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Enclosure Port
Phenomenon
Electrostatic discharge
Radiated RF EM fields
a)
Proximity fields from RF
wireless communications
equipment
Rated power frequency
magnetic fields
d) e)
a) The interface between the PATIENT physiological signal simulation,
if used, and the ME EQUIPMENT or ME SYSTEM shall be located
within 0,1 m of the vertical plane of the uniform field area in one
orientation of the ME EQUIPMENT or ME SYSTEM.
b) ME EQUIPMENT and ME SYSTEMS that intentionally receive
RF electromagnetic energy for the purpose of their operation
shall be tested at the frequency of reception. Testing may be
performed at other modulation frequencies identified by the RISK
MANAGEMENT PROCESS. This test assesses the BASIC SAFETY
and ESSENTIAL PERFORMANCE of an intentional receiver when
an ambient signal is in the passband. It is understood that the
receiver might not achieve normal reception during the test.
c) Testing may be performed at other modulation frequencies
identified by the RISK MANAGEMENT PROCESS.
Input A.C. Power Port
Basic EMC standard
Phenomenon
or test method
Electrical fast
IEC 61000-4-4
transients / bursts
a) l) o)
Surges
a) b) j) o)
IEC 61000-4-5
Line-to-line
Surges
a) b) j) k) o)
IEC 61000-4-5
Line-to-ground
Conducted
disturbances induced
IEC 61000-4-6
by RF fields
c) d) o)
Voltage dips
IEC 61000-4-11
f) p) r)
Voltage interruptions
IEC 61000-4-11
f) i) o) r)
a)
The test may be performed at any one power input voltage within
the ME EQUIPMENT or ME SYSTEM RATED voltage range. If
the ME EQUIPMENT or ME SYSTEM is tested at one power input
voltage, it is not necessary to re-test at additional voltages.
Basic EMC standard
or test method
IEC 61000-4-2
IEC 61000-4-3
IEC 61000-4-3
IEC 61000-4-8
Professional healthcare
facility environment
± 2 kV
100 kHz repetition frequency
± 0,5 kV, ± 1 kV
± 0,5 kV, ± 1 kV, ± 2 kV
3 V
m)
0,15 MHz – 80 MHz
6 V
in ISM bands between 0,15 MHz
m)
and 80 MHz
80 % AM at 1 kHz
0 % U
; 0,5 cycle
T
At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°
0 % U
; 1 cycle and
T
70 % U
; 25/30 cycles
T
Single phase: at 0°
0 % U ; 250/300 cycle
IMMUNITY TEST LEVELS
Professional healthcare
facility environment
± 8 kV contact
± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air
3 V/m
f)
80 MHz – 2,7 GHz
b)
80 % AM at 1 kHz
c)
See 8.10.
30 A/m
g)
50 Hz or 60 Hz
d) Applies only to ME EQUIPMENT and ME SYSTEMS with
magnetically sensitive components or circuitry.
e) During the test, the ME EQUIPMENT or ME SYSTEM may be
powered at any NOMINAL input voltage, but with the same
frequency as the test signal (see Table 1).
f) Before modulation is applied.
g) This test level assumes a minimum distance between the ME
EQUIPMENT or ME SYSTEM and sources of power frequency
magnetic field of at least 15 cm. If the RISK ANALYSIS shows
that the ME EQUIPMENT or ME SYSTEM will be used closer
than 15 cm to sources of power frequency magnetic field, the
IMMUNITY TEST LEVEL shall be adjusted as appropriate for
the minimum expected distance.
IMMUNITY TEST LEVELS
Home healthcare environment
3 V
0,15 MHz – 80 MHz
6 V
n)
between 0,15 MHz and 80 MHz
80 % AM at 1 kHz
e)
g)
h)
h)
b)
All ME EQUIPMENT and ME SYSTEM cables are attached during the test.
c)
Calibration for current injection clamps shall be performed in a 150 Ω
system.
Home healthcare
environment
10 V/m
f)
80 MHz – 2,7 GHz
b)
80 % AM at 1 kHz
c)
m)
in ISM and amateur radio bands
m)
n)
e)
q)
4
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