Mach LED 150F / 150 / 150FP
59320002
Edition 12
08.08.2018 / Bak We page 23/26
Table 4 – Enclosure port
Phenomenon
Basic EMC
standard or test
method
Immunity test levels
Professional healthcare
facility environment
Home healthcare
environment
Electrostatic
Discharge
IEC 61000-4-2
± 8 kV contact
± 2 kV, ± 4 kV, ± 8 kV , ± 15 kV air
Radiated RF EM
fields
a)
IEC 61000-4-3
3 V/m
f)
80 MHz - 2,7 GHz
b)
80 % AM at 1 kHz
c)
10 V/m
f)
80 MHz - 2,7 GHz
b)
80 % AM at 1 kHz
c)
Proximity fields from RF
wireless
communications
equipment
IEC 61000-4-3
See Table 9
Rated power frequency
magnetic fields
d) e)
IEC 61000-4-8
30 A/m
g)
50 Hz or 60 Hz
a)
The interface between the patient physiological signal simulation, if used, and the ME EQUIMENT and ME SYSTEM shall be
located within 0,1m of the vertical plane of the uniform field area in one orientation of the ME EQUIMENT and ME SYSTEMS.
b)
ME EQUIMENT and ME SYSTEMS that intentionally receive RF electromagnetic energy for the purpose of their operation shall
be tested at the frequency of reception. Testing may be performed at other modulation frequencies identified by the risk manage-
ment process. This test assesses the basic safety and essential performance of an intentional receiver when an ambient signal is
in the passband. It is understood that the receiver might not achieve normal reception during the test.
c)
Testing may be performed at other modulation frequencies identified by the risk management process.
d)
Applies only to ME EQUIMENT and ME SYSTEMS with magnetically sensitive components or circuitry.
e)
During the test, the ME EQUIMENT or ME SYSTEMS may be powered at any nominal input voltage, but with the same frequency
as the test signal (see Table 1).
f)
Before modulation is applied.
g)
This test level assumes a minimum distance between the ME EQUIMENT or ME SYSTEM and sources of power frequency mag-
netic field of at least 15 cm. If the risk analysis shows that the ME EQUIMENT or ME SYSTEM will be used closer than 15 cm to
sources of power frequency magnetic field, the immunity test level shall be adjusted as appropriate for the minimum expected
distance.
