European Standards for medicalĭevices require, when it is necessary to supply a sterile product item, that adventitious microbiologicalĬontamination of a medical device from all sources is minimized by all practical means. 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.Ī sterile product item is one which is free of viable micro-organisms.
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.
Part 2 of BS EN 556-1:2001 specifies the requirements for an aseptically processed medical device to be designated 'STERILE'. BS EN 556-1:2001 specifies the requirements for a terminally-sterilized medical device to beĭesignated 'STERILE'.
