ASTM F3456-22 PDF

Scope: 1.1 This guide provides a concise approach for users of powder bed fusion (PBF) processes to communicate the method(s) in which feedstock powders are controlled throughout the feedstock lifecycle. 1.1.1 Regulatory bodies may require descriptions of used powder reuse schemes in a submission. This is because a medical device’s performance can be affected by the condition of the powder feedstock and current regulations are not prescriptive to powder. 1.1.2 This guide is intended for users of both polymer and metal feedstock powders. 1.2 This guide does not cover powder specifications, recycling strategy, blending processes, lot control, or address contamination prevention. 1.3 This 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. 1.4 This 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.

ASTM F3456-22 Referenced Document

ANSI/AAMI/ISO 13485 Medical devices—Quality management systems— Requirements for regulatory purposes
ASTM B213 Standard Test Method for Flow Rate of Metal Powders
ASTM B214 Standard Test Method for Sieve Analysis of Metal Powders
ASTM B215 Standard Practices for Sampling Finished Lots of Metal Powders
ASTM B822 Standard Test Method for Particle Size Distribution of Metal Powders and Related Compounds by Light Scattering
ASTM B964 Standard Test Methods for Flow Rate of Metal Powders Using the Carney Funnel*， 2023-02-01 Update

2022 ASTM F3456-22 Standard Guide for Powder Reuse Schema in Powder Bed Fusion Processes for Medical Applications for Additive Manufacturing Feedstock Materials