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41
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 air discharge
+/- 2kV, +/-4kV,
+/- 6 kV, +/- 8kV
contact discharge
+/- 2kV, +/-4kV,
+/- 6 kV, +/8kV, +/-
15 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.
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