ASTM F 3335 : 2020

1.1This 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.

1.2This guide covers several qualitative and quantitative assessments of the presence and amount of residue remaining in or obtained by extraction in aqueous or organic solvents from powder bed fusion AM medical components.

1.3This guide pertains to devices in their finished state (after post-processing and subsequent manufacturing processes), as applicable. This guide may also be used to evaluate the effectiveness of cleaning processes between critical steps in the manufacturing process, to ensure minimal AM residue remains for cleaning processes downstream.

1.4This guide is not intended to evaluate the residue level in medical components that have been cleaned for reuse.

1.5Different cleaning methods, including high energy processes, can potentially damage small structures in AM parts. This guide does not address measurement or mitigation of this risk.

1.6This guide does not address the manufacturing occupational health issues of working with small particles (e.g., breathing hazards).

1.7The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.8This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.9This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.