The scope of this standard is to provide a standard test method to assess residual powder from finished medical devices made using powder bed fusion technologies.
additive manufacturing; medical; residual powder
The US FDA has long asked for an assessment of residual powder in finished medical devices. While ASTM F3335 provided a guide for multiple ways of performing this assessment, there is no normative test method to perform this activity. This standard method will allow medical device manufacturers and test houses to perform this assessment in a standardized manner reducing cost to develop unique assessment protocols and ensuring that results can be properly compared.
The title and scope are in draft form and are under development within this ASTM Committee.
Developed by Subcommittee: F42.07.03
Staff Manager: Pat Picariello
Date Initiated: 07-15-2022
Technical Contact: Paul Carpinone