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Standards Development
This document specifies the characteristics of, and corresponding test methods for bioinert ceramic material based on monolithic high purity alumina for use as bone spacers, bone replacements and components of orthopaedic joint prostheses. The suitability of the material for other applications is not established within the framework of this document.
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.
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