94
Table 16.
Guidance and manufacturer’s declaration –
electromagnetic immunity
Immunity Test
IEC 60601
Test Level
Compliance
Level
Electromagnetic
Environment Guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±8 kV contact
±15 kV air
±8 kV contact
±15 kV air
The relative humidity
should be at least 5%.
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for
power supply
lines
±1 kV for
input/output
lines
Not applicable No guidance for battery-
powered devices.
Surge
IEC 61000-4-5
±1 kV line to
line
±2 kV line to
ground
Not applicable No guidance for battery-
powered devices.
Voltage dips,
short
interruptions
IEC 61000-4-11
<5% U
T
40% U
T
70% U
T
Not applicable No guidance for battery-
powered devices.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
30 A/m
30 A/m
Power frequency
magnetic fields should
be at levels
characteristic of a
typical location in a
typical commercial or
hospital environment.
Summary of Contents for St. Jude Medical Patient Controller 3875
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