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.

1.1 This specification covers the material requirements for high-purity, dense aluminum oxide for load-bearing surgical implant applications.

1.2 This specification does not cover finished parts (for example, femoral heads, acetabular inserts, dental implants and the like). It is intended as a qualification of the material as delivered to the parts manufacturer.

1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.