标准编号:ISO 6474-1:2019
中文名称:外科植入物 陶瓷材料 第1部分:以高纯度氧化铝为基础的陶瓷材料
英文名称:Implants for surgery — Ceramic materials — Part 1: Ceramic materials based on high purity alumina
发布日期:2019-03
标准范围
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.