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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.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
C373 Test Method for Water Absorption, Bulk Density, Apparent Porosity, and Apparent Specific Gravity of Fired Whiteware Products
C1161 Test Method for Flexural Strength of Advanced Ceramics at Ambient Temperature
C1198 Test Method for Dynamic Youngs Modulus, Shear Modulus, and Poissons Ratio for Advanced Ceramics by Sonic Resonance
C1239 Practice for Reporting Uniaxial Strength Data and Estimating Weibull Distribution Parameters for Advanced Ceramics
C1259 Test Method for Dynamic Youngs Modulus, Shear Modulus, and Poissons Ratio for Advanced Ceramics by Impulse Excitation of Vibration
C1327 Test Method for Vickers Indentation Hardness of Advanced Ceramics
E112 Test Methods for Determining Average Grain Size
F981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone
American Society for Quality Control StandardASQ C1 Specification of General Requirements for a Quality Program
ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
ASTM F603-12, Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application, ASTM International, West Conshohocken, PA, 2012, www.astm.orgBack to Top