Safety Tests
Performance Verification Testing
3-28 Efficia CM Series Service Guide
Touch Leakage, Part 3
Figure 3-4 S(2) Part 3: Touch Leakage Current - NC (normal condition)
within a System
This measures leakage current of exposed metal parts of Instrument under Test (IUT)
within a system with Protective Earth (PE) normal condition (S4 = closed) and between
parts of the system within the patient environment; normal and reversed polarity using
S2 with S5 closed/open for each in turn of “Other instrument” making up the medical
electrical system.
Expected Test Results:
Normal condition maximum leakage current x1 100A
Touch Leakage, Part 4
Figure 3-5 S(2) Part 4: Touch Leakage current, Single Fault (open earth) within a
System
This measures leakage current of exposed metal parts of Instrument under Test (IUT)
within a system with Protective Earth (PE) open circuit (S4 = open) and between parts
of the system within the patient environment; normal and reversed polarity using S2 in
turn for all other equipment that is connected to the medical instrument under test. S5
closed/open for each in-turn of "Other Instrument" making up the medical electrical
system.
Expected Test Results:
Single Fault maximum leakage current x2 500A (IEC 60601-1)
Medical
S5
Medical Electrical
S5