ASTM International, Conshohocken, Pennsylvania, USA, has announced the publication of standard F3456, developed to provide guidance for medical device manufacturers on powder reuse in the Powder Bed Fusion (PBF) Additive Manufacturing process. ASTM’s Additive Manufacturing technologies committee (F42) developed the standard, which is now available to purchase.
According to ASTM International member Matthew Di Prima, the new standard explains seven broad reuse schema intended to give manufacturers information pertinent to regulatory bodies interested in understanding how powder reuse schemes affect medical device performance.
“Additive Manufacturing manufacturers of medical devices and regulatory bodies will find this new guide to be useful,” stated Di Prima. “The guide may also be useful to AM manufacturers to generally describe their reuse process to customers without having to give away specific manufacturing process information.”
F3456 is the first standard to be developed by the F42 Additive Manufacturing subcommittee on medical/biological standards. The subcommittee is said to welcome wider engagement in developing standards on the use of AM material specifications for medical applications.