SafeTrace – Medical Device Testing, Asset & Compliance Management

v1.0 | 2025-10-02 00:07Published

#	Title	Type	Limits	Unit	Actions
1	Protective Earth Resistance Measure PE from earth pin to accessible conductive parts.	NumericMeasure	-	Ω	Locked
2	Enclosure Leakage Current (NC) Measure enclosure leakage in normal condition using DIRECT or DIFFERENTIAL method.	NumericMeasure	-	µA	Locked
3	Patient/Applied-Part Leakage (NC) Measure patient leakage in normal condition.	NumericMeasure	-	µA	Locked
4	Patient/Applied-Part Leakage (SFC, open earth) Simulate open protective earth and measure leakage.	NumericMeasure	-	µA	Locked
5	Insulation Resistance Apply 500 VDC between mains parts and protective earth.	NumericMeasure	-	MΩ	Locked