Solutions for Metallic Bone Plate and Fixation Device Testing
Orthopedic metallic bone plates and angled fixation devices are used (with metallic bone screws) to hold fractured pieces of bone to their natural position. Due to the gravity of the implants application it is critical that medical device manufacturers understand the quality of their device and how their implant will perform in the patient once surgery is complete. To help standardize this analysis ASTM has developed two standards specific to Metallic Bone Plates and Angled Metallic Fixation Devices. These two standards focus on determining the maximum force the implant can withstand as well as the endurance properties.
ASTM F382 – Standard Specification and Test Method for Metallic Bone Plates
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 Specification and Test Method for Metallic Angled Orthopedic Fracture Fixation Devices
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
ADMET offers multiple mechanical force testing systems configured to meet and exceed these ASTM test standards. All of the systems are controlled with ADMET’s proven MTESTQuattro testing software that automatically performs each test according to ASTM and ISO standards, as well as custom test procedures.