本文件规定了用于制造治疗用细胞的设备（包括硬件、软件和耗材）的最低要求和一般注意事项。这包括用于处理用于治疗用途的细胞的设备，从细胞分离/选择、扩增、洗涤和体积减小开始，从细胞整理到用于储存用于治疗用途的细胞的冷冻保存。 本文件从目标方（即供应商或用户）和所涉及任务的阶段（即设计、使用或维护）等方面向供应商和用户提供设备和设备系统的设计、使用和维护指南。 本文件适用于单独或组合用于生产治疗用细胞的任何单元操作系统，满足用户要求。它适用于用于监控设备状态的设备。 它不适用于: 在护理点使用的用于治疗用途的细胞的处理设备； 用于分析目的的设备； 生物安全柜、通用细胞培养设备（如CO2培养箱等），以及控制多个设备系统或多个单元操作的软件。

This document specifies minimum requirements and general considerations for equipment, consisting of hardware, software and consumables, used in the manufacturing of cells for therapeutic use. This includes equipment for processing cells for therapeutic use starting from cell isolation/selection, expansion, washing and volume reduction, from cell finish through to cryopreservation for the storage of cells for therapeutic use. This document gives guidance on the design, use and maintenance of equipment and equipment systems to both suppliers and users from aspects including the target parties, i.e. supplier or user, and phase of involved task, i.e. design, use or maintenance. This document is applicable to any unit operation system that is used, alone or in combination, for the manufacturing of cells for therapeutic use, meeting user requirements. It is applicable to devices used for the purpose of monitoring equipment status. It does not apply to:

• processing equipment for cells for therapeutic use used at the point of care;
• devices used for analytical purposes;
• biosafety cabinets, general cell culture equipment (such as CO₂ incubators, etc.), and software to control multiple equipment systems or multiple unit operations.