Electrical Safety Inspection A-17
ELECTRICAL SAFETY INSPECTION FORM
Class I equipment
Overall assessment:
Opened repair type, not modify the power part
including transformer or patient circuit board
Opened repair type, modify the power part including
transformer or patient circuit board
Test item: 1, 2, 3, 4, 5, 6, 7, 8
Location: Technician:
Equipment: Control Number:
Manufacturer: Model: SN:
Measurement equipment /SN: Date of Calibration:
INSPECTION AND TESTING
Pass/Fail
/NA
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:
BF applied part:
NC:100μA, SFC: 500μA
Single Fault condition(SFC) □BF___μA
7 Mains on Applied Part Leakage □BF___μA
Max:
BF applied part: 5000μA
8
Patient Auxiliary
Leakage
Current
Normal condition(NC)
□BF___μA
Max:
BF applied part:
NC:100μA, SFC: 500μA
Single Fault condition(SFC) □BF___μA
Note:
4-protective grounding impedance testing is applicable for M9 + UMT-500Plus trolley and is not
applicable for unaccompanied M9 system or M9 system with UMT-500 trolley (without power
supply).
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:_____________________________