ASTM F2346 Standard and Dynamic Testing of Artificial Intervertebral Discs
The ATS Family of Companies (FoC) provides medical device testing for artificial intervertebral discs according to the ASTM F2346 standard. Artificial intervertebral discs are orthopedic implants that replace weak or narrowed discs in a patient’s spine. Typically, the orthopedic implant is inserted between two vertebrae in the cervical or lumbar regions.
Artificial discs can absorb the stresses on the vertebrae, reducing back pain and preserving spinal motion in patients with back pain or degenerative disc disease. To ensure the implants retain mechanical integrity in their intended environments, ASTM designed the F2346 standard for in vitro testing.
ASTM F2346: Artificial Intervertebral Disc Testing
The ASTM F2346 standard specifies methods and materials to compare how various artificial intervertebral discs react to static and dynamic loads. These tests subject the orthopedic implants to various conditions that simulate the shock and stress demanded by regular motion.
Artificial intervertebral discs typically consist of two keel or spike endplates and a core. Most FDA-approved orthopedic discs are made from a combination of plastic, metals, and coatings, such as:
- Cobalt chromium alloy
- Molybdenum
- Hydroxyapatite
- Titanium alloy
- Polyethylene
Types of Tests
Per ASTM requirements, the ATS FoC can conduct the test in a 0.9% saline bath at 37°C to simulate the temperature and moisture of the vertebral cavity. We can use the same equipment throughout the procedure, making minor adjustments depending on the test:
- Axial compression
- Compression shear
- Torsion testing
Static Tests
First, we determine the maximum load the product can endure. Next, we perform tests with compression, shear, and torque forces. During a torsion test, we apply physiological compression preloads based on the intended location of the artificial disk, with 100 N for the cervical region and 500 N for the lumbar region. Finally, we record variations in load, displacement, moment, and angle as needed.
We can calculate stiffness, yield displacement, yield load/moment, ultimate yield load/moment, and ultimate displacement.
Dynamic Tests
Our experts can also conduct dynamic tests to assess performance under changing conditions at a cyclic frequency of 2Hz. Using the same testing apparatus, we can subject the product to various fatigue loads or moments until the test reaches 10,000,000 cycles or functional failure occurs. We can calculate the endurance limit of the artificial disc through regression analysis and note the type of failure, failure mode, and any deformation or mechanical deterioration.
Our Commitment to Quality
The ATS FoC operates multiple ISO 17025-accredited labs nationwide. With a wide scope of accreditations in medical device testing, we are uniquely qualified to provide clients with dependable solutions.
Our experts use innovative technology and follow testing procedures outlined by regulatory and industry authorities to deliver comprehensive testing and analysis. Our quick turnaround rate gets products to market faster and helps clients make critical business decisions sooner.
Please call +1 (888) 287-5227 or submit an online request to schedule our artificial intervertebral disc testing services.
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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
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