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10.6 Compliance for emission and immunity standard
The product is tested and found compliant for EMC according to EN60601-1-2:2015 for Clause 7 and Clause
8. Documentation is tested and found compliant according to EN60601-1-2:2015 for Clause 5
10.6.1 Emission class and group
Phenomenon
Test method
Class
Group
Conducted RF emissions EN 55011
Class B
Group 1
Radiated RF emissions
EN 55011
Class B
Group 1
Harmonic current
emissions
EN 61000-3-2
Class A
-
Voltage changes, voltage
fluctuations and flicker
emissions
EN 61000-3-3
-
-
10.6.2 Immunity test levels
Phenomenon
Test method
Immunity test level
Electrostatic discharge
immunity
EN 61000-4-2
+/- 8 kV contact
+/- 2, 4, 8, 15 kV air
Electrostatic discharge
immunity
– I/O
SIO/SOP ports
EN 61000-4-2
+/- 8 kV contact,
+/- 2, 4, 8, 15 kV air
Connectors shall be tested.
Do not test pins, as they can not be contacted or touched,
under conditions of intended use.
Radiated RF
electromagnetic field
immunity
EN 61000-4-3
10 V/m 80 MHz to 800 MHz
20 V/m 800 MHz to 2.5 GHz
10 V/m 2.5 GHz to 2.7 GHz
80 % AM 1 kHz
Immunity to proximity
fields from RF wireless
communication
equipment
EN 61000-4-3
385 MHz, 27 V/m, 18 Hz PM (50 % duty cycle square wave)
450 MHz, 28 V/m, FM +/- 5 kHz dev., 1 kHz sine
710 MHz, 9 V/m, 217 Hz PM (50 % duty cycle square wave)
745 MHz, 9 V/m, 217 Hz PM (50 % duty cycle square wave)
780 MHz, 9 V/m, 217 Hz PM (50 % duty cycle square wave)
810 MHz, 28 V/m, 18 Hz PM (50 % duty cycle square wave)
870 MHz, 28 V/m, 18 Hz PM (50 % duty cycle square wave)
930 MHz, 28 V/m, 18 Hz PM (50 % duty cycle square wave)
1720 MHz, 28/ V/m, 217 Hz PM (50 % duty cycle square
wave)
1845 MHz, 28 V/m, 217 Hz PM (50 % duty cycle square wave)
1970 MHz, 28 V/m, 217 Hz PM (50 % duty cycle square wave)
2450 MHz, 28 V/m, 217 Hz PM (50 % duty cycle square wave)
5240 MHz, 9 V/m, 217 Hz PM (50 % duty cycle square wave)
5500 MHz, 9 V/m, 217 Hz PM (50 % duty cycle square wave)
5785 MHz, 9 V/m, 217 Hz PM (50 % duty cycle square wave)
Electrical fast
transient/burst immunity
– AC power ports
EN 61000-4-4
+/- 2 kV
100 kHz repetition frequency
Electrical fast
transient/burst immunity
– I/O SIO/SOP ports
EN 61000-4-4
+/- 1 kV
100 kHz repetition frequency
Surge immunity
– AC
power ports
EN 61000-4-5
Line-to-line: +/- 0.5, 1 kV line to line
Line-to-ground:
Not applicable, the device is a
Class II device