99.60 Withdrawal effective Aug 19, 1998
CEN
CEN/TC 204 Sterilization of medical devices
European Norm
11.080 Sterilization and disinfection
1.1 This European Standard specifies the requirements for a terminally-sterilized medical device to be labelled 'Sterile'. Note: For the purpose of the EC Directives for medical devices and for active implantable medical devices (see annex A), labelling a medical device 'Sterile' is only permissible when a validated sterilization process has been used. Requirements for the validation and routine control of processes for the sterilization of medical devices are specified in EN 550, EN 552 and EN 554. 1.2 This European Standard is not applicable to in vitro diagnostic medical devices.
Legislation related to this standard
WITHDRAWN
EN 556:1994
99.60
Withdrawal effective
Aug 19, 1998
WITHDRAWN
EN 556:1994 + A1:1998