标准摘要
[中文适用范围]： 本部分ISO 18192定义了脊柱核假体在ISO 18192-1规定的相对角运动条件下的测试程序。本部分ISO 18192适用于腰椎和颈椎假体。它不适用于全椎间盘置换和关节突关节置换。该方法包括磨损和疲劳测试。可能需要额外的机械测试，如蠕变测试。本部分ISO 18192不重现复杂的体内载荷和运动。使用此测试方法获得的磨损和疲劳数据将能够比较不同类型的植入物，但可能与临床磨损性能不同。本部分ISO 18192的用户应考虑运行额外的测试，以解决待测植入物设计的具体安全问题。 [外文原描述]： 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.
英文名称Implants for surgery — Wear of total intervertebral spinal disc prostheses — Part 2: Nucleus replacements