Cardiosecur PRO Benutzerhandbuch Seite 25

DIN EN 60601 1-1-2
Medical electrical equipment
Part 1-2: General requirements for safety:
Collateral standard: electromagnetic compliance; requirements and testing
DIN EN 60601 1-2-47
Medical electrical equipment
Part 2-47: Specific requirements for safety including essential performance characteristics for
outpatient electrocardiographic systems
Interference immunity against
Static electrical discharge
High frequency electromagnetic fields
(80 – 2500 mHz)
Fast transient disturbances (chest)
Surge voltages
Conducted disturbances, induced by high
frequency
Energy-related frequency – Magnetic field 50 Hz
(Helmholtz coil)
Voltage dips, short-term interruptions
Test levels as % of UT duration in supply
frequency periods
All testing at 100 and 240V each 50 Hz
V7.0
Testing accuracy
normative tested
air 8 kV
contact 6 (8) kV
housing 3 V/m
mains 2 kV
I/O 1 kV
unsym. 2 kV
sym. 1 kV
mains 3 V
I/O 3 V
housing 3 A/m
mains UT <5%
0,5 per.
100 – 240V 40%
50 / 60 Hz 100 per.
70%
500 per.
<5%
5000 per.
Result
8kV OK
8 kV OK
10 OK
V/m
2 kV n/a
- n/a
- n/a
1kV n/a
10 V n/a
- n/a
3 A/m n/a
<5% n/a
0,5
per.
40% n/a
100
per.
70% n/a
500
per.
<5% n/a
5000
per.
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