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EMC GUIDANCE
Table 2 – Guidance and manufacturer’s declaration – electromagnetic immunity – for all ME equipment and
ME systems.
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 test
IEC 60601
test level
Compliance level
Electromagnetic
environment – guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 kV air
Floors should be wood, concrete
or ceramic tile. If floors are overed
with synthetic material, the relative
humidity should be at least 30 %.
Electrical fast
transient/burst
IEC 61000-4-4
± 2 kV
for power supply lines
± 1 kV
for input/output lines
Not applicable
Mains power quality should be that
of a typical commercial or hospital
environment.