手术植入物 用于测试的合成解剖骨模型的规范和验证

[中文适用范围]： 本文件提供了用于植入物测试的合成解剖骨模型的规范和验证要求和建议。合成模型的解剖来源可以是来自计算机断层扫描 (CT) 的数字数据，也可以是任何其他来源，例如来自尸体标本或统计确定的形状数据。本文件涵盖的规范是 3D 形状和机械特性。本文件不考虑其他特性，例如颜色或外观特征。 [外文原描述]： This document provides requirements and recommendations for specification and verification of synthetic anatomical bone models for use in testing of implants. The anatomical source of the synthetic model can be digital data from computed tomography (CT) scanning or any other sources such as from cadaveric specimens or statistically determined shape data. The specifications covered in this document are 3D shape and mechanical characteristics. Other characteristics, such as colour or cosmetic features, are not considered in this document.