ASTM International Committee F04 on Medical and Surgical Materials and Devices has approved a new standard for a metallurgical implant material that is useful in a variety of surgical applications. ASTM F3046, Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy for Surgical Implant Applications (UNS R56320), was developed by Subcommittee F04.12 on Metallurgical Materials.
Mark Ransick, principal test engineer, Ethicon Surgical Care, and an F04.12 member, notes that ASTM F3046 fills a gap that has existed in the implant standards realm. “There are several ASTM standards for this alloy but most are for commercial applications and the one medical grade implant is for tubing,” says Ransick.
According to Ransick, one of the existing applications of the material covered in F3046 is staples used in different surgeries. The alloy can also be used in the form of shapes or bars for patient implantation.
Primary users of ASTM F3046 will be design and development engineers, material purchasers and material selection organizations within the medical device manufacturing industry. The following are some potential uses for ASTM F3046:
• Manufacturers will be able to use ASTM F3046 to specify the composition, properties and form of the material;
• Medical device companies can submit to regulatory bodies that their device or implant meets the requirements of ASTM F3046 when requesting approval of a device; and
• Laboratories can reference ASTM F3046 when an analysis is performed on this alloy.
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ASTM Committee F04 Next Meeting: May 6-9, 2014, May Committee Week, Toronto, Ontario, Canada
Technical Contact: Mark Ransick, Ethicon Surgical Care, Cincinnati, Ohio, Phone: 513-337-8069; email@example.com
ASTM Staff Contact: Pat Picariello, Phone: 610-832-9720; firstname.lastname@example.org
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April 11, 2014