Overview
ISO 18192-2:2010 specifies a laboratory test procedure to assess wear and fatigue of spinal nucleus replacements (nucleus prostheses) under the relative angular movement conditions defined in ISO 18192‑1. The procedure applies to both lumbar and cervical nucleus devices, and is intended to produce comparative wear/fatigue data in a controlled environment (simulated physiological fluid and temperature). It is not applicable to total disc replacements or facet joint replacements and does not replicate the full complexity of in vivo loads and motions.
Key topics and requirements
- Test principle: Nucleus implant mounted between simulated endplates; a motion restraint system simulates annulus shear stiffness while time‑varying axial loads and angular displacements (per ISO 18192‑1) are applied.
- Fluid and environment: Physiological test medium (calf serum diluted to a target protein concentration) maintained at body temperature; anti‑microbial agents and EDTA may be used with justification.
- Specimens and controls: Recommended minimum sample set for wear/fatigue testing (plus soak controls to correct for fluid uptake where applicable); user must justify fewer specimens.
- Apparatus specifics: Testing machine per ISO 18192‑1; motion‑restraint stiffness specified (example: ~115 N/mm ± tolerance); endplates of corrosion‑resistant material with defined surface finish; sealed test chamber and temperature control.
- Loading and frequency: Load ranges and angular displacements referenced to ISO 18192‑1; test frequency nominally 1 Hz (with defined acceptable tolerance and guidance for higher frequencies).
- Measurements and monitoring: Periodic stop points for cleaning and wear measurement; wear measurement methods per ISO 14242‑2 (gravimetric or dimensional); routine recording (e.g., pH, fluid changes).
- Reporting: Detailed test report requirements including specimen ID, machine description, test parameters, statistical results, wear‑versus‑cycle plots, deviations and justifications.
Applications and users
ISO 18192‑2 is used by:
- Medical device manufacturers developing or validating spinal nucleus prostheses
- Independent biomechanics and materials testing laboratories conducting wear and fatigue testing
- Regulatory and quality assurance teams preparing technical documentation and submission data
- R&D groups comparing materials/designs (polymeric, metallic, hydrogels) and assessing risk‑related mechanical behaviors
Practical uses include comparing relative wear performance of nucleus designs, supporting preclinical testing strategies, and informing additional targeted tests (creep, interface integrity) required for safety assessment.
Related standards
- ISO 18192‑1 - Loading and displacement parameters and environmental conditions for spinal disc wear testing (normative for motion profiles).
- ISO 14242‑2 - Methods of measurement for wear (referenced for gravimetric/dimensional measurement procedures).
Note: ISO 18192‑2 provides standardized comparative test methods but explicitly advises users to run additional tests addressing specific implant safety issues, since in vitro results can differ from clinical performance.
Open preview (PDF)Implants for surgery — Wear of total intervertebral spinal disc prostheses — Part 2: Nucleus replacements
