Medical Product Failure Analysis

The final goal of a product failure analysis is the determination of the mode and cause of failure.

Failure Analysis of medical products requires the use of unique mechanical, microscopic and analytical techniques. The first step is to perform a thorough inspection on the failed part, initially with an optical stereomicroscope and subsequently with a scanning electron microscope if applicable.  If sample (the size) allows it, mechanical testing provides the tensile, dynamic, impact, thermal and stiffness properties of the material(s).  While procedures vary, the primary mechanical tests provide a comparison between measured data to a specification, or to data generated by a known benchmark.  Computer-aided stress analysis can provide the stress distribution of the part in service, with the results detailing the geometrical effect of the failure.

Chemical testing provides the tools to check the failed compound recipe against a known formulation or benchmark compound, the thermal characteristics as well as its state of cure or processing consistency.   Chemical analysis is also used to detect and identify chemical contaminants still present in/on the failed part.

Failure Analysis Testing

  • Chemical Testing
  • Compound Analysis
  • Fatigue Testing
  • Finite Element Analysis (Computer-aided Stress Analysis)
  • Formula Reconstruction
  • Impact Testing
  • Mechanical/Physical Testing
  • Microscopic Analysis
  • Ultra High Strain Rate

If you would like more information about Medical Product Failure Analysis Services, please contact ARDL via email or by phone at (866) 778-ARDL or (330) 794-6600.

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