ASTM F2580: Scope and requirements
ASTM F2580-18: Standard Practice for Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prosthesis
- For this test method, a cyclic, constant-amplitude force is applied to modular metallic femoral stems.
- The test is intended to evaluate the fatigue performance of the modular connections in the metphyseal filling region of the femoral stem.
Here’s how the test works:
The stemmed femoral component is clamped in the fatigue testing machine and then subjected to a cyclic, typically sinusoidal load of constant amplitude. The goal is to test the mechanical endurance limit and failure behavior – particularly in the area of the modular connection – under repeated loading.
The test is run over a specified number of load cycles or until failure occurs, for example, due to cracking or fracture, and is used to evaluate the long-term stability and reliability of the implant.
The ZwickRoell testing fixture enables standards-compliant performance of fatigue tests to be performed on stemmed femoral components to ASTM F2580 by precisely reproducing the mechanical boundary conditions defined in the standard. For this purpose, the prosthesis stem is fixed in an embedding tube, whereby both the embedding height and the load-application angle can be precisely adjusted using the integrated alignment and embedding technology. This allows the real implant situation in the femur to be reproduced.
In the test sequence, the implanted shaft is then subjected to a cyclic, axially acting force in an electrodynamic testing machine or a HC Compact servohydraulic testing machine whereby the device can simulate both a clinically stable anchoring and a defined loosening state. This is particularly relevant because the standard provides for two different fatigue scenarios:
- a test in the area of the head-neck transition as well as
- a test on the prosthesis shaft itself
In combination with the testXpert R testing software, parameters such as sinusoidal load, load ratio and number of cycles can be controlled and evaluated in a standardized manner. The test programs enable the test to be performed quickly and reliably, while at the same time allowing individual adjustments.
Overall, the test fixture allows an efficient, valid, and standard-compliant evaluation of the fatigue strength and failure behavior of proximally fixed femoral hip prostheses.
Downloads
- Product Information: Test fixture for proximally fixed femoral hip prostheses to ASTM F2580 PDF 205 KB
- Industry Brochure: medical industry PDF 6 MB
- Product Information: Traceable and Reliable Test Results in Accordance with FDA 21 CFR Part 11 PDF 1 MB
- Industry Brochure: Biomechanics PDF 8 MB
