The Applied Technical Services Family of Companies (FoC) evaluates the characteristics of metallic bone plates in compliance with ASTM F383 metallic bone plate testing standards. Metallic bone plates are used during orthopedic reconstructive surgery and offer structural support to patients recovering from bone fractures. Orthopedic plates must undergo extensive evaluations examining their effectiveness and safety before their approval for clinical use. Our medical device testing lab offers ASTM-compliant testing that qualifies our client’s products and designs for FDA approval.
What is ASTM F382?
The American Society for Testing and Materials established ASTM F382 as the industry standard for determining the maximum force metallic bone plates can withstand. ASTM F382 outlines the steps to define metallic bone plate performance and geometric characteristics using fatigue and static test methods.
Bending Fatigue Properties Of Metallic Bone Plates
During this test, technicians load the specimen into a testing device before applying a predetermined number of bend cycles. The test continues until the sample endures the maximum number of cycles or breaks from the applied load. The procedure’s results offer insight into the material’s maximum moment, failure location, and failure mode.
Single Cycle Bend Testing of Metallic Bone
During this test, technicians load a metallic bone plate into a texting fixture and continue applying increasing levels of force until the plates deform and bend. The procedure helps technicians collect data on the sample’s bending strength, stiffness, and structural stiffness.
The Importance of Medical Device Testing
A medical device is an instrument, apparatus, or implant used to diagnose, treat, or mitigate injuries and illnesses. Medical device testing is an essential and highly regulated industry where manufacturers must adhere to FDA standards that ensure their medical devices’ functionality, safety, and reliability.
Our materials testing labs feature state-of-the-art technology capable of conducting ASTM-complaint and custom tests at a competitive price. Our engineers collaborate with clients to develop testing strategies that directly address the specific needs of their projects. Please submit an online service request or call +1 (888) 287-5227 to speak with an ATS representative about our ASTM F382 metallic bone plate testing services.
