Wear Testing of Medical Devices

We test a comprehensive range of medical device components including hip implants, knee replacements, spinal devices, and complex material interactions. Our testing covers femoral heads, acetabular liners, tibial inserts, and various material couples used in medical device manufacturing.

• Knee wear testing 

• Spine wear testing 

• Orbital hip testing 

 And within those, we conduct:  

• Tribological property characterization  

• Wear rate measurement  

• Mass loss analysis  

• Particulate characterization  

• Side-by-side predicate device comparison  

• ISO 14242-3 compliant testing 

• Force and displacement controlled testing  

• Complex motion simulation 

• Environmental chamber testing  

• Comprehensive reporting for regulatory submissions  

Orbital Hip Wear Testing: 

We conduct hip implant wear testing in compliance with ISO 14242-3, simulating walking kinematics with our advanced hip wear simulators. These simulators provide the complex motions needed for accurate wear testing, ensuring the performance of your implants in real-life scenarios. Hip implants are submerged in bovine solution in an environmental chamber, following ISO 14242-3. The implants undergo repeated motion cycles at 1Hz up to 5,000,000 cycles, with mass loss measurements taken periodically (typically 7 times during the test). All test stations are linked to ensure uniform axial force and displacement. The implants undergo repeated motion cycles, with mass loss measurements taken periodically (typically 7 times during the test). After testing, particulate from the femoral head/acetabular liner interaction is analyzed using SEM/EDS. 

Knee Wear Testing: 

We offer both force-controlled (ISO 14243-1) and displacement-controlled (ISO 14243-3) wear testing for knee replacement devices, simulating real-life gait kinematics. Our equipment measures wear between the femoral component and tibial insert. We simulate complex knee motions using force-controlled or displacement-controlled methods, including coupled axial force (Fz), anterior/posterior force (Fx), flexion/extension (My), and tibial rotation (Mz) to accurately simulate the complex, simultaneous motions of the human knee. Periodic mass loss measurements are taken using the stringent clean, dry, and weigh process per ISO 14243. The post-test particulate is also evaluated using scanning electron microscopy (SEM) after the conclusion of testing. 

Spine Wear Testing 

Element provides spine wear testing per ASTM F2423 and ISO 18192, using our advanced MTS Bionix® Spine Wear Simulator to replicate spinal implant conditions. Our 6-station simulator with load/soak control offers 6 degrees of freedom to meet ASTM F2423 and ISO 18192 standards. After testing, wear surfaces and particles are evaluated in our metallurgical lab using SEM, EDS, and stereoscopic equipment. 

• 6-station MTS Bionix® Spine Wear Simulator 

• Proprietary hip wear simulators 

• 6 test stations with load/soak controls  

• Scanning Electron Microscopy (SEM)  

• Energy Dispersive Spectroscopy (EDS)  

For orbital hip wear testing, our custom hip wear simulators feature 6 test stations with precise load/soak controls. Each station simulates walking movements with a 23° bi-axial rocking motion, replicating flexion/extension, abduction/adduction, and internal/external rotation. 

Our team operates from Life Sciences hubs across the world, providing global access to our expert capabilities. Find your nearest Life Sciences hub on our Locations Page. 

We offer more than just mechanical testing. Our medical device testing expertise covers the entire product lifecycle, from prototype development to feasibility trials, and supports various regulatory submissions including 510(k), CE, and other international certifications. Depending on your project requirements, a medical device wear test program typically lasts 4-6 months, requiring a reliable long-term testing partner.