【国外标准】 Standard Guide for Powder Reuse Schema in Powder Bed Fusion Processes for Medical Applications for Additive Manufacturing Feedstock Materials

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.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.