1、Designation: F603 12Standard Specification forHigh-Purity Dense Aluminum Oxide for Medical Application1This standard is issued under the fixed designation F603; the number immediately following the designation indicates the year of originaladoption or, in the case of revision, the year of last revis
2、ion. A number in parentheses indicates the year of last reapproval. A superscriptepsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This specification covers the material requirements forhigh-purity, dense aluminum oxide for load-bearing surgicalimplant applic
3、ations.1.2 This specification does not cover finished parts (forexample, femoral heads, acetabular inserts, dental implants andthe like). It is intended as a qualification of the material asdelivered to the parts manufacturer.1.3 The values stated in SI units are to be regarded asstandard. No other
4、units of measurement are included in thisstandard.2. Referenced Documents2.1 ASTM Standards:2C373 Test Method for Water Absorption, Bulk Density,Apparent Porosity, and Apparent Specific Gravity of FiredWhiteware ProductsC1161 Test Method for Flexural Strength of AdvancedCeramics at Ambient Temperatu
5、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
6、d Poissons Ratio for Advanced Ceramics byImpulse Excitation of VibrationC1327 Test Method for Vickers Indentation Hardness ofAdvanced CeramicsE112 Test Methods for Determining Average Grain SizeF981 Practice for Assessment of Compatibility of Biomate-rials for Surgical Implants with Respect to Effec
7、t ofMaterials on Muscle and Bone2.2 American Society for Quality Control Standard:3ASQ C1 Specification of General Requirements for a Qual-ity Program2.3 ISO Standard:4ISO 6474 Implants for SurgeryCeramic Materials Basedon Alumina3. Chemical Requirements3.1 The chemical composition shall be as follo
8、ws in Table 1,(measured by ICP-AES, XRF, or mass spectrocopy):4. Physical Requirements4.1 The minimum bulk density shall be (3.94 6 0.01) g/cm3as determined by Test Method C373 as applied with thefollowing modifications.4.1.1 Weight determination, 3.1 and 5.1 of Test MethodC373 shall be made to the
9、nearest 0.001 g.4.1.2 The calculation of bulk density in 12.1 of Test MethodC373 shall be calculated as follows:B 5Dd!/ M 2 S! (1)where:B = bulk density (g/cm3),D = dry weight (g),M = saturated weight (g),S = suspended weight (g), andd = density of water at the temperature when measurementis taken.4
10、.2 The median grain size shall be 4.5 m or less, inaccordance with Section 10 of Test Methods E112.5. Mechanical Requirements (Table 2)5.1 The average room temperature flexural strength for 10samples shall be no less than 400 MPa (58 000 psi) by fourpoint bend in accordance with Test Method C1161, t
11、estconfiguration B. The specimen shall be prepared in accordancewith Test Method C1161, 7.2.4, to a 500 grit finish.5.2 The room temperature elastic modulus shall be mea-sured in accordance with Test Method C1239 or Test MethodC1198.1This specification is under the jurisdiction of ASTM Committee F04
12、 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.13 on Ceramic Materials.Current edition approved Jan. 1, 2012. Published January 2012. Originallyapproved in 1983. Last previous edition approved in 2000 as F603 0 00, with waswithdrawn in March 2009 an
13、d reinstated in January 2012. DOI: 10.1520/F060312.2For 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
14、 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.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, We
15、st Conshohocken, PA 19428-2959, United States.5.3 The minimum Vickers Hardness values fora1kgloadshall be 18 GPa (2.56 3 106psi) in accordance with TestMethod C1327.5.4 The minimum Weibull modulus for 30 samples ascalculated using Test Method C1239 shall be no less than 8 byfour point bend in accord
16、ance with Test Method C1161, testconfiguration B. The specimens shall be prepared in accor-dance with Test Method C1161, 7.2.4, to a 500 grit finish.6. Test Specimen Fabrication6.1 Specific test specimens shall be prepared from the samebatch of material and by the same processes as those employedin
17、fabricating the ceramic implant device.7. Quality Program Requirements7.1 The producer shall maintain a quality program, such asthe program defined in ASQ C1.7.2 The manufacturer of surgical implants shall be assuredof the producers quality program for conformance to the intentof ASQ C1 or any other
18、 recognized program.8. Keywords8.1 advanced ceramics; alumina; aluminum oxide; ceramic;surgical implantAPPENDIXES(Nonmandatory Information)X1. RATIONALEX1.1 This standard is needed to ensure a high qualitymaterial for use in biological applications. The chemical,physical and mechanical requirements
19、serve as criteria for ahigh-purity, consistent product that can be implanted in thebody. These requirements provide specifications for biocom-patible grades of aluminum oxide for use in the physiologicalenvironments.X2. BIOCOMPATIBILITYX2.1 No known surgical implant has ever been shown to becomplete
20、ly free of adverse reactions in the human body.However, long term clinical experience has shown an accept-able level of biological response can be expected, if thematerial is used in appropriate applications.X2.2 Aluminum oxide in accordance with Section 3 hasbeen demonstrated to exhibit a well char
21、acterized biologicalresponse which is less than that exhibited by the referencematerials cited and tested in Practice F981 or equivalent ( Refs1-6).TABLE 1 Chemical PropertiesOxide Weight PercentAl2O3$ 99.5MgO # 0.5Other Oxides # 0.1TABLE 2 Mechanical PropertiesCompressive Strength GPa (ksi) 4Expect
22、ed Minimum (580)Average Flexural Strength MPa (psi)Required Minimum400(58 000)Elastic Modulus GPa (ksi)Required Minimum380(55 100)Vickers Hardness GPa (ksi)Required Minimum18(2.56 3 106)Weibull ModulusRequired Minimum8F603 122REFERENCES(1) Hentrich, R. L., Graves, G. A., Stein, H. G. and Bajpai, P.
23、K., “AnEvaluation of Inert and Resorbable Ceramics for Future ClinicalOrthopaedic Applications,” Journal of Biomedical Materials Re-search, Vol 5, 1971, p.25.(2) Griss, P., et al.,“ Experimentelle Untersuchung zur Gewebsvertrglich-keit oxidkeramischer (Al2O3) Abriebteilchen,” Archiv fr Orthopae-disc
24、he und Unfallchirurgie, Vol 76, 1973, pp. 270279.(3) Griss, P., et al., “Biological Activity and Histocompatibility of DenseAl2O3/MgO Ceramic Implants in Rats,” Journal of BiomedicalMaterials Research , Symposium No. 4, 1973, pp. 453462.(4) Griss, P., et al., “Experimental Analysis of Ceramic-Tissue
25、 Interac-tions: A Morphologic, Fluorescence-Optic and Radiographic Study onDense Aluminum Oxide in Various Animals,” Journal of BiomedicalMaterials Research, Symposium No. 5, Part 1, 1974, pp. 3948.(5) Richardson, W. C., et al., “Soft Tissue Response to a Series of DenseCeramic Materials and Two Cli
26、nically Used Biomaterials,” Publica-tions 415, National Bureau of Standards, 1974, pp. 3744.(6) Wolfson, S. H., et al., “Load-Bearing Capacity of FunctioningAluminaDental Endosseous Implants,” Journal of Dental Research, Vol 44,No. 1, 1976, pp. 2229.(7) Drre, E and Hbner, H., Alumina: Processing, Pr
27、operties andApplications, Springer-Verlag, New York (1984) Chapter 3, pp.74187.(8) Miyayama, M., et al., Engineering Properties of Single Oxides,Engineering Materials Handbook, Chapter 4: Ceramics and GlassesASM, Intl (1991) pp 748757.ASTM International takes no position respecting the validity of a
28、ny patent rights asserted in connection with any item mentionedin 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 re
29、vision at any time by the responsible technical committee 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. You
30、r comments will receive careful consideration at a meeting 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 copy
31、righted 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). Permission rights to photocopy the standard may also be secured from the ASTM website (www.astm.org/COPYRIGHT/).F603 123
