Hip joint prostheses testing measures how your product will withstand different levels of fatigue, compression, torsion, and bending over an extended period of time.
Element performs a variety of testing for partial and total hip joint prostheses, including those outlined in by the ISO 7206 specification. Our medical device testing experts work diligently to help you bring safe products to patients around the world.
Our ISO 7206 testing services
ISO 7206 provides industry guidance for the classification, dimensions, and test methods for partial and total hip joint prostheses. Element’s orthopedic device experts specialize in evaluating the endurance properties of hip joint replacements and are ready to assist with your testing needs.
Hip stem fatigue testing (ISO 7206-4)
Hip stem fatigue testing, governed by ISO 7206-4, applies an axial load to an implant that has been potted in such a way as to represent the loosening of the implant proximally. The orientation translates axial load into a combination of compression, torsion, and bending stresses on the stem of the specimen. Tests typically run to 5,000,000 cycles and must meet the load requirement of 2,300 N (517 lbs).
Femoral neck fatigue testing (ISO 7206-6)
Whereas stem fatigue testing simulates a loosened implant, femoral neck fatigue testing per ISO 7206-6 simulates loads experienced by a properly fixed implant during gait. Hip prostheses are expected to run out to 10,000,000 cycles without failure and tested at 5,340 N (1,200 lbs).
Femoral head compression testing (ISO 7206-10)
Femoral head testing applies static axial forces to ensure the prosthesis withstands the forces it’s exposed to while in use. Testing according to ISO 7206-10 helps determine the static compressive or tension loads that cause failure of the femoral neck and head assembly.
For more information about our hip joint prosthesis testing services or to request a quote, contact our experts today.
Additional test methods
- Modular connection testing
- Component interlock strength
- Assembly & disassembly force
- Fretting corrosion testing
- Axial push-in/out
- Acetabular cup fatigue
- Polymer characterization
- Porous coating testing
- Cytotoxicity testing
- Impingement testing
- Microbiological testing
- Range of motion
- Wear testing
- Failure analysis
Standards we test to
American Association for Laboratory Accreditation
ASTM F1440, ASTM F1612, ASTM F1714, ASTM F1814, ASTM F1820, ASTM F1875, ASTM F2009, ASTM F2582
International Organization for Standardization
ISO 14242, ISO 7206-4, ISO 7206-6, ISO 7206-8, ISO 7206-10
ASTM 2582: Testing Impingement of Hip Prostheses
Our medical device experts discuss challenges and recommendations for testing hip prosthesis impingement per ASTM F2582 including device design, instability and dislocation.
Test Protocol for Medical Devices
A protocol and plan will mitigate your risk, prevent confusion, set clear expectations, and preserve the necessary information for future reference and use.
Medical Device Testing Tips
Preparing for a medical device testing program can be a challenge for many manufacturers, especially if it is a new or novel product or if time is limited. Our medical device experts share their testing tips and best practices.
As a comprehensive testing partner, you’ll enjoy the benefit of a single supplier source for all of your testing needs, from mechanical testing and environmental simulation to EMC and wireless device testing.