27
Table 2
IEC 60601-1-2: 2014 4
th
Edition
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
± 8 kV contact
± 2, 4. 8, 15 kV air
± 8 kV contact
± 2, 4. 8, 15 kV air
Floors should be wood, concrete or ceramic
tile. If floors are covered with synthetic materi-
al, the relative humidity should be at least 30%.
Electrical fast transient/burst
IEC 61000-4-4
± 2 kV for power supply lines ± 2 kV for power supply lines
Mains power quality should be that of a typical
commercial or hospital environment.
Surge IEC 61000-4-5
± 1 kV differential mode
± 2 kV common mode
c
Mains power quality should be that of a typical
commercial or hospital environment.
Voltage dips
Voltage Interruptions
IEC 61000-4-11
0% U
T
,0,5 cycle
0% U
T
, 5 cycles
70% U
T
,30 cycles
0% U
T
‘300 cyles
0% U
T
,0,5 cycle
0% U
T
, 5 cycles
70% Uv ,30 cycles
0% U
T
‘300 cyles
Mains power quality should be that of a typical
commercial or hospital environment. If the user
of the device requires continued operation duri-
ng power mains interruptions, it is recommen-
ded that the device be powered from an unin-
terruptible power supply or a battery.
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.
NOTICE:
U
T
is the a.c. mains voltage prior to application of the test level.
