标准编号：ISO 6474-2:2019
中文名称：外科植入物 陶瓷材料 第2部分：带氧化锆增强的高纯度氧化铝基复合材料
英文名称：Implants for surgery — Ceramic materials — Part 2: Composite materials based on a high-purity alumina matrix with zirconia reinforcement
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 a zirconia-reinforced, high-purity alumina matrix composite for use
as bone spacers, bone replacements and components in orthopaedic joint prostheses.
This document is intended for composite materials which are based on an alumina matrix, i.e. alumina as
the dominating phase in the composite with a mass fraction of >60 %, similar to the material described
in ISO 6474-1, but extended by means of a certain amount of zirconia and other defined ingredients.
NOTE The required properties in this document differ from those in ISO 6474-1 with respect to strength
and fracture toughness. Furthermore, there are requirements specifically applicable for zirconia-containing
materials (see ISO 13356).
In the material composition as defined in this document, additional additives are listed. Typical
additives for alumina or zirconia ceramics are Mg, Y, Ce and others. Such additives can be useful in order
to improve the mechanical properties and/or the chemical stability of the alumina-zirconia composite
material.
This document does not cover biocompatibility (see ISO 10993-1). It is the responsibility of the
manufacturer to evaluate the biocompatibility of the specific ceramic composite material which is
produced within the framework of this document.
立即下载标准文件