10.6.2 Leakage Current Limits
The following acceptance limits and test conditions are summarized from IEC 60601 including national
deviations and IEC 62353 and in some cases are lower than that specified by the standards. In accordance
with these standards, fault conditions like Reverse Polarity of the supply mains and Open Neutral are no
longer required for field evaluation of leakage current. Because the main source of leakage current is the
mains supply, there are different acceptance limits depending on the configuration of the mains 100-130
VAC or 220-240 VAC (VAC = Volt mains).
Table 10-10 leakage current limits for operation on 100-130 Volt mains (US/Canada/Japan)
Leakage Current Test
System Power
Grounding/PE Conductor
Limit mA
Limit μA
Earth Leakage
On and Off
N/A
0.3*
300*
Chassis/Enclosure Leakage
On and Off
Closed
Open
0.1
0.3*
100
300*
Type BF Applied Parts
On (transmit)
Closed
Open
0.1
0.5
100
500
Type CF Applied Parts
On (transmit)
Closed
Open
0.01
0.05
10
50
Type BF Applied Parts (sink leakage,
mains voltage on applied part)
On and Off
Closed
5.0
5000
Type CF Applied Parts (sink leakage,
mains voltage on applied part)
On and Off
Closed
0.05
50
* UL 60601-1 standard
Note
Open Grounding is also known as “Lift Ground”.
Table 10-11 leakage current limits for system operation on 220-240 Volt mains
Leakage Current Test
System Power
Grounding/PE Conductor
Limit mA
Limit μA
Earth Leakage
On and Off
Open and Closed
0.5
500
Chassis/Enclosure Leakage
On and Off
Closed
Open
0.1
0.5
100
500
Type BF Applied Parts
On (transmit)
Closed
Open
0.1
0.5
100
500
Type CF Applied Parts
On (transmit)
Closed
Open
0.01
0.05
10
50
Type BF Applied Parts (sink leakage,
mains voltage on applied part)
On and Off
Closed
5.0
5000
Type CF Applied Parts (sink leakage,
mains voltage on applied part)
On and Off
Closed
0.05
50
Values based on IEC 60601
Table 10-12 ISO and mains applied limits*
Probe Type
Measurement
BF
5.0 mA (5000 μA)
CF
0.05 mA (50 μA)
* ISO and Mains Applied refers to the sink leakage test where mains (supply) voltage is applied to the
applied part to determine the amount of current that will pass (or sink) to ground if a patient is in contact with
mains voltage.
Note
Electrical leakage testing may be accomplished with any calibrated Electrical Safety Analyzer tool compliant
with AAMI/ESI 1993 or IEC 60601 or AS/NZS 3551 or IEC 62353 or other relevant national regulation.
Care and Maintenance
Voluson E-Series Service Manual
KTD106657 Revision 2
10-11
Summary of Contents for H48681XB
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