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:

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:

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:

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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