EN ISO 13408-6:2021
医疗保健产品的无菌加工.第6部分:隔离器系统
Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021)
2021-11
EN ISO 13408-6:2021 中，可能用到以下仪器设备
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- 标准号
- EN ISO 13408-6:2021
- 发布
- 2021年
- 发布单位
- 欧洲标准化委员会
- 当前最新
- EN ISO 13408-6:2021
- 适用范围
- 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.