The ATS Family of Companies (FoC) performs ISO 7206-4 testing on femoral components to ensure the safety of partial and total hip prostheses for human use.
Hip Endoprosthesis
The hip joint is a ball-and-socket joint between the acetabulum and the femur. A layer of cartilage and synovial membrane cushions the bones and minimizes friction to facilitate painless movement. Arthritis, disease, or injury can cause pain and mobility issues, however, that require surgical replacement for all or part of the joint with a prosthetic.
Hip prostheses typically include the following components:
- Metal stems
- Metal or ceramic balls
- Metal sockets
- Plastic, metal, or ceramic liners
ISO 7206-4 Fatigue Testing
The ATS FoC is ISO/IEC 17025:2017 accredited to perform the fatigue testing specified in ISO 7206-4. During this testing, our specialists subject the device to a variety of cyclical loads, including compression, tensile, and bending stresses, to simulate real-life forces.
Our experts continue to apply these forces until the device fails or survives a predetermined number of cycles. The ISO 7206-4 standard requires that products complete at least 5 million cycles of axial loads applied between 300 N and 2,300 N. If the product fails, our experts record the implant’s endurance properties:
- Endurance Limit – the maximum force the device withstands without damage or breaking
- Endurance Cycles – the corresponding number of axial loading cycles
Fatigue testing per ISO 7206-4 simulates proximal loosening, in which the implant begins to separate from the bone due to infection, wear debris, or impact damage, such as from a fall. Our clients request ISO 7206-4 testing to predict a device’s in vivo performance without risking a patient’s health in a clinical trial.
Our experts can tailor the testing environment to imitate human conditions. We can embed the test specimen in solid material to represent the loss of bone support during loosening and immerse the assembly in a fluid solution, such as deionized sodium chloride or distilled water.
Prepare for FDA Submissions
Medical devices must undergo rigorous evaluation to qualify for market distribution. Our services help clients determine if their products comply with industry regulations before submitting a device for premarket review.
ISO 7206-4 testing verifies whether a product satisfies quality and performance requirements. If a component fails the test, our thorough analysis supports our clients’ next steps, from disclosures to design changes.
Related Prosthetic Testing Services
ISO 7206-4 is part of a series of international standards for hip prosthetic testing. The ATS FoC is also qualified to perform hip implant testing according to the following standards:
About the ATS FoC
The ATS FoC provides a wide range of testing, inspection, and calibration services to national and international clients. Our qualified experts and state-of-the-art labs support clients involved in healthcare, medical device manufacturing, and the legal industry. As an ISO 9001:2015-registered company, we provide traceable and repeatable test results in accordance with client specifications, federal regulations, and industry standards.
Contact Us
Ensure your hip prosthetic is ready for FDA review. Call (888) 287-5227 or complete an inquiry form to request fatigue testing of your medical device.
