ISO 13408-6:2021 PDF

Scope: 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.

ISO 13408-6:2021 Referenced Document

ISO 11139 Sterilization of health care products — Vocabulary of terms used in sterilization and related equipment and process standards — Amendment 1: Amended and additional terms and definitions
ISO 13408-1:2008 Aseptic processing of health care products - Part 1: General requirements
ISO 13408-4 Aseptic processing of health care products - Part 4: Clean-in-place technologies
ISO 13408-7 Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products
ISO 14644-1:2015 Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration
ISO 14644-7 Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
ISO 18362 Manufacture of cell-based health care products — Control of microbial risks during processing — Amendment 1*， 2022-06-21 Update
ISO/IEC 90003 Software engineering - Guidelines for the application of ISO 9001:2015 to computer software

2021 ISO 13408-6:2021 Aseptic processing of health care products — Part 6: Isolator systems
2013 ISO 13408-6:2006/Amd 1:2013 Aseptic processing of health care products - Part 6: Isolator systems; Amendment 1
2005 ISO 13408-6:2005 Aseptic processing of health care products - Part 6: Isolator systems