEALTHCARE ENVIRONMENT.
210 Process requirements for the development of physiologic closed-loop
controllers
Delete the entire Clause 210.
– 4 – IEC 60601-2-21:2009/AMD1:2016
© IEC 2016
Annex AA
(informative)
Particular guidance and rationale

Add, immediately after the annex title, the following new text and figure:
AA.1 Requirements and the safety concept of this standard
Compliance with the minimum safety requirements specified in this particular standard is
predominantly checked by measurement of physical quantities such as the temperature. In
most cases the spatial location of the measuring site or the temporal development of the
quantity is of interest. Therefore, the expert group of this standard considered it helpful to
provide a synopsis of the requirements of this standard. Hence, Figure AA.1 illustrates the
requirements and their schematic measuring sites or expected temporal development. The
requirements as given by their clauses are set in brackets.

© IEC 2016
±2 °C
(201.12.1.102)
C D
M
A B
Range of CONTROL
SKIN TEMPERATURE
TEMPERATURE
Display
SENSOR
≤ 36 °C to ≤ 38 °C
(201.15.4.2.2.101)
36,3 °C ±0,3 °C
(201.12.1.101)
Setting of
CONTROL
TEMPERATURE
±0,5 °C
(201.12.1.103)
Temperature alarm
(201.15.4.2.1)
±1 °C
(201.15.4.2.1,
Overtemperature alarm
Test 2 addition to item b)
40 °C
Interruption of power supply alarm (201.12.3.101)
(201.11.1.2.2)
Maximum surface temperature (normal condition)
40 °C (for metals)
43 °C (for other materials)
Maximum surface temperature (single fault condition)
42 °C (for metals)
45 °C (for other materials)
Every 15 min alarm in Manual Mode for irradiance level (201.12.2.103)
> 10 mW/cm
IEC
NOTE Number in brackets indicate the relevant subclauses
Figure AA.1 – Illustration of the main requirements of this standard
AA.2 Particular guidance
Subclause 201.1.3 – Collateral standards
Delete the title and entire text.
Add the following new text:
Subclause 201.1.4 – Particular standards
It is the primary purpose of a BABY CONTROLLED RADIANT WARMER to maintain the temperature
as measured by a SKIN TEMPERATURE SENSOR. Hence, SKIN TEMPERATURE SENSORS which are

– 6 – IEC 60601-2-21:2009/AMD1:2016
© IEC 2016
applied to operate a BABY CONTROLLED RADIANT WARMER including the displayed value are
considered to be not a CLINICAL THERMOMETER in the sense of the particular standard
ISO 80601-2-56 unless they are specifically extended to measure the body temperature.
The term body temperature is used for all other temperatures of the human body except SKIN
TEMPERATURE as defined in IEC 60601-2-19.
Subclause 201.9.6.2.1.101 – Audible alarm sound level
Add, after the existing text, the following new text:
Reflecting rooms represent the acoustic situation in an intensive care nursery more
realistically than non-reflecting or semi-anechoic rooms that are very often used for sound
pressure measurements. However, reflecting rooms are not well defined and deliver less
reproducible values due to their variable size and geometry. The more idealized reverberation
chambers deliver very reproducible results but are sometimes difficult to get for tests.
Henceforth, the test can alternatively be performed in a semi-anechoic chamber that is very
often used to measure operating sound pressure level. Using a semi-anechoic chamber for
the measurements, the thresholds a
...