Emissions test
Com
pliance
Electromagnetic
environment -
guidance
RF emissions
CISPR 11
Class B
Harmonic
emissions IEC
61000-3-2
Not
applica
ble
Voltage
fluctua
tions/flicker
emissions IEC
61000-3-3
Not
applica
ble
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.
Immuni
ty test
IEC
60601
test
level
Com
pliance
level
Electromagnetic
environment -
guidance
Electro
static
dis
charge
(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%.
Electri
cal fast
tran
sient/b
urst IEC
61000-
4-4
±2 kV for
power
supply
lines
±1 kV for
input/o
utput
lines
±2 kV
for
power
supply
lines
Electrical 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)
Electrical power
quality should be
that of a typical
commercial or
hospital
environment.
Voltage
dips,
short
interrup
tions
and
voltage
varia
tions 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
Electrical power
quality should be
that of a typical
commercial or
hospital
environment. If the
user of the device
requires continued
operation during
power
interruptions, it is
recommended
that the device be
powered from an
uninterruptible
power supply or a
battery.
Power
fre
quency
(50/60
Hz)
magnet
ic 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 AC electrical voltage prior to
application of the test level.
Table 4 Guidance and manufacturer's
declaration – electromagnetic immunity
–for ME equipment and ME systems that
are not life supporting
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
Conducted RF
IEC
61000-4-6
3 Vrms
150 kHz to
80 MHz
3 Vrms
Radiated RF
IEC
61000-4-3
3 V/m
80 MHz to 2.5
GHz
3 V/m
Electromagnetic environment - guidance
Portable and mobile RF communications
equipment should be used no closer to any part of
the device, including cables, than the
recommended separation distance calculated from
the equation applicable to the frequency of the
transmitter.
Recommended separation distance:
d = 1.167
Ö
P
d = 1.167
Ö
P
80 MHz to 800MHz
d = 2.333
Ö
P
800 MHz to 2.5 GHz
where
P
is the maximum output power rating of
the transmitter in watts (W) according to the
transmitter manufacturer and
d
is the
recommended separation distance in metres (m).
