Fatigue Testing for Medical Implants & Devices
Fatigue and endurance testing evaluates how medical implants and their components withstand millions of cycles of physiological loading throughout their intended service life. Additionally, this testing uses a wide range of ISO and ASTM standards, including ISO 7206, ASTM F1717, and ASTM F1160, to verify the long-term durability of orthopedic, spinal, and coated implant components.
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When to Use Fatigue & Endurance Testing
Fatigue and endurance testing provides an effective solution when an implant or implant component must demonstrate long-term durability under cyclic loading. Additionally, manufacturers commonly request this testing for hip and knee prostheses, spinal fixation constructs, coated implant surfaces, and other implantable devices exposed to repeated in vivo loading. Furthermore, manufacturers use fatigue and endurance testing to support regulatory submissions, validate design or material changes, and investigate field observations.
The Importance of Fatigue & Endurance Testing
Nearly every implantable device experiences repeated loading throughout a patient’s lifetime, whether from gait, chewing, or spinal motion. A component that appears strong under a single static load can still fail after enough cycles of lower-magnitude loading. Comprehensive fatigue and endurance testing helps identify these vulnerabilities before a product ever reaches the field.
- Verified fatigue performance across the full range of implant device families
- Early identification of weaknesses that only appear under cyclic loading
- Reduced risk of long-term field failures caused by cyclic loading in vivo
- Objective, third-party data to support FDA and CE regulatory submissions
- Greater confidence in implant durability over the intended service life
Common Risks Reduced by Fatigue & Endurance Testing
- Progressive fatigue crack initiation and propagation under cyclic loading
- Loosening at modular junctions and fixation interfaces over time
- Coating delamination or wear debris generation from cyclic loading
- Inconsistent fatigue performance across manufacturing lots and processes
- Premature failure before the device’s intended service life is reached
How Fatigue & Endurance Testing Results Support Design Decisions
Laboratory fatigue data allows engineering teams to compare implant performance against the requirements defined by the applicable ISO or ASTM standard or an internal design specification. Results can pinpoint the specific location and mode of fatigue failure, giving engineers the information needed to make targeted design improvements.
Scope of Fatigue & Endurance Testing
The scope of fatigue and endurance testing spans hip, knee, spinal, and coated implant components, and extends beyond a simple pass or fail. It characterizes the relationship between applied load and cycle life across a wide range of device-specific test standards. Manufacturers use this testing to validate new designs, compare configurations, and confirm long-term durability.
Test Preparation and Sample Evaluation
Testing begins by documenting the sample, confirming the device or component configuration represents intended clinical use, and selecting the applicable test standard and fixture configuration based on device type and loading mode.
Cyclic Loading and Performance Evaluation
Fatigue and endurance testing applies cyclic loading at multiple load or stress levels to establish a fatigue life curve for the device or component, continuing to failure or a defined run-out cycle count, typically ranging from hundreds of thousands to several million cycles depending on the applicable standard.
Documentation and Final Reporting
After testing, laboratory personnel inspect each specimen for evidence of fracture, cracking, or permanent deformation. Reports document the test conditions, equipment used, load levels, cycle counts, failure modes, photographs, and final results.
Overview of Fatigue & Endurance Testing Services
Although test parameters vary by device type and applicable standard, Applus+ Reliable Analysis’s fatigue and endurance testing services commonly include the following evaluations.
Hip and Knee Implant Fatigue Testing
Cyclic testing of femoral stems, tibial trays, and femoral components in accordance with ISO 7206, ASTM F1800, and ASTM F3210.
Spinal Implant Fatigue Testing
Cyclic testing of fixation constructs, interbody devices, and artificial discs in accordance with ASTM F1717, ISO 12189, and ASTM F2346.
Coating Fatigue Testing
Cyclic shear and bending testing of implant coatings in accordance with ASTM F1160.
Expert Fatigue & Endurance Testing Laboratory
Applus+ Reliable Analysis’s ISO/IEC 17025 accredited laboratory offers expert fatigue and endurance testing across the full range of orthopedic, spinal, and coated implant devices. Applus+ Reliable Analysis has a full lab of test equipment which permits us to provide short lead times on scheduling. Ask about our full scope of fatigue testing for regulatory submission support.
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