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EVS-EN ISO 13408-6:2011

Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)

General information

Withdrawn from 01.06.2021
Base Documents
ISO 13408-6:2005; EN ISO 13408-6:2011
Directives or regulations
None

Standard history

Status
Date
Type
Name
01.06.2021
Main
02.04.2013
Amendment
03.08.2011
Main
Main
EVS-EN 13824:2005
This part of ISO 13408 specifies the requirements for isolator systems used for aseptic processing and offers guidance on qualification, bio-decontamination, validation, operation and control of isolator systems used for aseptic processing of health care products. This part of ISO 13408 is focused on the use of isolator systems to maintain aseptic conditions; this may include applications for hazardous materials. This part of ISO 13408 does not supersede or replace national regulatory requirements, such as Good Manufacturing Practices (GMPs) and/or compendial requirements that pertain in particular to national or regional jurisdictions.

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