This document specifies the requirements for an aseptically processed medical device to be designated 'STERILE'. Please comment by 14 March 2023. To access the full document, click here. NOTE For the purpose of the EU Directive(s) for medical devices (see Bibliography), designating that a medical device is 'STERILE' is permissible when a validated manufacturing and sterilization process has been applied. Requirements…
Ben KempJanuary 27, 2023