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EVS-EN ISO 13408-1:2011

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

General information

Withdrawn from 02.07.2015
Base Documents
ISO 13408-1:2008; EN ISO 13408-1:2011
Directives or regulations
None

Standard history

Status
Date
Type
Name
04.06.2013
Amendment
EVS-EN ISO 13408-1:2011/A1:2013
03.08.2011
Main
EVS-EN ISO 13408-1:2011
Main
EVS-EN 13824:2005
1.1 This part of ISO 13408 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. 1.2 This part of ISO 13408 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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