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2022/09/27
MEG010XN102-A11 (ENG)
14
EMC compliance table
EMC compliance according to IEC 60601-1-2 (2014) 4th Edition (EN 60601-1-2: 2015)
The
BIOSTIM
is intended to be used in the electromagnetic environment specified below.
The customer or user of the
BIOSTIM
should ensure that it is used in such an environment.
Emissions testing
Compliance Electromagnetic environment - guidelines
RF emissions
CISPR 11
Group 1
The
BIOSTIM uses
RF energy only for its internal functions. Therefore, its RF
emissions are very low and are not likely to cause interference in any
nearby electronic device.
RF emissions
CISPR 11
Class B
The
BIOSTIM is suitable for
use in all premises, including domestic premises
and those directly connected to the public low voltage power supply
network supplying buildings for domestic use.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations /
Flicker
IEC 61000-3-3
Compliant
EMC compliance according to IEC 60601-1-2 (2014) 4th Edition (EN 60601-1-2: 2015)
The
BIOSTIM
is intended for use in the electromagnetic environment specified below. The customer or user of
BIOSTIM
should ensure that it is used in such an environment.
IMMUNITY test
Test level IEC
60601-1-2
Level of
compliance
Electromagnetic environment - guidelines
Electrostatic
Discharge (ESD)
IEC 61000-4-2
± 8 kV in contact
± 15 kV in air
± 8 kV in contact
± 15 kV in air
The floors should be made of wood, concrete or
ceramic tiles. If the floors are covered with synthetic
materials, the relative humidity should be at least 30%.
Transients
fast in bursts
IEC 61000-4-4
± 2 kV for lines
power supply
electric
± 1 kV for lines
input/output
± 2 kV for lines
power supply
electric
The quality of the power supply should be that of a
typical commercial or hospital environment.
Surge voltage
transitional
IEC 61000-4-5
± 1 kV between
phases
± 2 kV between
phase and earth
± 1 kV between
phases
± 2 kV between
phase and earth
The quality of the power supply should be that of a
typical commercial or hospital environment.
Tension dips,
short cuts and
variations in
tension on
input lines
power supply
electric
IEC 61000-4-11
0% TU: 0.5 cycle
at 0, 45, 90, 135,
180, 225, 270 and
315 degrees
0% TU: 1 cycle and
70% TU; 25/30
cycles
Single-phase: at 0
degrees
0% UT; 250/300
cycles
0% TU: 0.5 cycle
at 0, 45, 90, 135,
180, 225, 270 and
315 degrees
0% TU: 1 cycle and
70% TU; 25/30
cycles
Single-phase: at 0
degrees
0% UT; 250/300
Cycles
The quality of the power supply should be that of a
typical commercial or hospital environment. If the user
of
BIOSTIM
requires continuous operation during power
outages, it is recommended that
BIOSTIM be
powered
from an uninterruptible power supply or battery.
NOTE UT is the AC mains voltage before the test level is
applied.
Magnetic field
to the frequency of
the power grid
(50/60 Hz)
IEC 61000-4-8
30 A/m
50Hz or 60Hz
30 A/m
50Hz or 60Hz
Magnetic fields at the frequency of the power system
should have levels characteristic of a representative
location in a typical commercial or hospital
environment.
EMC compliance according to IEC 60601-1-2 (2014) 4th Edition (EN 60601-1-2: 2015)
