本文件涉及与增材制造系统直接相关的安装确认（IQ）、操作确认（OQ）和性能确认（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，即工艺制图、风险评估和验证计划，是机器鉴定的必要前提条件，但它们不在本文件的范围内。 本文件提供了通过电子束工艺（PBF-EB/M）对粉末床熔融生产的金属零件进行批量生产的机器相关工艺评定的推荐做法。由于该过程与PBF-LB/M非常相似，本文件参考了ISO/ASTM TS 52930，仅指出了验证过程的差异。本文件适用于已经建立了全面质量体系的组织。 本文件涵盖了与增材制造设备直接相关的问题，不包括除粉末外的原料资格或后处理。 物理设施、人员、工艺和材料问题仅在支持机器资格认证所需的范围内包括在内。

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. This document provides recommended practices for machine-related process qualification for serial production of metal parts produced with the powder bed fusion, by electron beam process (PBF-EB/M). Since this process is very similar to the PBF-LB/M, this document references ISO/ASTM TS 52930, pointing only the differences on the validation processes. This document is addressed to organizations that already have a comprehensive quality system in place. This document covers issues directly related to the AM equipment and does not cover feedstock qualification or post processing beyond powder removal. Physical facility, personnel, process and material issues are only included to the extent necessary to support machine qualification.