IEC 60601-2-19:2020/AMD1:2023

IEC 60601-2-19 ®
Edition 3.0 2023-11
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
AMENDMENT 1
AMENDEMENT 1
Medical electrical equipment –
Part 2-19: Particular requirements for the basic safety and essential performance
of infant incubators
Appareils électromédicaux –
Partie 2-19: Exigences particulières pour la sécurité de base et les performances
essentielles des incubateurs pour nouveau-nés
IEC 60601-2-19:2020-09/AMD1:2023-11(en-fr)

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IEC 60601-2-19 ®
Edition 3.0 2023-11
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
AMENDMENT 1
AMENDEMENT 1
Medical electrical equipment –

Part 2-19: Particular requirements for the basic safety and essential performance

of infant incubators
Appareils électromédicaux –
Partie 2-19: Exigences particulières pour la sécurité de base et les performances

essentielles des incubateurs pour nouveau-nés

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.10  ISBN 978-2-8322-7660-0

– 2 – IEC 60601-2-19:2020/AMD1:2023
© IEC 2023
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-19: Particular requirements for the basic safety
and essential performance of infant incubators

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
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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
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8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
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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 60601-2-19:2020 has been prepared by subcommittee 62D: Particular
medical equipment, software, and systems, of IEC technical committee 62: Medical equipment,
software, and systems.
The text of this Amendment is based on the following documents:
Draft Report on voting
62D/2067/FDIS 62D/2092/RVD
Full information on the voting for its approval can be found in the report on voting indicated in
the above table.
© IEC 2023
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/1818/RR.

___________
201.1 Scope, object and related standards
Replace the existing footnote 1 with the following text:
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.

– 4 – IEC 60601-2-19:2020/AMD1:2023
© IEC 2023
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 INCUBATOR is based on a temperature measurement that 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 paragraph:
IEC 80601‑2‑49 [15] applies to an INFANT INCUBATOR supplied with dedicated physiological
monitoring. Measured parameters related to the inherent function of an INFANT INCUBATOR i.e.
the SKIN TEMPERATURE, are not considered to be a physiological monitoring unit as per
IEC 80601‑2‑49 [15].
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
Add the following new references under “Addition”:
ISO 10993-1:2018, Biological evaluation of medical devices – Part 1: Evaluation and testing
within a risk management process
ISO 18562-1:2017, Biocompatibility evaluation of breathing gas pathways in healthcare
applications – Part 1: Evaluation and testing within a risk management process

© IEC 2023
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".
201.3.208
INFANT
Add, after the existing definition, the following note to entry:
Note 1 to entry: INFANT includes premature/pre‑born baby and neonate baby/newborn baby.
Add, after the existing definition 201.3.212, the following new term and definition:
201.3.213
LOW FREQUENCY ELECTROMAGNETIC FIELDS
ELECTROMAGNETIC FIELDS with a frequency below 400 kHz
201.7.9.2.9 Operating instructions
Add, after the last item of the existing list, the following new text:
e) * a specification of the LOW FREQUENCY ELECTROMAGNETIC FIELD strength of the INFANT
INCUBATOR measured as specified below.
The LOW FREQUENCY ELECTROMAGNETIC FIELD strength of the INFANT INCUBATOR is measured
according to the following procedure:
Calibrated sensors for the electromagnetic field strength in the range of 10 Hz to 400 kHz shall
be placed at the point M (see Figure 201.102) in a plane parallel to and 5 cm above the
MATTRESS surface.
The INFANT INCUBATOR is operated as an AIR CONTROLLED INCUBATOR at a CONTROL TEMPERATURE
of 36 °C until STEADY TEMPERATURE CONDITION is reached. The LOW FREQUENCY
ELECTROMAGNETIC FIELD strength components in the vertical (z) and two perpendicular directions
(x and y) are then measured as a temporal average value for ΔT = 10 min for the point M. The
scalar product H shall then be calculated as
M
H HHH++
M Mx M y Mz
from the time‑averaged components HH, , H
Mx M y Mz
∆T
'
H H dt with n x, y, z
( )
Mn Mn
∫
t=0
∆T
Given the sensor already provides a scalar value of the magnetic field strength, calculation of
the scalar product is skipped. The scalar product H shall be disclosed in the instructions for
M
use.
==
=
– 6 – IEC 60601-2-19:2020/AMD1:2023
© IEC 2023
201.9.6.2.1.101 * Sound level within the COMPARTMENT
Replace the existing first paragraph with the following new paragraph:
In NORMAL USE, the sound level within the COMPARTMENT shall not exceed a sound pressure level
of L = 55 dB A and L = 75 dB A except as specified in 201.9.6.2.1.103.
eq,1h F,max
201.9.6.2.1.102 * Audible alarm sound level
Replace the existing text of this subclause with the following new text:
The auditory 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. For this test, the INFANT INCUBATOR shall be operated at a
CONTROL TEMPERATURE of 36 °C and at a maximum humidity.
Add, at the end of the existing subclause 201.11.6.6, the following new subclause:
201.11.7 *Biocompatibility of ME EQUIPMENT and ME SYSTEMS
Addition to the first paragraph:
aa) The COMPARTMENT of an INFANT INCUBATOR shall be evaluated for biocompatibility
according to ISO 18562‑1:2017.
bb) Those parts of COMPARTMENT that are in direct contact with the INFANT’S skin shall be
evaluated for biocompatibility according to ISO 10993‑1:2018.
INCUBATOR TEMPERATURE indication
201.12.1.105 * Accuracy of
Replace the existing third paragraph with the following new paragraph:
The AVERAGE TEMPERATURE device reading shall not differ from the AVERAGE INCUBATOR
TEMPERATURE, measured by a standard thermometer, by more than 0,9 °C, less the standard
thermometer error. The standard thermometer shall be accurate within ±0,15 °C. It shall have
a measuring range of at least 20 °C to 40 °C. If the temperature sensitive component of any
device is located at a point where the air temperature consistently differs from the INCUBATOR
TEMPERATURE, the device may be specially calibrated with an offset in order to meet the above
requirements. However, in this case, full details of the special calibration shall be specified in
the ACCOMPANYING DOCUMENTS.
201.15.4.2.1 Application
Replace the existing first and second paragraph of item aa) with the following new item:
AIR CONTROLLED INCUBATOR shall be equipped with a THERMAL CUT‑OUT that operates
aa) * An
independently of any THERMOSTAT. It shall be so arranged that the heater is disconnected,
and an auditory and visual warning is given at an INCUBATOR TEMPERATURE that does not
exceed 40 °C.
Add an asterisk in the first paragraph of item bb).

© IEC 2023
202 Electromagnetic disturbances – Requirements and tests
Add an asterisk (*) at the beginning of the clause title, and replace the existing text of this
clause, including 202.8.9, with:
IEC 60601‑1‑2:2014 and IEC 60601‑1‑2:2014/AMD1:2020 apply.
NOTE An INFANT INCUBATOR is not considered to be used in a HOME HEALTHCARE ENVIRONMENT.
AA.2 Rationale for particular clauses and subclauses
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 rationale of Subclause 201.4.3, the following new rationale:
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 surrounding air
temperature. 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 loop controller. Henceforth, the BABY CONTROLLED INCUBATOR is not
considered to be a physiological closed loop controller.
Provided, however, in future applications the temperature control of an INFANT INCUBATOR 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 201.4.3 – ESSENTIAL PERFORMANCE
Replace, in the existing second and third paragraph, "warmer" with "INFANT RADIANT WARMER"
(2 occurrences).
– 8 – IEC 60601-2-19:2020/AMD1:2023
© IEC 2023
Subclause 201.7.9.2.9 – Operating instructions
Add, after the existing list item d), the following new text:
e) LOW FREQUENCY ELECTROMAGNETIC FIELDS can have significant effect on the well‑being and
the development of an INFANT in an INFANT INCUBATOR. Studies by Bellieni et al. suggest that
LOW FREQUENCY ELECTROMAGNETIC FIELDS exceeding a certain level can impair the heart
frequency variability [16] and melatonin production [17] of INFANTS. The studies reveal that
heart frequency variability is noticeably decreased for a field strength higher than 800 nT
‑7 ‑3
(8 × 10 Tesla = 8 × 10 Gauss). A sharp threshold where impairment starts, however,
cannot be derived from the results of the study. In order to give users of INFANT INCUBATORS
‑6
a guideline the experts of the working group recommend a value of 1 µT (1 × 10 Tesla =
‑2
10 Gauss) as a threshold for an average LOW FREQUENCY ELECTROMAGNETIC FIELD strength
that should not be exceeded for a longer period of time.
A measuring height of 5 cm above the MATTRESS surface instead of 10 cm above it was
chosen assuming that LOW FREQUENCY ELECTROMAGNETIC FIELDS rather affects the INFANT’S
body while INCUBATOR TEMPERATURE (201.12.1.102, 201.12.1.104) or air velocity
(201.12.1.111) affect the INFANT’S (upper) surface.
Subclause 201.9.6.2.1.102 – Audible alarm sound level
Replace the existing last three paragraphs with the following new text:
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 by inspection and measurement of the audible alarm level using a sound
level meter, as required in subclause 201.9.6.2.1.101 of this particular standard, placed 1,5 m
above the floor and 3 m from the control unit. For this test, the INFANT INCUBATOR shall be
operated at a CONTROL TEMPERATURE of 36 °C and at a maximum humidity. The background
sound level measured shall be at least 10 dBA below that which is measured during the test.
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 control unit in a reflecting room. The auditory alarm may
be adjusted by the OPERATOR to a minimum lower level of 50 dBA.

© IEC 2023
Add, after the rationale of Subclause 201.11.6.6, the following new rationale:
Subclause 201.11.7 – Biocompatibility of ME EQUIPMENT and ME SYSTEMS
Within an INFANT INCUBATOR the parts forming the COMPARTMENT provide a plurality of functions.
Besides the main function of warming the INFANT there are several mainly mechanical functions.
Among them are safely bearing the INFANT on a MATTRESS that can be tilted and drawn out of
INFANT INCUBATOR. Very often a weighing scale is integrated. In order to provide such
the
mechanical functions, the parts forming the COMPARTMENT need to be mechanically robust.
Finally, these parts need to be easily reprocessed. Meeting these requirements restricts the
selection of possible materials considerably. As mentioned in ISO 18562‑1, during the selection
of materials the first consideration should be fitness for purpose, which among others,
comprises their thermal and mechanical properties. In view of the above mentioned limited
number of possible materials the RISK MANAGEMENT process may have to conduct a RISK benefit
analysis that outweighs the RISK posed by a material in relation to the benefit provided by
warming therapy and the related functions.
Following the above a RISK benefit ratio that describes an extension of TOLERABLE EXPOSURE
levels in favor of the benefit of warming therapy may be considered. Based on experiences in
the design and manufacture of INFANT INCUBATORS the experts consider a RISK benefit ratio of
up to 10 as adequate for the application in INFANT INCUBATORS. It must, however, be stated that
only very few experiences exist that show to what extent potentially harmful substances are
emitted by materials usually used in INFANT INCUBATOR COMPARTMENTS into the breathing gas.
The test conditions specified reflect a prolonged exposure time and worst case conditions that
can be expected for an INFANT INCUBATOR.
Subclause 201.15.4.2.1 – Application
Replace the existing text of list item aa) with the following new text:
aa) Tracheal inspired air with temperatures above 40 °C appear to increase the work of
breathing and the incidence of laryngeal spasm. The experts consider 40 °C an
appropriate temperature limit for the air an infant breathes.
An audible alarm for the event of failure of the primary THERMOSTAT and subsequent
rise of INCUBATOR TEMPERATURE, is intended to alert personnel to the danger of
over‑heating the INFANT.
aa), bb) If the thermal cut‑out shares resources with the thermostat, such as both being partly
implemented in software, the independence as required in this subclause yet applies.
Add, after the existing subclause 201.15.4.2.2.102, the new subclause:
Clause 202 – Electromagnetic disturbances – Requirements and tests
Thermal processes in warming therapy devices are mainly slow and the INCUBATOR
TEMPERATURE or the SKIN TEMPERATURE 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 INCUBATOR 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 electrical fast transient/burst IMMUNITY tests the heating actuator of
the device can be affected by the disturbance immediately while the INCUBATOR TEMPERATURE
or the SKIN TEMPERATURE as being dampened by heat transfer processes can react only with a
delay.
– 10 – IEC 60601-2-19:2020/AMD1:2023
© IEC 2023
Bibliography
Replace the existing reference [13] by the following new reference:
[13] 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
Add the following new references at the end of the Bibliography:
[15] IEC 80601‑2‑49:2018, Medical electrical equipment – Part 2‑49: Particular requirements
for the basic safety and essential performance of multifunction patient monitors
[16] BELLIENI, CV, ACAMPA, M, MAFFEI, M, MAFFEI, S, PERRONE, S, PINTO, I,
STACCHINI, N, BUONOCORE, G. Electromagnetic fields produced by incubators
influence heart rate variability in newborns. Arch Dis Child Fetal Neonatal Ed, 2008, 93:
p.298‑301
[17] BELLIENI, CV, TEI, M, IACOPONI, F, TATRANNO, M L, NEGRO, S, PROIETTI, F,
LONGINI, M, PERRONE, S, BUONOCORE, G. Is newborn melatonin production
influenced by electromagnetic fields produced by incubators? Early Human
Development, 2012, 88: p. 707‑710

© IEC 2023
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