ISO 18192-3

ASTM F1717

Spine corpectomy model

ASTM F1798

Spinal implants - interconnections mechanisms and subassemblies

ASTM F2077

Spinal cage test

ASTM F2193

Spinal components

ASTM F2267

Spinal implants subsidence test

ASTM F2346

Spinal disc static and fatigue test

ASTM F2624

Extra discal motion preserving implants

ASTM F2694 / F2790

Lumbar total facet prostheses

ASTM F2706

Occipital-cervical and occipital-cervical-thoracic model

ASTM F2789

Mechanical and functional characterization of nucleus devices

ASTM F3295

Impingement wear testing of total disc prostheses

ASTM F3631

Cage impact test

ISO 12189

Spine corpectomy model with anterior support

ISO 18192-1

Spinal disc wear test

ISO 18192-2

Nucleus replacement wear test

ISO 18192-3

Impingement-wear testing of lumbar prostheses

ISO 21534

Particular requirements for joint replacement implants

ISO 23089-2

Spinal cage pre-clinical mechanical assessment

PI-52

Expulsion test

PI-76

Spinous process plates

Impingement-wear testing of lumbar prostheses

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.

Your contact person

Jason Steffens, M.Sc.

Head of Tribology, Head of FEA