ASTM_F_2393_-_12.pdf

Designation:F239312Standard Specification forHigh-Purity Dense Magnesia Partially Stabilized Zirconia(Mg-PSZ)for Surgical Implant Applications1This standard is issued under the fixed designation F2393;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This specification covers material requirements forhigh-purity,dense zirconium oxide partially stabilized bymagnesium oxide(magnesia partially stabilized zirconia(Mg-PSZ)for surgical implant applications.1.2 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.3 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory requirements prior to use.2.Referenced Documents2.1 ASTM Standards:2C373 Test Method for Water Absorption,Bulk Density,Apparent Porosity,andApparent Specific Gravity of FiredWhiteware 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 Size2.2 American Society for Quality Standard(ASQ):C1 Specification of General Requirements for a QualityProgram32.3 ISO Standard:ISO 18754 Fine Ceramics(Advanced Ceramics,AdvancedTechnical Ceramics)Determination of Density and Ap-parent Porosity43.Chemical Requirements3.1 The chemical composition shall be as follows,measuredby ICP-ES,XRF,or mass spectroscopy:OxidesWeight percentZrO2+HfO2+MgO$99.8MgO3.1-3.4HfO2#2.0Total Other Oxides0.20Other OxidesFe2O30.01SiO20.05CaO0.02Al2O30.05NOTE1The radioactivity,defined as the sum of the massic activity ofU238,Ra226,Th232,and determined by g-spectroscopy on the ready-to-use powder,should be less than 200 Bq/Kg.4.Physical Requirements4.1 The minimum bulk density of magnesia partially stabi-lized zirconia shall be 5.800 g/cm3as determined by TestMethod C373 as supplied,with the following modifications orby ISO 18754.4.1.1 Weight determination per sections 3.1 and 5.1 of TestMethod C373 and section 7.1 of ISO 18754 shall be made suchthat it can be calculated and reported to four significant figures.1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devicesand is the direct responsibility ofSubcommittee F04.13 on Ceramic Materials.Current edition approved March 1,2012.Published March 2012.Originallyapproved in 2004.Last previous edition approved in 2010 as F2393 10.DOI:10.1520/F2393-12.2For 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 4.1.2 The calculation of bulk density in section 12.1 of TestMethod C373 or section 7.2 of ISO 18754 shall be as follows,to the second decimal place:rb5m1m32 m23r1(1)where:rb=the bulk density,expressed in kilograms per cubicmetre,m1=the mass of the dry test specimen,expressed inkilograms,m2=the apparent mass of the immersed test speciment,expressed in kilograms,m3=the mass of the soaked test specimen,expressed inkilograms,andr1=the density of the immersion liquid at the temperatureof the test,expressed in kilograms per cubic meter.4.2 The total porosity shall be no greater than 1.0 vol%andopen porosity shall be no greater than 0.1 vol%as determinedby Test Method C373.4.3 The microstructure of Mg-PSZ materials consists pri-marily of submicron tetragonal precipitates that are coherentwithin a matrix of cubic grains.The calculation of percentmonoclinic phase requires the inclusion of the cubic(111)peakthat effectively overlaps the tetragonal peak.The monoclinicphase,as determined by this method,shall be 15.0%or less ona polished surface with surface finish equivalent to 0.05 m Ra(0.8 m cutoff)both before and after autoclaving at 150C for24 h.Peak intensity of tetrag