ASTM F603-12
(Specification)Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application
Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application
SCOPE
1.1 This specification covers the material requirements for high-purity, dense aluminum oxide for load-bearing surgical implant applications.
1.2 This specification does not cover finished parts (for example, femoral heads, acetabular inserts, dental implants and the like). It is intended as a qualification of the material as delivered to the parts manufacturer.
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
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Designation:F603 −12
StandardSpecification for
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High-Purity Dense Aluminum Oxide for Medical Application
ThisstandardisissuedunderthefixeddesignationF603;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope Materials on Muscle and Bone
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2.2 American Society for Quality Control Standard:
1.1 This specification covers the material requirements for
ASQ C1Specification of General Requirements for a Qual-
high-purity, dense aluminum oxide for load-bearing surgical
ity Program
implant applications.
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2.3 ISO Standard:
1.2 This specification does not cover finished parts (for
ISO 6474Implants for Surgery—Ceramic Materials Based
example,femoralheads,acetabularinserts,dentalimplantsand
on Alumina
the like). It is intended as a qualification of the material as
delivered to the parts manufacturer.
3. Chemical Requirements
1.3 The values stated in SI units are to be regarded as
3.1 ThechemicalcompositionshallbeasfollowsinTable1,
standard. No other units of measurement are included in this
(measured by ICP-AES, XRF, or mass spectrocopy):
standard.
4. Physical Requirements
2. Referenced Documents
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4.1 Theminimumbulkdensityshallbe(3.94 60.01)g/cm
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2.1 ASTM Standards:
as determined by Test Method C373 as applied with the
C373Test Method for Water Absorption, Bulk Density,
following modifications.
ApparentPorosity,andApparentSpecificGravityofFired
4.1.1 Weight determination, 3.1 and 5.1 of Test Method
Whiteware Products
C373 shall be made to the nearest 0.001 g.
C1161Test Method for Flexural Strength of Advanced
4.1.2 Thecalculationofbulkdensityin12.1ofTestMethod
Ceramics at Ambient Temperature
C373 shall be calculated as follows:
C1198Test Method for Dynamic Young’s Modulus, Shear
B 5 D·d / M 2S (1)
~ ! ~ !
Modulus, and Poisson’s Ratio forAdvanced Ceramics by
Sonic Resonance
where:
C1239Practice for Reporting Uniaxial Strength Data and
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B = bulk density (g/cm ),
Estimating Weibull Distribution Parameters forAdvanced
D = dry weight (g),
Ceramics
M = saturated weight (g),
C1259Test Method for Dynamic Young’s Modulus, Shear
S = suspended weight (g), and
Modulus, and Poisson’s Ratio forAdvanced Ceramics by
d = density of water at the temperature when measurement
Impulse Excitation of Vibration
is taken.
C1327Test Method for Vickers Indentation Hardness of
4.2 The median grain size shall be 4.5 µm or less, in
Advanced Ceramics
accordance with Section 10 of Test Methods E112.
E112Test Methods for Determining Average Grain Size
F981Practice for Assessment of Compatibility of Biomate-
5. Mechanical Requirements (Table 2)
rials for Surgical Implants with Respect to Effect of
5.1 The average room temperature flexural strength for 10
samples shall be no less than 400 MPa (58000 psi) by four
1 point bend in accordance with Test Method C1161, test
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of
configurationB.Thespecimenshallbepreparedinaccordance
Subcommittee F04.13 on Ceramic Materials.
with Test Method C1161, 7.2.4, to a 500 grit finish.
Current edition approved Jan. 1, 2012. Published January 2012. Originally
approvedin1983.Lastpreviouseditionapprovedin2000asF603—000,withwas
withdrawninMarch2009andreinstatedinJanuary2012.DOI:10.1520/F0603–12.
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For referenced ASTM standards, visit the ASTM website, www.astm.org, or Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Milwaukee, WI 53203, http://www.asq.org.
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Standards volume information, refer to the standard’s Document Summary page on Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
the ASTM website. 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 States
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F603−12
TABLE 1 Chemical Properties
5.3 The minimum Vickers Hardness values fora1kg load
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Oxide Weight Percent shall be 18 GPa (2.56 × 10 psi) in accordance with Test
Al O $ 99.5
2 3
Method C1327.
MgO # 0.5
Other Oxides # 0.1
5.4 The minimum Weibull modulus for 30 samples as
calculated usingTest Method C1239 shall be no less than 8 by
four point bend in accordance with Test Method C1161, test
TABLE 2 Mechanical Properties
configuration B. The specimens shall be prepared in accor-
Compressive Strength GPa (ksi) 4
dance with Test Method C1161, 7.2.4, to a 500 grit finish.
Expected Minimum (580)
6. Test Specimen Fabrication
Average Flexural Strength MPa (psi) 400
Requ
...
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