The new Specification for Metal Injection Moulded 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 moulded 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 moulding allows for the design of new geometries and reduces manufacturing costs.
“Through ASTM F2989, the material properties of metal injection moulded unalloyed titanium components can be directly compared to components that are made with conventional methods,” Scharvogel said.
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 moulded component. The standard also defines the requirements as a baseline for the regulatory bodies.
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