ISO 18192-2:2010 外科植入物 整个脊椎间盘假体的磨损 第2部分：核替换

标准编号：ISO 18192-2:2010

中文名称：外科植入物 整个脊椎间盘假体的磨损 第2部分：核替换

英文名称：Implants for surgery — Wear of total intervertebral spinal disc prostheses — Part 2: Nucleus replacements

发布日期：2010-06

标准范围

ISO 18192-2:2010定义了在ISO 18192-1规定的相对角运动条件下脊柱细胞核假体的测试程序。ISO 18192？2:2010适用于腰椎和颈椎假体。它不适用于全椎间盘置换术和小关节置换术。该方法包括磨损和疲劳试验。可能需要进行额外的机械试验，如蠕变试验。ISO 18192？2:2010没有在体内再现复合物的载荷和运动。使用该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。ISO 18192？2 2010年的用户应该考虑运行额外的测试来解决个别植入物设计的特定安全问题。

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.

标准预览图