Evaluation of Medical Equipment/Implant Materials

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Failure Analysis/Strength Analysis of Medical Equipment

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

For test reports in English and other languages, just ask JFE-TEC!

JFE-TEC can also prepare test reports conforming to ASTM, ISO and other standards in English as well as Japanese.

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