ASTM F2393-2004 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-部分稳定锆石(Mg-PSZ)的标准规范》.pdf

1、Designation: F 2393 04Standard Specification forHigh-Purity Dense Magnesia Partially Stabilized Zirconia(Mg-PSZ) for Surgical Implant Applications1This standard is issued under the fixed designation F 2393; the number immediately following the designation indicates the year oforiginal adoption or, i

2、n 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 zirconium o

3、xide partially stabilized bymagnesium oxide (magnesia partially stabilized zirconia (Mg-PSZ) for surgical implant applications.1.2 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 a

4、ppro-priate safety and health practices and determine the applica-bility of regulatory requirements prior to use.2. Referenced Documents2.1 ASTM Standards:2C 373 Test Method for Water Absorption, Bulk Density,Apparent Porosity, and Apparent Specific Gravity of FiredWhiteware ProductsC 1145 Terminolo

5、gy of Advanced CeramicsC 1161 Test Method for Flexural Strength of AdvancedCeramics at Ambient TemperatureC 1198 Test Method for Dynamic Youngs Modulus, ShearModulus, and Poissons Ratio for Advanced Ceramic bySonic ResonanceC 1239 Practice for Reporting Uniaxial Strength Data andEstimating Weibull D

6、istribution Parameters for AdvancedCeramicsC 1259 Test Method for Dynamic Youngs Modulus, ShearModulus, and Poissons Ratio for Advanced Ceramic byImpulse Excitation of VibrationC 1327 Test Method for Vickers Indentation Hardness ofAdvanced CeramicsE 112 Test Method for Determining Average Grain Size

7、F 748 Practice for Selecting of Generic Biological TestMethods for Materials and DevicesF 981 Practice for Assessment of Compatibility of Bioma-terials for Surgical Implants with Respect to Effect ofMaterials on Muscle and Bone2.2 American Society for Quality Standard (ASQ):C1 Specification of Gener

8、al Requirements for a QualityProgram33. Chemical Requirements3.1 The chemical composition shall be as follows, measuredby ICP-AAS, XRF, or mass spectroscopy:Weight percentZrO2+ HfO2+ MgO $99.9MgO 3.1-3.4HfO2#2.0Other OxidesTotal 0.1Al2O30.05SiO20.05CaO 0.02Fe2O30.002NOTE 1The radioactivity, defined

9、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 5.820 g/cm3or greater as determined byTest Metho

10、d C 373 as supplied with the following modifica-tions.4.1.1 Weight determination in sections 3.1 and 5.1 of TestMethod C 373 shall be made such that it can be calculated andreported to four significant figures.4.1.2 The calculation of bulk density in section 12.1 of TestMethod C 373 shall be calcula

11、ted as follows:B 5 D2d!/M2S! (1)where:B = bulk density, g/cm3,D = dry weight, g,M = saturated weight, g,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

12、 edition approved May 1, 2004. Published June 2004.2For 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

13、 from American Society for Quality (ASQ), 600 N. Plankinton Ave.,Milwaukee, WI 53203.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.S = suspended weight, g, andd = density of water at the temperature when measurementis made.4.2 The

14、total porosity shall be no greater than 1.0 vol % andopen porosity shall be no greater than 0.1 vol % as determinedby Test Method C 373.4.3 The microstructure of Mg-PSZ materials consists pri-marily of submicron tetragonal precipitates that are coherentwithin a matrix of cubic grains. The calculatio

15、n 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 7.5 % or less ona polished surface with surface finish equivalent to 0.05 m Ra(0.8 m cutoff) both before and after aut

16、oclaving at 150C for24 h. Peak intensity of tetragonal and cubic phase (T(111) +C(111)at2Q = 30.2, and monoclinic phase, M(-111) at 2Q =31.3 shall be identified by X-ray diffraction (Cu Karadiation)analysis to calculate percent of monoclinic phase by thefollowing equation:4% monoclinic 5IM111!3 1.06

17、3IM111!3 1.063 1 IT111!1C111!3 100 (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 TestMethod E 112.5. Mechanical Properties5.1 The average room temperature flexural stren

18、gth shall be600 MPa (87 000 psi) or greater by 4 point bend testing inaccordance with Test Method C 1161, test configuration B. Aminimum of 10 samples are to be tested.5.2 Weibull modulus value is not considered mandatory forgeneral acceptance and use of this material. It shall beperformed when chan

19、ging 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 shall be evaluated in accordance with Practice C 1239.The minimum number of

20、 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 MethodC 1198. A rectangular specimen with dimensions of 60 by 10by 3 mm is recommended. An accep

21、table alternative testmethod for elastic modulus is Test Method C 1259.5.4 The minimum Vickers hardness value shall be 1000 HVin accordance with Test Method C 1327. The load shall be 9.8N (1kg) and the dwell time shall be 15 s.6. Test Specimen Fabrication6.1 Specific test specimens shall be prepared

22、 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 in ASQ C1 to maintain quality consistency of testspecimens.8. Keywords8.1 advanced

23、ceramics; magnesia partially stabilized zirco-nia; Mg-PSZ; surgical implant; zirconium oxideAPPENDIXES(Nonmandatory Information)X1. RATIONALEX1.1 Magnesia partially stabilized zirconia is commerciallyavailable for implantation purposes. This specification is de-signed to characterize the composition

24、 and properties of highpurity dense magnesia partially stabilized 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

25、 humanbody. Long-term clinical experience of the use of the materialreferred to in this specification, however, has shown that anacceptable level of biological response can be expected, if thematerial is used in appropriate applications.4Garvie, Ronald C., and Nicholson, Patrick F., “Phase Analysis

26、in ZirconiaSystems,” Journal of the American Ceramic Society, 55, 6, 1972, pp. 303-305.F2393042ASTM 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 determina

27、tion 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 and must be reviewed every five years andif not revised, either reapproved or with

28、drawn. 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 meeting of theresponsible technical committee, which you may attend. If you feel that you

29、r 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 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).F2393043