Regulatory Testing

Mechanical Testing and Analytical Studies

Accentus Medical has unrivalled 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.

To perform analytical studies, Accentus Medical accesses resources from its extensive scientific network of internationally recognised specialist centres. Employing the expertise and skills of experienced scientists as well as state-of-the-art facilities which are available through our network enables Accentus Medical to access and carry out a range of laboratory studies far beyond the scope of most orthopaedic test centres.

Mechanical Testing – setting the standard

All testing is performed in laboratories with ISO 13485 certified procedures, meeting the requirements of ISO, ASTM, and US FDA. Our technologically advanced orthopaedic implant testing facility incorporates computer-controlled systems with up to three moving axes, which enables us to perform many different testing programmes for a wide range of implant designs and materials. Specifically designed test equipment allows post-wear test weighing by particle analysis. To minimise contamination of testing fluids, this is performed under strict environmental control. The range of mechanical testing services include:

  • Single and multi-axis, static and shear
  • Wear testing
  • Strain-life fatigue testing in tension/compression, fully reversed-bending and torsion
  • Metallurgical failure
  • 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
  • Implant retrieval analysis to discover mode of failure
  • Serum biochemistry
  • Corrosion testing of metal combinations used in total joints
  • Characterisation of composite biomaterials
  • Tribological studies of bearing surfaces
  • Study of implant surfaces using scanning electron microscopy
  • Study of implant coatings utilising X-ray diffraction techniques.

Contact Us

T: +44 (0)1235 434 320
F: +44 (0)1235 434 329