本文件规定了基于高纯度氧化铝的生物稳定陶瓷骨替代材料的特性和相应的试验方法，该材料用作骨垫片、骨替代物和矫形关节假体组件。 本文件不包括生物相容性（见ISO 10993-1）。制造商有责任评估在本文件框架内生产的陶瓷材料的生物相容性。

This document specifies the characteristics of, and corresponding test methods for bio-stable ceramic bone substitute material based on high purity alumina for use as bone spacers, bone replacements and components of orthopaedic joint prostheses. This document does not cover biocompatibility (see ISO 10993-1). It is the responsibility of the manufacturer to evaluate the biocompatibility of ceramic materials which are produced within the framework of this document.