ASTM F603-12(2016)
(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 (Reapproved 2016)
Standard Specification for
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 F981Practice for Assessment of Compatibility of Biomate-
rials for Surgical Implants with Respect to Effect of
1.1 This specification covers the material requirements for
Materials on Muscle and Insertion into Bone
high-purity, dense aluminum oxide for load-bearing surgical
2.2 American Society for Quality Control Standard:
implant applications.
ASQ C1Specification of General Requirements for a Qual-
1.2 This specification does not cover finished parts (for
ity Program
example,femoralheads,acetabularinserts,dentalimplantsand
2.3 ISO Standard:
the like). It is intended as a qualification of the material as
ISO 6474Implants for Surgery—Ceramic Materials Based
delivered to the parts manufacturer.
on Alumina
1.3 The values stated in SI units are to be regarded as
standard. No other units of measurement are included in this
3. Chemical Requirements
standard.
3.1 The chemical composition shall be as shown in Table 1,
(measured by ICP-AES, XRF, or mass spectrocopy):
2. Referenced Documents
2.1 ASTM Standards:
4. Physical Requirements
C373Test Methods for Determination of Water Absorption
4.1 Theminimumbulkdensityshallbe(3.94 60.01)g/cm
andAssociated Properties byVacuum Method for Pressed
as determined by Test Method C373 as applied with the
Ceramic Tiles and Glass Tiles and Boil Method for
following modifications.
Extruded Ceramic Tiles and Non-tile Fired Ceramic
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
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
5. Mechanical Requirements (Table 2)
1 5.1 The average room temperature flexural strength for 10
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of
samples shall be no less than 400 MPa (58000 psi) by
Subcommittee F04.13 on Ceramic Materials.
four-point bend in accordance with Test Method C1161, test
Current edition approved Oct. 1, 2016. Published October 2016. Originally
approved in 1983. Last previous edition approved in 2012 as F603 – 12. DOI:
10.1520/F0603-12R16.
2 3
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.
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
F603−12 (2016)
TABLE 1 Chemical Properties
5.3 The minimum Vickers Hardness values fora1kg load
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
Required Minimum (58 0
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F603 − 12 F603 − 12 (Reapproved 2016)
Standard Specification for
High-Purity Dense Aluminum Oxide for Medical Application
This standard is issued under the fixed designation F603; the number immediately following the designation indicates the year of original
adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A superscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
1. 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.
2. Referenced Documents
2.1 ASTM Standards:
C373 Test Methods for Determination of Water Absorption and Associated Properties by Vacuum Method for Pressed Ceramic
Tiles and Glass Tiles and Boil Method for Extruded Ceramic Tiles and Non-tile Fired Ceramic Whiteware Products
C1161 Test Method for Flexural Strength of Advanced Ceramics at Ambient Temperature
C1198 Test Method for Dynamic Young’s Modulus, Shear Modulus, and Poisson’s Ratio for Advanced Ceramics by Sonic
Resonance
C1239 Practice for Reporting Uniaxial Strength Data and Estimating Weibull Distribution Parameters for Advanced Ceramics
C1259 Test Method for Dynamic Young’s Modulus, Shear Modulus, and Poisson’s Ratio for Advanced Ceramics by Impulse
Excitation of Vibration
C1327 Test Method for Vickers Indentation Hardness of Advanced Ceramics
E112 Test Methods for Determining Average Grain Size
F981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on
Muscle and Insertion into Bone
2.2 American Society for Quality Control Standard:
ASQ C1 Specification of General Requirements for a Quality Program
2.3 ISO Standard:
ISO 6474 Implants for Surgery—Ceramic Materials Based on Alumina
3. Chemical Requirements
3.1 The chemical composition shall be as followsshown in Table 1, (measured by ICP-AES, XRF, or mass spectrocopy):
4. Physical Requirements
4.1 The minimum bulk density shall be (3.94 6 0.01) g/cm as determined by Test Method C373 as applied with the following
modifications.
4.1.1 Weight determination, 3.1 and 5.1 of Test Method C373 shall be made to the nearest 0.001 g.
4.1.2 The calculation of bulk density in 12.1 of Test Method C373 shall be calculated as follows:
B5 ~D·d!/~M2 S! (1)
This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.13 on Ceramic Materials.
Current edition approved Jan. 1, 2012Oct. 1, 2016. Published January 2012October 2016. Originally approved in 1983. Last previous edition approved in 20002012 as
F603 —0 00, with was withdrawn in March 2009 and reinstated in January 2012. DOI: 10.1520/F0603–12. – 12. DOI: 10.1520/F0603-12R16.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’sstandard’s Document Summary page on the ASTM website.
Available from American Society for Quality (ASQ), 600 N. Plankinton Ave., Milwaukee, WI 53203, http://www.asq.org.
Available from American National Standards Institute (ANSI), 25 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 States
F603 − 12 (2016)
TABLE 1 Chemical Properties
Oxide Weight Percent
Al O $ 99.5
2 3
MgO # 0.5
Other Oxides # 0.1
where:
B = bulk density (g/cm ),
D = dry weight (g),
M = saturated weight (g),
S = suspended weight (g), and
d = density of water at the temperature when measurement is taken.
where:
B = bulk density (g/cm ),
D = dry weight (g),
M = saturated weight (g),
S = suspended weight (g), and
d = density of water at the temperature when measurement is taken.
4.2 The median grain size shall be 4.5 μm or less, in accordance with Section 10 of Test Methods E112.
5. Mechanical Requirements (Table 2)
5.1 The average room temperature flexural strength for 10 samples shall be no less than 400 MPa (58 000 psi) by four point
four-point bend in accordance with Test Method C1161, test configuration B. The specimen shall be prepared in accordance with
Test Method C1161, 7.2.4, to a 500 grit finish.
5.2 The room temperature elastic modulus shall be measured in accordance with Test Method C1239 or Test Method C1198.
5.3 The minimum Vickers Hardness values for a 1 kg load shall be 18 GPa (2.56 × 10 psi) in accordance with Test Method
C1327.
5.4 The minimum Weibull modulus for 30 samples as calculated using Test Method C1239 shall be no less than 8 by four point
four-point bend in accordance with Test Method C1161, test configuration B. The specimens shall be prepared in accordance with
Test Method C1161, 7.2.4, t
...
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