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Regulatory Testing

Mechanical Testing
Accentus Medical has many years of in-house experience at establishing mechanical test data protocols for orthopaedic implants that are designed to meet regulatory requirements, either as part of a design process, or to satisfy customer demands. All results are confidential, unless otherwise specified, and are delivered in a timely and cost effective manner.

Mechanical Testing – setting the standard

All testing is performed in a testing facility with ISO 13485 certified procedures, meeting the requirements of ISO, ASTM, and US FDA. Our Orthopaedic implant testing facility incorporates computer-controlled systems, which enables us to perform many different testing programmes for a wide range of implant designs and materials. The range of mechanical testing services include:

  • Single static tension/compression and shear
  • Strain-life fatigue testing in tension/compression
  • Surface engineering, roughness and abrasion.

Analytical studies – fit for purpose
Examples of analytical testing performed:

  • Metal ion analysis of blood serum from patients who have received a total hip replacement
  • Study of implant surfaces (including coating thickness / porosity) using scanning electron microscopy and associated analysis
  • Study of implant coatings utilising X-ray diffraction techniques.