ASTM F603-00 - 1.1.2000
 
1. Scope

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 F361 or equivalent (1 to 6).

 
2. Referenced Documents

C1239-13(2018)

Standard Practice for Reporting Uniaxial Strength Data and Estimating Weibull Distribution Parameters for Advanced Ceramics

C1259-21

Standard Test Method for Dynamic Young’s Modulus, Shear Modulus, and Poisson’s Ratio for Advanced Ceramics by Impulse Excitation of Vibration

F981-23

Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices

ASQ C1

Specification of General Requirements for a Quality Program

C1161-18(2023)

Standard Test Method for Flexural Strength of Advanced Ceramics at Ambient Temperature

C1327-15(2019)

Standard Test Method for Vickers Indentation Hardness of Advanced Ceramics

E112-13(2021)

Standard Test Methods for Determining Average Grain Size

C373-18(2023)

Standard Test Methods for Determination of Water Absorption and Associated Properties by Vacuum Method for Pressed Ceramic Tiles and Glass Tiles and Boil Method for Extruded Ceramic Tiles and Non-tile Fired Ceramic Whiteware Products

C1198-20

Standard Test Method for Dynamic Young´s Modulus, Shear Modulus, and Poisson´s Ratio for Advanced Ceramics by Sonic Resonance