Performance Verification Testing
Efficia CM Series Repair Guide 2-29
Safety Tests
Touch Leakage Testing
All monitors require the touch leakage tests part 1 and part 2. If the monitor under test
is part of a medical electrical system, such as an EHR, you must also perform “Touch
Leakage, Part 3” on page 2-30 and “Touch Leakage, Part 4” on page 2-30.
Touch Leakage, Part 1
Figure 2-2 S(2) Part 1: Touch Leakage Current, NC (Normal Condition)
Expected Test Results:
Normal condition maximum leakage current x1 100A
This measures leakage current of exposed metal parts of Instrument under Test (IUT)
within the patient environment; normal and reversed polarity using S2.
Safety test according to IEC 60601-1 / ES 60601-1
Touch Leakage, Part 2
Figure 2-3 S(2) Part 2: Touch Leakage Current, Single Fault (Open Earth)
Expected Test Results:
Single Fault maximum leakage current x2 500A (IEC 60601-1)
Medical Electrical