18
Appendix
19
Appendix
Table 2 – Guidance and MANUFACTURER’S declaration – electromagnetic IMMUNITY –
for all ME EQUIPMENT and ME SYSTEMS
The device is intended for use in the electromagnetic environment specified below.
The customer or the user of the device should assure that it is used in such an
environment.
Guidance and manufacture’s declaration – electromagnetic immunity
Immunity test
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
±2 kV for
power supply lines Not applicable
Not applicable
Not applicable
±1 kV line(s)
to line(s)
<5
%
UT
(>95
%
dip in UT)
for 0.5 cycle
40
%
UT
(60
%
dip in UT)
for 5 cycles
70
%
UT
(30
%
dip in UT)
for 25 cycles
<5
%
UT
(>95
%
dip in UT)
for 5 sec
3A/m
NOTE UT is the a.c. mains voltage prior to application of the test level.
IEC 60601
test level
Compliance
level
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electromagnetic
environment - guidance
Floors should be wood,
concrete or ceramic tile. If
floor are covered with
synthetic material, the
relative humidity should be
at least 30
%
.
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
3A/m
Power frequency
(50Hz) magnetic
field IEC
61000-4-8
Voltage dips,
short interrup-
tions and voltage
variations on
power supply
input lines IEC
61000-4-11
Electrical fast
transient/burst
IEC 61000-4-4
Surge IEC
61000-4-5
Table 4 Guidance and manufacture’s declaration – electromagnetic immunity –
for ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING
Guidance and manufacture’s declaration – electromagnetic immunity
Immunity test
3 Vrms
3 V/m
The device is intended for use in the electromagnetic environment specified below. The
customer or the user of the device should assure that it is used in such an environment.
Compliance
level
IEC 60601
test level
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 V/m 80 MHz
to 2.5 GHz
3 V
rms
150 kHz to
80 MHz
Electromagnetic environment -
guidance
Portable and mobile RF communications
equipment should be used no closer to
any part of the device including
cables, than the recommended
separation distance calculated from the
equation applicable to the frequency of
the transmitter.
Recommended separation distance
d = 1.167
d = 1.167 80 MHz to 800 MHz
d = 2.333 800 MHz to 2.5 GHz
where
P
is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter manufac-
turer and
d
is the recommended
separation distance in metres (m).
Field strengths from fixed RF transmit-
ters, as determined by an electromag-
netic site survey,
a
should be less than
the compliance level in each frequency
range.
Interference may occur in the vicinity of
equipment marked with the following
symbol:
