IEC 60601-2-19:2009

IEC 60601-2-19 ®
Edition 2.0 2009-02
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

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by
any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either IEC or
IEC's member National Committee in the country of the requester.
If you have any questions about IEC copyright or have an enquiry about obtaining additional rights to this publication,
please contact the address below or your local IEC member National Committee for further information.

Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite
ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie
et les microfilms, sans l'accord écrit de la CEI ou du Comité national de la CEI du pays du demandeur.
Si vous avez des questions sur le copyright de la CEI ou si vous désirez obtenir des droits supplémentaires sur cette
publication, utilisez les coordonnées ci-après ou contactez le Comité national de la CEI de votre pays de résidence.

IEC Central Office
3, rue de Varembé
CH-1211 Geneva 20
Switzerland
Email: inmail@iec.ch
Web: www.iec.ch
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.

About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigenda or an amendment might have been published.
ƒ Catalogue of IEC publications: www.iec.ch/searchpub
The IEC on-line Catalogue enables you to search by a variety of criteria (reference number, text, technical committee,…).
It also gives information on projects, withdrawn and replaced publications.
ƒ IEC Just Published: www.iec.ch/online_news/justpub
Stay up to date on all new IEC publications. Just Published details twice a month all new publications released. Available
on-line and also by email.
ƒ Electropedia: www.electropedia.org
The world's leading online dictionary of electronic and electrical terms containing more than 20 000 terms and definitions
in English and French, with equivalent terms in additional languages. Also known as the International Electrotechnical
Vocabulary online.
ƒ Customer Service Centre: www.iec.ch/webstore/custserv
If you wish to give us your feedback on this publication or need further assistance, please visit the Customer Service
Centre FAQ or contact us:
Email: csc@iec.ch
Tel.: +41 22 919 02 11
Fax: +41 22 919 03 00
A propos de la CEI
La Commission Electrotechnique Internationale (CEI) est la première organisation mondiale qui élabore et publie des
normes internationales pour tout ce qui a trait à l'électricité, à l'électronique et aux technologies apparentées.

A propos des publications CEI
Le contenu technique des publications de la CEI est constamment revu. Veuillez vous assurer que vous possédez
l’édition la plus récente, un corrigendum ou amendement peut avoir été publié.
ƒ Catalogue des publications de la CEI: www.iec.ch/searchpub/cur_fut-f.htm
Le Catalogue en-ligne de la CEI vous permet d’effectuer des recherches en utilisant différents critères (numéro de référence,
texte, comité d’études,…). Il donne aussi des informations sur les projets et les publications retirées ou remplacées.
ƒ Just Published CEI: www.iec.ch/online_news/justpub
Restez informé sur les nouvelles publications de la CEI. Just Published détaille deux fois par mois les nouvelles
publications parues. Disponible en-ligne et aussi par email.
ƒ Electropedia: www.electropedia.org
Le premier dictionnaire en ligne au monde de termes électroniques et électriques. Il contient plus de 20 000 termes et
définitions en anglais et en français, ainsi que les termes équivalents dans les langues additionnelles. Egalement appelé
Vocabulaire Electrotechnique International en ligne.
ƒ Service Clients: www.iec.ch/webstore/custserv/custserv_entry-f.htm
Si vous désirez nous donner des commentaires sur cette publication ou si vous avez des questions, visitez le FAQ du
Service clients ou contactez-nous:
Email: csc@iec.ch
Tél.: +41 22 919 02 11
Fax: +41 22 919 03 00
IEC 60601-2-19 ®
Edition 2.0 2009-02
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
PRICE CODE
INTERNATIONALE
W
CODE PRIX
ICS 11.040.10 ISBN 978-2-88910-217-4
– 2 – 60601-2-19 © IEC:2009
CONTENTS
FOREWORD.3
INTRODUCTION.5
201.1 Scope, object and related standards .6
201.2 Normative references .8
201.3 Terms and definitions.8
201.4 General requirements.10
201.5 General requirements for testing ME EQUIPMENT.11
201.6 Classification of ME EQUIPMENT and ME SYSTEMS .11
201.7 ME EQUIPMENT identification, marking and documents.11
201.8 Protection against electrical HAZARDS from ME EQUIPMENT.13
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS.13
201.10 Protection against unwanted and excessive radiation HAZARDS.15
201.11 Protection against excessive temperatures and other HAZARDS.15
201.12 Accuracy of controls and instruments and protection against hazardous
outputs.17
201.13 HAZARDOUS SITUATIONS and fault conditions.22
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) .22
201.15 Construction of ME EQUIPMENT .23
201.16 ME SYSTEMS .25
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS.25
202 Electromagnetic compatibility - Requirements and tests .25
210 Requirements for the development of physiologic closed-loop controllers.26
Annexes .26
Annex AA (informative) Particular guidance and rationale.27
Bibliography.34
Index of defined terms used in this particular standard.35

Figure 201.101 – INFANT SKIN TEMPERATURE measurement .9
Figure 201.102 – Variation of INCUBATOR TEMPERATURE.10
Figure 201.103 – Layout of weight test devices.20

Table 201.101 – Additional ESSENTIAL PERFORMANCE requirements.11

60601-2-19 © IEC:2009 – 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 second edition cancels and replaces the first edition published in 1990 and its
Amendment 1 (1996). This edition constitutes a technical revision. It was revised to
structurally align with the third edition (2005) of IEC 60601-1.
The text of this particular standard is based on the following documents:
FDIS Report on voting
62D/727/FDIS 62D/756/RVD
Full information on the voting for the approval of this particular standard can be found in the
report on voting indicated in the above table.

– 4 – 60601-2-19  IEC:2009
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this standard, 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.
ERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
– T
NOTED: SMALL CAPITALS.
In referring to the structure of this standard, 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 standard are preceded by the term “Clause” followed by the
clause number. References to subclauses within this particular standard are by number only.
In this standard, 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 standard conform to usage described in Annex H of the ISO/IEC
Directives, Part 2. For the purposes of this standard, the auxiliary verb:
– “shall” means that compliance with a requirement or a test is mandatory for compliance
with this standard;
– “should” means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this standard;
– “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 publication will remain unchanged until
the maintenance result date indicated on the IEC web site under "http://webstore.iec.ch" in
the data related to the specific publication. At this date, the publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
The contents of the corrigendum of February 2012 have been included in this copy.

60601-2-19 © IEC:2009 – 5 –
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.

– 6 – 60601-2-19 © IEC:2009
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
1)
Clause 1 of the general standard applies, except as follows:
201.1.1 Scope
Replacement:
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT
INCUBATORS, as defined in 201.3.209 of this standard, 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 standard are not covered by specific requirements in this standard
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:
– devices supplying heat via BLANKETS, PADS or MATTRESSES in medical use; for information
2)
see IEC 80601-2-35 [3] ;
– INFANT RADIANT WARMERS; for information, see IEC 60601-2-21 [2];
INFANT TRANSPORT INCUBATORS, for information, see IEC 60601-2-20 [1];
–
– INFANT PHOTOTHERAPY EQUIPMENT, for information see IEC 60601-2-50 [4].
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 201.3.208, which minimize
HAZARDS to PATIENT and OPERATOR, and to specify tests by which compliance with the
requirements can be verified.
—————————
1)
The general standard is IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for

basic safety and essential performance.
2)
Figures in square brackets refer to the Bibliography.

60601-2-19 © IEC:2009 – 7 –
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 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.
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 is 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 standard 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 60601-1-2 collateral standard,
203.4 in this particular standard addresses the content of Clause 4 of the 60601-1-3 collateral
standard, etc.). The changes to the text of the general standard 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, additional definitions in this standard are
numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and
additional items aa), bb), etc.
Subclauses or figures 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 standard" 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

– 8 – 60601-2-19 © IEC:2009
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
Clause 2 of the general standard applies, except as follows:
Amendment:
IEC 60601-1-2:2007, Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral standard: Electromagnetic compatibility –
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
NOTE Informative references are listed in the bibliography beginning on page 34.
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:
NOTE An index of defined terms is found beginning on page 35.
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)
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
an AIR CONTROLLED INCUBATOR which has the additional capability of automatically controlling
INCUBATOR air temperature in order to maintain the temperature as measured by a SKIN
the
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.

60601-2-19 © IEC:2009 – 9 –
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)
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
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

– 10 – 60601-2-19 © IEC:2009
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 one hour (see Figure 201.102)
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 subclause 201.15.4.2.1 of the
relevant particular standards (e.g. IEC 60601-2-21 or IEC 80601-2-35).
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.

60601-2-19  IEC:2009 – 11 –
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 standard when operating within
the following conditions
– an ambient temperature between +20 °C and +30 °C;
– an 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
Addition:
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)
Addition:
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.

– 12 – 60601-2-19 © IEC:2009
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 the following:
*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 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).
*k) A warning against the use of the SKIN TEMPERATURE SENSOR as a rectal temperature
sensor, if such a warning is applicable.

60601-2-19 © IEC:2009 – 13 –
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 subclause 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
201.7.9.3.1 General
Additional item:
– the MANUFACTURER shall specify in the ACCOMPANYING DOCUMENTS the maximum CO
concentration (see subclause 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 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

– 14 – 60601-2-19  IEC:2009
In NORMAL USE the sound level within the COMPARTMENT shall not exceed a sound pressure
level of 60 dB A except as specified in subclause 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. 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 dBA at a distance of 3 m
perpendicular to the front of the control unit in a reflecting room. The auditory alarm may be
adjusted by the OPERATOR to a minimum lower level of 50 dBA. 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 dBA 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 dBA. 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
subclause 201.9.6.2.1.101.
201.9.8 HAZARDS associated with support systems
201.9.8.3 Strength of PATIENT or OPERATOR support or suspension system
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:

60601-2-19 © IEC:2009 – 15 –
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 – 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
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 – 10 s
intervals until it equals 100 N and is to 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, e.g. 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.
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:

– 16 – 60601-2-19 © IEC:2009
– 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 subclauses 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 standard.
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
inspecting the ME EQUIPMENT.
60601-2-19 © IEC:2009 – 17 –
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
Additional subclauses:
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 201.101, 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 201.101, 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
thermometer shall be positioned with its temperature sensitive element adjacent to the SKIN
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.
SKIN TEMPERATURE and CONTROL TEMPERATURE
201.12.1.104 * Accuracy between
With an INFANT INCUBATOR working in the BABY CONTROLLED INCUBATOR mode with horizontal
MATTRESS orientation, the temperature as measured by the SKIN TEMPERATURE SENSOR shall
not differ from the CONTROL TEMPERATURE by more than 0,7 °C in STEADY TEMPERATURE
CONDITION.
– 18 – 60601-2-19  IEC:2009
Compliance is checked by the following test:
The SKIN TEMPERATURE SENSOR shall be freely suspended 10 cm above the centre of the
MATTRESS surface. The SKIN TEMPERATURE shall be measured at CONTROL TEMPERATURES of
36 °C.
If it can be demonstrated that an alternative test method is more relevant for this test the
MANUFACTURER may use that method to verify
...