EN ISO 13408-6 Test Standard for Aseptic Handling of Health Care Products

This part of ISO 13408-6 specifies requirements for isolator systems used for aseptic processing and provides guidance on the qualification, biodecontamination, validation, operation and control of isolator systems used for aseptic processing of healthcare products.

• This standard does not specify requirements for restricted access barrier systems (RABS).
• This standard does not replace national regulatory requirements such as Good Manufacturing Practices (GMPs) or summary requirements specifically related to national or regional jurisdictions.
• This standard does not specify requirements for isolators used for sterility testing; however, some of the principles and information in this document may apply to this application.
• This standard does not define biosafety containment requirements.

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