ASTM F2694 Lumbar Total Facet Prosthesis Testing
Prosthetic facets have multiple design options, such as ball-and-socket articulating joints and metallic load-bearing surfaces. The wide range of metals, polymers, and ceramics used to create prostheses requires complex testing.
To ensure a prothesis’s long-term function, the ATS FoC follows the recommendations of ASTM standard F2694 for cyclic loading procedures to study the wear, function, and kinematic behavior of prostheses.
ASTM F2694 Procedure
ATS FoC experts can perform the test in temperature-controlled, sterilized chambers, using a mounting component, like a clamp or fixture, to secure the prosthesis. First, we flood the testing chamber with a solution maintained at 37°C. Next, we subject the prosthesis to various worst-case scenarios that anticipate harsh in vivo conditions, including a compressive force that simulates the shear load in a spine at a frequency ≤2 Hz. We can maintain a magnitude of force (±5%) in the desired range of motion for the facet.
During the test, we can subject the facet to specified motions and loads:
- Flexion Loading/Extension Loading
- Lateral Bend Loading
- Axial Rotation Loading
Total Facet Prosthesis Analysis
Throughout the procedure, we take geometric measurements of all relevant functional surfaces of the test specimens to record how the product changes with wear. Our analysis includes additional factors, such as:
- Range of Motion (ROM)
- Load data
- Failure modes and deformations
- Filtered particle analysis
- Net wear
- Interval net wear rate
- Net volumetric wear
Medical Device Testing Quality Assurance
The ATS FoC empowers clients to make informed business decisions through our four broad service areas: consulting engineering, calibrations, testing, and analysis. We operate multiple ISO 17025-accredited labs across the continental U.S., which enables our quick turn-around rate as we meet our clients’ needs. Our experts regularly work with sophisticated technology to deliver precise and reliable results according to regulatory requirements and industry standards.
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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
Medical Device Testing
- Fatigue Testing Lab
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- Material Device Regulatory Compliance Testing
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- Prosthetic Testing Services