EN 556-2:2003 Sterilization of medical devices Requirements for medical devices to be designated STERILE Part 2: Requirements for aseptically processed medical devices
This European Standard specifies the requirements for an aseptically processed medical deviceto be designated 'STERILE'.NOTE ForThe purpose of the EU Directive(s) for medical devices (see Bibliography), designating that amedical device is 'STERILE' is only permissible when a validated sterilization process has been applied.Requirements for validation and routine control of aseptic processes are specified in prEN 13824 (inpreparation).
EN 556-2:2003 history
2015EN 556-2:2015 "Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 2: Requirements for aseptically processed medical devices"
2003EN 556-2:2003 Sterilization of medical devices Requirements for medical devices to be designated STERILE Part 2: Requirements for aseptically processed medical devices