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Table 11. Guidance and Manufacturer’s Declaration –
Electromagnetic Immunity
Immunity
Test
IEC 60601
Test Level
Compliance
Level
Electromag
-
netic
Environmen
t
Guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±8 kV contact
±15 kV air
±8 kV contact
±15 kV air
The relative
humidity should
be at least 15%.
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power
supply lines
±1 kV for input/
output lines
Not applicable
No guidance for
battery-powered
devices.
Surge
IEC 61000-4-5
±1 kV line to line
±2 kV line to
ground
Not applicable
No guidance for
battery-powered
devices.
Voltage dips,
short
interruptions
IEC 61000-4-11
<5% U
T
40% U
T
70% U
T
Not applicable
No guidance for
battery-powered
devices.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
30 A/m
30 A/m
Power frequency
magnetic fields
should be at
levels
characteristic of
a typical location
in a typical
commercial or
hospital
environment.
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to
80 MHz
3 Vrms
The device is
intended for use
in the
electromagnetic
environment in
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