This document specifies the requirements for an aseptically processed medical device to be designated ‘STERILE’.
Please comment by 14 March 2023.
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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 for validation and routine control of aseptic processes are specified in EN ISO 13408‑1. Specific requirements for the aseptic processing of solid medical devices and combination products are specified in ISO 13408‑7.