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
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
input 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
interruptions, 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.
