ASTM F2393-2012(2016) Standard Specification for High-Purity Dense Magnesia Partially Stabilized Zirconia (Mg-PSZ) for Surgical Implant Applications《外科植入物用高纯度致密氧化镁部分稳定氧化锆(Mg-PSZ)的标.pdf

1、Designation: F2393 12 (Reapproved 2016)Standard 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 oforigina

2、l 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, de

3、nse 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

4、 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

5、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 Temperatu

6、reC1198 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, an

7、d 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 QualityProg

8、ram32.3 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:Oxides Weight percentZrO2+HfO2+ MgO $99.8

9、MgO 3.1-3.4HfO2#2.0Total Other Oxides 0.20Other OxidesFe2O30.01SiO20.05CaO 0.02Al2O30.05NOTE 1The radioactivity, defined as the sum of the massic activity ofU238, Ra226, Th232, and determined by -spectroscopy on the ready-to-use powder, should be less than 200 Bq/Kg.4. Physical Requirements4.1 The m

10、inimum 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

11、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 Devices and is the direct responsibility ofSubcommittee F04.13 on Ceramic Materials.Current edition approved Oct. 1, 2016. Published

12、October 2016. Originallyapproved in 2004. Last previous edition approved in 2012 as F2393 12. DOI:10.1520/F2393-12R16.2For 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 t

13、o 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.Co

14、pyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States14.1.2 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:b5m1m32 m231(1)where:b= the bulk densit

15、y, expressed in kilograms per cubicmetre,m1= the mass of the dry test specimen, expressed inkilograms,m2= the apparent mass of the immersed test specimen,expressed in kilograms,m3= the mass of the soaked test specimen, expressed inkilograms, and1= the density of the immersion liquid at the temperatu

16、reof 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 tha

17、t 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 e

18、quivalent to 0.05 m Ra(0.8 m cutoff) both before and after autoclaving at 150C for24 h. Peak intensity of tetragonal and cubic phase (T(101) +C(111)at2 30.2, and monoclinic phase (M(-111) andM(111)at2 28.3 and 2 31.3, respectively) shall beidentified by X-ray diffraction (Cu Kradiation) analysis toc

19、alculate percent of monoclinic phase by the following equa-tion:5%M! 5IM2111!1IM111!IM111!1IM2111!1IC111!1IT101!(2)where:Ixyz= intensity of the named X-ray diffraction peak,M = monoclinic phase,T = tetragonal phase, andC = cubic phase.4.4 Grain size shall be determined and reported using TestMethods

20、 E112.5. Mechanical Properties5.1 The average room temperature flexural strength shall be600 MPa (87 000 psi) or greater by 4 point bend testing inaccordance with Test Method C1161, test configuration B. Aminimum of 10 samples are to be tested.5.2 Weibull modulus value is not considered mandatory fo

21、rgeneral acceptance and use of this material. It shall beperformed when changing suppliers or when the material isproduced via a different process. For certain applications, themanufacturer and end user may agree that Weibull modulustesting is mandatory. If Weibull modulus is determined, testresults

22、 shall be evaluated in accordance with Practice C1239.The minimum number of test specimens shall be 30 and theminimum acceptable uncensored, unbiased Weibull modulusshall be 10.5.3 The minimum room temperature elastic modulus shallbe 180 GPa (26 200 ksi) in accordance with Test MethodC1198.Arectangu

23、lar specimen with dimensions of 60 by 10 by3 mm is recommended. An acceptable alternative test methodfor elastic modulus is Test Method C1259.5.4 The minimum Vickers hardness value shall be 1000 HVin accordance with Test Method C1327. The load shall be 9.8N (1kg) and the dwell time shall be 15 s.6.

24、Test Specimen Fabrication6.1 Specific test specimens shall be prepared from the samebatch of material and by the same processes as those employedin fabricating ceramic implant devices.7. Quality Program Requirements7.1 The producer shall maintain a quality program, such asthose defined inASQ C1 to m

25、aintain quality consistency of testspecimens.8. Keywords8.1 advanced ceramics; magnesia partially stabilized zirco-nia; Mg-PSZ; surgical implant; zirconium oxide5Garvie, Ronald C., and Nicholson, Patrick F., “Phase Analysis in ZirconiaSystems,” Journal of the American Ceramic Society, Vol 55, No. 6,

26、 1972, pp.303305.F2393 12 (2016)2APPENDIXES(Nonmandatory Information)X1. RATIONALEX1.1 Magnesia partially stabilized zirconia is commerciallyavailable for implantation purposes. This specification is de-signed to characterize the composition and properties of highpurity dense magnesia partially stab

27、ilized zirconia (Mg-PSZ)to ensure consistency in the starting material used in themanufacture of medical devices.X2. BIOCOMPATIBILITYX2.1 No known surgical implant material has ever beenshown to be completely free of adverse reactions in the humanbody. Long-term clinical experience of the use of the

28、 materialreferred to in this specification, however, has shown that anacceptable level of biological response can be expected, if thematerial is used in appropriate applications.ASTM International takes no position respecting the validity of any patent rights asserted in connection with any item men

29、tionedin this standard. Users of this standard are expressly advised that determination of the validity 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

30、 and must be reviewed every five years andif not revised, either reapproved or withdrawn. Your comments 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 meetin

31、g of theresponsible technical committee, which you may attend. If you feel that your comments have not 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

32、Box C700, West Conshohocken, PA 19428-2959,United States. Individual reprints (single or multiple copies) 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 Copyright Clearance Center, 222Rosewood Drive, Danvers, MA 01923, Tel: (978) 646-2600; http:/ 12 (2016)3