58
Guidance and manufacturer’s declaration – electromagnetic immunity
Immunity test
IEC 60601-1-2 test level
Compliance level
Electromagnetic
environment – guidance
Electrostatic
discharge
(ESD)
EN 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.
If floors are covered with
synthetic material the
relative humidity level
should be at least 30%
Conducted
disturbances
inducted by RF
fields
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
strengths from fixed 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
field
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
Proximity fields
from RF
wireless
communication
s equipment
EN 61000-4-3
385 MHz - 27 V/m
450 MHz - 28 V/m
710, 745, 780 MHz - 9V/m
810, 870, 930 MHz - 28 V/m
1720, 1845, 1970, 2450 MHz
- 28 V/m
5240,5500, 5785 MHz - 9V/
m
385 MHz - 27 V/m
450 MHz - 28 V/m
710, 745, 780 MHz - 9V/m
810, 870, 930 MHz - 28 V/m
1720, 1845, 1970, 2450
MHz - 28 V/m
5240,5500, 5785 MHz - 9V/
m
Electrical fast
transient/burst
EN 61000-4-4
±1kV SIP/SOP ports
±2kV AC port
100kHz 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
Magnetic field
EN 61000-4-8
30A/m
50 Hz or 60 Hz
30A/m
50 Hz
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
Surge
IEC 61000-4-5
±0,5kV ±1kV; ±2 kV, AC
Mains, Line to Ground
±0,5kV ±1kV, AC Mains, Line
to Line
±0,5kV ±1kV; ±2 kV, AC
Mains, Line to Ground
±0,5kV ±1kV, AC Mains,
Line to Line