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ISO 13408-6:2021

Current Date published:

Aseptic processing of health care products — Part 6: Isolator systems

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.

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Related Information

Similar Standards

  • AS/NZS ISO 11137.1:2006

    Sterilization of health care products - Radiation - Requirements for development, validation and routine control of a sterilization process for medical devices

  • AS/NZS ISO 11137.3:2006

    Sterilization of health care products - Radiation - Guidance on dosimetric aspects

  • BS EN 556-1:2001

    Sterilization of medical devices. Requirements for medical devices to be designated "STERILE", Requirements for terminally sterilized medical devices

  • BS EN 556-2:2015

    Sterilization of medical devices. Requirements for medical devices to be designated "STERILE", Requirements for aseptically processed medical devices

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