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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
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrical fast
transient / burst
IEC 61000-4-4
Surge
IEC 61000-4-5
26
Manuel_BPM_book.indd 26
IEC 60601 test level
Compliance level
±6 kV contact
±6 kV contact
±8 kV air
±8 kV air
±2 kV for power
Not applicable
supply lines
±1 kV for input /
output lines
±1 kV line(s) to line(s)
Not applicable
±2 kV line(s) to earth
Electromagnetic
environment – guidance
Floors should be wood,
concrete or ceramic tile.
If floors are covered with
synthetic material, the
relative humidity should
be at least 30%.
Mains power quality
should be that of a
typical commercial or
hospital environment.
Mains power quality
should be that of a
typical commercial or
hospital environment.
06/06/2014 10:21:22

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