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Guidance and manufacturer’s declaration – electromagnetic immunity
Immunity test
IEC 60601-1-2 test
level
Compliance level
Electromagnetic
environment – guid-
ance
Electromagnetic
Discharge (ESD)
IEC 61000-4-2
±2kV, ±4kV, ±8kV,
±15kV air
±8kV contact
±2kV, ±4kV, ±8kV,
±15kV air
±8kV contact
Floors should be wood,
concrete or ceramic tile.
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synthetic material the
relative humidity level
should be at least 30%
Conducted
disturbances
inducted by RF
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EN 61000-4-6
3V in 0,15 MHz to
80 MHz
6V in ISM and amateur
radio bands between
0,15 MHz and 80 MHz
80% AM at 1 kHz
3V in 0,15 MHz to
80 MHz
6V in ISM and amateur
radio bands between
0,15 MHz and 80 MHz
80% AM at 1 kHz
Portable and mobile RF
communications
equipment should be
used no closer to any
part of the product,
including cables, than
1.0m, if the transmitter’s
output power rating
exceeds 1W
a
Field
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RF transmitters, as
determined by an
electromagnetic site
survey, should be less
than the compliance
level in each frequency
range
b
Interference may
occur in the vicinity of
equipment marked with
this symbol:
Radiated RF
electromagnetic
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EN 61000-4-3
Home Healthcare
environment 10 V/m
80 MHz to 2,7 GHz
80% AM at 1 kHz
Home Healthcare
environment 10 V/m
80 MHz to 2,7 GHz
80% AM at 1 kHz
Electrical fast
transient/burst
EN 61000-4-4
±1kV SIP/SOP ports
±2kV AC port
100 kHz repetition
frequency
±1kV SIP/SOP ports
±2kV AC port
100kHz repetition
frequency
Mains power supply
should be that of a
typical commercial or
hospital environment.
Power frequency
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EN 61000-4-8
30 A/m
30 A/m
Power frequency
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should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.