A-11 
 
A.9 Scheduled Electrical Safety Inspection   
For scheduled electrical safety inspection, test items 1, 2, 3, 4, 5, 6, 7, and 8 included in the 
ELECTRICAL SAFETY INSPECTION FORM shall be performed.   
ELECTRICAL SAFETY INSPECTION FORM 
Location: Technician: 
Equipment: Control Number: 
Manufacturer: Model:  SN: 
Measurement equipment /SN:  Date of Calibration: 
INSPECTION AND TESTING  Pass/Fail Limit 
1  Power Cord Plug     
2  Device Enclosure and Accessories     
3 Device Labeling     
4  Protective Earth Resistance  ____Ω  Max 0.2 Ω 
Normal condition 
(NC) 
 
____μA 
 
5 
Earth 
Leakage 
Single Fault 
condition (SFC) 
 
____μA 
 
Max:   
NC: 300μA(refer to 
UL60601-1) * 
NC: 500μA(refer to   
IEC60601-1) * 
SFC: 1000μA 
□BF____μA 
Normal condition 
(NC) 
□CF____μA 
 
□BF____μA 
6 
Patient 
Leakage 
Current 
Single Fault 
condition (SFC) 
□CF____μA 
 
Max: 
CF applied part: 
NC:10μA, SFC: 50μA 
BF applied part: 
NC:100μA, SFC: 
500μA 
□BF____μA 
7  Mains on Applied Part Leakage 
□CF____μA 
 
Max: 
CF applied part: 50μA 
BF applied part: 
5000μA  
□BF____μA 
Normal condition 
(NC) 
□CF____μA 
 
□BF____μA 
8 
Patient 
Auxiliary 
Current 
Single Fault condition 
(SFC) 
□CF____μA 
 
Max: 
CF applied part: 
NC:10μA, SFC: 50μA 
BF applied part: 
NC:100μA, SFC: 
500μA 
Note: The equipment sold to the United States shall comply with the requirement of 
UL60601-1; others shall comply with the requirement of IEC60601-1. 
 
Name/ Signature: __________________________ Date:_____________________________