SR EN ISO 13408-1:2016

Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)

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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General information

Status : Withdrawn
Approval date : 1/29/2016
Withdrawal date : 10/31/2024
Number of pages : 60
ICS : 11.080.01 Sterilization and desinfectation
Technical Committee : 377 - Medical devices

Relations with other standards:

Replaces SR EN ISO 13408-1:2011/A1:2013
Replaces SR EN ISO 13408-1:2011
Normative reference SR EN ISO 14698-2:2004
Normative reference SR EN ISO 14160:2011
Normative reference SR EN ISO 14971:2012
Normative reference SR EN ISO 13485:2012/AC:2012
Normative reference SR EN ISO 13408-6:2011/A1:2013
Normative reference SR EN ISO 13408-3:2011
Normative reference SR EN ISO 14698-1:2004
Normative reference SR EN ISO 13408-4:2011
Normative reference SR EN ISO 13485:2012
Normative reference SR EN ISO 14644-4:2002
Normative reference SR EN ISO 14698-2:2004/AC:2006
Normative reference SR EN ISO 14644-7:2005
Normative reference SR EN ISO 14644-5:2005
Normative reference SR EN ISO 14644-2:2002
Normative reference SR EN ISO 13408-5:2011
Normative reference SR EN ISO 11137-1:2006/A1:2013
Normative reference SR EN ISO 17665-1:2007
Normative reference SR EN ISO 14644-1:2002
Normative reference SR EN ISO 13408-2:2011
Normative reference SR EN ISO 11137-2:2013
Normative reference SR EN ISO 14937:2010
Normative reference SR EN ISO 20857:2013
Normative reference SR EN ISO 11135:2014
Normative reference SR EN ISO 13408-6:2011
Normative reference SR EN ISO 11137-1:2006
Normative reference SR EN ISO 14644-3:2006
Replaced by SR EN ISO 13408-1:2024