ASTM F2393-2012 Standard Specification for High-Purity Dense Magnesia Partially Stabilized Zirconia (Mg-PSZ) for Surgical Implant Applications《外科植入应用的高纯度浓厚镁部分稳定氧化锆(Mg-PSZ)的标准规格》.pdf

1、Designation:F239310 Designation: F2393 12Standard 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 oforigi

2、nal 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 for high-purity,

3、 dense zirconium oxide partially stabilized by magnesiumoxide (magnesia partially stabilized zirconia (Mg-PSZ) for surgical implant applications.1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.3 This standard does not pu

4、rport to address all of the safety concerns, if any, associated with its use. It is the responsibilityof the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatoryrequirements prior to use.2. Referenced Documents2.1 ASTM Standards:2C3

5、73 Test Method for Water Absorption, Bulk Density, Apparent Porosity, and Apparent Specific Gravity of Fired WhitewareProductsC1161 Test Method for Flexural Strength of Advanced Ceramics at Ambient TemperatureC1198 Test Method for Dynamic Youngs Modulus, Shear Modulus, and Poissons Ratio for Advance

6、d Ceramics by SonicResonanceC1239 Practice for Reporting Uniaxial Strength Data and Estimating Weibull Distribution Parameters for Advanced CeramicsC1259 Test Method for Dynamic Youngs Modulus, Shear Modulus, and Poissons Ratio for Advanced Ceramics by ImpulseExcitation of VibrationC1327 Test Method

7、 for Vickers Indentation Hardness of Advanced CeramicsE112 Test Methods for Determining Average Grain Size2.2 American Society for Quality Standard (ASQ):C1 Specification of General Requirements for a Quality Program32.3 ISO Standard:ISO 18754 Fine Ceramics (Advanced Ceramics, Advanced Technical Cer

8、amics)Determination of Density and ApparentPorosity43. Chemical Requirements3.1 The chemical composition shall be as follows, measured by ICP-ES, XRF, or mass spectroscopy:Oxides Weight percentZrO2+HfO2+ MgO $99.8MgO 3.1-3.4HfO2#2.0Total Other Oxides 0.20Other OxidesFe2O30.01SiO20.051This specificat

9、ion is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of SubcommitteeF04.13 on Ceramic Materials.Current edition approved Sept.March 1, 2010.2012. Published September 2010.March 2012. Originally approved in 2004. Last previ

10、ous edition approved in 20042010as F2393 104. DOI: 10.1520/F2393-102.2For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at serviceastm.org. For Annual Book of ASTM Standardsvolume information, refer to the standards Document Summary page on the ASTM w

11、ebsite.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.1This document is not an ASTM standard and is inte

12、nded only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Becauseit may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the curre

13、nt versionof the standard as published by ASTM is to be considered the official document.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.CaO 0.02Al2O30.05NOTE 1The radioactivity, defined as the sum of the massic activity of U238, Ra22

14、6, Th232, and determined by g-spectroscopy on the ready-to-usepowder, should be less than 200 Bq/Kg.4. Physical Requirements4.1 The minimum bulk density of magnesia partially stabilized zirconia shall be 5.800 g/cm3as determined by Test MethodC373 as supplied, with the following modifications or by

15、ISO 18754.4.1.1 Weight determination per sections 3.1 and 5.1 of Test Method C373 and section 7.1 of ISO 18754 shall be made such thatit can be calculated and reported to four significant figures.F2393 1224.1.2 The calculation of bulk density in section 12.1 of Test Method C373 or section 7.2 of ISO

16、 18754 shall be as follows, tothe second decimal place:rb5m1m3 m23r1(1)where:rb= the bulk density, expressed in kilograms per cubic metre,m1= the mass of the dry test specimen, expressed in kilograms,m2= the apparent mass of the immersed test speciment, expressed in kilograms,m3= the mass of the soa

17、ked test specimen, expressed in kilograms, andr1= the density of the immersion liquid at the temperature of the test, expressed in kilograms per cubic meter.4.2 The total porosity shall be no greater than 1.0 vol % and open porosity shall be no greater than 0.1 vol % as determined byTest Method C373

18、.4.3 The microstructure of Mg-PSZ materials consists primarily of submicron tetragonal precipitates that are coherent within amatrix of cubic grains. The calculation of percent monoclinic phase requires the inclusion of the cubic (111) peak that effectivelyoverlaps the tetragonal peak. The monoclini

19、c phase, as determined by this method, shall be 7.5%15.0 % or less on a polishedsurface with surface finish equivalent to 0.05 m Ra (0.8 m cutoff) both before and after autoclaving at 150C for 24 h. Peakintensity of tetragonal and cubic phase (T(101) + C(111) at 2Q 30.2, and monoclinic phase (M(-111

20、) and M(111) at 2Q 28.3and 2Q 31.3, respectively) shall be identified by X-ray diffraction (Cu Karadiation) analysis to calculate percent of monoclinicphase by the following equation:5%M! 5IM111!1 IM111!IM111!1 IM111!1 IC111!1 IT101!(2)where:Ixyz= intensity of the named X-ray diffraction peak,M = mo

21、noclinic phase,T = tetragonal phase, andC = cubic phase.4.4 Grain size shall be determined and reported using Test Method E112.5. Mechanical Properties5.1 The average room temperature flexural strength shall be 600 MPa (87 000 psi) or greater by 4 point bend testing inaccordance with Test Method C11

22、61, test configuration B. A minimum of 10 samples are to be tested.5.2 Weibull modulus value is not considered mandatory for general acceptance and use of this material. It shall be performedwhen changing suppliers or when the material is produced via a different process. For certain applications, t

23、he manufacturer andend user may agree that Weibull modulus testing is mandatory. If Weibull modulus is determined, test results shall be evaluatedin accordance with Practice C1239. The minimum number of test specimens shall be 30 and the minimum acceptable uncensored,unbiased Weibull modulus shall b

24、e 10.5.3 The minimum room temperature elastic modulus shall be 180 GPa (26 200 ksi) in accordance with Test Method C1198. Arectangular specimen with dimensions of 60 by 10 by 3 mm is recommended. An acceptable alternative test method for elasticmodulus is Test Method C1259.5.4 The minimum Vickers ha

25、rdness value shall be 1000 HV in accordance with Test Method C1327. The load shall be 9.8 N(1kg) and the dwell time shall be 15 s.6. Test Specimen Fabrication6.1 Specific test specimens shall be prepared from the same batch of material and by the same processes as those employed infabricating cerami

26、c implant devices.7. Quality Program Requirements7.1 The producer shall maintain a quality program, such as those defined in ASQ C1 to maintain quality consistency of testspecimens.8. Keywords8.1 advanced ceramics; magnesia partially stabilized zirconia; Mg-PSZ; surgical implant; zirconium oxide5Gar

27、vie, Ronald C., and Nicholson, Patrick F., “Phase Analysis in Zirconia Systems,” Journal of the American Ceramic Society, 55, 6, 1972, pp. 303-305. Journal ofthe American Ceramic Society, Vol 55, No. 6, 1972, pp. 303305.F2393 123APPENDIXES(Nonmandatory Information)X1. RATIONALEX1.1 Magnesia partiall

28、y stabilized zirconia is commercially available for implantation purposes. This specification is designedto characterize the composition and properties of high purity dense magnesia partially stabilized zirconia (Mg-PSZ) to ensureconsistency in the starting material used in the manufacture of medica

29、l devices.X2. BIOCOMPATIBILITYX2.1 No known surgical implant material has ever been shown to be completely free of adverse reactions in the human body.Long-term clinical experience of the use of the material referred to in this specification, however, has shown that an acceptablelevel of biological

30、response can be expected, if the material is used in appropriate applications.ASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentionedin this standard. Users of this standard are expressly advised that determination of the valid

31、ity of any such patent rights, and the riskof infringement of such rights, are entirely their own responsibility.This standard is subject to revision at any time by the responsible technical committee and must be reviewed every five years andif not revised, either reapproved or withdrawn. Your comme

32、nts are invited either for revision of this standard or for additional standardsand should be addressed to ASTM International Headquarters. Your comments will receive careful consideration at a meeting of theresponsible technical committee, which you may attend. If you feel that your comments have n

33、ot received a fair hearing you shouldmake your views known to the ASTM Committee on Standards, at the address shown below.This standard is copyrighted by ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,United States. Individual reprints (single or multiple co

34、pies) of this standard may be obtained by contacting ASTM at the aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org). Permission rights to photocopy the standard may also be secured from the ASTM website (www.astm.org/COPYRIGHT/).F2393 124