Investigator: Anna C. Fraker

Technical Description:

Biomedical implant reliability depends largely on the corrosion, wear, and fatigue resistance of the materials used to make the implant. This project examines the techniques used to characterize the influence of composition, microstructures, processing, and surface preparation on the performance and durability of metallic biomaterials and the application of these techniques to the characterization of new alloys for use in implants. This project also participates in standards development for medical materials and devices.

Technical Objectives:

• Determine the electrochemical behavior of materials developed for aerospace and defense applications to determine the suitability of these materials for use as surgical implants.

• Prepare a database that would eventually go to the Food and Drug Administration (FDA) on all aspects of these materials, including heat treatment, mechanical properties, corrosion behavior, biocompatibility and other properties.

• Interact with Howard University and George Washington University in studies of coupled metals in dentistry and materials used in the spine and neurosurgery, respectively.

• Participate and provide data for the development of standards for beta titanium alloys and for updating existing standards.

Anticipated Outcome:

• Technology transfer of an aerospace alloy to health use by alloy modification and characterization. Data on biocompatibility, mechanical properties, corrosion and suitability for surgical implants is being provided to the Food and Drug Administration (FDA).

• Participation in the ASTM F-4 Committee on Medical and Surgical Materials and Devices to develop standards and specifications for titanium alloys that are being considered for use as surgical implant materials.

Accomplishments for FY 1995:

• Data showing electrochemical behavior and the importance of microstructures in a beta titanium alloy (Ti21SRx) were provided to the consortium for inclusion with data from mechanical tests and biocompatibility tests that eventually will go to the FDA.

• Provided information on corrosion testing of implant materials to the FDA for use in standard test method development in the International Organization for Standardization (ISO).

• Summarized mechanical properties, microstructures, effects of heat treating and corrosion behavior of titanium alloys for surgical implant use.

• Reported on corrosion studies of dental casting alloys coupled with titanium.

• Prepared a review of implant materials and the use of ASTM standards.

Impacts and Technical Highlights:

• The results of this work are being used by a biomedical implant consortium consisting of titanium alloy producers and biomedical implant producers to evaluate alloys for use in implants and, eventually, will be included in the submission of the FDA.

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Last modified: Mon Jan 06 09:46:15 1997 Metallurgy Webmeister