ASTM F603-83(1995)

Standard Specification for High-Purity Dense Aluminum Oxide for Surgical Implant Application

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).

General Information

• Status: Historical
• Publication Date: 31-Dec-1999
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.13 - Ceramic Materials

Relations

• Replaced By: ASTM F603-00 - Standard Specification for High-Purity Dense Aluminum Oxide for Surgical Implant Application (Withdrawn 2009)
• Effective Date: 01-Jan-2000
• Referred By: ASTM F1672-14(2019) - Standard Specification for Resurfacing Patellar Prosthesis (Withdrawn 2023)
• Effective Date: 01-Jan-2000
• 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• Referred By: ASTM F2091-15 - Standard Specification for Acetabular Prostheses (Withdrawn 2023)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

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
Designation: F 603 – 83 (Reapproved 1995)
Standard Specification for
High-Purity Dense Aluminum Oxide for Surgical Implant
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 (Al O ) content of 99.5 % or greater.
2 3
3.2 The combined total of silicon dioxide (SiO ) and alkali
1.1 This specification covers the material requirements for
oxides shall be no greater than 0.1 %.
high-purity, dense aluminum oxide for surgical implant appli-
3.3 For referee purposes, Methods C 573 shall be used.
cations.
1.2 The values stated in SI units are to be regarded as the
4. Physical Requirements
standard.
4.1 The minimum bulk density shall be 3.90 g/cm as
1.3 Aluminum oxide in accordance with Section 3 has been
determined by Test Methods C 20 as applied with the following
demonstrated to exhibit a well-characterized biological re-
modifications:
sponse which is less than that exhibited by the reference
4.1.1 The sample volume in 2.1 of Test Methods C 20 shall
materials cited and tested in Practice F 361 or equivalent
2 be approximately 300 mm or greater.
(1-6).
4.1.2 Weight determinations in 3.1 and 5.1 of Test Methods
2. Referenced Documents C 20 shall be made to the nearest 0.0005 g.
4.1.3 The calculation of bulk density in 12.1 of Test
2.1 ASTM Standards:
Methods C 20 shall be calculated as follows:
C 20 Test Methods for Apparent Porosity, Water Absorp-
tion, Apparent Specific Gravity, and Bulk Density of B 5 D/~D 2 W! (1)
Burned Refractory Brick and Shapes by Boiling Water
where:
C 573 Methods for Chemical Analysis of Fireclay and
4 B 5 bulk density,
High-Alumina Refractories
D 5 dry weight, and
C 674 Test Methods for Flexural Properties of Ceramic
W 5 suspended weight.
Whiteware Materials
4.2 The average grain size shall be 7 μm or less, in
E 112 Test Methods for Determining Average Grain Size
accordance with Section 10 of Test Methods E 112.
F 361 Practice for Assessment of Compatibility of Metallic
Materials for Surgical Implants with Respect to Effect of
7 5. Mechanical Requirements
Materials on Tissue
5.1 The minimum room temperature flexural strength shall
2.2 American Society for Quality Control
be 400 MPa (58 000 psi) in accordance with Test Methods
C 1 Specification of General Requirements for a Quality
C 674 as applied with the following modification:
Program
5.1.1 The specimen geometry in 5.2 of Test Methods C 674
3. Chemical Requirements
shall be rectangular, approximately 5 by 5 mm in cross section
and at least 35 mm in length.
3.1 The chemical analysis shall indicate an aluminum oxide
5.2 The minimum room temperature elastic modulus shall
be 380 000 MPa (55.1 3 10 psi) in accordance with Test
This specification is under the jurisdiction of ASTM Committee F-4 on Medical
Methods C 674 except that the specimen geometry shall be
and Surgical Materials and Devices, and is the direct responsibility of Subcommittee
modified as in 5.1.1.
F04.13 on Ceramic Materials.
Current edition approved Nov. 28, 1983. Published February 1984.
6. Test Specimen Fabrication
The boldface numbers in parentheses refer to the list of references appended to
this specification.
6.1 Specific test specimens shall be prepared from the same
Annual Book of ASTM Standards, Vol 15.01.
4 batch of material and by the same processes as those employed
Annual Book of ASTM Standards, Vol 03.06.
in
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