手术植入物 髋关节部分和全髋关节假体 第12部分：压配式髋臼组件的变形试验方法

[中文适用范围]： 本文件规定了在特定实验室条件下测定全髋关节置换用压配型髋臼部件短期变形的试验方法。本文件还定义了试验条件，以便考虑影响部件的重要参数，并描述了如何设置试样进行测试。 所述方法旨在用于测量全髋关节置换中使用的各种设计和材料的髋臼部件在负载下的变形量以及卸载后的塑性变形量。这些测量值随后用于评估与所评估髋臼部件的髋臼杯变形相关的风险，以确定其性能是否会受到不利影响。在评估与髋臼部件变形相关的风险时，考虑各种设计、材料和手术植入因素（例如第8条中确定的因素），以及必要时，将结果与在相同条件下测试的参考植入物进行比较可能是有用的。根据此评估，可能需要进行超出本文件范围的额外测试或临床数据，或两者兼而有之。 体内髋臼部件的负载通常与本测试方法中定义的负载不同。此处获得的结果不能用于直接预测体内性能。 本文件不涵盖检查试样的方法。 [外文原描述]： This document specifies a test method for determining short-term deformation of a press-fit acetabular component for total hip joint replacement under specific laboratory conditions. This document also defines the conditions of testing so that the important parameters that affect the components are taken into account and it describes how the specimen is set up for testing. The described method is intended to be used to measure the amount of deformation under load and plastic deformation after unloading of various designs and materials used for acetabular components in total hip joint replacement. These measurements are then used in an evaluation of risks associated with acetabular cup deformation for the acetabular component under evaluation to determine if its performance can be adversely affected. In the evaluation of risks associated with acetabular component deformation, it can be useful to take into consideration various design, material and surgical implantation factors (e.g. those identified in Clause 8 ), and, if necessary, a comparison of results to a reference implant tested under the same conditions. Depending on this evaluation, either additional testing or clinical data, or both, which is outside the scope of this document, can be necessary. The loading of the acetabular components in vivo differs, in general, from the loading defined in this test method. The results obtained here cannot be used to directly predict in vivo performance. This document does not cover methods that examine the test specimens.