1、Designation: F 603 00Standard Specification forHigh-Purity Dense Aluminum Oxide for Medical Application1This standard is issued under the fixed designation F 603; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last rev
2、ision. 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 the material requirements forhigh-purity, dense aluminum oxide for load bearing surgicalimplant app
3、lications.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.2. Refe
4、renced Documents2.1 ASTM Standards:C 373 Test Method for Water Absorption, Bulk Density,Apparent Porosity, and Apparent Specific Gravity of FiredWhiteware Products2C 1161 Test Method for Flexural Strength of AdvancedCeramics at Ambient Temperature3C 1198 Test Method for Dynamic Youngs Modulus, Shear
5、Modulus, and Poissons Ratio for Advanced Ceramics bySonic Resonance3C 1239 Standard Practice for Reporting Uniaxial StrengthData and Estimating Weibull Distribution Parameters forAdvanced Ceramics3C 1259 Test Method for Dynamic Youngs Modulus, ShearModulus and Poissons Ratio for Advanced Ceramics by
6、Impulse Excitation of Vibration3C 1327 Standard Test Method for Vickers Indentation Hard-ness of Advanced Ceramics3E 112 Methods for Determining Average Grain Size4F 981 Practice for Assessment of Compatibility of Bioma-terials for Surgical Implants with Respect to Effect ofMaterials on Muscle and B
7、one52.2 American Society for Quality Control:C 1 Specification of General Requirements for a QualityProgram62.3 ISO:ISO 6474:1994 Implants for Surgery - Ceramic MaterialsBased on Alumina73. Chemical Requirements3.1 The Chemical composition shall be as follows in Table1, (measured by ICP-AES, XRF or
8、mass spectrocopy):4. Physical Requirements4.1 The minimum bulk density shall be (3.94 6 .01) g/cm3as determined by Test Method C 373 as applied with thefollowing modifications.4.1.1 Weight determination, 3.1 and 5.1 of C 373 shall bemade to the nearest 0.001 g.4.1.2 The calculation of bulk density i
9、n 12.1 of C 373 shallbe calculated as follows:B 5Dd!/ M 2 S! (1)where:B 5 Bulk density (g/cm3)D 5 Dry weight (g)M 5 Saturated weight (g)S 5 Suspended weight (g)d 5 Density of water at the temperature when measure-ment is taken.4.2 The median grain size shall be 4.5 m or less, inaccordance with Secti
10、on 10 of Methods E 112.5. 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 C 1161 testconfiguration B. The specimen shall be prepared in accordancewith Test Me
11、thod C 1161 7.2.4 to a 500 grit finish.5.2 The room temperature elastic modulus shall be mea-sured in accordance with C 1259 or C 1198.5.3 The minimum Vickers Hardness values fora1Kgloadshall be 18 GPa (2.56 3 106psi) in accordance with TestMethod C 1327.1This specification is under the jurisdiction
12、 of ASTM Committee F-4 on Medicaland Surgical Materials and Devices, and is the direct responsibility of SubcommitteeF04.13 on Ceramic Materials.Current edition approved Jan 10, 2000. Published April 2000. Originallypublished as F 603 83. Last previous edition F 603 93 (95).2Annual Book of ASTM Stan
13、dards, 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 13.01.6Available from American Society for Quality Control, 161 West WisconsinAve., Milwaukee, WI 52303.7Available from the American National Standards Institute 1
14、1 West 42nd St.13th Floor, New York, NY 10036.1Copyright ASTM, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, United States.5.4 The minimum Weibull modulus for 30 samples ascalculated using C 1239 shall be no less than 8 by four pointbend in accordance with Test Method C 1161, test configu
15、ra-tion B. The specimens shall be prepared in accordance withTest Method C 1161 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 fabricating the ceramic implant device.7.
16、Quality Program Requirements7.1 The producer shall maintain a quality program, such asthe program defined in ASQC C 1.7.2 The manufacturer of surgical implants shall be assuredof the producers quality program for conformance to the intentof ASQC C 1 or any other recognized program.8. Keywords8.1 adv
17、anced 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 serve as criteria for ahigh-purity, co
18、nsistent 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 becompletely free of adverse reactions in the hu
19、man 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 characterized biologicalresponse which is
20、less than that exhibited by the referencematerials cited and tested in Practice F 981 or equivalent ( Refs1-6).TABLE 1 Chemical PropertiesOxide Weight PercentAl2O3$ 99.5MgO # 0.5Other Oxides # 0.1TABLE 2 Mechanical PropertiesCompressive Strength GPa (ksi) 4Expected Minimum (580)Average Flexural Stre
21、ngth 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 Minimum8F 6032REFERENCES(1) Hentrich, R.L., Graves, G.A., Stein, H.G. and Bajpai, P.K., “AnEvaluation of Inert and Resorbable C
22、eramics for Future ClinicalOrthopaedic Applications,” Journal of Biomedical Materials Research,Vol. 5, 1971, p.25.(2) Griss, P., et al.,“ Experimentelle Untersuchung zur Gewebsvertrgli-chkeit oxidkeramischer (Al2O3) Abriebteilchen,” Archiv fr Orthopae-dische und Unfallchirurgie, Vol. 76, 1973, pp. 2
23、70-279.(3) Griss, P., et al., “Biological Activity and Histocompatibility of DenseAl2O3/MgO Ceramic Implants in Rats,” Journal of Biomedical Mate-rials Research Symposium No. 4, 1973, pp. 453-462.(4) Griss, P., et al., “Experimental Analysis of Ceramic-Tissue Interac-tions: A Morphologic, Fluorescen
24、ce-Optic and Radiographic Study onDense Aluminum Oxide in Various Animals,” Journal of BiomedicalMaterials Research, Symposium No. 5, Part 1, 1974, pp. 39-48.(5) Richardson, W.C., et al., “Soft Tissue Response to a Series of DenseCeramic Materials and Two Clinically Used Biomaterials,” Publica-tions
25、 415, National Bureau of Standards, 1974, pp. 37-44.(6) Wolfson, S.H., et al., “Load-Bearing Capacity of Functioning AluminaDental Endosseous Implants,” Journal of Dental Research, Vol. 44,No. 1, 1976, pp. 22-29.(7) Drre, E and Hbner, H., Alumina: Processing, Properties andApplications, Springer-Ver
26、lag, New York (1984) Chapter 3, pp. 74-187.(8) Miyayama, M., et al., Engineering Properties of Single Oxides,Engineering Materials Handbook, Chapter 4: Ceramics and GlassesASM, Intl (1991) pp 748-757.The American Society for Testing and Materials takes no position respecting the validity of any pate
27、nt rights asserted in connectionwith any item mentioned in this standard. Users of this standard are expressly advised that determination of the validity of any suchpatent rights, and the risk of infringement of such rights, are entirely their own responsibility.This standard is subject to revision
28、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 Headquarters. Your comments will recei
29、ve careful consideration at a meeting of the responsibletechnical committee, which you may attend. If you feel that your comments have not received a fair hearing you should make yourviews known to the ASTM Committee on Standards, at the address shown below.This standard is copyrighted by ASTM, 100
30、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 above address or at610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website (www.astm.org).F 6033
