Standard Guide for Powder Reuse Schema in Powder Bed Fusion Processes for Medical Applications for Additive Manufacturing Feedstock Materials

Importancia y uso:

4.1 In PBF systems, powder is often reused to increase feedstock efficiency by reducing waste. While in many applications the customer can rely on the manufacturer’s validation and verification activities to ensure their PBF process produces parts of the appropriate quality, some medical device regulatory bodies ask for the powder reuse schema to ensure that any effect of powder reuse on final device performance is assessed.5 The intention of this guide is to provide manufacturers, customers, and regulatory bodies concise terminology to describe powder feedstock reuse schema for PBF using metal or polymer feedstock. Additionally, a well-defined powder reuse schema may reduce the risk of feedstock contamination and associated defects within the manufacturer’s quality management system. Each schema represents a broad reuse strategy and is intended to be used as the starting point in describing a powder strategy to customers and regulatory bodies. While the focus of this guide is for medical applications, the schema referenced can be used for non-medical applications.

Subcomité:

F42.07

Referida por:

F3604-23, F3592-23

Volúmen:

10.04

Número ICS:

11.120.10 (Medicaments), 25.030 (Additive manufacturing)

Palabras clave:

additive manufacturing; powder bed fusion; powder reuse;