Table 6
Input a.c. power port
Phenomenon Basic EMC
standard
Immunity test levels Immunity test levels
Professional healtcare Home healthcare
facility environment environment
Electrical fast
transients / bursts
a), l), o)
IEC 61000-4-4 ±2 kV ±2 kV
Surges
a), b), j), o)
Line-to-line
IEC 61000-4-5 ±0,5 kV, ±1 kV ±0,5 kV, ±1 kV
Surges
a), b), j), k), o)
Line-to-ground
IEC 61000-4-5 ±0,5 kV, ±1 kV, ±2 kV ±0,5 kV, ±1 kV, ±2 kV
Conducted disturbances
induced by RF field
c), d), o)
IEC 61000-4-6 3 V
m)
3 V
m)
0,15 MHz – 80 MHz 0,15 MHz – 80 MHz
6 V
m)
in ISM bands between
0,15 MHz and 80 MHz
n)
6 V
m)
in ISM and amateur radio bands
between 0,15 MHz and 80 MHz
n)
80% AM at 1 kHz
e)
80% AM at 1 kHz
e)
Voltage dips
f), p), r)
IEC 61000-4-11 0% U
T
; 0,5 cycle
g)
At 0°, 45°, 90°, 135°, 180°,
225°, 270° and 315°
q)
0% U
T
; 0,5 cycle
g)
At 0°, 45°, 90°, 135°, 180°,
225°, 270° and 315°
q)
0% U
T
; 1 cycle and 70% U
T
; 25/30 cycles
h)
0% U
T
; 1 cycle and 70% U
T
; 25/30 cycles
h)
Single phase: at 0° Single phase: at 0°
Voltage interruption
f), i), o), r)
IEC 61000-4-11 0% U
T
; 250/300 cycle
h)
0% U
T
; 250/300 cycle
h)
a)
The test may be performed at any one power input voiltage 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 necessery to re-test at additional voltages.
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.
d)
If the frequency stepping skips over an ISM amateur band, as applicable, an additional test frequency shall be used in the IMS or amateur radio band. This applies to each ISM and radio band
within the specified frequency range.
e)
Testing may be performed at other modulation frequencies identified by the risk management process.
f)
ME equipment and ME system with a d.c. power input intended for use with a.c.-to-d.c. converters shall be tested using a converter that meets the specification of the manufacturer of the
ME equipment or ME system. The immunity test levels are applied to the a.c. power input of the converter.
g)
Applicable only to ME equipment and ME systems connected to single-phase a.c. mains.
h)
E.g. 10/12 means 10 periods at 50 Hz or 12 periods at 60 Hz.
i)
ME equipment and ME systems with rated input current greater than 16 A/phase shall be interrupted once for 250/300 cycles at any angle and at all phases at the same time ( if applicable).
ME equipment and ME systems with battery backup shall resume line power operation after the test. or ME equipment and ME systems with rated input current not exceeding 16 A,
all phases shall be interrupted simultaneously.
j)
ME equipment and ME systems that do not have a surge protection device in the primary power circuit may be tested only at ±2 kV line(s) to earth and ±1 kV line(s) to line(s)..
k)
Not applicable to class II ME equipment and ME systems.
l)
Direct coupling shall be used.
m)
r.m.s., before modulation is applied.
n)
The ISM (industrial, scientific and medical) bands between 0,15 MHz and 80 MHz are 6,765 to 6,795 MHz; 13,553 to 13,567 MHz; 26,957 to 27,283 MHz; and 40,66 to 40,70 MHz.
The amateur radio bands between 0,15 and 80 MHz are 1,8 to 2,0 MHz; 3,5 to 4,0 MHz; 5,3 to 5,4 MHz; 7,0 to 7,3 MHz; 10,1 to 10,15 MHz; 14,0 to 14,2 MHz; 18,07 to 18,17 MHz;
21,0 to 21,4 MHz; 24,89 to 24,99 MHz; 28,0 to 29,7 MHz and 50,0 to 54,0 MHz;
o)
Applicable to ME equipment and ME systems with rated input current less than or equal to 16 A/phase and ME equipment and ME systems with rated input current greater than 16 A/phase.
p)
Applicable to ME equipment and ME systems with rated input current less than or equal to 16 A/phase.
q)
At some phase angles, applying this test to ME equipment with transformer mains power input might cause an overcurrent protection device to open. This can occur due to magnetic flux saturation
of the transformer core after the voltage dip. If this occurs, the ME equipment of ME system shall provide basic safety during and after the test.
r)
For ME equipment of ME systems that have multiple voltage settings or auto ranging voltage capability, the test shall be performed at the minimum and maximum rated input voltage.
ME equipment of ME systems with a rated input voltage range of less than 25% of the highest rated input voltage shall be tested at one rated input voltage within the range.
(† IEC60601-1-2:2014 / table 1, Note c) for examples calculations.
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