Applied Technical Services specializes in the wear testing of intervertebral spinal disc prosthesis. As spinal prostheses become more popular, new manufacturers must rigorously test their implants to ensure effectiveness, safety, and regulatory compliance. Our medical device testing experts perform wear tests on intervertebral spinal disc prosthesis in accordance with ISO 18192.
What is an Intervertebral Spinal Disc Prosthesis?
An intervertebral spinal disc prosthesis is an artificial medical implant designed to replace a damaged or degenerative spinal disc while preserving the spine’s mobility and flexibility. The implant mimics a disc’s biomechanical properties while relieving the patient’s pain and discomfort.
There are two types of intervertebral disc prosthesis, cervical prosthesis and lumbar prosthesis, each representing the respective part of the spine in which they’re used.
What is ISO 18192?
ISO 18192 establishes a standardized framework for evaluating the wear of intervertebral spinal disc prostheses. The standard’s test methods replicate the complex mechanical motions, loads, and fluid exposure experienced by the human spine. The standard helps laboratories assess the long‑term wear behavior, wear particle generation, and integrity of the prosthesis.
During the tests, technicians subject the sample to axial compression at 1 Hz while submerged in a solution simulating bodily fluids. Technicians continue testing until the sample completes 10 million cycles or fails.
For companies performing intervertebral disc wear testing, ISO 18192 offers an internationally recognized methodology for demonstrating device reliability, safety, and functional longevity.
Our Intervertebral Spinal Disc Prosthesis Testing Services
Our intervertebral spinal disc wear testing services help medical device manufacturers validate their spinal disc prosthesis designs. Conducted in accordance with ISO 18192, our testing replicates realistic spinal loading and motion to ensure our clients’ products meet industry standards.
Our staff has decades of collective experience and a commitment to helping manufacturers develop products that benefit patients and healthcare providers.
Contact Us
Partner with our team to ensure your intervertebral disc prostheses meet the highest standards of safety, performance, and reliability. Call +1 (888) 287-5227 to learn more about our capabilities or submit a webform to request wear testing now.
