1、Designation:F 1873 98Standard Specification forHigh-Purity Dense Yttria Tetragonal Zirconium OxidePolycrystal(Y-TZP)for Surgical Implant Applications1This standard is issued under the fixed designation F 1873;the number immediately following the designation indicates the year oforiginal adoption or,
2、in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon(e)indicates an editorial change since the last revision or reapproval.1.Scope1.1 This specification covers material requirements forhigh-purity dense yttria tetragonal
3、 zirconium oxide polycrystal(Y-TZP)for surgical implant applications.1.2 The values stated in SI units are to be regarded as thestandard.2.Referenced Documents2.1 ASTM Standards:C 373 Test Method for Water Absorption,Bulk Density,Apparent Porosity,and Apparent Specific Gravity of FiredWhiteware Prod
4、ucts2C 1161 Test Method for Flexural Strength of AdvancedCeramics at Ambient Temperature3C 1198 Test Method for Dynamic Youngs Modulus,ShearModulus,and Poissons Ratio for Advanced Ceramics bySonic Resonance3C 1239 Practice for Reporting Uniaxial Strength Data andEstimating Weibull Distribution Param
5、eters for AdvancedCeramics3C 1259 Test Method for Dynamic Youngs Modulus,ShearModulus,and Poissons Ratio for Advanced Ceramic byImpulse Excitation of Vibration3C 1327 Test Method for Vickers Identation Hardness ofAdvanced Ceramics4E 112 Test Method for Determining Average Grain Size4F 748 Practice f
6、or Selecting Generic Biological TestMethods for Materials and Devices5F 981 Practice for Assessment of Compatibility ofBiomaterials for Surgical Implants with respect to Effectsof Materials on Muscle and Bone52.2American Society for Quality Control Document:C 1 Specification of General Requirements
7、for a QualityProgram63.Chemical Composition3.1 The chemical composition shall be as follows,measuredby X-ray fluorescence(XRF)or mass spectroscopy:Weight%ZrO2HfO2+Y2O3$99Y2O34.5 to 5.4HfO2#5Al2O3#0.5Other Total Oxides#0.5TiO2SiO2CaOFe2O3Na2OK2ONOTE1The radioactivity,defined as the sum of the massic
8、activity ofU238,Ra226,Th232and determined by g-spectroscopy on the ready to usepowder,should be less than 200 Bq/kg.This value will be reviewed at thenext revision of this standard and will be based upon the radioactivity datafrom ceramic implant manufacturers.4.Physical Properties4.1 The minimum bu
9、lk density of yttrium oxide stabilizedzirconium oxide shall be 6.00 g/cm3or greater as determinedby Test Method C 373 as applied with the followingmodifications:4.1.1 Weight determination in 3.1 and 5.1 of Test MethodC 373 shall be made to the nearest 0.5 mg.4.1.2 The calculation of bulk density in
10、12.1 of Test MethodC 373 shall be calculated as follows:B5Dd!/M2S!(1)where:B5 bulk density,g/cm3,D 5 dry weight,g,M 5 saturated weight,g,S5 suspended weight,g,andd5 density of water at the temperature when measurementis taken.4.2 The total porosity shall be no greater than 1.0 vol%andopen porosity s
11、hall be no greater than 0.1 vol%as determinedby Test Method C 373.4.3 Grain SizeThe mean linear intercept distance shall be0.6 m or less,in accordance with Section 10 of Test MethodE 112.1This specification is under the jurisdiction ofASTM Committee F-4 on Medicaland Surgical Materials and Devices a
12、nd is the direct responsibility of SubcommitteeF04.13 on Ceramic Materials.Current edition approved June 10,1998.Published August 1998.2Annual Book of ASTM Standards,Vol 15.02.3Annual Book of ASTM Standards,Vol 15.01.4Annual Book of ASTM Standards,Vol 03.01.5Annual Book of ASTM Standards,Vol 13.01.6
13、Available from theAmerican National Standards Institute,11 W.42nd St.,13thFloor,New York,NY 10036.1AMERICAN SOCIETY FOR TESTING AND MATERIALS100 Barr Harbor Dr.,West Conshohocken,PA 19428Reprinted from the Annual Book of ASTM Standards.Copyright ASTM4.4 The monoclinic phase shall be 5%or less on a p
14、olishedsurface with surface finish equivalent to 0.05 m Ra(0.8 mcutoff).Peak height of tetragonal phase,T(111)at 2u530.2,and monoclinic phase,M(1 11)at 2u528.2 and M(111)at2u531.3 shall be identified by X-ray diffraction(Copper KAlpha radiation)analysis to calculate percent of monoclinicphase by the
15、 following equation(1)7:monoclinic phase%5M1 11!1M111!/M1 11!1T111!1M111!(2)5.Mechanical Properties5.1 The average room temperature flexural strength shall be800 MPa(116 ksi)or greater by four point bend in accordancewith Test Method C 1161.A minimum of ten samples(samplesize“B”)are to be tested.5.2
16、 A Weibull modulus value is not considered mandatoryfor general acceptance and use of this material.For certainapplications,the manufacturer and end user may agree thatWeibull modulus testing is mandatory.If Weibull modulus istested it shall be tested in accordance with Practice C 1239.The minimum number of specimens tested shall be 30 and theminimum acceptable Weibull modulus shall be 10.5.3 The minimum room temperature elastic modulus shallbe 200 GPa(293106psi)in accordance with Test MethodC 1
