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EMC Guidance
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
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrical fast
transient / burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines
IEC 61000-4-11
Power frequency
(50 / 60 Hz) magnetic
field
IEC 61000-4-8
NOTE U
is the a.c. mains voltage prior to application of the test level.
T
59
IEC 60601 test level
Compliance level
±6 kV contact
±6 kV contact
±8 kV air
±8 kV air
±2 kV for power
Not applicable
supply lines
± 1 kV for input /
output lines
±1 kV line(s)
Not applicable
to line(s)
± 2 kV line(s) to
earth
<5% U
Not applicable
T
(>95% dip in U
)
T
for 0.5 cycle
40% U
T
(60% dip in U
)
T
for 5 cycles
70% U
T
(30% dip in U
)
T
for 25 cycles
<5% U
T
(>95% dip in U
)
T
for 5 s
3A / m
3A / m
Electromagnetic environment – guidance
Floors should be wood, concrete or ceramic tile. If floors are
covered with synthetic material, the relative humidity
should be at least 30 %.
Mains power quality should be that of a typical commercial
or hospital environment.
Mains power quality should be that of a typical commercial
or hospital environment.
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.
Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical commercial or
hospital environment.
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