IEC 60601-2-19:2009/AMD1:2016
(Amendment)Amendment 1 - Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
Amendment 1 - Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
Amendement 1 - Appareils électromédicaux - Partie 2-19: Exigences particulières pour la sécurité de base et les performances essentielles des incubateurs pour nouveau-nés
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IEC 60601-2-19 ®
Edition 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)
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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• withdrawn,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
...
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