New Standard Aids Use of Powder Bed Fusion in Medical Device Manufacturing

Powder reuse schemes affect medical device performance

Published: Tuesday, June 28, 2022 - 12:00

(ASTM: West Conshohocken, PA) -- A new ASTM International standard will provide guidance to medical device manufacturers on powder reuse in powder bed fusion manufacturing processes. ASTM’s additive manufacturing technologies committee (F42) developed the standard, which is now available as F3456.

According to ASTM International member Matthew Di Prima, the new standard explains seven broad reuse schema that will 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,” says 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’s additive manufacturing subcommittee on medical/biological standards. The subcommittee welcomes wider engagement in developing standards on the use of AM material specification for medical applications.

About The Author

Quality Digest

For 40 years Quality Digest has been the go-to source for all things quality. Our newsletter, Quality Digest, shares expert commentary and relevant industry resources to assist our readers in their quest for continuous improvement. Our website includes every column and article from the newsletter since May 2009 as well as back issues of Quality Digest magazine to August 1995. We are committed to promoting a view wherein quality is not a niche, but an integral part of every phase of manufacturing and services.