EndoLab - Implant Testing Services Implant Testing

Spinal implants
 

Spinal components - ASTM F2193Spinal components - ASTM F2193 Spinal implants - interconnections mechanisms and subassemblies - ASTM F1798Spinal implants - interconnections mechanisms and subassemblies - ASTM F1798 Spine Corpectomy Model - ASTM F1717Spine Corpectomy Model - ASTM F1717 Spinal cage test - ASTM F2077Spinal cage test - ASTM F2077 Spinal disc wear test - ISO 18192-1Spinal disc wear test - ISO 18192-1 Spinal implants subsidence test - ASTM F2267Spinal implants subsidence test - ASTM F2267 Nucleus replacement wear test - ISO 18192-2Nucleus replacement wear test - ISO 18192-2 Expulsion Test - PI-52Expulsion Test - PI-52 Spine corpectomy model with anterior support - ISO 12189Spine corpectomy model with anterior support - ISO 12189 Extra discal motion preserving implants - ASTM F2624Extra discal motion preserving implants - ASTM F2624 Lumbar total facet prostheses - ASTM F2694/F2790Lumbar total facet prostheses - ASTM F2694/F2790 Occipital-cervical and occipital-cervical-thoracic model - ASTM F2706Occipital-cervical and occipital-cervical-thoracic model - ASTM F2706 Spinous process plates - PI-76Spinous process plates - PI-76 Mechanical and Functional Characterization of Nucleus Devices - ASTM F2789Mechanical and Functional Characterization of Nucleus Devices - ASTM F2789 Impingement-wear testing of lumbar prostheses - ISO 18192-3Impingement-wear testing of lumbar prostheses - ISO 18192-3 Particular requirements for joint replacement implants - ISO 21534Particular requirements for joint replacement implants - ISO 21534 Impingement wear testing of total disc prostheses - ASTM F3295Impingement wear testing of total disc prostheses - ASTM F3295 Spinal Disc Static and Fatigue Test - ASTM F2346Spinal Disc Static and Fatigue Test - ASTM F2346 Spinal Cage Pre-clinical Mechanical Assessment - ISO 23089-2Spinal Cage Pre-clinical Mechanical Assessment - ISO 23089-2

Impingement-wear testing of lumbar prostheses - ISO 18192-3

Normative References  



ISO 18192-3: Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 3: Impingement-wear testing and corresponding environmental conditions for test of lumbar prostheses under adverse kinematic conditions  


This test method covers a procedure to simulate impingement between the inferior and superior endplate in a spinal disc prosthesis; the subsequent assessment of wear; and assessment of contact pattern.

The EndoLab® spine simulator is used for this type of testing. An axial load and a time-varying angular displacement are applied to the lumbar prostheses. The axial load remains constant during impingement and fluctuates in a sinusoidal waveform during the remaining movement. Thus, a constant moment is applied during impingement.

The specimens are inspected after 125 thousand, 250 thousand, 500 thousand and after 1 million cycles. At each inspection, the wear of the prostheses is determined by gravimetric measurements.

SEM of the bearing surfaces as well as particle analysis can be performed.

 

Implant Testing - Impingement-wear testing of lumbar prostheses - ISO 18192-3