Solutions for Artificial Shoulder Implant Prosthesis Testing
Exceptional performance of artificial shoulder prosthesis is critical. Although ASTM and ISO do not have any specific wear test requirements, for FDA approval, medical device manufacturers must show that its device addresses the issue of safety and effectiveness. To do this device manufactures must verify that the prosthesis has appropriate endurance and is not subject to failure when exposed to normal loads. ASTM specifies that all implants must be statically tested in Accordance with ASTM F1829. Although ASTM and ISO do not have any specific wear/dynamic test requirements many manufacturers test their implants similar to other ISO standards (ISO 7206 – Part 4) to determine the endurance properties of their device.
ADMET offers multiple mechanical force testing systems configured to meet and exceed ASTM and ISO 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.