Table 2
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
IEC 60601-1-2
test
test level
Electrostatic
±8 kV contact
discharge (ESD)
±15 kV air
IEC 61000-4-2
Power supply lines:
Electrical fast
±2 kV
transient/burst
input/output lines:
IEC 61000-4-4
±1 kV
line(s) to line(s): ±1 kV
Surge
line(s) to earth: ±2 kV
IEC61000-4-5
100 kHz repetition
frequency
Voltage dips,
0%UT; 0.5 cycle
short
At 0°, 45°, 90°, 135°,
interruptions
180°,225°,270° and 315°
and voltage
0%UT ; 1 cycle and 70%
variations on
UT ; 25/30 cycles
power supply
Single phase: at 0°
input lines
0% UT ; 300 cycle
IEC 61000-4-11
Power
frequency
30 A/m
(50/60Hz)
50Hz/60Hz
magnetic field
IEC 61000-4-8
NOTE 1: UT is the a.c. mains voltage prior to application of the test level.
42
Compliance level Electromagnetic
environment – guidance
Floors should be wood,
concrete or ceramic tile.
±8 kV contact
If floors are covered with
±15 kV air
synthetic material, the
relative humidity should
be at least 30%.
Mains power quality
Power supply lines:
should be that of a typical
±2 kV
commercial or hospital
environment.
Mains power quality
line(s) to line(s): ±1 kV
should be that of a typical
100 kHz repetition
commercial or hospital
frequency
environment.
0% UT; 0.5 cycle
At 0°, 45°, 90°, 135°,
180°,225°,270° and
Mains power quality
315° 0% UT; 1 cycle
should be that of a typical
and 70% UT; 25/30
commercial or hospital
cycles Single phase:
environment.
at 0° 0% UT;
300 cycle
Power frequency magnetic
fields should be at levels
30 A/m
characteristic of a typical
50Hz/60Hz
location in a typical
commercial or hospital
environment.
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
IEC 60601-1-2
Compliance
test
test level
level
150 kHz to
150 kHz to
80 MHz:
80 MHz:
3 Vrms
Conducted
3 Vrms 6Vrms
6Vrms (in ISM
RF IEC
(in ISM and
and amateur
61000-4-6
amateur radio
radio bands)
bands) 80%
80% Am at
Am at 1kHz
1kHz
Radiated
10V/m,
10V/m,
RF IEC
80% Am at
80% Am at
61000-4-3
1kHz
1kHz
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the device is used
exceeds the applicable RF compliance level above, the device should be observed to verify
normal operation. If abnormal performance is observed, additional measures may be
necessary, such as re-orienting or relocating the device.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.
Electromagnetic environment –
guidance
Portable and mobile RF ommunications
equipment should be used no closer to any
part of the device, including cables, than
the recommended separation distance
calculated from the equation appropriate
for the frequency of the transmitter.
Recommended separation distances:
d=0.35
P
d=1.2
P
80 MHz to
Where P is the maximum
800 MHz:
output power rating of the
d=1.2
transmitter in watts (W)
P
800 MHz to
according to the transmitter
2.7 GHz:
manufacturer, d is the
d=2.3
recommended separation
P
distance in meters (m). Field
strengths from fixed RF
transmitters, as determined
by an electromagnetic
site survey, should be less
than the compliance level
in each frequency range.
Interference may occur in
the vicinity of equipment
marked with the following
symbol:
43