Standard

ISO 13408-6:2005

Jun 2005 Withdrawn

Note: Latest version: ISO 13408-6:2021

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Aseptic processing of health care products — Part 6: Isolator systems — Amendment 1 Withdrawn ISO 13408-6:2005/Amd 1:2013 Amendment from Publication date: Mar 2013 Pages: 4 Language: English, French Services: Online, Online + Pdf

Abstract

ISO 13408-6:2005 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. ISO 13408-6:2005 is focused on the use of isolator systems to maintain aseptic conditions; this may include applications for hazardous materials. ISO 13408-6:2005 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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Standard from ISO
Published: June 20 2005
Withdrawn: April 13 2021
Period for objection until: July 23 2004
Edition: 1
Document type: IS
Pages
ISBN:

Publisher: ISO
Distributor: ISO
ICS: 11.080.01
International TC: ISO/TC 198

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Revised by: ISO 13408-6:2021
Adopted by: NF EN ISO 13408-6:2011

ISO 13408-6:2005

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ISO 13408-6:2021

ISO 13408-6:2005

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Version history Related Corrigenda and Amendments (1)

ISO 13408-6:2005/Amd 1:2013

Version history History (2)

ISO 13408-6:2021

ISO 13408-6:2005

Abstract

Products specifications

Product Relations

Product life cycle