A-9
ELECTRICAL SAFETY INSPECTION FORM
Overall assessment
Scheduled inspection Test item: 1, 2, 3, 4, 5, 6, 7
Unopened repair type Test item: 1, 2, 3
Opened repair type, not replace the power part including
transformer or patient circuit board
Test item: 1, 2, 3, 4
Opened repair type, replace the power part including transformer Test item: 1, 2, 3, 4, 5
Opened repair type, replace patient circuit board Test item: 1, 2, 3, 4, 6, 7
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
5
Earth
Leakage
Normal
condition(NC)
____μA
Max:
NC: 300μA(refer to
UL60601-1) *
NC: 500μA(refer to
IEC60601-1) *
SFC: 1000μA
Single Fault
condition(SFC)
____μA
6
Patient
Leakage
Current
Normal
condition(NC)
□BF____μA
Max:
CF applied part:
NC:10μA, SFC: 50μA
BF applied part:
NC:100μA, SFC: 500μA
□CF____μA
Single Fault
condition(SFC)
□BF____μA
□CF____μA
7 Mains on Applied Part Leakage
□BF____μA
Max:
CF applied part: 50μA
BF applied part:
5000μA
□CF____μA
Note: The equipment which sell to America shall comply with the requirement of UL60601-1,
others shall comply with the requirement of IEC60601-1.
Name/ Signature: __________________________ Date:_____________________________
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