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Table 1 Guidance and manufacturer's
declaration – electromagnetic emissions
- for all ME equipment and ME systems
Guidance and manufacturer's declaration –
electromagnetic emissions
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.
Emissions test Com
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic
emissions IEC
61000-3-2
Voltage
fluctua
tions/flicker
emissions IEC
61000-3-3
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.
Immu
nity
test
Electro
static
dis
charge
(ESD)
IEC
61000-
4-2
Electri
cal fast
tran
sient/b
urst IEC
61000-
4-4
Surge
IEC
61000-
4-5
Voltage
dips,
short
interrup
tions
and
voltage
varia
tions on
power
supply
input
lines IEC
61000-
4-11
Power
fre
quency
(50/60
Hz)
magnet
ic field
IEC
61000-
4-8
Note: UT is the AC mains 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
Conducted RF
IEC
61000-4-6
Radiated RF
IEC
61000-4-3
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
pli
ance
Group 1 The device must emit
Class B
Not
applica
ble
Not
applica
ble
IEC
60601
test
level
±6 kV
contact
±8 kV air
±2 kV for
power
supply
lines
±1 kV for
input/o
utput
lines
±1 kV
line(s) to
line(s)
±2 kV
line(s) to
earth
<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
3A/m
IEC 60601
TEST LEVEL
3 Vrms
150 kHz to
80 MHz
3 V/m
80 MHz to 2.5
GHz
Electromagnetic
environment -
guidance
electromagnetic
energy in order to
perform its intended
function. Nearby
electronic equipment
may be affected.
Com
Electromagnetic
pli
environment -
ance
guidance
level
±6 kV
Floors should be
contact
wood, concrete or
±8 kV
ceramic tile. If
air
floors are covered
with synthetic
material, the
relative humidity
should be at least
30%.
±2 kV
Mains power
for
quality should be
power
that of a typical
supply
commercial or
lines
hospital
environment.
±1 kV
Mains power
line(s)
quality should be
to
that of a typical
line(s)
commercial or
hospital
environment.
<5% UT
Mains power
(>95%
quality should be
dip in
that of a typical
UT) for
commercial or
0.5
hospital
cycle
environment. If the
40% UT
user of the device
(60%
requires continued
dip in
operation during
UT ) for
power mains
5
interruptions, it is
cycles
recommended
70% UT
that the device be
(30%
powered from an
dip in
uninterruptible
UT ) for
power supply or a
25
battery.
cycles
<5% UT
(>95%
dip in
UT ) for
5 s
3A/m
Power frequency
magnetic fields
should be at levels
characteristic of a
typical location in
a typical
commercial or
hospital
environment.
Compliance
level
3 Vrms
3 V/m
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