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.
Keywords
additive manufacturing; medical; residual powder
Rationale
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.
Work Item Status
Date Initiated: 07-15-2022
Technical Contact: William Hayes
Item: 000
Ballot:
Status: