99.60 Withdrawal effective Sep 2, 2015
CEN
CEN/TC 204 Sterilization of medical devices
European Norm
11.080.01 Sterilization and disinfection in general
This European Standard specifies the requirements for an aseptically processed medical device to be designated 'STERILE'.
NOTE For the purpose of the EU Directive(s) for medical devices (see Bibliography), designating that a medical device is 'STERILE' is only permissible when a validated sterilization process has been applied. Requirements for validation and routine control of aseptic processes are specified in prEN 13824 (in preparation).
Legislation related to this standard
WITHDRAWN
EN 556-2:2003
99.60
Withdrawal effective
Sep 2, 2015
WITHDRAWN
EN 556-2:2015