Orthopedic Implants Mechanical Testing Solutions
The mechanical testing of orthopedic implants involves various methods to assess the implants strength, durability, and performance. Common tests include tension, compression, bend, fatigue, torsion and wear. These tests are crucial to ensuring the implants’ safety and efficacy. The U.S. Food and Drug Administration (FDA) categorizes medical devices into Class I, II, or III based on their risks and the regulatory controls necessary to provide a reasonable assurance of safety and effectiveness. Testing standards for medical devices are often developed for the specific medical device to be tested, as desired biomechanical properties per material and per application vary.
ADMET testing systems are trusted by leading medical device manufacturers, universities, and research laboratories to determine the mechanical properties and endurance limits of biomaterials, medical devices and implants. Our systems meet FDA 21 CFR part 11 requirements and are capable of performing static and fatigue tests in tension, compression, bending, torsion, axial-torsion and planar biaxial according to ASTM and ISO standards. Our ability to design a system to fit specific needs allows ADMET to provide testing solutions for even the most unique and demanding applications.