EN
26
SAFETY AND PERFORMANCE STANDARDS
The Daylight has been designed and manufactured to conform to the highest standards
of safety and performance including electromagnetic compatibility (EMC). The Daylight
conforms to the applicable requirements of the following:
This appliance meets the requirement of Medical Device
Directive 93/42/EEC for medical appliances.
The appliance is complied with the following emission and immunity standard, and test
level:
Immunity Test standard
Electrostatic discharge (ESD)
IEC 61000-4-2
Electrical fast transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, interruptions and
variations on power supply
input lines
IEC 61000-4-1 1
Power frequency (50/60 Hz)
magnetic fi eld
IEC 61000-4-8
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
IEC 60601-1-2 Test Level
±8kV contact
±2kV, ±4kV, ±8kV, ±15kV air
±2kV for power supply lines
±1kV
100 kHz repetition frequency
±0.5kV, ±1kV differential lines
±0.5kV, ±1kV, ±2kV common
mode
0 % UT; 0.5 cycle. At 0°,
45°, 90°, 135°, 180°, 225°,
270° and 315°.
0 % UT; 1 cycle and 70 % UT;
25/30 cycles; Single phase:
at 0°.
0 % UT; 250/300 cycles
30A/m
50Hz / 60Hz
3V, 0.15MHz - 80MHz
6V in ISM and amateur radio
bands between 0.15MHz and
80MHz; 80 % AM at 1 kHz
10 V/m
80MHz to 2.7GHz
80 % AM at 1kHz
Compliance Level
±8kV contact
±2kV, ±4kV, ±8kV, ±15kV air
±2kV for power supply lines
Not applicable
100 kHz repetition frequency
±0.5kV, ±1kV differential lines
Not applicable
0 % UT; 0.5 cycle. At 0°,
45°, 90°, 135°, 180°, 225°,
270° and 315°.
0 % UT; 1 cycle and 70 % UT;
25/30 cycles; Single phase:
at 0°.
0 % UT; 250/300 cycle
30A/m
50Hz / 60Hz
3V, 0.15MHz - 80MHz
6V in ISM and amateur radio
bands between 0.15MHz and
80MHz; 80 % AM at 1 kHz
10 V/m
80MHz to 2.7GHz
80 % AM at 1kHz