标准摘要
[中文适用范围]： 本文件规定了脊柱融合器间盘体固定装置（IBFDs）用于脊柱融合术程序中的机械评估要求。本文件重点放在机械要求上，无意涵盖各种类型 IBFDs 的各种评估 [外文原描述]： This document specifies requirements for the mechanical assessment of spinal intervertebral body fusion devices (IBFDs) used in spinal arthrodesis procedures. This document focuses on mechanical requirements and does not intend to cover all assessments for various types of IBFDs.
英文名称Implants for surgery — Pre-clinical mechanical assessment of spinal implants and particular requirements — Part 2: Spinal intervertebral body fusion devices