Anhang
Appendix
41
Table 1 – Compliance level for Immunity tests
Guidance and manufacturer’s declaration – electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below.
The user of the device should make sure that it is used in such an environment.
Immunity tests
EN/IEC 60601 test level
Compliance level
Electromagnetic environment – guidance
Electrostatic discharge (ESD)
acc. to IEC 61000-4-2
± 8 kV Contact discharge
± 15 kV Air discharge
± 8 kV Contact discharge
± 15 kV Air discharge
Floors should be wood, concrete or ceramic tile.
If floors are covered with synthetic material, the
relative humidity should be at least 30%.
Rapid transient electrical
Interferences/bursts acc. to
IEC 61000-4-4
± 2 kV for power lines
± 1 kV for input and output lines
100 kHz repetition
± 2 kV/1 kV
± 1 kV for input and output lines
100 kHz repetition
The power supply quality should be that of a typical
commercial or hospital environment.
Surges
acc. to 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
The power supply quality should be that of a typical
commercial or hospital environment.
Voltage dips, short
interruptions and fluctuations
of the supply voltage
acc. to IEC 61000-4-11
Voltage Dip:
Dip to 0 % for 1 cycle
@ 0° phase angle
Dip to 70 % for 25/30 cycles
@ 0° phase angle
Dropout to 0 % for 0.5 cycle
@ 0°, 45°, 90°, 135°, 180°,
225°, 270° & 315° phase angles
Voltage interruption:
100 % for 250/300 cycles
Voltage Dip:
Dip to 0 % for 1 cycle
@ 0° phase angle
Dip to 70 % for 25/30 cycles
@ 0° phase angle
Dropout to 0 % for 0.5 cycle
@ 0°, 45°, 90°, 135°, 180°, 225°,
270° & 315° phase angles
Voltage interruption:
100 % for 250/300 cycles
The power supply quality should be that of a typical
commercial or hospital environment.
If the user of the device requires continued operation
during power mains interruptions, it is recommended
that the device be powered from an uninterruptible
power supply or a battery.
Magnetic field at the supply
frequency (50/60 Hz)
acc. to IEC 61000-4-8
30 A/m at 50 Hz/60 Hz
30 A/m at 50 Hz/60 Hz
If image distortion occurs, it may be necessary
to position the device further from sources of
electromagnetic fields or to install magnetic shielding.
Before installing the device, the electromagnetic field
should be measured to ensure that it is sufficiently
low.
Radiated, radio-frequency,
electromagnetic field immunity
test acc. to IEC 61000-4-3
3 V/m 80 MHz to 2.7 GHz
*Refer table 2 for wireless Proximity
RF field test levels
3 V/m 80 MHz to 2.7 GHz
Immunity to conducted
disturbances, induced
by radio-frequency fields
acc. to IEC 61000-4-6
3 V
rms
on 150 kHz to 80 MHz
1 kHz 80% AM modulation
6 V
rms
in ISM bands
3 V
rms
on 150 kHz to 80 MHz
1 kHz 80 % AM modulation
6 V
rms
in ISM bands
Anexo
