Guidance and manufacturer's declaration - electromagnetic immunity
Pursuant to IEC 60601-1-2:2014 - Medical electrical equipment - Part 1-2: General requirements for
basic safety and essential performance - Collateral Standard: Electromagnetic disturbances
The equipment is intended for use in the electromagnetic environment specified below. The customer or the
user of the equipment should assure that it is used in such an environment.
Immunity test
±8 kV contact
Electrostatic
±15 kV air
discharge (ESD)
IEC 61000-4-2
±2 kV for power
Electrical fast
transient/burst
supply
IEC 61000-4-4
lines
±1 kV for
input/output lines
±1 kV differential
Surge
IEC 61000-4-5
mode
±2 kV common
mode
Voltage dips,
U
short interruption,
(at 0, 45, 90, 135,
and voltage
180, 225, 270 and
315°)
variations on
power
supply
U
input lines IEC
60601-4-11
U
cycles (at 0°)
U
cycles
Power frequency
N/A
(50/60 Hz)
IEC 61000-4-8
NOTE: U
is the A.C. mains voltage prior to application of the test level.
T
NP-DK50 2V 50, 2x2V 110-27_12-2021-MD
IEC 60601-1-2
Compliance level
test level
±8 kV contact
±15 kV air
±2 kV
100 kHz repetition
frequency
Applied to mains
connection
±1 kV L-N
±2 kV L-PE; N-PE
Applied to mains
connection
=0%, 0,5 cycle
U
=>95%, 0,5 cycle
T
T
(at 0, 45, 90, 135, 180,
225, 270 and 315°)
U
=>95%, 1 cycle
T
=0%, 1 cycle
T
U
=70% (30% dipp U
T
=70% 25/30
25(50Hz)/30(60Hz)
T
cycles (at 0°)
=0%, 250/300
U
=>95%,
T
T
250(50Hz)/300(60Hz)
cycle
N/A
Electromagnetic environment -
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.
Mains power quality should be
that of a typical commercial or hospital
environment.
The device stops and restarts
automatically at each dip. In this case
does not occur unacceptable pressure
),
drop.
T
The equipment does not contain
magnetically sensitive components or
circuits.
-14-
DK50 2V/50
DK50 2x2V/110
guidance
12/2021