SIST EN IEC 60601-2-19:2021

SLOVENSKI STANDARD
01-september-2021
Nadomešča:
SIST EN 60601-2-19:2009
SIST EN 60601-2-19:2009/A1:2017
SIST EN 60601-2-19:2009/A11:2012
Medicinska električna oprema - 2-19. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti otroških inkubatorjev (IEC 60601-2-19:2020)
Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and
essential performance of infant incubators (IEC 60601-2-19:2020)
Medizinische elektrische Geräte - Teil 2-19: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Säuglingsinkubatoren (IEC
60601-2-19:2020)
Appareils électromédicaux - Partie 2-19: Exigences particulières pour la sécurité de base
et les performances essentielles des incubateurs pour nouveau-nés (IEC 60601-2-
19:2020)
Ta slovenski standard je istoveten z: EN IEC 60601-2-19:2021
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN IEC 60601-2-19

NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2021
ICS 11.040.10 Supersedes EN 60601-2-19:2009 and all of its
amendments and corrigenda (if any)
English Version
Medical electrical equipment - Part 2-19: Particular requirements
for the basic safety and essential performance of infant
incubators
(IEC 60601-2-19:2020)
Appareils électromédicaux - Partie 2-19: Exigences Medizinische elektrische Geräte - Teil 2-19: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des incubateurs pour nouveau-nés wesentlichen Leistungsmerkmale von Säuglingsinkubatoren
(IEC 60601-2-19:2020) (IEC 60601-2-19:2020)
This European Standard was approved by CENELEC on 2020-10-07. CENELEC members are bound to comply with the CEN/CENELEC
Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
Management Centre or to any CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.

European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2021 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 60601-2-19:2021 E

European foreword
The text of document 62D/1764/FDIS, future edition 3 of IEC 60601-2-19, prepared by SC 62D
"Electromedical equipment" of IEC/TC 62 "Electrical equipment in medical practice" was submitted to
the IEC-CENELEC parallel vote and approved by CENELEC as EN IEC 60601-2-19:2021.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2022-01-16
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2024-07-16
document have to be withdrawn
This document supersedes EN 60601-2-19:2009 and all of its amendments and corrigenda (if any).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national committee. A
complete listing of these bodies can be found on the CENELEC website.
Endorsement notice
The text of the International Standard IEC 60601-2-19:2020 was approved by CENELEC as a
European Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards
indicated:
IEC 60601-2-20:2020 NOTE Harmonized as EN IEC 60601-2-20:2020 (not modified)
IEC 60601-2-21:2020 NOTE Harmonized as EN IEC 60601-2-21:2020 (not modified)
IEC 60601-2-35:2020 NOTE Harmonized as EN IEC 80601-2-35:2020 (not modified)
IEC 60601-2-50:2020 NOTE Harmonized as EN IEC 60601-2-50:2020 (not modified)
IEC 61672-1 NOTE Harmonized as EN 61672-1
ISO 80601-2-56 NOTE Harmonized as EN ISO 80601-2-56
IEC 60601-1-10 NOTE Harmonized as EN 60601-1-10
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments)
applies.
NOTE 1 Where an International Publication has been modified by common modifications, indicated by (mod),
the relevant EN/HD applies.
NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is
available here: www.cenelec.eu.
The Annex ZA of EN 60601-1:2006/A1:2013 applies with the following additions:
Publication Year Title EN/HD Year
IEC 60601-1 2005 Medical electrical equipment - Part 1: EN 60601-1 2006
General requirements for basic safety and
essential performance
- -  + corrigendum Mar. 2010
+ A1 2012  + A1 2013
- -  + A12 2014
The Annex ZA of EN 60601-1:2006/A1:2013 applies with the following replacements:
IEC 60601-1-2 2014 Medical electrical equipment - Part 1-2: EN 60601-1-2 2015
General requirements for basic safety and
essential performance - Collateral
Standard: Electromagnetic disturbances -
Requirements and tests
IEC 60601-2-19 ®
Edition 3.0 2020-09
INTERNATIONAL
STANDARD
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 978-2-8322-8711-8
– 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

IEC 60601-2-19:2020 © IEC 2020 – 3 –
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,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as "IEC
Publication(s)"). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC 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.
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.

IEC 60601-2-19:2020 © IEC 2020 – 5 –
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.

IEC 60601-2-19:2020 © IEC 2020 – 7 –
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.

IEC 60601-2-19:2020 © IEC 2020 – 9 –
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
IEC 60601-2-19:2020 © IEC 2020 – 11 –

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:

IEC 60601-2-19:2020 © IEC 2020 – 13 –
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).

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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.
IEC 60601-2-19:2020 © IEC 2020 – 15 –
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.

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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:

IEC 60601-2-19:2020 © IEC 2020 – 17 –
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.

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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 eac
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