标准摘要
[中文适用范围]： 本文件规定了基于氧化锆增强、高纯度氧化铝基复合材料的生物稳定陶瓷骨替代材料的特性和相应的测试方法，该材料用作骨间隔物、骨替代物和骨科关节假体组件。 本文件适用于基于氧化铝基体的复合材料，即氧化铝作为复合材料中的主要相，其质量分数 >60%，类似于所描述的材料。 注：本文件中所需的性能与 ISO 中的不同。 6474-1 的强度和断裂韧性。 此外，还有专门适用于含氧化锆材料的要求（参见 ISO 13356）。 在本文件中定义的材料组合物中，列出了额外的添加剂。 氧化铝或氧化锆陶瓷的典型添加剂是 Mg、Y、Ce 等。 此类添加剂可用于改善氧化铝-氧化锆复合材料的机械性能和/或化学稳定性。 本文件不涵盖生物相容性（参见 ISO 10993-1）。 制造商有责任评估在本文件框架内生产的特定陶瓷复合材料的生物相容性。 [外文原描述]： 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.
英文名称Implants for surgery — Ceramic materials — Part 2: Composite materials based on a high-purity alumina matrix with zirconia reinforcement