Standard

SN EN ISO 13408-1:2011

Sep 2011 Withdrawn

Note: Latest version: SN EN ISO 13408-1:2024

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Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008/Amd 1:2013); Amendment A1 Withdrawn SN EN ISO 13408-1/A1:2013 Amendment from Publication date: Jul 2013 Version: Pages: 5 Language: English, French, German Services: Online, Online + Pdf

Abstract

ISO 13408-1:2008 specifies the general requirements for, and offers guidance on, processes, programmes and procedures for development, validation and routine control of the manufacturing process for aseptically-processed health care products.ISO 13408-1:2008 includes requirements and guidance relative to the overall topic of aseptic processing. Specific requirements and guidance on various specialized processes and methods related to filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in other parts of ISO 13408.

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Standard from INB
Published: September 1 2011
Withdrawn: November 1 2015
Effective: September 1 2011
Document type: EN
Pages
ISBN:

ICS: 11.080.01
Publisher: SNV
Distributor: SNV
National Committee: INB/NK 171

Product Relations

Replaced by: SN EN ISO 13408-1:2015
Adopted from: ISO 13408-1:2008, IDT
Replaces: SN EN 13824:2005

Extended editions Extended editions (0)

Version history Related Corrigenda and Amendments (1)

SN EN ISO 13408-1/A1:2013

Version history History (4)

SN EN ISO 13408-1:2024

SN EN ISO 13408-1:2015