The medical device testing experts at the Applied Technical Services Family of Companies conduct spinal implant testing to ensure the safety, durability, quality, and compliance of implants designed to support, replace, or stabilize the spine.
Spinal Implant Medical Device Testing
Spinal implants are complex medical devices, containing components such as rods, screws, plates, and interbody cages that are used in surgeries to treat conditions such as spinal deformities, degenerative disc disease, and fractures. Given their importance in maintaining spinal integrity and supporting the bodyโs movement, spinal implants must be subjected to thorough testing before they can be approved for clinical use, including fatigue testing, tensile testing, shear testing, and even chemical analysis.
Mechanical Testing
One of the main focuses of spinal implant testing is mechanical performance. As the spine is a complex structure that supports the bodyโs weight while allowing for flexibility and movement, implants used in spinal surgeries need to mimic this functionality to providing both stability and the ability to withstand different forces of varying intensity.
ATSโ mechanical testing labs use state-of-the-art equipment to simulate real-world conditions, subjecting spinal implants to compressive, tensile, and torsion testing to ensure functionality and structural integrity through daily activities, such as walking, bending, and lifting. Fatigue testing applies repeated cycles of loading and unloading to a test subject, assessing the long-term durability of the materials to verify the implantโs lifespan.
Biocompatibility Testing
As spinal implants can come into direct contact with bone, muscle, and other types of tissue, biocompatibility testing ensures that implants are made of non-toxic materials that do not cause adverse reactions from the body. Biocompatibility testing evaluates materials to identify causes of inflammation, allergic reactions, or rejection. This is done through cytotoxicity assays and histopathological evaluations, which examine how cells react to the implant material and assess post-implantation tissue response. Biocompatibility testing helps to verify that implant materials are safe and biocompatible to prevent complications after surgery.
Spinal Implant Testing Standards
ATS conducts medical device testing to a wide range of standards, including those set by the American Society of Testing and Materials and the International Organization for Standardization.
- ASTM F1717
- ASTM F2077
- ASTM F382
- ISO 10993
- ISO 13779
- ISO 14630
- ISO 12189
- ISO 5832
The Medical Implant Testing Experts at ATS
Applied Technical Services is proud to be the preferred medical implant testing provider for some of the nationโs most well-established manufacturers. Submit a request form on this page or callย 1 (888) 287-5227ย today for a free quote or additional information on spinal implant testing services.