33
Guidance and manufacturer’s declaration – electromagnetic immunity (cont.)
Immunity test
IEC 60601
test level
Compliance
level
Electromagnetic environment
– guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
+/- 2kV, +/- 4kV,
+/- 6 kV, +/- 8kV
contact discharge
+/- 2kV, +/- 4kV,
+/- 6 kV, +/- 8kV,
+/- 15 kV
air discharge
+/- 2kV, +/- 4kV,
+/- 6 kV, +/- 8kV
contact discharge
+/- 2kV, +/- 4kV,
+/- 6 kV, +/- 8kV,
+/- 15 kV
air discharge
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
100 kHz
repetition
frequency
± 2 kV
100 kHz repetition
frequency
Mains power quality should be that
of a typical commercial or hospital
environment.
Surge
IEC 61000-4-5
± 0,5 kV, ± 1 kV
Line-to-line
± 0,5 kV, ± 1 kV
Line-to-line
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 % UT; 0,5 cycle
At 0°, 45°, 90°,
135°, 180°, 225°,
270°, and 315°
0 % UT; 0,5 cycle
At 0°, 45°, 90°,
135°, 180°, 225°,
270°, and 315°
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the breast
pump requires continued operation
during power mains interruptions, it is
recommended that the breast pump
be powered from an uninterruptible
power supply or a battery.
Power
frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
30 A/m, 50 or
60 Hz
30 A/m, 50/60 Hz
It may be necessary to position the
breast pump further from sources
of power frequency magnetic fields
or to install magnetic shielding. The
power frequency magnetic field
should be measured in the intended
installation location to assure that it is
sufficiently low.
NOTE:
U
T
is the a.c. mains voltage prior to application of the test level.
