EN
12
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
±6 kV contact
±8 kV air
±8 kV contact
±15 kV air
Floors should be
wood, concrete
or ceramic tile. If
floors are covered
with synthetic
material, the
relative humidity
should be at least
30%.
Electrical Fast
Transient/
Burst
IEC 61000-4-4
±2 kV for power
supply lines
±1 kV for input/
output lines
N/A. Battery
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quality should be
that of a typical
commercial
or hospital
environment.
Surge
IEC 61000-4-5
±1 kV differential
mode
±2 kV common
mode
N/A. Battery
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Main power
quality should be
that of a typical
commercial
or hospital
environment.
Voltage
dips, short
interruptions
and voltage
variations on
power supply
input lines
IEC 61000-4-11
<5% U (>95% dip in
TU) for 0.5 cycle
40% U (60% dip in
TU) for 5 cycles
70% U (30% dip in
TU) for 25 cycles
<5% U (>95% dip in
TU) for 5 sec
N/A. Battery
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Main power
quality should be
that of a typical
commercial
or hospital
environment.
Power
Frequency
(50/60Hz)
Magnetic
Fields
IEC 61000-4-8
3 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.
