8.5 Electromagnetic immunity, radio-frequencies
The medical device is designed for use in the magnetic and electromagnetic environment
described in the table below. The user and/or installer must ensure conformity of the
electromagnetic environment.
Caution: RF portable communication devices must not be used (including peripheral devices
such as antenna cables and external antennas) closer than 30 cm (12 inches) from any part of the
medical device, including the cables specified by the manufacturer. Otherwise, the performance
of those devices could be impaired.
Immunity test
Test level
Radiated radio-
frequency
electromagnetic
fields (IEC
61000-4-3)
9 V/m
710 MHz, 745 MHz,
Nearby fields
780 MHZ, 5240 MHz,
emitted by
5550 MHz, 5785 MHz
wireless RF
27 V/m
communications
385 MHz
devices
(IEC 61000-4-
28 V/m
3 provisional
450 MHz, 810 MHz,
method)
870 MHz, 930 MHz,
1720 MHz, 1845 MHz,
1970 MHz, 2450 MHz
Conducted
disturbances,
induced by RF
fields
RF (IEC 61000-
4-6)
10 V/m
80 MHz at 2.7 GHz
80% MA at 1 kHz
3 V/m
80 MHz at 2.7 GHz
80% MA at 1 kHz
3 V
150 KHz at 80 MHz
6 V in ISM band and
band ranging from
0.15 MHZ to 80 MHZ,
including amateur
radio band
80% MA at 1 KHz
3 V
150 KHz at 80 MHz
6 V in ISM band
and band between
0.15 MHz and 80 MHz
80% MA at 1 KHz
Conformity level
10 V/m
80 MHz at 2.7 GHz
80% MA at 1 kHz
3 V/m
80 MHz at 2.7 GHz
80% MA at 1 kHz
9 V/m
710 MHz, 745 MHz,
780 MHZ, 5240 MHz,
5550 MHz, 5785 MHz
27 V/m
385 MHz
28 V/m
450 MHz, 810 MHz,
870 MHz, 930 MHz,
1720 MHz, 1845 MHz,
1970 MHz, 2450 MHz
3 V
150 KHz at 80 MHz
6 V in ISM band and
band ranging from
0.15 MHZ to 80 MHZ,
including amateur
radio band
80% MA at 1 KHz
3 V
150 KHz at 80 MHz
6 V in ISM band
and band between
0.15 MHz and 80 MHz
80% MA at 1 KHz
Electromagnetic
environment - Guide
Professional healthcare
facility environment
and home healthcare
environment.
Professional healthcare
facility environment
and home healthcare
environment.
Professional healthcare
facility environment
and home healthcare
environment.
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