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12 | 04.10.2021 | Page 44
Immunity test
Test level – IEC
60601
Compliance
level
Electromagnetic
environment - Guidelines
Discharge of
static electricity
(ESD) in
accordance with
EIC 61000-4-2
± 6 kV contact
discharge
± 8 kV air
discharge
± 6 kV contact
discharge
± 8 kV air
discharge
The floor should be made of
wood, concrete, or of tiles. In
case of synthetic flooring,
relative air humidity should be
at least 30%.
Electrical fast
transient
burst/immunity
test in
accordance with
IEC 61000-4-4
± 2 kV for power
cables
± 1 kV for input
and output cables
± 2 kV for power
cables
± 1 kV for input
and output cables
The quality of supply voltage
should comply with that of a
typical commercial or hospital
environment.
Surge voltage in
accordance with
IEC 61000-4-5
± 1 kV outer
conductor-outer
conductor
± 2 kV outer
conductor-ground
± 1 kV outer
conductor-outer
conductor
± 2 kV outer
conductor-ground
The quality of supply voltage
should comply with that of a
typical commercial or hospital
environment.
Voltage drops,
short
interruptions,
and fluctuations
in supply voltage
in accordance
with IEC 61000-
4-11
95% voltage drop
for ½ period
60% voltage drop
for 5 periods
30% voltage drop
for 25 periods
95% voltage drop
for 5 s
95% voltage drop
for ½ period
60% voltage drop
for 5 periods
30% voltage drop
for 25 periods
95% voltage drop
for 5 s
The quality of supply voltage
should comply with that of a
typical commercial or hospital
environment. If the device is
to continue functioning
uninterruptedly in case of
power interruptions, it is
recommended that the device
be operated via uninterrupted
power supply or a battery.
Magnetic field at
supply frequency
(50/60 Hz)
in accordance
with IEC 61000-
4-8
3 A/m 3 A/m In supply frequency, the
magnetic fields should comply
with the values characteristic
of locations in a typical
commercial or hospital
environment.
Conducted RF
disturbances in
accordance with
IEC 61000-4-6
3 V rms
150 kHz to 80
MHz
3 V rms
150 kHz to 80
MHz
When operating portable or
mobile RF communication
devices (transmitters), a
safety distance should be
observed to all parts of the
device, including cables,
calculated on the basis of one
of the following equations
depending on the transmission
frequency.
Recommended safety
distance:
d = 1.2
P
150 kHz to 80 MHz
d = 1.2
P
80 MHz to 800
MHz
d = 2.3
P
800 MHz to 2.5
GHz
Radiated RF
disturbances in
accordance with
IEC 61000-4-3
3 V/m
80 MHz to 2.5
GHz
3 V/m
80 MHz to 2.5
GHz
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