Table 8. Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
Immunity Test
IEC 60601 Test Level
Compliance Level
Electromagnetic Environment
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 which radiated RF disturbances
are controlled. The customer or
the user of the device can help
prevent electromagnetic
interference by maintaining a
minimum distance between
portable and mobile RF
6 Vrms (ISM/Radio bands
between 150 kHz to 80 MHz)
80% AM at 1 kHz
6 Vrms
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