ASTM F2423 Wear and Fatigue Testing of Total Disc Prostheses
ASTM F2423 is a guide for wear and fatigue testing of artificial intervertebral discs under kinematic and functional cyclic loading or motion. Manufacturers use the tests recommended by ASTM F2423 to compare the wear and fatigue characteristics of various intervertebral disc (IVD) designs.
IVD refers to total disc prostheses designed to support loads and transmit spinal motion between articulating joints or compliant materials. ASTM F2423 applies to lumbar and cervical prostheses. These devices can consist of a variety of materials, including metals, ceramics, polymers, and combinations of the three. Two popular designs that ASTM F2423 covers are:
- Ball-and-socket articulating joints
- Biconcave joints with free-floating third body
- Biconcave joints with semi-constrained third body
- Metallic endplates that bond with elastomer cores
- Single-axis hinge joints
ASTM F2423 Testing
The ATS FoC performs standards-based wear and fatigue testing in our A2LA-certified medical device testing labs. ASTM F2423 outlines tests for cervical and lumbar devices based on their intended insertion location.
First, we insert the device into an environmentally controlled fatigue testing apparatus capable of reaching 55 Kip. Then, we introduce the testing medium, a bovine serum maintained around 37˚ C throughout the test. We can adjust the temperature upon client specification.
Next, we subject the device to the different loads and motions expected of daily life when in vivo:
- Flexion and extension
- Rotation
- Lateral bend
Every 1,000,000th cycle, we pause the test to inspect the prosthesis using visual testing, microscopy, and other methods for close examination. We also take geometric measurements of surfaces to determine physical changes over time.
The test terminates upon functional failure or runout (the 10,000,000th cycle), anticipating long-term function. Finally, we gather wear debris from the testing medium for analysis.
Analysis
ASTM F2423 describes analysis of mechanical failure and Mode 1 wear, the result of articulation between primary bearing surfaces. However, don’t stop the test until runout or functional failure. To study wear, our experts use gravimetric analysis of weight and changes in the shape and roughness of articulating surfaces.
Our experts study mechanical failure by charting the propagation defects (such as cracking) or de-bonding until functional failure occurs.
We use wear and fatigue testing to calculate the following:
- Net wear
- Net wear rate
- Volumetric wear
About the ATS FoC
The ATS FoC operates multiple ISO/IEC 17025-accredited labs across the nation. We deliver high-quality customer service by using powerful technology, testing to standards and custom specifications, and providing thorough analysis.
Please call +1 (888) 287-5227 or complete the form on this page to request wear and fatigue tests that comply with standards and guidelines such as ASTM F2423.
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Medical Device Testing
ASTM Testing
- ASTM F1044 Shear Testing of CaP and Metallic Coatings
- ASTM F1160 Shear and Bending Fatigue of Coatings
- ASTM F1264 Intramedullary Fixation Device Testing
- ASTM F1357 Articulating Total Wrist Implant Testing
- ASTM F1378 Shoulder Prostheses Testing
- ASTM F1541 ESFD Testing
- ASTM F1672 Patellar Prosthesis Testing
- ASTM F1714 Gravimetric Wear Assessment of Prosthetic Hip Design in Simulator Device Testing
- ASTM F1717 Spinal Implant Testing
- ASTM F1781 Elastomeric Flexible Hinge Finger Total Joint Implants Testing
- ASTM F1798 Spinal Implant Subassembly Testing
- ASTM F1820 Modular Acetabular Device Strength Testing
- ASTM F1829 Glenoid Locking Mechanism Shear Testing
- ASTM F1875 Fretting Corrosion Testing of Hip Implant Interfaces
- ASTM 2009 Modular Prostheses Taper Connection Testing
- ASTM F2025 Wear Assessment of Polymeric Components
- ASTM F2028 Glenoid Loosening Testing
- ASTM F2077 Intervertebral Body Fusion Device Testing
- ASTM F2183 Small Punch Testing
- ASTM F2193 Spinal Fixation Components
- ASTM F2267 Measuring Subsidence of Intervertebral Fusion Devices
- ASTM F2346 Standard and Dynamic Testing of Artificial Intervertebral Discs
- ASTM F2423 Wear and Fatigue Testing of Total Disc Prostheses
- ASTM F2502 Absorbable Plate and Screw Testing
- ASTM F2554 CAS System Precision Testing
- ASTM F2624 Static, Dynamic, and Wear Testing of Extra-Discal Spinal Implants
- ASTM F2624 Spinal Implant Dynamic Testing
- ASTM F2694 Lumbar Total Facet Prosthesis Testing
- ASTM F2706 Spinal Implant Fatigue Testing
- ASTM F2789 Mechanical and Functional Characterization of Nucleus Devices
- ASTM F2790 Static and Dynamic Testing of Total Facet Prostheses
- ASTM F382 Metallic Bone Plates Testing
- ASTM F384 Angled Orthopedic Fixation Testing
- ASTM F543 Metallic Medical Bone Screw Testing
- ASTM F564 Metallic Bone Staple Testing
ISO Testing
- Biocompatibility Testing for Medical Devices ISO 10993
- ISO-10328 Structural Testing of Lower Limb Prosthetics
- ISO 10993 Biocompatibility
- ISO 10993 Biocompatibility Testing
- ISO 10993 Testing
- ISO 10993 Testing Lab
- ISO 18192-1 Wear Testing for Intervertebral Disc Prostheses
- ISO 12189 Fatigue Testing of Flexible Spinal Implants
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