IEC 60601-2-20:2009/AMD1:2016
(Amendment)Amendment 1 - Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators
Amendment 1 - Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators
Amendement 1 - Appareils électromédicaux - Partie 2-20: Exigences particulières pour la sécurité de base et les performances essentielles des incubateurs de transport pour nouveau-nés
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IEC 60601-2-20 ®
Edition 2.0 2016-04
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
AM ENDMENT 1
AM ENDEMENT 1
Medical electrical equipment –
Part 2-20: Particular requirements for the basic safety and essential performance
of infant transport incubators
Appareils électromédicaux –
Partie 2-20: Exigences particulières pour la sécurité de base et les performances
essentielles des incubateurs de transport pour nouveau-nés
IEC 60601-2-20:2009-02/AMD1:2016-04(en-fr)
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IEC 60601-2-20 ®
Edition 2.0 2016-04
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
AM ENDMENT 1
AM ENDEMENT 1
Medical electrical equipment –
Part 2-20: Particular requirements for the basic safety and essential performance
of infant transport incubators
Appareils électromédicaux –
Partie 2-20: Exigences particulières pour la sécurité de base et les performances
essentielles des incubateurs de transport pour nouveau-nés
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.10 ISBN 978-2-8322-3343-6
– 2 – IEC 60601-2-20:2009/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/1325/FDIS 62D/1346/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• withdrawn,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
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.
© IEC 2016
201.1.4 Particular standards
Add an asterisk at the beginning of the title, as follows:
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 TRANSPORT
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”.
Remove the reference to IEC 60601-1-10:2007.
201.3 Terms and definitions
Replace, in the first paragraph, “IEC 60601-1:2005” by “IEC 60601-1”.
201.3.204
BABY CONTROLLED TRANSPORT 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:
*k) a statement that the INFANT TRANSPORT 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, the phrase “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:
– 4 – IEC 60601-2-20:2009/AMD1:2016
© IEC 2016
For radiated radio-frequency electromagnetic fields, the INFANT TRANSPORT 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;
– for BASIC SAFETY and ESSENTIAL PERFORMANCE, Table 4 for EMERGENCY MEDICAL SERVICES
ENVIRONMENT applies (i.e. the system may fail to provide its intended function but shall not
create a safety HARM).
210 Requirements for the development of physiologic closed-loop controllers
Delete the entire Clause 210.
Add, before the annexes, the following new clause:
212 * Requirements for medical electrical equipment and medical electrical
systems intended for use in the emergency medical services environment
IEC 60601-1-12 applies except as follows:
212.4.2.1 * Environmental conditions of transport and storage between uses
Subclause 4.2.1 of IEC 60601-1-12 does not apply.
212.4.2.2.1 Continuous operating conditions
Subclause 4.2.2.1 of IEC 60601-1-12 does not apply.
NOTE Subclause 201.5.3 of this standard applies instead.
212.4.2.2.2 Transient operating conditions
Subclause 4.2.2 of IEC 60601-1-12 does not apply.
NOTE Subclause 201.12.1.113 of this standard applies instead.
212.5 * Classification of ME EQUIPMENT and ME SYSTEMS
Clause 5 of IEC 60601-1-12 does not apply.
NOTE See the additional statement in the instructions for use required by 212.6.3.2 of this particular standard.
212.6.3.2 Additional requirements for an electrical power source
Addition:
The instructions for use shall contain a statement that the TRANSPORT INCUBATOR may only be
used with supply mains that is regularly checked for proper PE connection.
212.6.3.4 * Additional requirements for operating instructions
Subclause 6.3.4 of IEC 60601-1-12 does not apply.
© IEC 2016
212.6.3.5 *Additional requirements for ME EQUIPMENT messages
Subclause 6.3.5 of IEC 60601-1-12 does not apply.
212.7 * Protection against electrical HAZARDS from ME EQUIPMENT
Clause 7 of IEC 60601-1-12 does not apply.
212.8.1 * Additional requirements for ingress of water or particulate matter into ME
EQUIPMENT and ME SYSTEMS
Subclause 8.1 of IEC 60601-1-12 does not apply.
212.9 Accuracy of controls and instruments and protection against hazardous
outputs
Clause 9 of IEC 60601-1-12 does not apply.
NOTE Clause 201.12.1.113 of this standard applies instead
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.
– 6 – IEC 60601-2-20:2009/AMD1:2016
© IEC 2016
1 °C
(201.12.1.105)
1,5 °C (201.12.1.102)
(2,0 °C tilted )
C
D
M
Air: 1,0 °C
A B
Skin: 0,5 °C
(201.7.4.2)
Air range
SKIN TEMPERATURE ±1,5 °C (20 °C to 30 °C
Display
Skin range
SENSOR
±2,0 °C (10 °C to 20 °C
(201.15.4.2.2)
36,3 °C
±0,3 °C (201.12.1.106)
(201.12.1.103)
(201.12.2.101)
Setting of
CONTROL
TEMPERATURE
0,7 °C
(201.12.1.104)
THERMAL
CUT-OUT
(201.15.4.2.1)
Overshoot maximum
+2 °C (201.12.1.108)
±1 °C
(201.12.1.101)
Maximum surface temperature
(201.11.1.2.2)
40 °C / 43 °C
Interruption of power
(201.12.3.103)
supply alarm
Room
(201.15.4.2.1)
temperature Overtemperature alarm
Warm-up
40 °C aa)
time
(201.12.1.107)
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
© IEC 2016
Subclause 201.1.4 – Particular standards
It is the primary purpose of a BABY CONTROLLED TRANSPORT INCUBATOR to maintain the
temperature as measured by a SKIN TEMPERATURE SENSOR. Hence, SKIN TEMPERATURE SENSORS
which are applied to operate a BABY CONTROLLED TRANSPORT INCUBATOR including the
displayed value are considered to be not a CLINICAL THERMOMETER in th
...
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