Guidance and manufacturer’s declaration – electromagnetic immunity
The [EQUIPMENT or SYSTEM] is intended for use in the electromagnetic environment specified
below. The customer or the user of the [EQUIPMENT or SYSTEM] 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%. If ESD interfere
with the operation of equipment, counter
measurements such as wrist strap,
grounding shall be considered.
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
differential mode
±
2 kV common
mode
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% 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 sec
Not applicable
Mains power quality should be that of a
typical
commercial
or
hospital
environment.
If
the
user
of
the
[equipment or system] requires continued
operation
during
power
mains
interruptions, it is recommended that the
[equipment or system] be powered from
an uninterruptible power supply or a
battery.
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.
20
Rev
：A1
