7 Testing and Maintenance
71
Measuring circuit for the measurement of Applied Part Leakage Current - Direct method
according to IEC/EN 62353
This test measures applied part leakage current from applied part to earth caused by external main
voltage on the applied part. Each polarity combination possible shall be tested. There are no parts of
the equipment that are not protectively earthed. This safety test is based on IEC/EN 60601-1, IEC/
EN 62353, UL2601-1 Ed. 2/UL60601-1:2003 and CSA 601.1-M90. Report the highest value. (X1).
NOTE
All values for current and voltage are the root mean square (r.m.s.) values, unless otherwise stated.
In case of an IT-power system, this safety test measurement requires a special measuring circuit, for
example with its own integrated TN-system or use of an external isolation transformer attached to the
safety test device.
System Test
After mounting and setting up a system, perform system safety tests according to IEC 60601-
1:2005+A1:2012/EN 60601-1:2006+AC:2010.
What is a Medical Electrical System?
A medical electrical system is a combination of at least one medical electrical device and other electrical
equipment, interconnected by functional connection or use of a multiple portable socket-outlet.
• Devices forming a system must comply with IEC 60601-1:2005+A1:2012/EN 60601-
1:2006+AC:2010.
• Any electrical device such as IT equipment that is connected to the medical electrical equipment
must comply with IEC 60601-1:2005+A1:2012/EN 60601-1:2006+AC:2010 and be tested
accordingly.
General Requirements for a System
After installation or subsequent modification, a system must comply with the requirements of the
system standard IEC 60601-1:2005+A1:2012/EN 60601-1:2006+AC:2010. Compliance is checked by
Test Expected test results
Applied Part Leakage Current test (Single Fault
Condition - mains on applied part)
X1 <= 5000 μA (BF)
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