ASTM_F_603_-_12_2016.pdf

Designation:F60312(Reapproved 2016)Standard Specification forHigh-Purity Dense Aluminum Oxide for Medical Application1This standard is issued under the fixed designation F603;the number immediately following the designation indicates the year of originaladoption or,in the case of revision,the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscriptepsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This specification covers the material requirements forhigh-purity,dense aluminum oxide for load-bearing surgicalimplant applications.1.2 This specification does not cover finished parts(forexample,femoral heads,acetabular inserts,dental implants andthe like).It is intended as a qualification of the material asdelivered to the parts manufacturer.1.3 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.2.Referenced Documents2.1 ASTM Standards:2C373 Test Methods for Determination of Water Absorptionand Associated Properties by Vacuum Method for PressedCeramic Tiles and Glass Tiles and Boil Method forExtruded Ceramic Tiles and Non-tile Fired CeramicWhiteware ProductsC1161 Test Method for Flexural Strength of AdvancedCeramics at Ambient TemperatureC1198 Test Method for Dynamic Youngs Modulus,ShearModulus,and Poissons Ratio for Advanced Ceramics bySonic ResonanceC1239 Practice for Reporting Uniaxial Strength Data andEstimating Weibull Distribution Parameters for AdvancedCeramicsC1259 Test Method for Dynamic Youngs Modulus,ShearModulus,and Poissons Ratio for Advanced Ceramics byImpulse Excitation of VibrationC1327 Test Method for Vickers Indentation Hardness ofAdvanced CeramicsE112 Test Methods for Determining Average Grain SizeF981 Practice for Assessment of Compatibility of Biomate-rials for Surgical Implants with Respect to Effect ofMaterials on Muscle and Insertion into Bone2.2 American Society for Quality Control Standard:3ASQ C1 Specification of General Requirements for a Qual-ity Program2.3 ISO Standard:4ISO 6474 Implants for SurgeryCeramic Materials Basedon Alumina3.Chemical Requirements3.1 The chemical composition shall be as shown in Table 1,(measured by ICP-AES,XRF,or mass spectrocopy):4.Physical Requirements4.1 The minimum bulk density shall be(3.94 6 0.01)g/cm3as determined by Test Method C373 as applied with thefollowing modifications.4.1.1 Weight determination,3.1 and 5.1 of Test MethodC373 shall be made to the nearest 0.001 g.4.1.2 The calculation of bulk density in 12.1 of Test MethodC373 shall be calculated as follows:B 5Dd!/M 2 S!(1)where:B=bulk density(g/cm3),D=dry weight(g),M=saturated weight(g),S=suspended weight(g),andd=density of water at the temperature when measurementis taken.4.2 The median grain size shall be 4.5 m or less,inaccordance with Section 10 of Test Methods E112.5.Mechanical Requirements(Table 2)5.1 The average room temperature flexural strength for 10samples shall be no less than 400 MPa(58 000 psi)byfour-point bend in accordance with Test Method C1161,test1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.13 on Ceramic Materials.Current edition approved Oct.1,2016.Published October 2016.Originallyapproved in 1983.Last previous edition approved in 2012 as F603 12.DOI:10.1520/F0603-12R16.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.3Available from American Society for Quality(ASQ),600 N.Plankinton Ave.,Milwaukee,WI 53203,http:/www.asq.org.4Available from American National Standards Institute(ANSI),25 W.43rd St.,4th Floor,New York,NY 10036,http:/www.ansi.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 configuration B.The specimen shall be prepared in accordancewith 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 MethodC1198.5.3 The minimum Vickers Hardness values for a 1 kg loadshall be 18 GPa(2.56 106psi)in accordance with TestMethod C1327.5.4 The minimum Weibull modulus for 30 samples ascalculated using Test Method C1239 shall be no less than 8 byfour-point bend in accordance with Test Method C1161,testconfiguration B.The specimens shall be prepared in accor-dance with Test Method C1161,7.2.4,to a 500 grit finish.6.Test Specimen Fabrication6.1 Specific test specimens shall be prepared from the samebatch of material and by the same processes as those employedin fabricating the ceramic implant device.7.Quality Program Requirements7.1 The producer shall maintain a quality program,such asthe program defined in ASQ C1.7.2 The manufacturer of surgical implants shall be assuredof the pro