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
±6 kV contact
±8 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
±2 kV for power
supply lines
±1 kV for input /
output lines
Mains power quality should be
similar to that of a typical
commercial or hospital
environment.
Surge
IEC 61000-4-5
±1 kV common
mode
±2 kV differential
mode
±1 kV common
mode
±2 kV differential
mode
Mains power quality should be
similar to 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
T
1)
(>95% dip of U
T
)
for 1/2 cycle
40% U
T
(60% dip of U
T
)
for 5 cycles
70% U
T
(30% dip of U
T
)
for 25 cycles
<5% U
T
(>95% dip of U
T
)
for 5 s
<5% U
T
1)
(>95% dip of U
T
)
for 1/2 cycle
40% U
T
(60% dip of U
T
)
for 5 cycles
70% U
T
(30% dip of U
T
)
for 25 cycles
<5% U
T
(>95% dip of U
T
)
for 5 s
Mains power quality should be
similar to that of a typical
commercial or hospital
environment. When the user of
the Medical Electrical Equipment
continued function also calls in
the event of disruption of supply,
it is recommended the EUT from
an uninterruptible power supply
or a battery.
Power frequency
(50 Hz/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m
3 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 V
eff
150 kHz to
80 MHz
3 V
eff
150 kHz to
80 MHz
Portable and mobile RF
communication equipment should
be used no closer to any part of
the EUT, including cables, than
the recommended separation
distance calculated from the
equation applicable to the
frequency of the transmitter.
– 60 –
