A-3 
 
A.6 ELECTRICAL SAFETY INSPECTION FORM 
Inspection and Testing  Limit 
1  Power Cord Plug   
2  Device Enclosure and Accessories  / 
3 Device Labeling  / 
4  Protective Earth Resistance  Max 0.2 Ω 
5  Earth Leakage  Normal condition(NC)  Max:     
NC: 300μA(refer to UL60601-1) 
SFC: 1000μA 
Single Fault condition(SFC) 
6  Patient Leakage Current  Normal condition(NC)  Max: 
CF applied part: 
NC:10μA, SFC: 50μA 
BF applied part: 
NC:100μA, SFC: 500μA 
Single Fault condition(SFC) 
7  Mains on Applied Part Leakage  Max: 
CF applied part: 50μA 
BF applied part: 5000μA   
8  Patient Auxiliary Current  Normal condition(NC)  Max: 
CF applied part: 
NC:10μA, SFC: 50μA 
BF applied part: 
NC:100μA, SFC: 500μA