Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application

Abstract

This specification covers the material requirements for high-purity, dense aluminum oxide for load bearing surgical implant applications. It mainly addresses qualification of the material as delivered to the parts manufacturer, and does not cover finished parts such as femoral heads, acetabular inserts, dental implants, and the like. The material requirements to which the aluminum oxides shall conform are physical properties such as bulk density, weight, and grain size; chemical composition that shall be measured either by ICP-AES, XRF, or mass spectroscopy; and mechanical properties such as compressive strength, flexural strength, elastic modulus, Vickers hardness, and Weibull modulus.