IEC 60601-2-19:2020

IEC 60601-2-19 ®
Edition 3.0 2020-09
REDLINE VERSION
INTERNATIONAL
STANDARD
colour
inside
Medical electrical equipment –
Part 2-19: Particular requirements for the basic safety and essential performance
of infant incubators
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IEC 60601-2-19 ®
Edition 3.0 2020-09
REDLINE VERSION
INTERNATIONAL
STANDARD
colour
inside
Medical electrical equipment –

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

performance of infant incubators

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040.10 ISBN 978-2-8322-8843-6

– 2 – IEC 60601-2-19:2020 RLV © IEC 2020
CONTENTS
FOREWORD . 3
INTRODUCTION . 6
201.1 Scope, object and related standards. 7
201.2 Normative references . 9
201.3 Terms and definitions . 9
201.4 General requirements . 12
201.5 General requirements for testing ME EQUIPMENT . 13
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 13
201.7 ME EQUIPMENT identification, marking and documents . 14
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 15
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 15
201.10 Protection against unwanted and excessive radiation HAZARDS . 18
201.11 Protection against excessive temperatures and other HAZARDS . 18
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 19
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 25
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 25
201.15 Construction of ME EQUIPMENT . 25
201.16 ME SYSTEMS. 28
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 28
202 Electromagnetic compatibility disturbances – Requirements and tests . 28
210 Requirements for the development of physiologic closed-loop controllers .
Annexes . 30
Annex AA (informative) Particular guidance and rationale . 31
Bibliography . 40
Index of defined terms used in this particular standard. 41

Figure 201.102101 – Variation of INCUBATOR TEMPERATURE . 10
Figure 201.101102 – Positioning of air temperature sensors . 11
Figure 201.103 – Layout of weight test devices . 22
Figure AA.1 – Illustration of the main requirements of this document . 31

Table 201.101 – Additional ESSENTIAL PERFORMANCE requirements . 13

INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

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

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
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6) All users should ensure that they have the latest edition of this publication.
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This redline version of the official IEC Standard allows the user to identify the changes
made to the previous edition. A vertical bar appears in the margin wherever a change
has been made. Additions are in green text, deletions are in strikethrough red text.

– 4 – IEC 60601-2-19:2020 RLV © IEC 2020
International standard IEC 60601-2-19 has been prepared by subcommittee 62D:
Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
This third edition cancels and replaces the second edition published in 2009 and
Amendment 1:2016. This edition constitutes a technical revision.
This edition includes the following significant technical change with respect to the previous
edition: re-dating of normative references.
The text of this International Standard is based on the following documents:
FDIS Report on voting
62D/1764/FDIS 62D/1774/RVD
Full information on the voting for the approval of this International Standard can be found in
the report on voting indicated in the above table.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this document, the following print types are used:
– requirements and definitions: roman type;
– test specifications: italic type;
– informative material appearing outside of tables, such as notes, examples and references: in smaller type.
Normative text of tables is also in a smaller type;
– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
NOTED: SMALL CAPITALS.
In referring to the structure of this document, the term
– "clause" means one of the seventeen numbered divisions within the table of contents,
inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
– "subclause" means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
subclauses of Clause 7).
References to clauses within this document are preceded by the term "Clause" followed by
the clause number. References to subclauses within this particular standard are by number
only.
In this document, the conjunctive "or" is used as an "inclusive or" so a statement is true if any
combination of the conditions is true.
The verbal forms used in this document conform to usage described in Clause 7 of the
ISO/IEC Directives, Part 2. For the purposes of this document, the auxiliary verb:
– "shall" means that compliance with a requirement or a test is mandatory for compliance
with this document;
– "should" means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this document;
– "may" is used to describe a permissible way to achieve compliance with a requirement or
test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
indicates that there is guidance or rationale related to that item in Annex AA.

A list of all parts of the IEC 60601 series, published under the general title Medical electrical
equipment, can be found on the IEC website.
The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under "http://webstore.iec.ch" in the data related to
the specific document. At this date, the document will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
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 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
implementation nationally not earlier than 3 years from the date of publication.

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.
– 6 – IEC 60601-2-19:2020 RLV © IEC 2020
INTRODUCTION
The minimum safety requirements specified in this particular standard are considered to
provide for a practical degree of safety in the operation of INFANT INCUBATOR equipment.
This particular standard amends and supplements IEC 60601-1:2005, Medical electrical
equipment – Part 1: General requirements for basic safety and essential performance,
hereinafter referred to as the general standard.
The requirements are followed by specifications for the relevant tests.
A general guidance and rationale for the requirements of this particular standard are given in
Annex AA.
It is considered that knowledge of the reasons for these requirements will not only facilitate
the proper application of this particular standard but will, in due course, expedite any revision
necessitated by changes in clinical practice or as a result of developments in technology.
However, this annex does not form part of the requirements of this standard.

MEDICAL ELECTRICAL EQUIPMENT –

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

201.1 Scope, object and related standards
Clause 1 of the general standard applies, except as follows:
201.1.1 * Scope
Replacement:
This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT
INCUBATORS, as defined in 201.3.209, also referred to as ME EQUIPMENT.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to
ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the
case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS
within the scope of this document are not covered by specific requirements in this document,
except in 7.2.13 and 8.4.1 of the general standard.
NOTE See also 4.2 of the general standard.
This particular standard specifies safety requirements for INFANT INCUBATORS, but alternate
methods of compliance with a specific clause, by demonstrating equivalent safety, will not be
judged as non-compliant, if the MANUFACTURER has demonstrated in his RISK MANAGEMENT FILE
that the RISK presented by the HAZARD has been found to be of an acceptable level when
weighed against the benefit of treatment from the device.
This particular standard does not apply to:
– INFANT TRANSPORT INCUBATORS; for information, see IEC 60601-2-20 [1] ;
– INFANT RADIANT WARMERS; for information, see IEC 60601-2-21 [2];
– devices supplying heat via BLANKETS, PADS or MATTRESSES in medical use; for information
see IEC 80601-2-35 IEC 60601-2-35 [3];
– INFANT PHOTOTHERAPY EQUIPMENT; for information see IEC 60601-2-50 [4].
SKIN TEMPERATURE SENSORS which are applied to operate a BABY CONTROLLED INCUBATOR
including the displayed value are not considered to be a CLINICAL THERMOMETER in the sense
of the particular standard ISO 80601-2-56.
____________
The general standard is IEC 60601-1 and IEC 60601-1:2005/AMD1:2012, Medical electrical equipment – Part 1:

General requirements for basic safety and essential performance.
Figures in square brackets refer to the Bibliography.

– 8 – IEC 60601-2-19:2020 RLV © IEC 2020
201.1.2 Object
Replacement:
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements for INFANT INCUBATORS as defined in 201.3.208209, which
minimize HAZARDS to PATIENT and OPERATOR, and to specify tests by which compliance with
the requirements can be verified.
201.1.3 * Collateral standards
Addition:
This particular standard refers to those applicable collateral standards that are listed in
Clause 2 of the general standard and Clause 201.2 of this particular standard.
IEC 60601-1-2 and IEC 60601-1-10 apply as modified in Clauses 202 and 210 respectively.
IEC 60601-1-3 does not apply. All other published collateral standards in the IEC 60601-1
series apply as published.
IEC 60601-1-2:2014 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
Replacement:
In the IEC 60601 series, particular standards may modify, replace or delete requirements
contained in the general standard and collateral standards as appropriate for the particular
ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements.
A requirement of a particular standard takes priority over the general standard.
For brevity, IEC 60601-1 and IEC 60601-1:2005/AMD1:2012 is are referred to in this
particular standard as the general standard. Collateral standards are referred to by their
document number.
The numbering of clauses and subclauses of this particular standard corresponds to that of
the general standard with the prefix "201" (e.g. 201.1 in this document addresses the content
of Clause 1 of the general standard) or applicable collateral standard with the prefix "20x"
where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this
particular standard addresses the content of Clause 4 of the IEC 60601-1-2 collateral
standard, 203.4 in this particular standard addresses the content of Clause 4 of the
IEC 60601-1-3 collateral standard, etc.). The changes to the text of the general standard and
applicable collateral standards are specified by the use of the following words:
"Replacement" means that the clause or subclause of the general standard or applicable
collateral standard is replaced completely by the text of this particular standard.
"Addition" means that the text of this particular standard is additional to the requirements of
the general standard or applicable collateral standard.
"Amendment" means that the clause or subclause of the general standard or applicable
collateral standard is amended as indicated by the text of this particular standard.

Subclauses, figures or tables which are additional to those of the general standard are
numbered starting from 201.101. However, due to the fact that definitions in the general
standard are numbered 3.1 through 3.139 3.147, additional definitions in this document are
numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and
additional items aa), bb), etc.
Subclauses, figures or tables which are additional to those of a collateral standard are
numbered starting from 20x, where "x" is the number of the collateral standard, e.g. 202 for
IEC 60601-1-2, 203 for IEC 60601-1-3, etc.
The term "this document" is used to make reference to the general standard, any applicable
collateral standards and this particular standard taken together.
Where there is no corresponding clause or subclause in this particular standard, the clause or
subclause of the general standard or applicable collateral standard, although possibly not
relevant, applies without modification; where it is intended that any part of the general
standard or applicable collateral standard, although possibly relevant, is not to be applied, a
statement to that effect is given in this particular standard.
201.2 Normative references
NOTE Informative references are listed in the Bibliography.
Clause 2 of the general standard applies, except as follows:
Amendment
Addition:
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
IEC 60601-1:2005/AMD1:2012
Replacement:
IEC 60601-1-2:20072014, Medical electrical equipment – Part 1-2: General requirements for
basic safety and essential performance – Collateral standard: Electromagnetic compatibility
disturbances – Requirements and tests
Addition:
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
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005,
apply, except as follows: and IEC 60601-1:2005/AMD1:2012 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following
addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp

– 10 – IEC 60601-2-19:2020 RLV © IEC 2020
NOTE An index of defined terms is found on page 41.
Addition:
201.3.201
AIR CONTROLLED INCUBATOR
INFANT INCUBATOR in which the air temperature is automatically controlled by an air
temperature sensor according to the CONTROL TEMPERATURE set by the OPERATOR
201.3.202
AVERAGE INCUBATOR TEMPERATURE
average of the INCUBATOR TEMPERATURE readings taken at regular intervals achieved during
STEADY TEMPERATURE CONDITION (see Figure 201.102)
SEE Figure 201.101
Figure 201.101 – Variation of INCUBATOR TEMPERATURE
201.3.203
AVERAGE TEMPERATURE
average of temperature readings taken at regular intervals at any specified point in the
COMPARTMENT achieved during STEADY TEMPERATURE CONDITION
201.3.204
BABY CONTROLLED INCUBATOR
AIR CONTROLLED INCUBATOR which has the additional capability of automatically controlling the
INCUBATOR air temperature in order to maintain the temperature as measured by a SKIN
TEMPERATURE SENSOR according to the CONTROL TEMPERATURE set by the OPERATOR
NOTE An INFANT INCUBATOR operating as a BABY CONTROLLED INCUBATOR is a PHYSIOLOGIC CLOSED-LOOP
CONTROLLER as defined in IEC 60601-1-10.
201.3.205
COMPARTMENT
environmentally-controlled enclosure intended to contain an INFANT and with transparent
section(s) which allows for viewing of the INFANT
201.3.206
CONTROL TEMPERATURE
temperature selected at the temperature control

201.3.207
INCUBATOR TEMPERATURE
temperature of the air at a point 10 cm above the centre of the MATTRESS surface in the
COMPARTMENT (see Figure 201.101, point M)
SEE Figure 201.102, point M
Key
M INCUBATOR TEMPERATURE sensor
A, B, C, D air temperature sensor
The measuring points A to D and M are in a plane parallel to and at a distance of 10 cm from the MATTRESS.
Figure 201.102 – Positioning of air temperature sensors
201.3.208
INFANT
PATIENT up to the age of three months and a weight less than 10 kg
201.3.209
INFANT INCUBATOR
ME EQUIPMENT having a COMPARTMENT which is provided with the means to control the
environment of the INFANT primarily by heated air within the COMPARTMENT
201.3.210
SKIN TEMPERATURE
temperature of the skin of the INFANT at a point on which the SKIN TEMPERATURE SENSOR is
placed
201.3.211
SKIN TEMPERATURE SENSOR
sensing device intended to measure the INFANT SKIN TEMPERATURE

– 12 – IEC 60601-2-19:2020 RLV © IEC 2020
C
A
M
D
B
IEC  253/09
Key
M = INCUBATOR TEMPERATURE sensor
A, B, C, D = Air temperature sensor
The measuring points A to D and M are in a plane parallel to and at a distance of 10 cm from the
MATTRESS.
Figure 201.101 – Positioning of air temperature sensors

INCUBATOR
Temperature
TEMPERATURE
variation
AVERAGE
INCUBATOR
TEMPERATURE
11 °C
Ambient
temperature
Time
Warm up time Steady temperature condition
IEC  254/09
Figure 201.102 – Variation of INCUBATOR TEMPERATURE
201.3.212
STEADY TEMPERATURE CONDITION
condition reached when the INCUBATOR TEMPERATURE does not vary by more than 1 °C over a
period of 1 h (see Figure 201.102)
SEE Figure 201.101
201.4 General requirements
Clause 4 of the general standard applies, except as follows:
201.4.1 Conditions for application to ME EQUIPMENT or ME SYSTEMS
Addition:
For INFANT INCUBATORS which combine alternative heat sources, for instance INFANT
INCUBATORS with integrated radiant warmers, devices supplying heat via BLANKETS, PADS or
MATTRESSES, etc., the safety requirements of the particular standards for these alternative
heat sources, if any, shall be met. The safety requirements of this particular standard shall not
be altered by such additional heat sources specified by the MANUFACTURER, details of which
are provided in the instruction for use.
Compliance is checked by the tests of Clause 201.11 and 201.15.4.2.1 of the relevant
particular standards (e.g. IEC 60601-2-21:2020 or IEC 80601-2-35 IEC 60601-2-35:2020).
201.4.3 * ESSENTIAL PERFORMANCE
Addition:
201.4.3.101 ESSENTIAL PERFORMANCE of INFANT INCUBATORS
ESSENTIAL PERFORMANCE requirements are found in the subclauses listed in Table 201.101.
Table 201.101 – Additional ESSENTIAL PERFORMANCE requirements
Requirement Subclause
ESSENTIAL PERFORMANCE requirement 1 201.12.1.104 or generation of a visual and
audible alarm in compliance with 201.15.4.2.1 ee)
ESSENTIAL PERFORMANCE requirement 2 201.12.1.106 or generation of a visual and
audible alarm in compliance with 201.15.4.2.1 dd)

201.5 General requirements for testing ME EQUIPMENT
Clause 5 of the general standard applies, except as follows:
201.5.3 * Ambient temperature, humidity, atmospheric pressure
Replacement of item a):
a) * After the ME EQUIPMENT to be tested has been set up for NORMAL USE (according to 5.7),
the ME EQUIPMENT shall comply with the requirements of this document when operating
within the following conditions:
– ambient temperature between +20 °C and +30 °C;
– ambient air velocity less than 0,3 m/s.
Addition:
If not otherwise specified in this particular standard, all tests shall be carried out at an
ambient temperature within the range of 21 °C to 26 °C.
201.5.4 Other conditions
Additional item to the existing list:
aa) If not otherwise specified, the CONTROL TEMPERATURE shall be 36 °C ± 1 °C and shall
always exceed the ambient temperature by at least 3 °C.
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
Clause 6 of the general standard applies.

– 14 – IEC 60601-2-19:2020 RLV © IEC 2020
201.7 ME EQUIPMENT identification, marking and documents
Clause 7 of the general standard applies, except as follows:
201.7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts
(see also Table C.1 of the general standard)
Additional subclauses:
201.7.2.101 * Oxygen monitor
An INFANT INCUBATOR not equipped with an integral oxygen monitor and which provides means
for oxygen administration shall be marked in a prominent position with a text which states:
"Use an oxygen monitor when oxygen is administered".
NOTE See also 7.5 of the general standard.
201.7.2.102 Heater surface temperature
If a heater is accessible without the use of a TOOL, a notice sign (see 7.5 of the general
standard) or marking shall be displayed adjacent to the heater giving warning of high surface
temperature.
201.7.4 Markings of controls and instruments (see also Table C.3 of the general
standard)
201.7.4.2 * Control devices
Addition:
Temperature controls shall be clearly marked with temperature settings on or adjacent to the
control. The markings shall be provided at intervals of not greater than 0,5 °C for AIR
CONTROLLED INCUBATORS and not greater than 0,25 °C for BABY CONTROLLED INCUBATORS.
Marking of the maximum and the minimum values of controls and indicators shall be such that
no confusion can arise with regard to the position of the control or the indicated values.
201.7.9.2.2 * Warning and safety notices
Addition:
The instructions for use shall include contain the following additional items.
*a) * A statement that an INFANT INCUBATOR should be used only by appropriately trained
personnel and under the direction of qualified medical personnel familiar with currently
known RISKS and benefits of INFANT INCUBATOR use.
*b) * A warning that direct sunlight or other radiant heat sources can cause an increase in
INCUBATOR TEMPERATURE to dangerous levels.
*c) * A statement that the use of oxygen increases the danger of fire and that auxiliary
equipment producing sparks shall not be placed in the INFANT INCUBATOR.
*d) * A warning that even small quantities of flammable agents, such as ether and alcohol,
left in the INFANT INCUBATOR can cause fire in connection with oxygen.
*e) * A statement of the maximum allowed weight of additional equipment which might be
placed on shelves connected to the INFANT INCUBATOR.
f) For an INFANT INCUBATOR having a TYPE B APPLIED PARTS where the INFANT may not be
isolated from earth, a warning that particular care must shall be taken to ensure that
additional equipment connected to the INFANT is electrically safe.

g) A warning stating that administration of oxygen may increase the noise level for the
INFANT within the INFANT INCUBATOR.
h) Explanation of the operation of supplementary oxygen equipment supplied for use with
INFANT INCUBATOR or as specified in the ACCOMPANYING DOCUMENTS.
the
i) A statement that an oxygen analyzer shall be used when oxygen is delivered to the
INFANT.
j) Details of any specified combinations of ME EQUIPMENT (see 201.4.1).
*k) * A warning against the use of the SKIN TEMPERATURE SENSOR as a rectal temperature
sensor, if such a warning is applicable.
l) * A statement that the INFANT INCUBATOR cannot differentiate between an increase in
core temperature with a cold skin (fever) and a low core and SKIN TEMPERATURE
(hypothermia), and a recommendation to monitor the temperature of the PATIENT.
201.7.9.2.8 * Start-up PROCEDURE
Addition:
The instructions for use shall additionally contain a specification of the warm-up time of the
INFANT INCUBATOR measured as specified in 201.12.1.107.
201.7.9.2.9 * Operating instructions
Addition:
The instructions for use shall contain the following additional items:
a) * a recommendation of the position and method of use of the SKIN TEMPERATURE SENSOR;
b) information on how and when to verify the functionality of the ALARM SYSTEM;
c) * information about the range of CONTROL TEMPERATURE and relative humidity of the
INFANT INCUBATOR; if the INFANT INCUBATOR is not supplied with means for control of the
degree of humidity, this shall be stated in the instructions for use;
d) * a statement of the maximum allowed weight of additional equipment which might be
placed on shelves connected to the INFANT INCUBATOR.
201.7.9.3 Technical description (see also Table C.6 of the general standard)
201.7.9.3.1 General
Additional item to the first paragraph:
– the MANUFACTURER shall specify in the ACCOMPANYING DOCUMENTS the maximum CO
concentration (see subclause 201.12.4.2.101)
– the maximum CO concentration (see 201.12.4.2.101).
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
Clause 8 of the general standard applies.
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS
Clause 9 of the general standard applies, except as follows:

– 16 – IEC 60601-2-19:2020 RLV © IEC 2020
201.9.2 MECHANICAL HAZARDS associated with moving parts
201.9.2.1 General
Addition:
This requirement is not applicable to an air circulating fan if it is accessible only when no
INFANT is present in the INFANT INCUBATOR and appropriate ME EQUIPMENT parts are removed
for cleaning.
201.9.6.2 Acoustic energy
201.9.6.2.1 Audible acoustic energy
Additional subclauses:
201.9.6.2.1.101 * Sound level within the COMPARTMENT
In NORMAL USE, the sound level within the COMPARTMENT shall not exceed a sound pressure
level of 60 dB(A) except as specified in 201.9.6.2.1.103.
Compliance is checked by the following test:
With the microphone of a sound level meter complying with the requirements of
IEC 61672-1 [5] positioned 100 mm to 150 mm above the centre of the INFANT tray, the
INFANT
measured sound level shall not exceed the specified values. For this test, the
INCUBATOR shall be operated at a CONTROL TEMPERATURE of 36 °C and at a maximum humidity.
The background sound level measured inside the COMPARTMENT shall be at least 10 dB below
that which is measured during the test.
201.9.6.2.1.102 * Audible alarm sound level
Audible ALARM SIGNALS shall have a sound level of at least 65 dB(A) 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 dB(A). If the frequency of the
OPERATOR, these requirements shall apply to all the
auditory alarms is adjustable by the
individual selectable frequencies.
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 dB(A) below that which is measured
during the test.
201.9.6.2.1.103 * Audible alarms sound level within COMPARTMENT
When any INFANT INCUBATOR alarm is sounding, the sound level in the COMPARTMENT shall not
exceed 80 dB(A). If the frequency of the auditory alarms is adjustable by the OPERATOR, this
shall apply to all the individual selectable frequencies.
Compliance is checked by the following test:
The alarm shall be actuated and the measurement shall be carried out as described in
201.9.6.2.1.101.
201.9.8 MECHANICAL HAZARDS associated with support systems
PATIENT or OPERATOR support or suspension systems
201.9.8.3 Strength of
201.9.8.3.1 General
Amendment:
The normal load for an INFANT is reduced to 10 kg.
Additional subclauses:
201.9.8.3.101 * Barriers
The INFANT shall be safely retained within the COMPARTMENT by barriers such as walls or side
panels. Barriers intended to be opened or removed to allow access to the INFANT, such as
doors, ports etc., shall close so as not to open under the test conditions specified below. It
shall not be possible for barriers to be insecurely closed or latched whilst appearing to be
engaged. The mechanical integrity of the INFANT INCUBATOR shall be maintained under the
following test conditions.
Compliance is checked by inspection and by the following test:
With all access port doors deliberately made as insecure as possible, without the use of a
TOOL, whilst still appearing to be engaged, a horizontal force shall be applied to the centre of
the access port door. The force shall be increased gradually from zero to 20 N in an interval
of 5 s to 10 s and shall be held at maximum for 5 s.
201.9.8.3.102 MATTRESS tray
If the MATTRESS tray can be extended outside the enclosure, it shall be restrained to ensure
that the tray remains attached to the INFANT INCUBATOR, is supported and does not tip under
INFANT.
the weight of the
Compliance is checked by the following test:
A gradually increasing downward force is applied to the middle of the outside edge of the
MATTRESS tray whilst in the fully extended position. The force is increased over 5 s to 10 s
intervals until it equals 100 N and is to shall be maintained for a period of 1 min. The tray
shall not incline by more than 5° to the horizontal axis of the INFANT INCUBATOR and there shall
be no visible evidence of damage to the supporting structures.
Additional subclause:
201.9.8.101 Supports and mounting brackets for ACCESSORIES
Supports and mounting brackets for accessories shall be suitable and of adequate strength
for their purpose.
Compliance is checked by inspection and by the following test:
A gradually increasing force is applied so as to act vertically through the centre of the
supports and mounting brackets, for example an ACCESSORY shelf in the extended position
with a MANUFACTURER's recommended load. The force is increased from zero in a 5 s to 10 s
interval, until it equals three times the recommended load and is sustained for a period of
1 min. There shall be no evidence of damage to the items under test.

– 18 – IEC 60601-2-19:2020 RLV © IEC 2020
201.10 Protection against unwanted and excessive radiation HAZARDS
Clause 10 of the general standard applies.
201.11 Protection against excessive temperatures and other HAZARDS
Clause 11 of the general standard applies, except as follows:
201.11.1 Excessive temperature in ME EQUIPMENT
201.11.1.2.2 APPLIED PARTS not intended to supply heat to a PATIENT
Replacement:
The temperature of the surfaces intended to be in contact with a PATIENT shall not exceed
40 °C. The temperature of other surfaces accessible to the PATIENT shall not exceed 40°C for
metal surfaces and 43 °C for other materials.
These requirements apply in NORMAL CONDITIONS and SINGLE FAULT CONDITIONS including:
– failure of the air circulation;
– failure of a THERMOSTAT;
– disconnection of the SKIN TEMPERATURE SENSOR.
Compliance is checked by the following test:
The maximum temperature of surfaces intended to be in contact with and surfaces accessible
to the INFANT shall be measured according to 11.1.2 of the general standard and include test
conditions as described in the compliance test of 201.12.3.101 and 201.15.4.2.1 of this
particular standard.
201.11.2 * Fire prevention
Subclause 11.2 of the general standard applies.
201.11.6.2 * Overflow in ME EQUIPMENT
Addition:
If a water reservoir is provided as an integral part of the INFANT INCUBATOR, it shall have a
water level indicator with "max." and "min." markings if the level of the water in the tank
cannot be seen. The tank shall be so designed that it can be drained without tilting the INFANT
INCUBATOR.
Compliance is checked by inspection.
201.11.6.3 Spillage on ME EQUIPMENT and ME SYSTEMS
Replacement:
INFANT INCUBATORS shall be so constructed that spillage does not wet parts which if wetted
might cause a safety HAZARD.
Such spillage is considered a SINGLE FAULT CONDITION.
Compliance is checked by the following test:

The ME EQUIPMENT shall be positioned as for NORMAL USE with the canopy in the normal
position; 200 ml of water is poured on any point of the top surface of the ME EQUIPMENT. After
this test, the ME EQUIPMENT shall comply with the requirements of this document.
201.11.6.6 * Cleaning and disinfection of ME EQUIPMENT and ME SYSTEMS
Addition:
A humidifier, if provided, shall be designed to permit the application of PROCEDURES that effect
microbiological decontamination between uses.
SUPPLY MAINS to ME EQUIPMENT
201.11.8 Interruption of the power supply /
Addition:
The ME EQUIPMENT shall be so designed that an interruption and a restoration of the power
supply of up to 10 min does not change the CONTROL TEMPERATURE or other preset values.
Compliance is checked by switching the SUPPLY MAINS off and then switching on and
inspecting the ME EQUIPMENT.
201.12 Accuracy of controls and instruments and protection against
hazardous outputs
Clause 12 of the general standard applies, except as follows:
201.12.1 Accuracy of controls and instruments
Addition:
201.12.1.101 * Stability of INCUBATOR TEMPERATURE
During STEADY TEMPERATURE CONDITION, the INCUBATOR TEMPERATURE shall not differ from the
AVERAGE INCUBATOR TEMPERATURE by more than 0,5 °C.
Compliance is checked by measurement at CONTROL TEMPERATURES of 32 °C and 36 °C over a
period of at least 1 h.
201.12.1.102 * Uniformity of INCUBATOR TEMPERATURE
With an INFANT INCUBATOR working as an AIR CONTROLLED INCUBATOR and the CONTROL
TEMPERATURE set at any temperature within its range, the AVERAGE TEMPERATURE in each of
the points A, B, C, and D as specified in the test instruction shall not differ from the AVERAGE
INCUBATOR TEMPERATURE by more than 0,8 °C in NORMAL USE. In any position of the tilted
MATTRESS, it shall not differ by more than 1 °C.
Compliance is checked by the following test:
Calibrated temperature sensors shall be placed at five points in a plane parallel to and 10 cm
above the MATTRESS surface. Point M shall be a point 10 cm above the centre of the MATTRESS
(see Figure 201.101102, point M). The other points shall be the centres of the four areas
formed by lines, which divide both the width and the length in two parts (see Figure
201.101102, points A to D). The AVERAGE TEMPERATURE at each of these five points shall be
measured at CONTROL TEMPERATURES of 32 °C and 36 °C.

– 20 – IEC 60601-2-19:2020 RLV © IEC 2020
The difference between the AVERAGE INCUBATOR TEMPERATURE (point M) and the measured
values at points A, B, C, and D shall be compared as specified. The test shall be undertaken
with the INFANT INCUBATOR MATTRESS tray horizontal and at the two extremes of its tilt angle.
201.12.1.103 * Accuracy of SKIN TEMPERATURE SENSOR
The accuracy of the SKIN TEMPERATURE SENSOR for measuring SKIN TEMPERATURE shall be
within ±0,3 °C.
Compliance is checked by the following test:
The SKIN TEMPERATURE SENSOR shall be immersed in a water bath which has the
...

IEC 60601-2-19 ®
Edition 3.0 2020-09
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
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

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IEC 60601-2-19 ®
Edition 3.0 2020-09
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
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 978-2-8322-9982-1

– 2 – IEC 60601-2-19:2020 © IEC 2020
CONTENTS
FOREWORD . 3
INTRODUCTION . 6
201.1 Scope, object and related standards . 7
201.2 Normative references . 9
201.3 Terms and definitions. 9
201.4 General requirements . 11
201.5 General requirements for testing ME EQUIPMENT . 12
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 12
201.7 ME EQUIPMENT identification, marking and documents . 12
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 14
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 14
201.10 Protection against unwanted and excessive radiation HAZARDS . 16
201.11 Protection against excessive temperatures and other HAZARDS . 16
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 18
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 24
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 24
201.15 Construction of ME EQUIPMENT . 24
201.16 ME SYSTEMS . 27
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 27
202 Electromagnetic disturbances – Requirements and tests . 27
Annex AA (informative) Particular guidance and rationale . 29
Bibliography . 37
Index of defined terms used in this particular standard. 38

Figure 201.101 – Variation of INCUBATOR TEMPERATURE . 10
Figure 201.102 – Positioning of air temperature sensors . 11
Figure 201.103 – Layout of weight test devices . 21
Figure AA.1 – Illustration of the main requirements of this document . 29

Table 201.101 – Additional ESSENTIAL PERFORMANCE requirements . 12

INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

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

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,
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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
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3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
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4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
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between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
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5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with an IEC Publication.
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
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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) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
International standard IEC 60601-2-19 has been prepared by subcommittee 62D:
Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
This third edition cancels and replaces the second edition published in 2009 and
Amendment 1:2016. This edition constitutes a technical revision.
This edition includes the following significant technical change with respect to the previous
edition: re-dating of normative references.

– 4 – IEC 60601-2-19:2020 © IEC 2020
The text of this International Standard is based on the following documents:
FDIS Report on voting
62D/1764/FDIS 62D/1774/RVD
Full information on the voting for the approval of this International Standard can be found in
the report on voting indicated in the above table.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this document, the following print types are used:
– requirements and definitions: roman type;
– test specifications: italic type;
– informative material appearing outside of tables, such as notes, examples and references: in smaller type.
Normative text of tables is also in a smaller type;
– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
NOTED: SMALL CAPITALS.
In referring to the structure of this document, the term
– "clause" means one of the seventeen numbered divisions within the table of contents,
inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
– "subclause" means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
subclauses of Clause 7).
References to clauses within this document are preceded by the term "Clause" followed by
the clause number. References to subclauses within this particular standard are by number
only.
In this document, the conjunctive "or" is used as an "inclusive or" so a statement is true if any
combination of the conditions is true.
The verbal forms used in this document conform to usage described in Clause 7 of the
ISO/IEC Directives, Part 2. For the purposes of this document, the auxiliary verb:
– "shall" means that compliance with a requirement or a test is mandatory for compliance
with this document;
– "should" means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this document;
– "may" is used to describe a permissible way to achieve compliance with a requirement or
test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
indicates that there is guidance or rationale related to that item in Annex AA.
A list of all parts of the IEC 60601 series, published under the general title Medical electrical
equipment, can be found on the IEC website.

The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under "http://webstore.iec.ch" in the data related to
the specific document. At this date, the document will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
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 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
implementation nationally not earlier than 3 years from the date of publication.

– 6 – IEC 60601-2-19:2020 © IEC 2020
INTRODUCTION
The minimum safety requirements specified in this particular standard are considered to
provide for a practical degree of safety in the operation of INFANT INCUBATOR equipment.

MEDICAL ELECTRICAL EQUIPMENT –

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

201.1 Scope, object and related standards
Clause 1 of the general standard applies, except as follows:
201.1.1 * Scope
Replacement:
This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT
INCUBATORS, as defined in 201.3.209, also referred to as ME EQUIPMENT.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to
ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the
case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS
within the scope of this document are not covered by specific requirements in this document,
except in 7.2.13 and 8.4.1 of the general standard.
NOTE See also 4.2 of the general standard.
This particular standard specifies safety requirements for INFANT INCUBATORS, but alternate
methods of compliance with a specific clause, by demonstrating equivalent safety, will not be
judged as non-compliant, if the MANUFACTURER has demonstrated in his RISK MANAGEMENT FILE
that the RISK presented by the HAZARD has been found to be of an acceptable level when
weighed against the benefit of treatment from the device.
This particular standard does not apply to:
– INFANT TRANSPORT INCUBATORS; for information, see IEC 60601-2-20 [1] ;
– INFANT RADIANT WARMERS; for information, see IEC 60601-2-21 [2];
– devices supplying heat via BLANKETS, PADS or MATTRESSES in medical use; for information,
see IEC 60601-2-35 [3];
– INFANT PHOTOTHERAPY EQUIPMENT; for information see IEC 60601-2-50 [4].
SKIN TEMPERATURE SENSORS which are applied to operate a BABY CONTROLLED INCUBATOR
including the displayed value are not considered to be a CLINICAL THERMOMETER in the sense
of the particular standard ISO 80601-2-56.
____________
The general standard is IEC 60601-1 and IEC 60601-1:2005/AMD1:2012, Medical electrical equipment – Part 1:

General requirements for basic safety and essential performance.
Figures in square brackets refer to the Bibliography.

– 8 – IEC 60601-2-19:2020 © IEC 2020
201.1.2 Object
Replacement:
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements for INFANT INCUBATORS as defined in 201.3.209, which minimize
HAZARDS to PATIENT and OPERATOR, and to specify tests by which compliance with the
requirements can be verified.
201.1.3 Collateral standards
Addition:
This particular standard refers to those applicable collateral standards that are listed in
Clause 2 of the general standard and Clause 201.2 of this particular standard.
IEC 60601-1-2:2014 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
Replacement:
In the IEC 60601 series, particular standards may modify, replace or delete requirements
contained in the general standard and collateral standards as appropriate for the particular
ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements.
A requirement of a particular standard takes priority over the general standard.
For brevity, IEC 60601-1 and IEC 60601-1:2005/AMD1:2012 are referred to in this particular
standard as the general standard. Collateral standards are referred to by their document
number.
The numbering of clauses and subclauses of this particular standard corresponds to that of
the general standard with the prefix "201" (e.g. 201.1 in this document addresses the content
of Clause 1 of the general standard) or applicable collateral standard with the prefix "20x"
where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this
particular standard addresses the content of Clause 4 of the IEC 60601-1-2 collateral
standard, 203.4 in this particular standard addresses the content of Clause 4 of the
IEC 60601-1-3 collateral standard, etc.). The changes to the text of the general standard and
applicable collateral standards are specified by the use of the following words:
"Replacement" means that the clause or subclause of the general standard or applicable
collateral standard is replaced completely by the text of this particular standard.
"Addition" means that the text of this particular standard is additional to the requirements of
the general standard or applicable collateral standard.
"Amendment" means that the clause or subclause of the general standard or applicable
collateral standard is amended as indicated by the text of this particular standard.
Subclauses, figures or tables which are additional to those of the general standard are
numbered starting from 201.101. However, due to the fact that definitions in the general
standard are numbered 3.1 through 3.147, additional definitions in this document are
numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and
additional items aa), bb), etc.

Subclauses, figures or tables which are additional to those of a collateral standard are
numbered starting from 20x, where "x" is the number of the collateral standard, e.g. 202 for
IEC 60601-1-2, 203 for IEC 60601-1-3, etc.
The term "this document" is used to make reference to the general standard, any applicable
collateral standards and this particular standard taken together.
Where there is no corresponding clause or subclause in this particular standard, the clause or
subclause of the general standard or applicable collateral standard, although possibly not
relevant, applies without modification; where it is intended that any part of the general
standard or applicable collateral standard, although possibly relevant, is not to be applied, a
statement to that effect is given in this particular standard.
201.2 Normative references
NOTE Informative references are listed in the Bibliography.
Clause 2 of the general standard applies, except as follows:
Addition:
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
IEC 60601-1:2005/AMD1:2012
Replacement:
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
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005 and
IEC 60601-1:2005/AMD1:2012 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following
addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
NOTE An index of defined terms is found on page 38.
Addition:
201.3.201
AIR CONTROLLED INCUBATOR
INFANT INCUBATOR in which the air temperature is automatically controlled by an air
temperature sensor according to the CONTROL TEMPERATURE set by the OPERATOR
201.3.202
AVERAGE INCUBATOR TEMPERATURE
average of the INCUBATOR TEMPERATURE readings taken at regular intervals achieved during
STEADY TEMPERATURE CONDITION
SEE Figure 201.101
– 10 – IEC 60601-2-19:2020 © IEC 2020

Figure 201.101 – Variation of INCUBATOR TEMPERATURE
201.3.203
AVERAGE TEMPERATURE
average of temperature readings taken at regular intervals at any specified point in the
COMPARTMENT achieved during STEADY TEMPERATURE CONDITION
201.3.204
BABY CONTROLLED INCUBATOR
AIR CONTROLLED INCUBATOR which has the additional capability of automatically controlling the
INCUBATOR air temperature in order to maintain the temperature as measured by a SKIN
TEMPERATURE SENSOR according to the CONTROL TEMPERATURE set by the OPERATOR
201.3.205
COMPARTMENT
INFANT and with transparent
environmentally-controlled enclosure intended to contain an
section(s) which allows for viewing of the INFANT
201.3.206
CONTROL TEMPERATURE
temperature selected at the temperature control
201.3.207
INCUBATOR TEMPERATURE
temperature of the air at a point 10 cm above the centre of the MATTRESS surface in the
COMPARTMENT
SEE Figure 201.102, point M
Key
M INCUBATOR TEMPERATURE sensor
A, B, C, D air temperature sensor
The measuring points A to D and M are in a plane parallel to and at a distance of 10 cm from the MATTRESS.
Figure 201.102 – Positioning of air temperature sensors
201.3.208
INFANT
PATIENT up to the age of three months and a weight less than 10 kg
201.3.209
INFANT INCUBATOR
ME EQUIPMENT having a COMPARTMENT which is provided with the means to control the
environment of the INFANT primarily by heated air within the COMPARTMENT
201.3.210
SKIN TEMPERATURE
temperature of the skin of the INFANT at a point on which the SKIN TEMPERATURE SENSOR is
placed
201.3.211
SKIN TEMPERATURE SENSOR
sensing device intended to measure the INFANT SKIN TEMPERATURE
201.3.212
STEADY TEMPERATURE CONDITION
condition reached when the INCUBATOR TEMPERATURE does not vary by more than 1 °C over a
period of 1 h
SEE Figure 201.101
201.4 General requirements
Clause 4 of the general standard applies, except as follows:
201.4.1 Conditions for application to ME EQUIPMENT or ME SYSTEMS
Addition:
For INFANT INCUBATORS which combine alternative heat sources, for instance INFANT
INCUBATORS with integrated radiant warmers, devices supplying heat via BLANKETS, PADS or
MATTRESSES, etc., the safety requirements of the particular standards for these alternative
heat sources, if any, shall be met. The safety requirements of this particular standard shall not
be altered by such additional heat sources specified by the MANUFACTURER, details of which
are provided in the instruction for use.

– 12 – IEC 60601-2-19:2020 © IEC 2020
Compliance is checked by the tests of Clause 201.11 and 201.15.4.2.1 of the relevant
particular standards (e.g. IEC 60601-2-21:2020 or IEC 60601-2-35:2020).
201.4.3 * ESSENTIAL PERFORMANCE
Addition:
201.4.3.101 ESSENTIAL PERFORMANCE of INFANT INCUBATORS
ESSENTIAL PERFORMANCE requirements are found in the subclauses listed in Table 201.101.
Table 201.101 – Additional ESSENTIAL PERFORMANCE requirements
Requirement Subclause
ESSENTIAL PERFORMANCE requirement 1 201.12.1.104 or generation of a visual and
audible alarm in compliance with 201.15.4.2.1 ee)
ESSENTIAL PERFORMANCE requirement 2 201.12.1.106 or generation of a visual and
audible alarm in compliance with 201.15.4.2.1 dd)

201.5 General requirements for testing ME EQUIPMENT
Clause 5 of the general standard applies, except as follows:
201.5.3 Ambient temperature, humidity, atmospheric pressure
Replacement of item a):
a) * After the ME EQUIPMENT to be tested has been set up for NORMAL USE (according to 5.7),
the ME EQUIPMENT shall comply with the requirements of this document when operating
within the following conditions:
– ambient temperature between +20 °C and +30 °C;
– ambient air velocity less than 0,3 m/s.
Addition:
If not otherwise specified in this particular standard, all tests shall be carried out at an
ambient temperature within the range of 21 °C to 26 °C.
201.5.4 Other conditions
Additional item to the existing list:
aa) If not otherwise specified, the CONTROL TEMPERATURE shall be 36 °C ± 1 °C and shall
always exceed the ambient temperature by at least 3 °C.
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
Clause 6 of the general standard applies.
201.7 ME EQUIPMENT identification, marking and documents
Clause 7 of the general standard applies, except as follows:

201.7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts
(see also Table C.1 of the general standard)
Additional subclauses:
201.7.2.101 * Oxygen monitor
An INFANT INCUBATOR not equipped with an integral oxygen monitor and which provides means
for oxygen administration shall be marked in a prominent position with a text which states:
"Use an oxygen monitor when oxygen is administered".
NOTE See also 7.5 of the general standard.
201.7.2.102 Heater surface temperature
If a heater is accessible without the use of a TOOL, a notice sign (see 7.5 of the general
standard) or marking shall be displayed adjacent to the heater giving warning of high surface
temperature.
201.7.4.2 * Control devices
Addition:
Temperature controls shall be clearly marked with temperature settings on or adjacent to the
control. The markings shall be provided at intervals of not greater than 0,5 °C for AIR
CONTROLLED INCUBATORS and not greater than 0,25 °C for BABY CONTROLLED INCUBATORS.
Marking of the maximum and the minimum values of controls and indicators shall be such that
no confusion can arise with regard to the position of the control or the indicated values.
201.7.9.2.2 Warning and safety notices
Addition:
The instructions for use shall contain the following additional items.
a) * A statement that an INFANT INCUBATOR should be used only by appropriately trained
personnel and under the direction of qualified medical personnel familiar with currently
known RISKS and benefits of INFANT INCUBATOR use.
b) * A warning that direct sunlight or other radiant heat sources can cause an increase in
INCUBATOR TEMPERATURE to dangerous levels.
c) * A statement that the use of oxygen increases the danger of fire and that auxiliary
equipment producing sparks shall not be placed in the INFANT INCUBATOR.
d) * A warning that even small quantities of flammable agents, such as ether and alcohol,
left in the INFANT INCUBATOR can cause fire in connection with oxygen.
e) * A statement of the maximum allowed weight of additional equipment which might be
placed on shelves connected to the INFANT INCUBATOR.
f) For an INFANT INCUBATOR having a TYPE B APPLIED PARTS where the INFANT may not be
isolated from earth, a warning that particular care shall be taken to ensure that
additional equipment connected to the INFANT is electrically safe.
g) A warning stating that administration of oxygen may increase the noise level for the
INFANT within the INFANT INCUBATOR.
h) Explanation of the operation of supplementary oxygen equipment supplied for use with
the INFANT INCUBATOR or as specified in the ACCOMPANYING DOCUMENTS.
i) A statement that an oxygen analyzer shall be used when oxygen is delivered to the
INFANT.
j) Details of any specified combinations of ME EQUIPMENT (see 201.4.1).

– 14 – IEC 60601-2-19:2020 © IEC 2020
k) * A warning against the use of the SKIN TEMPERATURE SENSOR as a rectal temperature
sensor, if such a warning is applicable.
l) * A statement that the INFANT INCUBATOR cannot differentiate between an increase in
SKIN TEMPERATURE
core temperature with a cold skin (fever) and a low core and
(hypothermia), and a recommendation to monitor the temperature of the PATIENT.
PROCEDURE
201.7.9.2.8 * Start-up
Addition:
The instructions for use shall additionally contain a specification of the warm-up time of the
INFANT INCUBATOR measured as specified in 201.12.1.107.
201.7.9.2.9 Operating instructions
Addition:
The instructions for use shall contain the following additional items:
a) * a recommendation of the position and method of use of the SKIN TEMPERATURE SENSOR;
b) information on how and when to verify the functionality of the ALARM SYSTEM;
c) * information about the range of CONTROL TEMPERATURE and relative humidity of the
INFANT INCUBATOR; if the INFANT INCUBATOR is not supplied with means for control of the
degree of humidity, this shall be stated in the instructions for use;
d) * a statement of the maximum allowed weight of additional equipment which might be
placed on shelves connected to the INFANT INCUBATOR.
201.7.9.3 Technical description (see also Table C.6 of the general standard)
201.7.9.3.1 General
Additional item to the first paragraph:
– the maximum CO concentration (see 201.12.4.2.101).
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
Clause 8 of the general standard applies.
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS
Clause 9 of the general standard applies, except as follows:
201.9.2 MECHANICAL HAZARDS associated with moving parts
201.9.2.1 General
Addition:
This requirement is not applicable to an air circulating fan if it is accessible only when no
INFANT is present in the INFANT INCUBATOR and appropriate ME EQUIPMENT parts are removed
for cleaning.
201.9.6.2 Acoustic energy
201.9.6.2.1 Audible acoustic energy
Additional subclauses:
COMPARTMENT
201.9.6.2.1.101 * Sound level within the
In NORMAL USE, the sound level within the COMPARTMENT shall not exceed a sound pressure
level of 60 dB(A) except as specified in 201.9.6.2.1.103.
Compliance is checked by the following test:
With the microphone of a sound level meter complying with the requirements of
IEC 61672-1 [5] positioned 100 mm to 150 mm above the centre of the INFANT tray, the
measured sound level shall not exceed the specified values. For this test, the INFANT
INCUBATOR shall be operated at a CONTROL TEMPERATURE of 36 °C and at a maximum humidity.
COMPARTMENT shall be at least 10 dB below
The background sound level measured inside the
that which is measured during the test.
201.9.6.2.1.102 * Audible alarm sound level
Audible ALARM SIGNALS shall have a sound level of at least 65 dB(A) 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 dB(A). If the frequency of the
auditory alarms is adjustable by the OPERATOR, these requirements shall apply to all the
individual selectable frequencies.
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 dB(A) below that which is measured
during the test.
COMPARTMENT
201.9.6.2.1.103 * Audible alarms sound level within
When any INFANT INCUBATOR alarm is sounding, the sound level in the COMPARTMENT shall not
OPERATOR, this
exceed 80 dB(A). If the frequency of the auditory alarms is adjustable by the
shall apply to all the individual selectable frequencies.
Compliance is checked by the following test:
The alarm shall be actuated and the measurement shall be carried out as described in
201.9.6.2.1.101.
201.9.8 MECHANICAL HAZARDS associated with support systems
201.9.8.3 Strength of PATIENT or OPERATOR support or suspension systems
201.9.8.3.1 General
Amendment:
The normal load for an INFANT is reduced to 10 kg.

– 16 – IEC 60601-2-19:2020 © IEC 2020
Additional subclauses:
201.9.8.3.101 * Barriers
The INFANT shall be safely retained within the COMPARTMENT by barriers such as walls or side
panels. Barriers intended to be opened or removed to allow access to the INFANT, such as
doors, ports etc., shall close so as not to open under the test conditions specified below. It
shall not be possible for barriers to be insecurely closed or latched whilst appearing to be
engaged. The mechanical integrity of the INFANT INCUBATOR shall be maintained under the
following test conditions.
Compliance is checked by inspection and by the following test:
With all access port doors deliberately made as insecure as possible, without the use of a
TOOL, whilst still appearing to be engaged, a horizontal force shall be applied to the centre of
the access port door. The force shall be increased gradually from zero to 20 N in an interval
of 5 s to 10 s and shall be held at maximum for 5 s.
ATTRESS tray
201.9.8.3.102 M
If the MATTRESS tray can be extended outside the enclosure, it shall be restrained to ensure
INFANT INCUBATOR, is supported and does not tip under
that the tray remains attached to the
the weight of the INFANT.
Compliance is checked by the following test:
A gradually increasing downward force is applied to the middle of the outside edge of the
MATTRESS tray whilst in the fully extended position. The force is increased over 5 s to 10 s
intervals until it equals 100 N and shall be maintained for a period of 1 min. The tray shall not
INFANT INCUBATOR and there shall be no
incline by more than 5° to the horizontal axis of the
visible evidence of damage to the supporting structures.
Additional subclause:
201.9.8.101 Supports and mounting brackets for ACCESSORIES
Supports and mounting brackets for accessories shall be suitable and of adequate strength
for their purpose.
Compliance is checked by inspection and by the following test:
A gradually increasing force is applied so as to act vertically through the centre of the
ACCESSORY shelf in the extended position
supports and mounting brackets, for example an
with a MANUFACTURER's recommended load. The force is increased from zero in a 5 s to 10 s
interval, until it equals three times the recommended load and is sustained for a period of
1 min. There shall be no evidence of damage to the items under test.
201.10 Protection against unwanted and excessive radiation HAZARDS
Clause 10 of the general standard applies.
201.11 Protection against excessive temperatures and other HAZARDS
Clause 11 of the general standard applies, except as follows:

201.11.1 Excessive temperature in ME EQUIPMENT
PPLIED PARTS not intended to supply heat to a PATIENT
201.11.1.2.2 A
Replacement:
The temperature of the surfaces intended to be in contact with a PATIENT shall not exceed
40 °C. The temperature of other surfaces accessible to the PATIENT shall not exceed 40°C for
metal surfaces and 43 °C for other materials.
These requirements apply in NORMAL CONDITIONS and SINGLE FAULT CONDITIONS including:
– failure of the air circulation;
– failure of a THERMOSTAT;
– disconnection of the SKIN TEMPERATURE SENSOR.
Compliance is checked by the following test:
The maximum temperature of surfaces intended to be in contact with and surfaces accessible
to the INFANT shall be measured according to 11.1.2 of the general standard and include test
conditions as described in the compliance test of 201.12.3.101 and 201.15.4.2.1 of this
particular standard.
201.11.2 * Fire prevention
Subclause 11.2 of the general standard applies.
ME EQUIPMENT
201.11.6.2 * Overflow in
Addition:
If a water reservoir is provided as an integral part of the INFANT INCUBATOR, it shall have a
water level indicator with "max." and "min." markings if the level of the water in the tank
cannot be seen. The tank shall be so designed that it can be drained without tilting the INFANT
INCUBATOR.
Compliance is checked by inspection.
201.11.6.3 Spillage on ME EQUIPMENT and ME SYSTEMS
Replacement:
INFANT INCUBATORS shall be so constructed that spillage does not wet parts which if wetted
HAZARD.
might cause a safety
Such spillage is considered a SINGLE FAULT CONDITION.
Compliance is checked by the following test:
The ME EQUIPMENT shall be positioned as for NORMAL USE with the canopy in the normal
position; 200 ml of water is poured on any point of the top surface of the ME EQUIPMENT. After
this test, the ME EQUIPMENT shall comply with the requirements of this document.

– 18 – IEC 60601-2-19:2020 © IEC 2020
201.11.6.6 * Cleaning and disinfection of ME EQUIPMENT and ME SYSTEMS
Addition:
A humidifier, if provided, shall be designed to permit the application of PROCEDURES that effect
microbiological decontamination between uses.
201.11.8 Interruption of the power supply / SUPPLY MAINS to ME EQUIPMENT
Addition:
The ME EQUIPMENT shall be so designed that an interruption and a restoration of the power
supply of up to 10 min does not change the CONTROL TEMPERATURE or other preset values.
Compliance is checked by switching the SUPPLY MAINS off and then switching on and
ME EQUIPMENT.
inspecting the
201.12 Accuracy of controls and instruments and protection against
hazardous outputs
Clause 12 of the general standard applies, except as follows:
201.12.1 Accuracy of controls and instruments
Addition:
201.12.1.101 * Stability of INCUBATOR TEMPERATURE
During STEADY TEMPERATURE CONDITION, the INCUBATOR TEMPERATURE shall not differ from the
AVERAGE INCUBATOR TEMPERATURE by more than 0,5 °C.
Compliance is checked by measurement at CONTROL TEMPERATURES of 32 °C and 36 °C over a
period of at least 1 h.
201.12.1.102 * Uniformity of INCUBATOR TEMPERATURE
With an INFANT INCUBATOR working as an AIR CONTROLLED INCUBATOR and the CONTROL
TEMPERATURE set at any temperature within its range, the AVERAGE TEMPERATURE in each of
the points A, B, C, and D as specified in the test instruction shall not differ from the AVERAGE
INCUBATOR TEMPERATURE by more than 0,8 °C in NORMAL USE. In any position of the tilted
MATTRESS, it shall not differ by more than 1 °C.
Compliance is checked by the following test:
Calibrated temperature sensors shall be placed at five points in a plane parallel to and 10 cm
above the MATTRESS surface. Point M shall be a point 10 cm above the centre of the MATTRESS
(see Figure 201.102, point M). The other points shall be the centres of the four areas formed
by lines, which divide both the width and the length in two parts (see Figure 201.102, points A
to D). The AVERAGE TEMPERATURE at each of these five points shall be measured at CONTROL
TEMPERATURES of 32 °C and 36 °C.
The difference between the AVERAGE INCUBATOR TEMPERATURE (point M) and the measured
values at points A, B, C, and D shall be compared as specified. The test shall be undertaken
with the INFANT INCUBATOR MATTRESS tray horizontal and at the two extremes of its tilt angle.

201.12.1.103 * Accuracy of SKIN TEMPERATURE SENSOR
The accuracy of the SKIN TEMPERATURE SENSOR for measuring SKIN TEMPERATURE shall be
within ±0,3 °C.
Compliance is checked by the following test:
The SKIN TEMPERATURE SENSOR shall be immersed in a water bath which has the capability of
controlling the temperature of the water such that it fluctuates by less than ±0,1 °C around its
controlled value. The water bath temperature shall be at a nominal 36 °C. A standard
SKIN
thermometer shall be positioned with its temperature sensitive element adjacent to the
TEMPERATURE SENSOR. The displayed SKIN TEMPERATURE shall not differ from the water bath
temperature, measured within an uncertainty not greater than 0,05 °C, by more than 0,3 °C.
201.12
...

IEC 60601-2-19 ®
Edition 3.1 2023-11
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
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

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IEC 60601-2-19 ®
Edition 3.1 2023-11
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
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 978-2-8322-7850-5

IEC 60601-2-19 ®
Edition 3.1 2023-11
CONSOLIDATED VERSION
REDLINE VERSION
VERSION REDLINE
colour
inside
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

– 2 – IEC 60601-2-19:2020+AMD1:2023 CSV
© IEC 2023
CONTENTS
FOREWORD . 3
INTRODUCTION . 6
INTRODUCTION to Amendment 1 . 6
201.1 Scope, object and related standards. 7
201.2 Normative references . 9
201.3 Terms and definitions . 10
201.4 General requirements . 12
201.5 General requirements for testing ME EQUIPMENT . 12
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 13
201.7 ME EQUIPMENT identification, marking and documents . 13
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 15
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 15
201.10 Protection against unwanted and excessive radiation HAZARDS . 18
201.11 Protection against excessive temperatures and other HAZARDS . 18
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 19
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 25
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 25
201.15 Construction of ME EQUIPMENT . 25
201.16 ME SYSTEMS. 28
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 28
202 * Electromagnetic disturbances – Requirements and tests . 28
Annexes . 29
Annex AA (informative) Particular guidance and rationale . 30
Bibliography . 40
Index of defined terms used in this particular standard. 42

Figure 201.101 – Variation of INCUBATOR TEMPERATURE . 10
Figure 201.102 – Positioning of air temperature sensors . 11
Figure 201.103 – Layout of weight test devices . 22
Figure AA.1 – Illustration of the main requirements of this document . 30

Table 201.101 – Additional ESSENTIAL PERFORMANCE requirements . 12

© IEC 2023
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

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

FOREWORD
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between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with an IEC Publication.
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) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
This consolidated version of the official IEC Standard and its amendment has been
prepared for user convenience.
IEC 60601-2-19 edition 3.1 contains the third edition (2020-09) [documents
62D/1764/FDIS and 62D/1774/RVD] and its amendment 1 (2023-11) [documents
62D/2067/FDIS and 62D/2092/RVD].
In this Redline version, a vertical line in the margin shows where the technical content
is modified by amendment 1. Additions are in green text, deletions are in strikethrough
red text. A separate Final version with all changes accepted is available in this
publication.
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© IEC 2023
International standard IEC 60601-2-19 has been prepared by subcommittee 62D:
Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
This third edition constitutes a technical revision.
This edition includes the following significant technical change with respect to the previous
edition: re-dating of normative references.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this document, the following print types are used:
– requirements and definitions: roman type;
– test specifications: italic type;
– informative material appearing outside of tables, such as notes, examples and references: in smaller type.
Normative text of tables is also in a smaller type;
– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
NOTED: SMALL CAPITALS.
In referring to the structure of this document, the term
– "clause" means one of the seventeen numbered divisions within the table of contents,
inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
– "subclause" means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
subclauses of Clause 7).
References to clauses within this document are preceded by the term "Clause" followed by
the clause number. References to subclauses within this particular standard are by number
only.
In this document, the conjunctive "or" is used as an "inclusive or" so a statement is true if any
combination of the conditions is true.
The verbal forms used in this document conform to usage described in Clause 7 of the
ISO/IEC Directives, Part 2. For the purposes of this document, the auxiliary verb:
– "shall" means that compliance with a requirement or a test is mandatory for compliance
with this document;
– "should" means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this document;
– "may" is used to describe a permissible way to achieve compliance with a requirement or
test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
indicates that there is guidance or rationale related to that item in Annex AA.
A list of all parts of the IEC 60601 series, published under the general title Medical electrical
equipment, can be found on the IEC website.

© IEC 2023
The committee has decided that the contents of this document and its amendment 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,
• replaced by a revised edition, or
• amended.
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 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
implementation nationally not earlier than 3 years from the date of publication.

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.
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© IEC 2023
INTRODUCTION
The minimum safety requirements specified in this particular standard are considered to
provide for a practical degree of safety in the operation of INFANT INCUBATOR equipment.

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.

© IEC 2023
MEDICAL ELECTRICAL EQUIPMENT –

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

201.1 Scope, object and related standards
Clause 1 of the general standard applies, except as follows:
201.1.1 * Scope
Replacement:
This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT
INCUBATORS, as defined in 201.3.209, also referred to as ME EQUIPMENT.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to
ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the
case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS
within the scope of this document are not covered by specific requirements in this document,
except in 7.2.13 and 8.4.1 of the general standard.
NOTE See also 4.2 of the general standard.
This particular standard specifies safety requirements for INFANT INCUBATORS, but alternate
methods of compliance with a specific clause, by demonstrating equivalent safety, will not be
judged as non-compliant, if the MANUFACTURER has demonstrated in his RISK MANAGEMENT FILE
that the RISK presented by the HAZARD has been found to be of an acceptable level when
weighed against the benefit of treatment from the device.
This particular standard does not apply to:
– INFANT TRANSPORT INCUBATORS; for information, see IEC 60601-2-20 [1] ;
– INFANT RADIANT WARMERS; for information, see IEC 60601-2-21 [2];
– devices supplying heat via BLANKETS, PADS or MATTRESSES in medical use; for information,
see IEC 60601-2-35 [3];
– INFANT PHOTOTHERAPY EQUIPMENT; for information see IEC 60601-2-50 [4].
SKIN TEMPERATURE SENSORS which are applied to operate a BABY CONTROLLED INCUBATOR
including the displayed value are not considered to be a CLINICAL THERMOMETER in the sense
of the particular standard ISO 80601-2-56.
____________
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.
Figures in square brackets refer to the Bibliography.

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© IEC 2023
201.1.2 Object
Replacement:
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements for INFANT INCUBATORS as defined in 201.3.209, which minimize
HAZARDS to PATIENT and OPERATOR, and to specify tests by which compliance with the
requirements can be verified.
201.1.3 * Collateral standards
Addition:
This particular standard refers to those applicable collateral standards that are listed in
Clause 2 of the general standard and Clause 201.2 of this particular standard.
IEC 60601-1-2:2014 and IEC 60601‑1‑2:2014/AMD1:2020 applies apply 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.
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
Replacement:
In the IEC 60601 series, particular standards may modify, replace or delete requirements
contained in the general standard and collateral standards as appropriate for the particular
ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements.
A requirement of a particular standard takes priority over the general standard.
For brevity, IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601‑1:2005/AMD2:2020 are referred to in this particular standard as the general
standard. Collateral standards are referred to by their document number.
The numbering of clauses and subclauses of this particular standard corresponds to that of
the general standard with the prefix "201" (e.g. 201.1 in this document addresses the content
of Clause 1 of the general standard) or applicable collateral standard with the prefix "20x"
where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this
particular standard addresses the content of Clause 4 of the IEC 60601-1-2 collateral
standard, 203.4 in this particular standard addresses the content of Clause 4 of the
IEC 60601-1-3 collateral standard, etc.). The changes to the text of the general standard and
applicable collateral standards are specified by the use of the following words:
"Replacement" means that the clause or subclause of the general standard or applicable
collateral standard is replaced completely by the text of this particular standard.
"Addition" means that the text of this particular standard is additional to the requirements of
the general standard or applicable collateral standard.

© IEC 2023
"Amendment" means that the clause or subclause of the general standard or applicable
collateral standard is amended as indicated by the text of this particular standard.
Subclauses, figures or tables which are additional to those of the general standard are
numbered starting from 201.101. However, due to the fact that definitions in the general
standard are numbered 3.1 through 3.147, additional definitions in this document are
numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and
additional items aa), bb), etc.
Subclauses, figures or tables which are additional to those of a collateral standard are
numbered starting from 20x, where "x" is the number of the collateral standard, e.g. 202 for
IEC 60601-1-2, 203 for IEC 60601-1-3, etc.
The term "this document" is used to make reference to the general standard, any applicable
collateral standards and this particular standard taken together.
Where there is no corresponding clause or subclause in this particular standard, the clause or
subclause of the general standard or applicable collateral standard, although possibly not
relevant, applies without modification; where it is intended that any part of the general
standard or applicable collateral standard, although possibly relevant, is not to be applied, a
statement to that effect is given in this particular standard.
INFANT INCUBATOR supplied with dedicated physiological
IEC 80601‑2‑49 [15] applies to an
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
NOTE Informative references are listed in the Bibliography.
Clause 2 of the general standard applies, except as follows:
Addition:
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
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
Replacement:
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
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© IEC 2023
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601‑1:2005/AMD2:2020 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following
addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
NOTE An index of defined terms is found on page 42.
Addition:
201.3.201
AIR CONTROLLED INCUBATOR
INFANT INCUBATOR in which the air temperature is automatically controlled by an air
temperature sensor according to the CONTROL TEMPERATURE set by the OPERATOR
201.3.202
AVERAGE INCUBATOR TEMPERATURE
average of the INCUBATOR TEMPERATURE readings taken at regular intervals achieved during
STEADY TEMPERATURE CONDITION
SEE Figure 201.101
Figure 201.101 – Variation of INCUBATOR TEMPERATURE
201.3.203
AVERAGE TEMPERATURE
average of temperature readings taken at regular intervals at any specified point in the
COMPARTMENT achieved during STEADY TEMPERATURE CONDITION
201.3.204
BABY CONTROLLED INCUBATOR
AIR CONTROLLED INCUBATOR which has the additional capability of automatically controlling the
INCUBATOR air temperature in order to maintain the temperature as measured by a SKIN
TEMPERATURE SENSOR according to the CONTROL TEMPERATURE set by the OPERATOR

© IEC 2023
201.3.205
COMPARTMENT
environmentally-controlled enclosure intended to contain an INFANT and with transparent
section(s) which allows for viewing of the INFANT
201.3.206
CONTROL TEMPERATURE
temperature selected at the temperature control
201.3.207
INCUBATOR TEMPERATURE
temperature of the air at a point 10 cm above the centre of the MATTRESS surface in the
COMPARTMENT
SEE Figure 201.102, point M
Key
M INCUBATOR TEMPERATURE sensor
A, B, C, D air temperature sensor
The measuring points A to D and M are in a plane parallel to and at a distance of 10 cm from the MATTRESS.
Figure 201.102 – Positioning of air temperature sensors
201.3.208
INFANT
PATIENT up to the age of three months and a weight less than 10 kg
Note 1 to entry: INFANT includes premature/pre‑born baby and neonate baby/newborn baby.
201.3.209
INFANT INCUBATOR
ME EQUIPMENT having a COMPARTMENT which is provided with the means to control the
environment of the INFANT primarily by heated air within the COMPARTMENT
201.3.210
SKIN TEMPERATURE
temperature of the skin of the INFANT at a point on which the SKIN TEMPERATURE SENSOR is
placed
201.3.211
SKIN TEMPERATURE SENSOR
sensing device intended to measure the INFANT SKIN TEMPERATURE

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© IEC 2023
201.3.212
STEADY TEMPERATURE CONDITION
condition reached when the INCUBATOR TEMPERATURE does not vary by more than 1 °C over a
period of 1 h
SEE Figure 201.101
201.3.213
LOW FREQUENCY ELECTROMAGNETIC FIELDS
ELECTROMAGNETIC FIELDS with a frequency below 400 kHz
201.4 General requirements
Clause 4 of the general standard applies, except as follows:
201.4.1 Conditions for application to ME EQUIPMENT or ME SYSTEMS
Addition:
For INFANT INCUBATORS which combine alternative heat sources, for instance INFANT
INCUBATORS with integrated radiant warmers, devices supplying heat via BLANKETS, PADS or
MATTRESSES, etc., the safety requirements of the particular standards for these alternative
heat sources, if any, shall be met. The safety requirements of this particular standard shall not
be altered by such additional heat sources specified by the MANUFACTURER, details of which
are provided in the instruction for use.
Compliance is checked by the tests of Clause 201.11 and 201.15.4.2.1 of the relevant
particular standards (e.g. IEC 60601-2-21:2020 or IEC 60601-2-35:2020).
201.4.3 * ESSENTIAL PERFORMANCE
Addition:
201.4.3.101 ESSENTIAL PERFORMANCE of INFANT INCUBATORS
ESSENTIAL PERFORMANCE requirements are found in the subclauses listed in Table 201.101.
Table 201.101 – Additional ESSENTIAL PERFORMANCE requirements
Requirement Subclause
ESSENTIAL PERFORMANCE requirement 1 201.12.1.104 or generation of a visual and
audible alarm in compliance with 201.15.4.2.1 ee)
ESSENTIAL PERFORMANCE requirement 2 201.12.1.106 or generation of a visual and
audible alarm in compliance with 201.15.4.2.1 dd)

201.5 General requirements for testing ME EQUIPMENT
Clause 5 of the general standard applies, except as follows:
201.5.3 Ambient temperature, humidity, atmospheric pressure
Replacement of item a):
a) * After the ME EQUIPMENT to be tested has been set up for NORMAL USE (according to 5.7),
the ME EQUIPMENT shall comply with the requirements of this document when operating
within the following conditions:

© IEC 2023
– ambient temperature between +20 °C and +30 °C;
– ambient air velocity less than 0,3 m/s.
Addition:
If not otherwise specified in this particular standard, all tests shall be carried out at an
ambient temperature within the range of 21 °C to 26 °C.
201.5.4 Other conditions
Additional item to the existing list:
aa) If not otherwise specified, the CONTROL TEMPERATURE shall be 36 °C ± 1 °C and shall
always exceed the ambient temperature by at least 3 °C.
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
Clause 6 of the general standard applies.
201.7 ME EQUIPMENT identification, marking and documents
Clause 7 of the general standard applies, except as follows:
201.7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts
(see also Table C.1 of the general standard)
Additional subclauses:
201.7.2.101 * Oxygen monitor
An INFANT INCUBATOR not equipped with an integral oxygen monitor and which provides means
for oxygen administration shall be marked in a prominent position with a text which states:
"Use an oxygen monitor when oxygen is administered".
NOTE See also 7.5 of the general standard.
201.7.2.102 Heater surface temperature
If a heater is accessible without the use of a TOOL, a notice sign (see 7.5 of the general
standard) or marking shall be displayed adjacent to the heater giving warning of high surface
temperature.
201.7.4.2 * Control devices
Addition:
Temperature controls shall be clearly marked with temperature settings on or adjacent to the
control. The markings shall be provided at intervals of not greater than 0,5 °C for AIR
and not greater than 0,25 °C for BABY CONTROLLED INCUBATORS.
CONTROLLED INCUBATORS
Marking of the maximum and the minimum values of controls and indicators shall be such that
no confusion can arise with regard to the position of the control or the indicated values.
201.7.9.2.2 Warning and safety notices
Addition:
The instructions for use shall contain the following additional items.

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© IEC 2023
a) * A statement that an INFANT INCUBATOR should be used only by appropriately trained
personnel and under the direction of qualified medical personnel familiar with currently
known RISKS and benefits of INFANT INCUBATOR use.
b) * A warning that direct sunlight or other radiant heat sources can cause an increase in
INCUBATOR TEMPERATURE to dangerous levels.
c) * A statement that the use of oxygen increases the danger of fire and that auxiliary
equipment producing sparks shall not be placed in the INFANT INCUBATOR.
d) * A warning that even small quantities of flammable agents, such as ether and alcohol,
left in the INFANT INCUBATOR can cause fire in connection with oxygen.
e) * A statement of the maximum allowed weight of additional equipment which might be
placed on shelves connected to the INFANT INCUBATOR.
f) For an INFANT INCUBATOR having a TYPE B APPLIED PARTS where the INFANT may not be
isolated from earth, a warning that particular care shall be taken to ensure that
INFANT is electrically safe.
additional equipment connected to the
g) A warning stating that administration of oxygen may increase the noise level for the
INFANT within the INFANT INCUBATOR.
h) Explanation of the operation of supplementary oxygen equipment supplied for use with
the INFANT INCUBATOR or as specified in the ACCOMPANYING DOCUMENTS.
i) A statement that an oxygen analyzer shall be used when oxygen is delivered to the
NFANT.
I
j) Details of any specified combinations of ME EQUIPMENT (see 201.4.1).
SKIN TEMPERATURE SENSOR as a rectal temperature
k) * A warning against the use of the
sensor, if such a warning is applicable.
l) * A statement that the INFANT INCUBATOR cannot differentiate between an increase in
core temperature with a cold skin (fever) and a low core and SKIN TEMPERATURE
PATIENT.
(hypothermia), and a recommendation to monitor the temperature of the
201.7.9.2.8 * Start-up PROCEDURE
Addition:
The instructions for use shall additionally contain a specification of the warm-up time of the
INFANT INCUBATOR measured as specified in 201.12.1.107.
201.7.9.2.9 Operating instructions
Addition:
The instructions for use shall contain the following additional items:
SKIN TEMPERATURE SENSOR;
a) * a recommendation of the position and method of use of the
b) information on how and when to verify the functionality of the ALARM SYSTEM;
c) * information about the range of CONTROL TEMPERATURE and relative humidity of the
INFANT INCUBATOR; if the INFANT INCUBATOR is not supplied with means for control of the
degree of humidity, this shall be stated in the instructions for use;
d) * a statement of the maximum allowed weight of additional equipment which might be
INFANT INCUBATOR.
placed on shelves connected to the
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:

© IEC 2023
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
strength components in the vertical (z) and two perpendicular
ELECTROMAGNETIC FIELD
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
M
for use.
201.7.9.3 Technical description (see also Table C.6 of the general standard)
201.7.9.3.1 General
Additional item to the first paragraph:
– the maximum CO concentration (see 201.12.4.2.101).
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
Clause 8 of the general standard applies.
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS
Clause 9 of the general standard applies, except as follows:
201.9.2 MECHANICAL HAZARDS associated with moving parts
201.9.2.1 General
Addition:
This requirement is not applicable to an air circulating fan if it is accessible only when no
INFANT is present in the INFANT INCUBATOR and appropriate ME EQUIPMENT parts are removed
for cleaning.
==
=
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© IEC 2023
201.9.6.2 Acoustic energy
201.9.6.2.1 Audible acoustic energy
Additional subclauses:
COMPARTMENT
201.9.6.2.1.101 * Sound level within the
In NORMAL USE, the sound level within the COMPARTMENT shall not exceed a sound pressure
level of 60 dB(A) L = 55 dB A and L = 75 dB A except as specified in 201.9.6.2.1.103.
eq,1h F,max
Compliance is checked by the following test:
With the microphone of a sound level meter complying with the requirements of
IEC 61672-1 [5] positioned 100 mm to 150 mm above the centre of the INFANT tray, the
measured sound level shall not exceed the specified values. For this test, the INFANT
INCUBATOR shall be operated at a CONTROL TEMPERATURE of 36 °C and at a maximum humidity.
COMPARTMENT shall be at least 10 dB below
The background sound level measured inside the
that which is measured during the test.
201.9.6.2.1.102 * Audible alarm sound level
Audible ALARM SIGNALS shall have a sound level of at least 65 dB(A) 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 dB(A). If the frequency of the
auditory alarms is adjustable by the OPERATOR, these requirements shall apply to all the
individual selectable frequencies.
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 dB(A) below that which is measured
during the test.
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.
COMPARTMENT
201.9.6.2.1.103 * Audible alarms sound level within
When any INFANT INCUBATOR alarm is sounding, the sound level in the COMPARTMENT shall not
exceed 80 dB(A). If the frequency of the auditory alarms is adjustable by the OPERATOR, this
shall apply to all the individual selectable frequencies.
Compliance is checked by the following test:
The alarm shall be actuated and the measurement shall be carried out as described in
201.9.6.2.1.101.
© IEC 2023
201.9.8 MECHANICAL HAZARDS associated with support systems
PATIENT or OPERATOR support or suspension systems
201.9.8.3 Strength of
201.9.8.3.1 General
Amendment:
The normal load for an INFANT is reduced to 10 kg.
Additional subclauses:
201.9.8.3.101 * Barriers
The INFANT shall be safely retained within the COMPARTMENT by barriers such as walls or side
panels. Barriers intended to be opened or removed to allow access to the INFANT, such as
doors, ports etc., shall close so as not to open under the test conditions specified below. It
shall not be possible for barriers to be insecurely closed or latched whilst appearing to be
engaged. The mechanical integrity of the INFANT INCUBATOR shall be maintained under the
following test conditions.
Compliance is checked by inspection and by the following test:
With all access port doors deliberately made as insecure as possible, without the use of a
TOOL, whilst still appearing to be engaged, a horizontal force shall be applied to the centre of
the access port door. The force shall be increased gradually from zero to 20 N in an interval
of 5 s to 10 s and shall be held at maximum for 5 s.
201.9.8.3.102 MATTRESS tray
If the MATTRESS tray can be extended outside the enclosure, it shall be restrained to ensure
that the tray remains attached to the INFANT INCUBATOR, is supported and does not tip under
INFANT.
the weight of the
Compliance is checked by the following test:
A gradually increasing downward force is applied to the middle of the outside edge of the
MATTRESS tray whilst in the fully extended position. The force is increased over 5 s to 10 s
intervals until it equals 100 N and shall be maintained for a period of 1 min. The tray shall not
incline by more than 5° to the horizontal axis of the INFANT INCUBATOR and there shall be no
visible evidence of damage to the supporting structures.
Additional subclause:
201.9.8.101 Supports and mounting brackets for ACCESSORIES
Supports and mounting brackets for accessories shall be suitable and of adequate strength
for their purpose.
Compliance is checked by inspection and by the following test:
A gradually increasing force is applied so as to act vertically through the centre of the
supports and mounting brackets, for example an ACCESSORY shelf in the extended position
with a MANUFACTURER's recommended load. The force is increased from zero in a 5 s to 10 s
interval, until it equals three times the recommended load and is sustained for a period of
1 min. There shall be no evidence of damage to the items under test.

– 18 – IEC 60601-2-19:2020+AMD1:2023 CSV
© IEC 2023
201.10 Protection against unwanted and excessive radiation HAZARDS
Clause 10 of the general standard applies.
201.11 Protection against excessive temperatures and othe
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