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ČSN EN ISO 13408-6 (855264)
Aseptic processing of health care products - Part 6: Isolator systems
Translate name
STANDARD published on 1.11.2021
The information about the standard:
Designation standards: ČSN EN ISO 13408-6
Classification mark: 855264
Catalog number: 512997
Publication date standards: 1.11.2021
SKU: NS-1041159
The number of pages: 44
Approximate weight : 132 g (0.29 lbs)
Country: Czech technical standard
Category: Technical standards ČSN
The category - similar standards:
Annotation of standard text ČSN EN ISO 13408-6 (855264):
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
Preview of the standard ČSN EN ISO 13408-6 (855264)
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