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Table 2
Guidance and manufacturer’s declaration – electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below.
The customer or the user of the device 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
±8 kV contact
±15 kV air
±8 kV cont act
±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
power supply lines:
±2 kV
input/output lines:
±1 kV
power supply lines:
±2 kV
Mains power quality should be
that of a typical commercial or
hospital environment.
Surge
IEC61000-4-5
line(s) to line(s):
±1 kV
line(s) to earth:
±2 kV
100 kHz repetition
frequency
line(s) to line(s):
±1 kV
100 kHz repetition
frequency
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
0% 0.5 cycle
At 0°, 45°, 90°, 135°,
180°, 225°, 270°
and 315°
0% 1 cycle
and 70% 25/30 cycles
Single phase: at 0
0% 300 cycle
0% 0.5 cycle
At 0°, 45°, 90°, 135°,
180°, 225°, 270°
and 315°
0% 1 cycle
and 70% 25/30 cycles
Single phase: at 0
0% 300 cycle
Mains power quality should be
that of a typical commercial or
hospital environment.
Power frequency
(50Hz/60Hz)
magnetic field
IEC 61000-4-8
30 A/m
50Hz/60Hz
30 A/m
50Hz/60Hz
Power frequency magnetic
fields should be at levels charac-
teristic of a typical location in a
typical commercial or hospital
environment.
NOTE: UT is the a.c. mains voltage prior to application of the test level.
EMC GUIDANCE
167


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