Performance Test Checklist
Description Set Measured Pass Fail N/A
UOM Values Values Limit/
Tolerance
UOM=unit of Measurement
Remarks/ Status: ( Performance report)
Test Equipment Used
Test Device: Test Device:
Model: Model:
Serial No: Serial No:
PPM Check List
Planned Preventive Maintenance (PPM) Checklist Pass/Fail/ Not Available
Physically Inspection
1. Chassis/Housing Examine for cleanliness and general physical condition.
2. Mount/Fastener Examine for mount/fastener general physical condition.
3. Caster/Brakes Examine for caster/breaks general physical condition.
4. AC plug Examine AC plug physical condition
5. Line Cord Examine for line cord physical condition.
6. Strain relief Examine the strain relief at both ends of the line cords.
7. Fuse Check correct value fuse rating is use
8. Cables Inspect the patient cable and leads and strain relief.
9. Fitting/Connectors Examine for connectors physical condition and smooth Movement
between male female contacts.
10.Pump Check for pump physical condition
11.Control/Switches Examine for controls and switches physical condition
and free movement
12.Indicator/Display Examine for indicator/Display operational
13.Alarm Check audible alarm for indicator/Display Operational
14.Label Check label legibility.
Internal Inspection
15.Cleanliness Clean interior and exterior of the equipment.
16.Lubricate Lubricate paper drive and recorder mechanism.
17.Battery Check internal battery(Replace according manufacture requirement )
Performance
18.Lubricate Lubricate paper drive and recorder mechanism.
19.Battery Check main external battery.(Replace if required)
Safety Test & Performance
20.Electrical Safety Test Perform EST as stated and required in IEC 60601.01(refer to EST
report).
21 Performance Test according to Hospital Engineering Planned Preventive
Planned Preventive Maintenance (PPM) Results:
No safety relevant defects
Defects corrected immediately
Defect which require repair and removed from service
Significant defects, this unit beyond feasible repair.
Remarks/ Status: (Physical Inspection) Notes:
Evidence Attachment: (Physical Defect) If needed for exception of incident.
Evidence Pic 1
Evidence Pic 2
Evidence Pic 3
Evidence Pic 4
Notes:
Sample User Training Verification Form
Name: _____________________ Position: ___________________________
Medical Device Manufacturer/ Model Trained Date of Assessment/ Comment
Supplier By training Review date
Department __________________ date employment commenced __
Sample Bin Card for Spare Parts
Date Doc. No. Received Quantity Batch Expiry Rema
(Receiving or from or No. Date
Issuing) Issued to Receive Issued Loss/Adj Balance
d
Item Description: ___________________ Item Code Number: _________________________
Calibration and Testing Tools
Defibrillator analyzers
Ultrasound meters
Electrosurgical analyzers
Ventilator Taste
Infusion pump analyzers
Gas Flow Analyzers
NIBP analyzers
Temperature / Humidity Calibration
Criteria for standard biomedical work shop
s.no Standard criteria for biomedical work shop Met Unmet
1 Presence of well-equipped staff office with mini
library (e - library ) at the workshop
2 Presence of mini- store(for spare part and
accessories) in the medical device workshop
3 Presence of maintenance, calibration & testing tools,
appropriate gases (e.g. Acetylene, oxygen) & other
tools
4 Availability of equipped maintenance training
workshop capable of mechanical & electrical
activities
5 Presence of appropriate and adequate space for
loading and unloading of medical devices
6 Rest room
