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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:
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