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.
Diese Norm legt die Anforderungen für in der Endpackung zu sterilisierende Medizinprodukte, die als "STERIL" gekennzeichnet werden, fest.