The biomedical industry requires various degrees of regulatory and validation testing. Smithers Rapra 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.
Bone Plate Testing
For medical bone plates, Smithers Rapra 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.
Common Test Methods for Internal Fixation
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:
- Annex A1 - Standard Test Method for Single Cycle Bend Testing of Metallic Bone Plates
- Annex A2 - Standard Test Method for Determining the Bending Fatigue Properties of Metallic Bone Plates
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:
- Annex A1 - Standard Test Method for Single Cycle Compression Bend Testing of Metallic Angled Orthopedic Fracture Fixation Devices
- Annex A2 - Standard Test Method for Determining the Bending Fatigue Properties of Metallic Angled Orthopedic Fracture Fixation Devices
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