IEC 60601-2-19:2009/AMD1:2016

IEC 60601-2-19 ®
Edition 2.0 2016-04
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
AM ENDMENT 1
AM ENDEMENT 1
Medical electrical equipment –
Part 2-19: Particular requirements for the basic safety and essential performance
of infant incubators
Appareils électromédicaux –
Partie 2-19: Exigences particulières pour la sécurité de base et les performances
essentielles des incubateurs pour nouveau-nés

IEC 60601-2-19:2009-02/AMD1:2016-04(en-fr)

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 l'IEC ou du Comité national de l'IEC du pays du demandeur. Si vous avez des
questions sur le copyright de l'IEC ou si vous désirez obtenir des droits supplémentaires sur cette publication, utilisez
les coordonnées ci-après ou contactez le Comité national de l'IEC de votre pays de résidence.

IEC Central Office Tel.: +41 22 919 02 11
3, rue de Varembé Fax: +41 22 919 03 00
CH-1211 Geneva 20 info@iec.ch
Switzerland 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.

IEC Catalogue - webstore.iec.ch/catalogue Electropedia - www.electropedia.org
The stand-alone application for consulting the entire The world's leading online dictionary of electronic and
bibliographical information on IEC International Standards, electrical terms containing 20 000 terms and definitions in
Technical Specifications, Technical Reports and other English and French, with equivalent terms in 15 additional
documents. Available for PC, Mac OS, Android Tablets and languages. Also known as the International Electrotechnical
iPad. Vocabulary (IEV) online.

IEC publications search - www.iec.ch/searchpub IEC Glossary - std.iec.ch/glossary
The advanced search enables to find IEC publications by a 65 000 electrotechnical terminology entries in English and
variety of criteria (reference number, text, technical French extracted from the Terms and Definitions clause of
committee,…). It also gives information on projects, replaced IEC publications issued since 2002. Some entries have been
and withdrawn publications. collected from earlier publications of IEC TC 37, 77, 86 and

CISPR.
IEC Just Published - webstore.iec.ch/justpublished

Stay up to date on all new IEC publications. Just Published IEC Customer Service Centre - webstore.iec.ch/csc
details all new publications released. Available online and If you wish to give us your feedback on this publication or
also once a month by email. need further assistance, please contact the Customer Service
Centre: csc@iec.ch.
A propos de l'IEC
La Commission Electrotechnique Internationale (IEC) 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 IEC
Le contenu technique des publications IEC est constamment revu. Veuillez vous assurer que vous possédez l’édition la
plus récente, un corrigendum ou amendement peut avoir été publié.

Catalogue IEC - webstore.iec.ch/catalogue Electropedia - www.electropedia.org
Application autonome pour consulter tous les renseignements Le premier dictionnaire en ligne de termes électroniques et
bibliographiques sur les Normes internationales, électriques. Il contient 20 000 termes et définitions en anglais
Spécifications techniques, Rapports techniques et autres et en français, ainsi que les termes équivalents dans 15
documents de l'IEC. Disponible pour PC, Mac OS, tablettes langues additionnelles. Egalement appelé Vocabulaire
Android et iPad. Electrotechnique International (IEV) en ligne.

Recherche de publications IEC - www.iec.ch/searchpub Glossaire IEC - std.iec.ch/glossary
La recherche avancée permet de trouver des publications IEC 65 000 entrées terminologiques électrotechniques, en anglais
en utilisant différents critères (numéro de référence, texte, et en français, extraites des articles Termes et Définitions des
comité d’études,…). Elle donne aussi des informations sur les publications IEC parues depuis 2002. Plus certaines entrées
projets et les publications remplacées ou retirées. antérieures extraites des publications des CE 37, 77, 86 et

CISPR de l'IEC.
IEC Just Published - webstore.iec.ch/justpublished

Restez informé sur les nouvelles publications IEC. Just Service Clients - webstore.iec.ch/csc
Published détaille les nouvelles publications parues. Si vous désirez nous donner des commentaires sur cette
Disponible en ligne et aussi une fois par mois par email. publication ou si vous avez des questions contactez-nous:
csc@iec.ch.
IEC 60601-2-19 ®
Edition 2.0 2016-04
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
AM ENDMENT 1
AM ENDEMENT 1
Medical electrical equipment –

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

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

essentielles des incubateurs pour nouveau-nés

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.10 ISBN 978-2-8322-3342-9

– 2 – IEC 60601-2-19:2009/AMD1:2016
© IEC 2016
FOREWORD
This amendment has been prepared by subcommittee 62D: Electromedical equipment of IEC
technical committee 62: Electrical equipment in medical practice.
The text of this amendment is based on the following documents:
FDIS Report on voting
62D/1324/FDIS 62D/1345/RVD
Full information on the voting for the approval of this amendment can be found in the report
on voting indicated in the above table.
The committee has decided that the contents of this amendment and the base publication will
remain unchanged until the stability date indicated on the IEC website under
"http://webstore.iec.ch" in the data related to the specific publication. At this date, the
publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
_____________
INTRODUCTION
Replace, in the second paragraph, “IEC 60601-1:2005” by “IEC 60601-1”.
201.1 Scope, object and related standards
Replace, in footnote 1), “IEC 60601-1:2005” by “IEC 60601-1”.
201.1.3 * Collateral standards
Delete the asterisk (*) from the title.
Replace the second paragraph by the following text:
IEC 60601-1-2 applies as modified in Clause 202. IEC 60601-1-3 and IEC 60601-1-10 do not
apply. All other published collateral standards in the IEC 60601-1 series apply as published.
201.1.4 Particular standards
Add an asterisk at the beginning of the title, as follows:

© IEC 2016
201.1.4 * Particular standards
Add the following paragraph at the end of this subclause:
SKIN TEMPERATURE SENSORS which are applied to operate a BABY CONTROLLED INCUBATOR
including the displayed value are considered to be not a CLINICAL THERMOMETER in the sense
of the particular standard ISO 80601-2-56.
201.2 Normative references
Replace “IEC 60601-1-2:2007” by “IEC 60601-1-2”.
Delete the IEC 60601-1-10:2007 reference.
201.3 Terms and definitions
Replace, in the first paragraph, “IEC 60601-1:2005” by “IEC 60601-1”.
201.3.204
BABY CONTROLLED INCUBATOR
Remove the note at the end of the entry.
201.7.9.2.2 * Warning and safety notices
Add, after the existing text, the following new text:
*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.
201.12.1.109 * Accuracy of indication of relative humidity
Replace, in the first paragraph, “of actual measured value” by “relative humidity”.
202 Electromagnetic compatibility – Requirements and tests
Replace, in the first paragraph, “IEC 60601-1-2:2007” by “IEC 60601-1-2”.
202.6.2.3 Radiated RF electromagnetic fields
Replace the number, title and entire text by the following new subclause number, title and
text:
202.8.9 IMMUNITY TEST LEVELS
Addition:
For radiated radio-frequency electromagnetic fields, the INFANT INCUBATOR and/or system shall
– continue to perform its intended function as specified by the MANUFACTURER at a level up
to 3 V/m for the frequency range of the collateral standard for EMC.

– 4 – IEC 60601-2-19:2009/AMD1:2016
© IEC 2016
NOTE An INFANT INCUBATOR is not considered to be used in a HOME HEALTHCARE ENVIRONMENT.
210 Requirements for the development of physiologic closed-loop controllers
Delete the entire Clause 210.
Annex AA
(informative)
Particular guidance and rationale

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

© IEC 2016
0,8 °C
(201.12.1.105)
0,8 °C (201.12.1.102)
(1,0 °C tilted )
C
D
M
A B
Air: 0,5 °C
Skin: 0,25 °C
(201.7.4.2)
Air range
1,5 °C
SKIN TEMPERATURE
Display (201.15.4.2.2.101)
(201.12.1.106)
SENSOR
Skin range
36,3 °C
(201.15.4.2.2.102)
±0,3 °C
(201.12.1.103)
(201.12.2.101)
Setting of
CONTROL
0,7 °C
TEMPERATURE
(201.12.1.104)
THERMAL
CUT-OUT
(201.15.4.2.1)
Overshoot maximum
+2 °C (201.12.1.108)
±0,5 °C
(201.12.1.101)
Temperature alarm (201.15.4.2.1)
dd)
Air ±3 °C
ee)
Skin ±1 °C
Maximum surface
(201.11.1.2.2)
temperature
Room
temperature Interruption of power
(201.12.3.103)
Warm-up
supply alarm
time
Overtemperature alarm
(201.15.4.2.1)
(201.12.1.107)
Air controlled 38 °C
aa)
Baby controlled 40 °C bb)
IEC
NOTE Numbers in brackets indicate the relevant subclauses.
Figure AA.1 – Illustration of the main requirements of this standard
AA.2 Particular guidance
Subclause 201.1.3 – Collateral standards
Delete the title and entire text.
Add the following new text:
11 °C
°C
– 6 – IEC 60601-2-19:2009/AMD1:2016
© IEC 2016
Subclause 201.1.4 – Particular standards
It is the primary purpose of a BABY CONTROLLED INCUBATOR to maintain the temperature as
measured by a SKIN TEMPERATURE SENSOR. Hence, SKIN TEMPERATURE SENSORS which are
applied to operate a BABY CONTROLLED INCUBATOR including the displayed value are
considered to be not a CLINICAL THERMOMETER in the sense of the particular standard
ISO 80601-2-56 unless they are specifically extended to measure the body temperature.
The term body temperature is used for all other temperatures of the human body except SKIN
TEMPERATURE.
Subclause 201.7.9.2.2 – Warnings and safety notices
Replace the text in e) by the following new text:
e) The overloading of shelves could result in the INFANT INCUBATOR tipping over or
mechanical damage which could result in a HAZARD. Subclause 9.4.2.2 of IEC 60601-1
meets the test requirement necessary for INFANT INCUBATORS.
Add, after the existing text in k), the following new text:
l) The INFANT INCUBATOR cannot differentiate between an increase in core temperature with a
cold skin (fever) and a low core and SKIN TEMPERATURE (hypothermia). Therefore, in all
situations it is recommended that the temperature of the PATIENT be monitored separately.
Subclause 201.9.6.2.1.102 – Audible alarm sound level
Add, after the existing text, the following new text:
Reflecting rooms represent the acoustic situation in an intensive care nursery more
realistically than non-reflecting or semi-anechoic rooms that are very often used for sound
pressure measurements. However, reflecting rooms are not well defined and deliver less
reproducible values due to their variable size and geometry. The more idealized reverberation
chambers deliver very reproducible results but are sometimes difficult to get for tests.
Henceforth, the test can alternatively be performed in a semi-anechoic chamber that is very
often used to measure operating sound pressure level. Using a semi-anechoic chamber for
the measurements, the thresholds are lowered. This takes into account that reverberation
chambers when compared with semi-anechoic chambers obtain sound pressure levels that
are reflected mainly at the ceiling which can be considered as low compared to the typical
height of a device and to a minor extent by the lateral walls. For measurements in a semi-
anechoic chamber and
...