1.1 本文件解决了与增材制造系统直接相关的安装资格（IQ）、操作资格（OQ）和性能资格（PQ）问题，这些问题对材料的固结有直接影响。工艺验证的前三个要素（工艺流程图、风险评估和验证计划）是机器确认的必要先决条件，但是，它们超出了本文档的范围。 1.2 本文件涵盖与增材制造设备直接相关的问题，不涵盖除粉末去除之外的原料鉴定或后处理。 1.3 物理设施、人员、工艺和材料问题仅包括在支持机器鉴定所必需的范围内。 1.4 本国际标准是根据关于制定国际标准、指南和建议的原则的决定i中确定的国际公认的标准化原则制定的由世界贸易组织技术性贸易壁垒（TBT）委员会发布。

1.1 This document addresses installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) issues directly related to the additive manufacturing system that has a direct influence on the consolidation of material. The first three elements of process validation, process mapping, risk assessment, and validation planning, are necessary pre-conditions to machine qualification, however, they are outside the scope of this document. 1.2 This document covers issues directly related to the AM equipment and does not cover feedstock qualification or post processing beyond powder removal. 1.3 Physical facility, personnel, process and material issues are only included to the extent necessary to support machine qualification. 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.