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ILNAS-EN ISO 13408-1:2015 Edition 06/2015
Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)
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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.

Status

Standard - Superseded

Origin

Technical Committee :
CEN/TC 204 : Sterilization of medical devices

Implementation

start of the vote on the project      date of ratification (dor)    20/05/2015
end of the vote on the project      date of anouncement (doa)    30/09/2015
start of the vote on the final project      date of publication (dop)    31/12/2015
end of the vote on the final project      date of withdrawal (dow)    31/12/2015


Publication Official Journal
of the Grand-Duchy of Luxembourg
31/12/2015
Reference Mémorial A N° 264

Relations

Evolutions
ILNAS-EN ISO 13408-1:2024

Relations to older standards
ILNAS-EN ISO 13408-1:2011/A1:2013
ILNAS-EN ISO 13408-1:2011

International Classification for Standards (ICS codes) :

11.080.01 : Sterilization and disinfection in general

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