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Page Rigel Medical
62353+
user Manual V1.4
Applied Part Leakage
The Applied Part Leakage Test measures the total leakage deriving from the combined
Patient Connections within an Applied Part to earth and any conductive or non
conductive parts on the enclosure (either connected or isolated from earth) under the
fault condition Mains on Applied Parts.
The Applied Part Leakage Test is applicable to Floating type (BF & CF) Applied Parts
only either Class I or II.
All Patient Connections of a single function within an Applied Part shall be connected
together (BF & CF) and measured one at the time.
Applied Parts (& Patient Connections) not part of the measurement shall be left floating.
(ie not connected to real earth).
The test is conducted by applying a current limited (3.5mA) mains potential sinusoidal
50Hz signal (60Hz where this is the mains frequency) between the Applied Part and the
Enclosure and Earth connection of the EUT connected to real Earth.
Leakage measurements to IEC 62353 are done using the RMS value instead of the
separate AC and DC values used in the IEC 60601-1 standard.
The IEC 62353 / Applied Part Leakage can be performed in two different methods;
Direct Method
Alternative Method
Direct method
: The 1kΩ measuring device (equivalent to that used in the IEC 60601
standard
– see Appendix C)
is positioned in the leakage return path to earth between
the Applied Part and the real earth grouped with EUT earth and conductive parts not
connected to earth (Class I) or the real earth connected to the Class II enclosure.
Measurements are done in both polarities of the incoming mains.
The EUT must be positioned floating to avoid secondary earth connections influencing
the measuring process.
Warning
This Applied Part Direct Leakage test is similar to that of the F-Type leakage
test according to IEC 60601 using a equivalent current limited voltage source to