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Table 2:
Guidance and MANUFACTURER’S declaration – electromagnetic IMMUNITY – for all ME EQUIPMENT and ME SYSTEMS
EMC Guidance
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
Not applicable
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
Not applicable
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
<5% U
T
(>95% dip in U
T
)
for 0.5 cycle
Not applicable
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.
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
Power frequency
(50 / 60 Hz) 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 U
T
is the a.c. mains voltage prior to application of the test level.
Содержание 1862.42
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