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ISO 13408-6:2021

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

Apr 13, 2021

General information

90.20     Apr 15, 2026

ISO

ISO/TC 198

International Standard

11.080.01  

English   French  

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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.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 13408-6:2005

WITHDRAWN
ISO 13408-6:2005/Amd 1:2013

NOW

PUBLISHED
ISO 13408-6:2021
90.20 Standard under periodical review
Apr 15, 2026

National adoptions

SRPS EN ISO 13408-6:2021  
ISS

Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021)

60.60   Standard published

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