1.1 本指南为粉末床融合（PBF）工艺的用户提供了一种简洁的方法，以交流在整个原料生命周期中控制原料粉末的方法。 1.1.1 监管机构可能要求在提交文件中描述废旧粉末再利用方案。这是因为医疗器械的性能可能会受到粉末原料条件的影响，而当前的法规对粉末没有规定。 1.1.2 本指南适用于聚合物和金属原料粉末的用户。 1.2 本指南不涵盖粉末规格、回收策略、混合过程、批次控制或污染预防。 1.3 本标准并非旨在解决与其使用相关的所有安全问题（如有）。本标准的用户有责任在使用前制定适当的安全、健康和环境实践，并确定监管限制的适用性。 1.4 本国际标准是根据世界贸易组织技术性贸易壁垒（TBT）委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认标准化原则制定的。 ====意义和用途====== 4.1 在PBF系统中，粉末经常被重复使用，以通过减少废物来提高进料效率。虽然在许多应用中，客户可以依靠制造商的验证和验证活动来确保其PBF工艺生产的零件具有适当的质量，但一些医疗器械监管机构要求提供粉末再利用方案，以确保评估粉末再利用对最终器械性能的任何影响。 5. 本指南旨在为制造商、客户和监管机构提供简明的术语，以描述使用金属或聚合物原料的多溴联苯的粉末原料再利用方案。 此外，定义明确的粉末再利用方案可以降低原料污染和制造商质量管理体系内相关缺陷的风险。每个模式都代表了广泛的重用策略，旨在作为向客户和监管机构描述粉末策略的起点。虽然本指南的重点是医疗应用，但引用的模式可用于非医疗应用。

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. ====== Significance And Use ====== 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.