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Hlavní stránka>BS EN ISO 13408-6:2021 - TC Tracked Changes. Aseptic processing of health care products Isolator systems
sklademVydáno: 2021-11-15
BS EN ISO 13408-6:2021 - TC Tracked Changes. Aseptic processing of health care products Isolator systems

BS EN ISO 13408-6:2021 - TC

Tracked Changes. Aseptic processing of health care products Isolator systems

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Označení normy:BS EN ISO 13408-6:2021 - TC
Počet stran:112
Vydáno:2021-11-15
ISBN:978 0 539 19912 3
Status:Tracked Changes
Počet stran (Anglicky):112
ISBN (Anglicky):978 0 539 19912 3
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BS EN ISO 13408-6:2021 - TC


This standard BS EN ISO 13408-6:2021 - TC Tracked Changes. Aseptic processing of health care products is classified in these ICS categories:
  • 11.080.01 Sterilization and disinfection in general
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.