Rev: A1
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Guidance and manufacturer’s declaration – electromagnetic immunity
The [EQUIPMENT or SYSTEM] is intended for use in the electromagnetic environment
specified below. The customer or the user of the [EQUIPMENT or SYSTEM] should assure
that it is used in such an environment.
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%. If
ESD interfere with the operation of
equipment, counter measurements
such as wrist strap, grounding shall
be considered.
Electrical fast
transient/burst IEC
61000-4-4
±
2 kV for
power supply
lines
Not
applicable
Mains power quality should be that
of a typical commercial or hospital
environment.
Surge
IEC 61000-4-5
±
1 kV
differential
mode
±
2 kV common
mode
Not
applicable
Mains 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% UT
(
>
95% dip in
UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
< 5% UT
(
>
95% dip in
UT)
for 5 sec
Not
applicable
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the
[equipment or system] requires
continued operation during power
mains interruptions, it is
recommended that the [equipment or
system] be powered from an
uninterruptible power supply or a
battery.
Power frequency
(50/60 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.
