CEN - EN ISO 13408-6
Aseptic processing of health care products - Part 6: Isolator systems
|Publication Date:||1 May 2021|
|ICS Code (Sterilization and disinfection in general):||11.080.01|
This document specifies the requirements for and provides guidance on the specification, selection, qualification, bio-decontamination,
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.