Immunity test
Electrostatic discharge (ESD)
acc. to IEC 61000-4-2
Electrical fast transient/burst
IEC 61000-4-4
Surge IEC 61000-4-5
Voltage dips, short interruptions
and voltage variations on power
supply input lines
IEC 61000-4-11
Power frequency (50/60 Hz)
magnetic field IEC 61000-4-8
Comment: U
is the a.c. supply voltage prior to application of the test level.
T
The EUT is intended for use in the electromagnetic environment specified below. The customer or the user of the EUT
Immunity test
IEC 60601 test level
Conducted RF
3 Veff
IEC 61000-4-6
150 kHz to 80 MHz
Radiated HF
3 V/m
IEC 61000-4-3
80MHz to 2,5GHz
Note 1:
At 80Hz and 800MHz, the higher frequency range applies.
Note 2:
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects
and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular / cordless) telephones and land mobile radios, amateur radio, AM and FM
radio broadcast and TV broadcast cannot be predicted theoretically with accuracy.
To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength
in the location in which the EUT is used exceeds the applicable RF compliance level above, the EUT should be observed to verify normal operation.
If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the EUT.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V / m.
Guidance and manufacturer declaration - Electromagnetic immunity
The EUT is intended for use in the electromagnetic environment specified below.
The customer or the user of the EUT should assure that it is used in such environment.
IEC 60601 test level
± 6 kV contact discharge
± 8 kV air discharge
± 2 kV for mains cables
± 1 kV for input and output lines
± 1 kV voltage phase – phase,
± 2 kV voltage phase – earth
< 5% U
, (>95% dip in U
)
T
T
for 1/2 period
40% U
, (60% dip in U
)
T
T
for 5 periods
70% U
, (30% dip in U
)
T
T
for 25 periods
<5% U
, (>95% dip in U
)
T
T
for 5 seconds
3 A/m
Guidance and manufacturer's declaration – electromagnetic immunity
should assure that it is used in such environment.
Compliance level
3 V eff
3 V/m
med 0413
Compliance level
± 6 kV contact discharge
± 8 kV air discharge
± 2 kV for mains cables
± 1 kV for input and output lines
± 1 kV voltage phase – phase
± 2 kV voltage phase – earth
< 5% U
, (>95% dip in U
)
T
T
for 1/2 period
40% U
, (60% dip in U
)
T
T
for 5 periods
70% U
, (30% dip in U
)
T
T
for 25 periods
<5% U
, (>95% dip in U
)
T
T
for 5 seconds
3 A/m
Electromagnetic environment Guidelines
Portable and mobile RF communication equipment should be used no
closer to any part of the EUT, including cables, than the recommended
separation distance calculated from the equation applicable to the
frequency of the transmitter.
Recommended separation distance:
d = 3,5/3 * SQRT (P/W)
d = 3,5/3 * SQRT (P/W) 80 MHz to 800 MHz
d = 7/3 * SQRT (P/W) 800 MHz to 2,5 GHz
where P is the maximum output power rating of the transmitter in
watts (W) according to the transmitter manufacturer and d is the
recommended separation distance in metres (m).
Field strengths from fixed RF transmitters, as determined by an
electromagnetic site surveya
level in each frequency range.
Interference may occur in the vicinity of equipment marked with the
following symbol:
2018-03-15
Electromagnetic environment – Guideline
Floors should be wood, concrete or covered with
ceramic tiles. If floors are covered with synthetic
material, the relative humidity should be at least
30 %.
The supply voltage quality should be that of a
typical commercial or hospital environment.
Mains power quality should be that of a typical
commercial or hospital environment.
Mains power quality should be that of a typical
commercial or hospital environment. If the user
of the ME device requires continued operation
during power mains interruptions, it is recom-
mended that the EUT be powered by a UPS
(uninterruptible power supply) or a battery.
Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typical commercial or hospital environment.
a
, should be less than the compliance
b
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