ASTM F603-12(R2020) pdf free download

ASTM F603-12(R2020) pdf free download.Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application
1. Scope
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 accor- dance with internationally recognized principles on standard- ization established in the Decision on Principles for the Development of International Standards, Guides and Recom- mendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
2. Referenced Documents
2.1 ASTM Standards: 2 C373 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 C1161 Test Method for Flexural Strength of Advanced Ceramics at Ambient Temperature C1198 Test Method for Dynamic Young’s Modulus, Shear Modulus, and Poisson’s 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 Young’s Modulus, Shear Modulus, and Poisson’s 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 Biomate- rials for Surgical Implants with Respect to Effect of Materials on Muscle and Insertion into Bone 2.2 American Society for Quality Control Standard: 3 ASQ C1 Specification of General Requirements for a Qual- ity Program 2.3 ISO Standard: 4 ISO 6474 Implants for Surgery—Ceramic Materials Base
3. Chemical Requirements
3.1 The chemical composition shall be as shown in Table 1, (measured by ICP-AES, XRF, or mass spectrocopy):
4. Physical Requirements
4.1 The minimum bulk density shall be (3.94 6 0.01) g/cm 3 as determined by Test Method C373 as applied with the following modifications. 4.1.1 Weight determination, 3.1 and 5.1 of Test Method C373 shall be made to the nearest 0.001 g. 4.1.2 The calculation ofbulk density in 12.1 ofTest Method C373 shall be calculated as follows:
5. Mechanical Requirements (Table 2)
5.1 The average room temperature flexural strength for 10 samples shall be no less than 400 MPa (58 000 psi) by four-point bend in accordance with Test Method C1161, test configuration B. The specimen shall be prepared in accordance with Test Method C1161, 7.2.4, to a 500 grit finish. 5.2 The room temperature elastic modulus shall be mea- sured in accordance with Test Method C1239 or Test Method C1198. 5.3 The minimum Vickers Hardness values for a 1 kg load shall be 18 GPa (2.56 × 10 6 psi) in accordance with Test Method C1327. 5.4 The minimum Weibull modulus for 30 samples as calculated using Test Method C1239 shall be no less than 8 by four-point bend in accordance with Test Method C1161, test configuration B. The specimens shall be prepared in accor- dance with Test Method C1161, 7.2.4, to a 500 grit finish.
6. Test Specimen Fabrication
6.1 Specific test specimens shall be prepared from the same batch ofmaterial and by the same processes as those employed in fabricating the ceramic implant device.
7. Quality Program Requirements
7.1 The producer shall maintain a quality program, such as the program defined in ASQ C1. 7.2 The manufacturer of surgical implants shall be assured ofthe producer’s quality program for conformance to the intent of ASQ C1 or any other recognized program.