1、Designation: F603 12 (Reapproved 2016)Standard 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
2、year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscriptepsilon () 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 surgical
3、implant applications.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 asstand
4、ard. No other units of measurement are included in thisstandard.2. Referenced Documents2.1 ASTM Standards:2C373 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
5、 Fired CeramicWhiteware ProductsC1161 Test Method for Flexural Strength of AdvancedCeramics at Ambient TemperatureC1198 Test Method for Dynamic Youngs Modulus, ShearModulus, and Poissons Ratio for Advanced Ceramics bySonic ResonanceC1239 Practice for Reporting Uniaxial Strength Data andEstimating We
6、ibull Distribution Parameters for AdvancedCeramicsC1259 Test Method for Dynamic Youngs Modulus, ShearModulus, and Poissons Ratio for Advanced Ceramics byImpulse Excitation of VibrationC1327 Test Method for Vickers Indentation Hardness ofAdvanced CeramicsE112 Test Methods for Determining Average Grai
7、n SizeF981 Practice for Assessment of Compatibility of Biomate-rials for Surgical Implants with Respect to Effect ofMaterials on Muscle and Insertion into Bone2.2 American Society for Quality Control Standard:3ASQ C1 Specification of General Requirements for a Qual-ity Program2.3 ISO Standard:4ISO 6
8、474 Implants for SurgeryCeramic Materials Basedon Alumina3. Chemical Requirements3.1 The chemical composition shall be as shown 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 C37
9、3 as applied with thefollowing modifications.4.1.1 Weight determination, 3.1 and 5.1 of Test MethodC373 shall be made to the nearest 0.001 g.4.1.2 The calculation of bulk density in 12.1 of Test MethodC373 shall be calculated as follows:B 5 Dd!/M 2 S! (1)where:B = bulk density (g/cm3),D = dry weight
10、 (g),M = saturated weight (g),S = suspended weight (g), andd = density of water at the temperature when measurementis taken.4.2 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 flexura
11、l strength for 10samples shall be no less than 400 MPa (58 000 psi) byfour-point bend in accordance with Test Method C1161, test1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.13 on C
12、eramic Materials.Current edition approved Oct. 1, 2016. Published October 2016. Originallyapproved in 1983. Last previous edition approved in 2012 as F603 12. DOI:10.1520/F0603-12R16.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.
13、org. For Annual Book of ASTMStandards volume information, refer to 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
14、 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States1configuration B. The specimen shall be prepared in accordancewith Test Method C1161, 7.2.4, to a 500 grit finish.5.2 The ro
15、om temperature elastic modulus shall be mea-sured in accordance with Test Method C1239 or Test MethodC1198.5.3 The minimum Vickers Hardness values fora1kgloadshall be 18 GPa (2.56 106psi) in accordance with TestMethod C1327.5.4 The minimum Weibull modulus for 30 samples ascalculated using Test Metho
16、d C1239 shall be no less than 8 byfour-point bend in accordance 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
17、 of material and by the same processes as those employedin 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
18、program for conformance to the intentof ASQ C1 or any other 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 appli
19、cations. The chemical,physical and mechanical requirements 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
20、No known surgical implant has ever been shown to becompletely 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
21、 with Section 3 hasbeen demonstrated to exhibit a well characterized 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 M
22、echanical PropertiesCompressive Strength GPa (ksi) 4Expected 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(2.56 106)Weibull ModulusRequired Minimum8F603 12 (2016)2REFERENCES(
23、1) Hentrich, R. L., Graves, G. A., Stein, H. G. and Bajpai, P. K., “AnEvaluation of Inert and Resorbable Ceramics for Future ClinicalOrthopaedic Applications,” Journal of Biomedical MaterialsResearch, Vol 5, 1971, p.25.(2) Griss, P., et al.,“Experimentelle Untersuchung zur Gewebsvertrglich-keit oxid
24、keramischer (Al2O3) Abriebteilchen,”Archiv fr Orthopaedi-sche 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) Gr
25、iss, P., et al.,“Experimental Analysis of Ceramic-Tissue Interac-tions:AMorphologic, 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 Resp
26、onse to a Series of DenseCeramic Materials and Two Clinically Used Biomaterials,”Publications 415, National Bureau of Standards, 1974, pp. 3744.(6) Wolfson, S. H., et al., “Load-Bearing Capacity of FunctioningAlumina Dental Endosseous Implants,” Journal of Dental Research,Vol 44, No. 1, 1976, pp. 22
27、29.(7) Drre, E and Hbner, H., Alumina: Processing, Properties 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 Inte
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31、ndards, 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). 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
