Work Item
ASTM WK82776

New Test Method for Additive Manufacturing for Medical - Powder Bed Fusion - Assessment of Residual Powder

1. Scope

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

Committee: F42

Staff Manager: Pat Picariello

Work Item Status

Date Initiated: 07-15-2022

Technical Contact: William Hayes

Item: 000