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Table 2 Guidance and MANUFACTURER’s declaration – electromagnetic IMMUNITY
for all ME EQUIPMENT and ME SYSTEMS
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
±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%.
Electrical fast transient/burst
IEC 61000-4-4
±2 kV for
power supply lines
±1 kV for
input/output lines
±2 kV for power
supply lines
Mains power quality should be that of a
typical commercial or hospital environment.
Surge IEC 61000-4-5
±1 kV line(s)
to line(s)
±2 kV line(s)
to earth
±1 kV line(s) to
line(s)
Mains power quality should be that of a
typical commercial or hospital environment.
Voltage dips, short interruptions
and voltage variations on power
supply i
nput 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 s
<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 s
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 inter-
ruptions,
it is recommended that the device be powered
from an uninterruptible power supply or a battery.
Power frequency
(50/60Hz) magnetic field IEC 61000-
4-8
3A/m
3A/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.
