90.92 Standard to be revised Jun 5, 2022
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 a terminally-sterilized medical device to be designated 'STERILE'. Part 2 of 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), designation of a medical device as 'STERILE' is only permissible when a validated sterilization process has been applied. Requirements for validation and routine control of processes for the sterilization of medical devices are specified in EN 550, EN 552, EN 554, EN ISO 14160 and EN ISO 14937.
Legislation related to this standard
WITHDRAWN
EN 556:1994 + A1:1998
PUBLISHED
EN 556-1:2001
90.92
Standard to be revised
Jun 5, 2022
PUBLISHED
EN 556-1:2001/AC:2006
IN_DEVELOPMENT
FprEN 556-1