1.1 本文件论述了与直接影响材料整合的添加剂制造系统直接相关的安装鉴定（IQ）、操作鉴定（OQ）和性能鉴定（PQ）问题。工艺验证的前三个要素、工艺映射、风险评估和验证规划是机器鉴定的必要先决条件，然而，它们不在本文件的范围内。 1.2 本文件涵盖与AM设备直接相关的问题，不涵盖除粉以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需的范围内。 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。

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.