ISO 18192-2

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

Nucleus replacement wear test

Normative References

ISO 18192-2: Implants for surgery – Wear of total spinal intervertebral disc prostheses – Part 2: Nucleus replacements  

This International Standard defines a test procedure for the relative angular movement between articulating components and specifies the pattern of the applied force, speed and duration of testing, sample configuration and test environment to be used for the wear testing of spinal nucleus prostheses.

Three moving axes as well as one computer controlled dynamic loading axis are used to simulate the in-vivo conditions. The shear stiffness of the annulus is simulated by a motion restraint system. All tests are performed under newborn calf serum diluted with deionized water with a resulting protein content of 20g/l. In general, six specimens plus two soak controls are tested simultaneously. The amount of wear is determined by weight loss of the specimens according to ISO 14242-2. The test is stopped after 10 million cycles.

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