Business Development Manager, Medical Device Testing
United StatesContact Alison
The biomedical industry requires various degrees of regulatory and validation testing. Smithers offers expertise in physical and mechanical testing techniques for numerous types of medical devices including orthopedic fixation and trauma devices.
Orthopedic fixation devices include bone plates, screws and other internal and external devices used to treat bone fractures and other conditions.
For medical bone plates, Smithers utilizes axial fatigue testing to measure performance related to their mechanical characteristics. ASTM F382 and ASTM F384 are the most common specifications used to test bone plates against performance expectations. ASTM F382 is the typical standard for evaluating straight plates while ASTM F834 is used to evaluate angled plates.
ASTM F382 – Standard Test Method for Metallic Bone Plates
This standard covers bend to failure and cyclic fatigue bending (straight plates) methods and includes the following test methods:
ASTM F384 – Standard Method for Metallic Angled Orthopedic Fracture Fixation Devices
This standard covers bend failure and cyclic fatigue bending for angled plates and includes the following test methods: