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Standard Guide for Powder Reuse Schema in Powder Bed Fusion Processes for Medical Applications for Additive Manufacturing Feedstock Materials
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 StandardDetails, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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