DANSK DS/ISO 18192-2 PDF

ISO 18192‑2:2010 defines a test procedure for spinal nucleus prostheses under the relative angular movement conditions specified by ISO 18192‑1. ISO 18192‑2:2010 is applicable to both lumbar and cervical prostheses. It is not applicable to total disc replacements and facet joint replacements. The method includes wear and fatigue testing. Additional mechanical tests such as creep tests can be required. ISO 18192‑2:2010 does not reproduce the complex in vivo loads and motions. The wear and fatigue data obtained with this test method will enable comparison between different types of implant but can differ from the clinical wear performance. The user of ISO 18192‑2:2010 should consider running additional tests addressing specific safety issues of the individual implant design to be tested.