ASTM F603-00

Standard Specification for High-Purity Dense Aluminum Oxide for Surgical Implant Application (Withdrawn 2009)

ABSTRACT
This specification covers the material requirements for high-purity, dense aluminum oxide for load bearing surgical implant applications. It mainly addresses qualification of the material as delivered to the parts manufacturer, and does not cover finished parts such as femoral heads, acetabular inserts, dental implants, and the like. The material requirements to which the aluminum oxides shall conform are physical properties such as bulk density, weight, and grain size; chemical composition that shall be measured either by ICP-AES, XRF, or mass spectroscopy; and mechanical properties such as compressive strength, flexural strength, elastic modulus, Vickers hardness, and Weibull modulus.
SCOPE
1.1 This specification covers the material requirements for high-purity, dense aluminum oxide for surgical implant applications.  
1.2 The values stated in SI units are to be regarded as the standard.  
1.3 Aluminum oxide in accordance with Section 3 has been demonstrated to exhibit a well-characterized biological response which is less than that exhibited by the reference materials cited and tested in Practice F361 or equivalent (1 to 6).
WITHDRAWN RATIONALE
This specification covers the material requirements for high-purity, dense aluminum oxide for load bearing surgical implant applications.
Formerly under the jurisdiction of Committee F04 on Medical and Surgical Materials and Devices, this specification was withdrawn in March 2009 in accordance with section 10.5.3.1 of the Regulations Governing ASTM Technical Committees, which requires that standards shall be updated by the end of the eighth year since the last approval date.

General Information

• Status: Historical
• Publication Date: 31-Dec-1999
• Withdrawal Date: 04-Mar-2009
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.13 - Ceramic Materials

Relations

• Replaces: ASTM F603-83(1995) - Standard Specification for High-Purity Dense Aluminum Oxide for Surgical Implant Application
• Effective Date: 01-Jan-2000
• Replaced By: ASTM F603-12 - Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application
• Effective Date: 01-Jan-2012
• Referred By: ASTM F2345-21 - Standard Test Methods for Determination of Cyclic Fatigue Strength of Ceramic Modular Femoral Heads
• Effective Date: 01-Jan-2000
• Referred By: ASTM F763-22 - Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials
• Effective Date: 01-Jan-2000
• Referred By: ASTM F981-23 - Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices
• Effective Date: 01-Jan-2000
• Referred By: ASTM F1378-18e1 - Standard Specification for Shoulder Prostheses
• Effective Date: 01-Jan-2000
• Referred By: ASTM F2091-15 - Standard Specification for Acetabular Prostheses (Withdrawn 2023)
• Effective Date: 01-Jan-2000
• Referred By: ASTM F2027-16 - Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
• Effective Date: 01-Jan-2000
• Referred By: ASTM F1714-96(2018) - Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices
• Effective Date: 01-Jan-2000
• Referred By: ASTM F1672-14(2019) - Standard Specification for Resurfacing Patellar Prosthesis (Withdrawn 2023)
• Effective Date: 01-Jan-2000

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F 603 – 00
Standard Specification for
1
High-Purity Dense Aluminum Oxide for Medical Application
This standard is issued under the fixed designation F 603; 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 (e) indicates an editorial change since the last revision or reapproval.
1. Scope 2.2 American Society for Quality Control:
C 1 Specification of General Requirements for a Quality
1.1 This specification covers the material requirements for
6
Program
high-purity, dense aluminum oxide for load bearing surgical
2.3 ISO:
implant applications.
ISO 6474:1994 Implants for Surgery - Ceramic Materials
1.2 This specification does not cover finished parts (for
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Based on Alumina
example,femoralheads,acetabularinserts,dentalimplantsand
the like). It is intended as a qualification of the material as
3. Chemical Requirements
delivered to the parts manufacturer.
3.1 The Chemical composition shall be as follows in Table
1.3 The values stated in SI units are to be regarded as
1, (measured by ICP-AES, XRF or mass spectrocopy):
standard.
4. Physical Requirements
2. Referenced Documents
3
4.1 The minimum bulk density shall be (3.94 6 .01) g/cm
2.1 ASTM Standards:
as determined by Test Method C 373 as applied with the
C 373 Test Method for Water Absorption, Bulk Density,
following modifications.
Apparent Porosity, andApparent Specific Gravity of Fired
2 4.1.1 Weight determination, 3.1 and 5.1 of C 373 shall be
Whiteware Products
made to the nearest 0.001 g.
C 1161 Test Method for Flexural Strength of Advanced
3 4.1.2 The calculation of bulk density in 12.1 of C 373 shall
Ceramics at Ambient Temperature
be calculated as follows:
C 1198 Test Method for Dynamic Young’s Modulus, Shear
•
Modulus, and Poisson’s Ratio for Advanced Ceramics by
B5~D d!/ ~M 2 S! (1)
3
Sonic Resonance
where:
C 1239 Standard Practice for Reporting Uniaxial Strength
3
B = Bulk density (g/cm )
Data and Estimating Weibull Distribution Parameters for
D = Dry weight (g)
3
Advanced Ceramics
M = Saturated weight (g)
C 1259 Test Method for Dynamic Young’s Modulus, Shear
S = Suspended weight (g)
Modulus and Poisson’s Ratio for Advanced Ceramics by
d = Density of water at the temperature when measure-
3
Impulse Excitation of Vibration
ment is taken.
C 1327 StandardTestMethodforVickersIndentationHard-
4.2 The median grain size shall be 4.5 µm or less, in
3
ness of Advanced Ceramics
accordance with Section 10 of Methods E 112.
4
E 112 Methods for Determining Average Grain Size
F 981 Practice for Assessment of Compatibility of Bioma-
5. Mechanical Requirements (Table 2)
terials for Surgical Implants with Respect to Effect of
5.1 The average room temperature flexural strength for 10
5
Materials on Muscle and Bone
samples shall be no less than 400 MPa (58,000 psi) by four
point bend in accordance with Test Method C 1161 test
1
configuration B. The specimen shall be prepared in accordance
ThisspecificationisunderthejurisdictionofASTMCommitteeF-4onMedical
andSurgicalMaterialsandDevices,andisthedirectresponsibilityofSubcommittee
with Test Method C 1161 7.2.4 to a 500 grit finish.
F04.13 on Ceramic Materials.
Current edition approved Jan 10, 2000. Published April 2000. Originally
published as F 603 – 83. Last previous edition F 603 – 93 (95).
2 6
Annual Book of ASTM Standards, Vol 15.02. Available from American Society for Quality Control, 161 West Wisconsin
3
Annual Book of ASTM Standards, Vol 15.01. Ave., Milwaukee, WI 52303.
4 7
Annual Book of ASTM Standards, Vol 03.01. Available from the American National Standards Institute 11 West 42nd St.
5
Annual Book of ASTM Standards, Vol 13.01. 13th Floor, New York, NY 10036.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
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F 603
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 3 10 psi) in accordance with Test
Method C 1327.
Al O $ 99.5
2 3
MgO # 0.5
5.4 The minimum Weibull modulus for 30 samples as
Other Oxides # 0.1
calculated using C 1239 shall be no less than 8 by four point
bend in accordance with Test Method C 1161, test configura-
tion B. The specimens shall be prepared in accordance with
TABLE 2 Mechanical Properties
Test Method C 1161 7.2.4 to a 500 grit finish.
Compressive Strength GPa (ksi) 4
Expected Minimum (580)
6. Test Specimen Fabrication
6.1 Specific test specimens shall be prepared from the same
Average Flexural Strength MPa (psi) 400
Required Minimum (58,000)
batch of material and by the same processes as those employed
in fabricating the ceramic implant device.
Elastic Modu
...