99.60 Withdrawal effective Jun 29, 2011
CEN
CEN/TC 204 Sterilization of medical devices
European Norm
11.080.01 Sterilization and disinfection in general
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.
Legislation related to this standard
WITHDRAWN
EN 13824:2004
99.60
Withdrawal effective
Jun 29, 2011
PUBLISHED
EN ISO 13408-4:2011
PUBLISHED
EN ISO 13408-3:2011
PUBLISHED
EN ISO 13408-5:2011
WITHDRAWN
EN ISO 13408-6:2011
WITHDRAWN
EN ISO 13408-1:2011
WITHDRAWN
EN ISO 13408-2:2011