1. Scope
1.1 This standard provides guidance for assessing the manufacturing material residues
in medical devices fabricated using additive manufacturing (AM) techniques, specifically,
from powder bed fusion AM technologies.
1.1.1 Some of the techniques discussed in this guide may be applicable to devices fabricated
by other types of AM equipment (e.g., stereolithography). Given each AM technique’s
characteristics and post-processing challenges, there could be additional risks or
considerations associated with some AM techniques or materials that are not addressed
by this guide.