46
STANDARD COMPLIANCE
Comment:
a) The test is applicable to all d.c. power PORTS intended to be connected permanently to cables longer
than 3 m.
b) All ME EQUIPMENT and ME SYSTEM cables shall be attached during the test.
c) INTERNALLY POWERED ME EQUIPMENT is exempt from this test if it cannot be used during battery
charging, is of less than 0,4 m maximum dimension including the maximum length of all cables specified
and has no connection to earth, telecommunications systems, any other equipment or a PATIENT.
d) The test may be performed with the ME EQUIPMENT or ME SYSTEM powered at any one of its
NOMINAL input voltages.
e) Testing may be performed at other modulation frequencies identified by the RISK MANAGEMENT
PROCESS.
f) For ME EQUIPMENT and ME SYSTEMS intended to be installed in passenger cars and light commercial
vehicles including ambulances fitted with 12 V electrical systems or commercial vehicles including
ambulances fitted with 24 V electrical systems.
g) Direct coupling shall be used.
h) r.m.s., before modulation is applied.
i) If the frequency stepping skips over an ISM or amateur radio band, as applicable, an additional test
frequency shall be used in the ISM or amateur radio band. This applies to each ISM and amateur radio
band within the specified frequency range.
j) The ISM (industrial, scientific and medical) bands between 0,15 MHz and 80 MHz are 6,765 MHz to 6,795
MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz. The
amateur radio bands between 0,15 MHz and 80 MHz are 1,8 MHz to 2,0 MHz, 3,5 MHz to 4,0 MHz, 5,3 MHz
to 5,4 MHz, 7 MHz to 7,3 MHz, 10,1 MHz to 10,15 MHz, 14 MHz to 14,2 MHz, 18,07 MHz to 18,17 MHz,
21,0 MHz to 21,4 MHz, 24,89 MHz to 24,99 MHz, 28,0 MHz to 29,7 MHz and 50,0 MHz to 54,0 MHz.
Phenomenon
Electrical fast
transient/bursts
IEC 610004-4 (a, g)
Professional healthcare
facility environment
± 2 kV
100 kHz Repetition frequency
Input d.c. power port
Surges (a, b, g)
IEC 61000-4-5
± 0,5 kV, ± 1 kV line to line
± 0,5 kV, ± 1 kV, ± 2 kV line to ground
Immunity test levels
Home healthcare
environment
Conducted
disturbances
induced by RF
fields a) c) d) i)
IEC 61000-4-6
3 V (h)
150 kHz - 80 MHz
6 V(h) in ISM bands between 150
kHz - 80 MHz c)
80% AM 1 kHz c)
3 V (h)
150 kHz - 80 MHz
6 V(h) in ISM and amateur radio
bands between 150 kHz - 80 MHz c)
80% AM 1 kHz c)
Electrical transient
Conduction along
supply lines f)
ISO 7637-2
Not applicable As specified in ISO 7637-2
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