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ASTM F2193 Spinal Fixation Components

The ATS Family of Companies (FoC) provides ASTM F2193 testing for spinal fixation devices, such as spinal screws, rods, and plates. ASTM F2193 sets consistent terminology, specifications, and testing methods for spinal components across the medical device manufacturing industry.

What is ASTM F2193?

ASTM F2193 provides a standard language for defining a device’s geometry, dimensions, classification, material specifications, and performance. The standard’s consistent labeling and testing methods help surgeons make informed decisions when selecting spinal implant components. ASTM F2193 describes proper handling and packaging of the spinal components. This standard also requires labels for all components to include the following:

  • Mechanical behavior
  • Material properties
  • Terminology
  • Dimensions
  • Size
  • Instrumentation

Finally, ASTM F2193 describes the testing methods to determine static and dynamic characteristics of a spinal component to anticipate the device’s short-term stability until complete arthrodesis.

ASTM F2193 includes four annexes that explain the motivation and procedures for 4-point bend tests and static and fatigue strength measurements. The first annex describes performance tests for determining driving torque and axial pull-out load. Meanwhile, the other three annexes detail specifications for a 4-point bend test based on the component.

Bend Testing with ATS FoC

Our medical device testing lab houses state-of-the-art machines for rigorous testing conditions and precise measurements. When evaluating spinal components, we perform static testing by applying a load at a constant rate until failure. Meanwhile, our fatigue tests involve sinusoidal cyclic loads applied at a constant frequency until failure or reaching the runout limit. We can adjust the fluid, temperature, and other conditions that impact a component’s performance in vivo to meet client specifications.

We use ASTM F2193 tests to help clients compare a component’s fatigue characteristics with other designs. Our experts also use static and fatigue tests to uncover a component’s properties:

  • Bending stiffness
  • Bending structural stiffness
  • Bending yield moment
  • Bending fatigue moment
  • Bending ultimate moment

About the ATS FoC

The ATS FoC operates multiple ISO/IEC 17025 accredited labs that regularly perform calibrations and mechanical, nondestructive, chemical, and electrical tests. Our experts draw on decades of combined experience with medical device testing to deliver quick and reliable services that help manufacturers reach the market faster.

Please call +1 (888) 287-5227 or complete the request form on this page for ASTM F2193 static and fatigue testing on your spinal components.

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