ASTM-F603 › Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application
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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 surgical implant applications.
1.2 The values stated in SI units are to be regarded as the standard.
1.3 Aluminum oxide in accordance with Section 3 has been demonstrated to exhibit a well-characterized biological response which is less than that exhibited by the reference materials cited and tested in Practice
Aluminum oxide; Ceramic materials; high-purity dense aluminum oxide (for surgical implant application),; spec; ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
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2012 R20 EDITION
Aug. 28, 2020