Bionet Cardio7e - Manufacturer Declaration

V 1.31
2021. 05 162 / 171 Doc. # : BN-OP-C7
4) Manufacturer Declaration
Electromagnetic Compatibility Information
Phenomenon
Basic EMC
standard or test
method
Test level/requirement
Mains terminal
disturbance voltage
CISPR 11
Group1, Class A
Radiated disturbance
CISPR 11
Group1, Class A
Harmonic Current Emission
IEC 61000-3-2
Class A
Voltage change,
Voltage fluctuations and
Flicker Emission
IEC 61000-3-3
Pst: 1
Plt: 0.65
Tmax:0.5
dmax: 4%
dc: 3.3%
Electrostatic Discharge
Immunity
IEC 61000-4-2
± 8 kV/Contact
± 2, ± 4, ± 8, ± 15 kV/Air
Radiated RF
Electromagnetic Field
Immunity
IEC 61000-4-3
3 V/m
80 MHz - 2.7 GHz
80% AM at 1 kHz
Immunity to Proximity Fields
from RF wireless
Communications Equipment
IEC 61000-4-3
Table 9 in
IEC 60601-1-2: 2014
Electrical Fast
Transient/Burst Immunity
IEC 61000-4-4
± 2 kV, 100 kHz
repetition frequency
± 1 kV, 100 kHz
repetition frequency
Surge Immunity
IEC 61000-4-5
Line to Line
± 0.5 kV, ± 1 kV
Line to Ground
± 0.5 kV, ± 1 kV,
± 2 kV