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
devices 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 ± 8 kV contact
Floors should be wood,
concrete or ceramic tile. If floors
are covered with synthetic
material, the relative humidity
should be at least 30 %.
± 15 kV air ± 15 kV air
Electrical fast
transient/burst IEC
61000-4-4
± 2 kV for power supply
lines
± 2 kV for power supply
lines
Mains power quality should be
that of a typical commercial or
hospital environment.
± 1 kV for input/output
lines
NA
Surge
IEC 61000-4-5
2 kV
0, 90, 180 & 270
degree phase angles
2 kV
0, 90, 180 & 270
degree phase angles
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
100% drop, 0.5 periods
(0°, 45°, 90°, 135°, 180°,
225°, 270°, 315°)
100% drop, 0.5 periods
(0°, 45°, 90°, 135°, 180°,
225°, 270°, 315°)
Mains power quality should be
that of a typical commercial or
hospital environment. If the user
of the device requires continued
operation during power mains
interruptions, it is recommended
that the device be powered from
an uninterruptible power supply
or a battery.
100% dip, 1 period 100% dip, 1 period
30% dip, 25/30 periods 30% dip, 25/30 periods
100% drop, 5 seconds 100% drop, 5 seconds
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.
Note
UT is the a.c. mains voltage prior to application of the test level.