This document 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 ISO 11135, EN ISO 11137, EN ISO 14160, EN ISO 14937, EN ISO 17665-1, EN ISO 20857, EN ISO 25424 and ISO 22441.