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Appendix D: Guidance and Manufacturer’s Declaration
Electromagnetic Immunity
Table 55. 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
+/- 6 kV contact
+/- 8 kV air
+/- 6 kV contact
+/- 8 kV air
Floors should be wood, concrete or
ceramic tile. If floors are covered
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
+/- 2 kV for power
supply lines
+/- 1 kV for
input/output
lines
Mains power quality should be that
of a typical commercial or hospital
environment.
Surge
IEC 61000-4-5
+/- 1 kV line(s) to
line(s)
+/- 2 kV line(s) to
earth
+/- 1 kV line(s) to
line(s)
+/- 2 kV line(s) to
earth
Mains power quality should be that
of a typical commercial or hospital
environment.
Voltage dips,
short
interruptions and
voltage
variations on
power supply
input lines
IEC 61000-4-11
<5%
U
T
(>95% dip in
U
T
)
for 0,5 cycle
40%
U
T
(60% dip in
U
T
)
for 5 cycles
70%
U
T
(30% dip in
U
T
)
for 25 cycles
<5%
U
T
(>95% dip in
U
T
)
for 5 s
<5%
U
T
(>95% dip in
U
T
)
for 0,5 cycle
40%
U
T
(60% dip in
U
T
)
for 5 cycles
70%
U
T
(30% dip in
U
T
)
for 25 cycles
<5%
U
T
(>95% dip in
U
T
)
for 5 s
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the
LUKE arm system requires
continued operation during power
mains interruptions, it is
recommended that the LUKE arm
system be powered from an
uninterruptible power supply or a
battery.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic fields
should be at levels characteristic of
a typical location in a typical
commercial or hospital
environment.
NOTE:
U
T
is the a.c. mains voltage prior to application of the test level.
