14
・
Signal input/output parts port
Phenomenon
Basic EMC
standard or test
method
IMMUNITY TEST LEVELS
Professional healthcare facility environment
Electrostatic discharge
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4
IEC61000-4-2
± 8 kV contact
± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air
Conducted disturbance by
RF field
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1
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3
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5
IEC61000-4-6
6 V
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6
0,15 MHz – 80 MHz
6 V
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6
in ISM bands between 0,15 MHz and 80 MHz
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7
80% AM at 1 kHz
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2
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1: SIP/SOPS whose maximum cable length is less than 3 m in length are excluded.
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2: Testing may be performed at other modulation frequencies identified by the RISK MANAGEMENT PROCESS.
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3: Calibration for current injection clamps shall be performed in a 150 Ω system.
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4: Connectors shall be tested per 8.3.2 and Table 4 of IEC 61000-4-2:2008. For insulated connector shells,
perform air discharge testing to the connector shell and the pins using the rounded tip finger of the ESD
generator, with the exception that the only connector pins that are tested are those that can be contacted or
touched, under conditions of INTENDED USE, by the standard test finger shown in Figure 6 of the general
standard, applied in a bent or straight position.
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5: 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.
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6: r.m.s., before modulation is applied.
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7: The ISM (industrial, scientific and medical) bands between 150 kHz 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.
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15: 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.
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16: Applicable to ME EQUIPMENT and ME SYSTEMS with RATED input current less than or equal to 16 A /
phase.
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17: 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 or ME SYSTEM shall provide
BASIC SAFETY during and after the test.
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18: For ME EQUIPMENT and 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
and 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 rage.
