Evaluation of Medical Equipment/Implant Materials
Failure Analysis/Strength Analysis of Medical Equipment
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Contributing to higher quality in medical equipment by failure analysis and strength analysis conforming to ASTM standards.
Outline and Objects of Analysis
Outline of analysis
Analysis of cause of damage in damaged equipment, and evaluation of strength properties of equipment.
Applicable medical equipment (examples)
- Surgical instruments: Drills, drill bits, screwdrivers, reamers, forceps, etc.
- Fasteners: Screws, pins, bone plates, nails, rods, wires, etc.
Analysis Method and Tests Performed
Failure analysis
- Observation of fracture surface by scanning electron microscope, etc., estimation of failure mode and origin, analysis of cause of fracture.
Strength analysis
- Preparation of jigs for various types of medical devices, installation of tensile test machine, fatigue test machine, and torsion testing machine, and measurement of tensile/compressive properties, bending properties, fatigue strength, and torsional strength of medical devices in accordance with ASTM standards.
- Testing is possible in accordance with the following ASTM standards: ASTM Medical Devices and Service F1798, F1717, F2077
Actual failure analysis/strength analysis performed:
- 50 cases/year
Examples of Failure Analysis and Strength Analysis
-
Electron microscope photograph of fracture
surface of damaged screw
→ Analysis result: The point of origin was an area of
stress concentration in the thread
root; fatigue fracture occurred as a result of repeated bending stress. -
Results of bending test of medical device in
accordance with ASTM F1798
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