Association News

ASTM Standard covers unalloyed Ti components for implants.

Press Release Summary:

Mar 27, 2013 - Subcommittee F04.12 on Metallurgical Materials has developed ASTM F2989, Specification for Metal Injection Molded Unalloyed Titanium Components for Surgical Implant Applications. According to E04 member Matthias Scharvogel, this standard allows for design of new geometries and reduces manufacturing costs. It covers chemical, mechanical, and metallurgical requirements for 3 grades and also defines requirements as baseline for regulatory bodies.

ASTM International - West Conshohocken, PA

Original Press Release

Unalloyed Titanium Components Used for Surgical Implants Covered in New ASTM Standard

Press release date: Mar 25, 2013

W. CONSHOHOCKEN, Pa.—ASTM F2989 is a new ASTM International standard that covers unalloyed titanium components that are used for surgical implants. The new Specification for Metal Injection Molded Unalloyed Titanium Components for Surgical Implant Applications was developed by Subcommittee F04.12 on Metallurgical Materials, part of ASTM International Committee F04 on Medical and Surgical Materials and Devices.

ASTM F2989 covers the chemical, mechanical and metallurgical requirements for three grades of metal injection molded unalloyed titanium components to be used in the manufacture of surgical implants.

Matthias Scharvogel, managing director, Element 22 GmbH, and an F04 member, says that the manufacturing process for implants made by metal injection molding allows for the design of new geometries and reduces manufacturing costs.

“Through ASTM F2989, the material properties of metal injection molded unalloyed titanium components can be directly compared to components that are made with conventional methods,” says Scharvogel.

In addition to manufacturers and medical companies, ASTM F2989 will be used as the basis for laboratories that test the material properties of the metal injection molded component. The standard also defines the requirements as a baseline for the regulatory bodies.

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ASTM Committee F04 Next Meeting: May 21-24, 2013, May Committee Week, Indianapolis, Ind.

Technical Contact: Matthias Scharvogel, Element 22 GmbH, Kiel, Germany, Phone: +49-431-659-4620; matthias.scharvogel@element22.de

ASTM Staff Contact: Pat Picariello, Phone: 610-832-9720; ppicariello@astm.org
ASTM PR Contact: Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org