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ILNAS-EN 13824:2004 Edition 11/2004
Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
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Abstract

This document specifies requirements for the design and operation of aseptic processing facilities and the validation and routine control of aseptic processes for the preparation of sterile liquid medical devices. It is not applicable to those pharmaceutical products where the requirements of the relevant good manufacturing practices are applicable. NOTE Many of the principles included in this document can be applied to certain aseptically processed sterile solid medical devices.

Status

Standard - Withdrawn

Origin

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

Directives

90/385/EEC : Active implantable medical devices
93/42/EEC : Medical devices

Implementation

start of the vote on the project    31/10/2002   date of ratification (dor)    14/10/2004
end of the vote on the project    31/12/2002   date of anouncement (doa)    28/02/2005
start of the vote on the final project    08/07/2004   date of publication (dop)    31/05/2005
end of the vote on the final project    08/09/2004   date of withdrawal (dow)    31/05/2005


Publication Official Journal
of the Grand-Duchy of Luxembourg
01/03/2005
Reference

Relations

Evolutions
ILNAS-EN ISO 13408-3:2011
ILNAS-EN ISO 13408-4:2011
ILNAS-EN ISO 13408-5:2011
ILNAS-EN ISO 13408-6:2011
ILNAS-EN ISO 13408-1:2011
ILNAS-EN ISO 13408-2:2011

International Classification for Standards (ICS codes) :

11.080.01 : Sterilization and disinfection in general

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