卫生保健产品的无菌加工 - 第6部分:隔离器系统

[中文适用范围]： 本文件规定了与医疗保健产品无菌加工和基于细胞的医疗保健产品加工相关的隔离系统的规范、选择、鉴定、生物净化、验证、操作和控制的要求并提供指导。 本文件没有规定限制进入屏障系统（RABS）的要求。 本文件不会取代或取代国家监管要求，例如良好生产规范 (GMP) 和/或特别与国家或地区司法管辖区相关的概要要求。 本文件没有规定用于无菌测试的隔离器的要求；然而，本文件中的一些原则和信息可能适用于本应用。 本文件没有定义生物安全遏制要求。 [外文原描述]： This document specifies the requirements for and provides guidance on the specification, selection, qualification, bio-decontamination, validation, operation and control of isolator systems related to aseptic processing of health care products and processing of cell-based health care products. This document does not specify requirements for restricted access barrier systems (RABS). This document does not supersede or replace national regulatory requirements such as Good Manufacturing Practices (GMPs) and/or compendia requirements that pertain in particular to national or regional jurisdictions. This document does not specify requirements for isolators used for sterility testing; however, some of the principles and information in this document could be applicable to this application. This document does not define biosafety containment requirements.