<p>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.</p>
<p>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.</p>
Registration number (WIID)
69906
Scope
<p>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.</p>
<p>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.</p>
