[Recommendation for validation and routine monitoring of sterilization processes with ethylene oxide for medical...

The European Medical Device Directives specifically address sterilization issues in a number of instances. The European Standards for sterilization of medical devices, especially EN 550, EN 554, EN 556 regulate the manufacture, installation and operation of sterilizers as well as the validation of sterilization processes, on using ethylene oxide (EN 550) or moist heat (EN 554) for sterilization. This recommendation is intended as a source of information for conducting validation according to EN 550 and concomitantly for ensuring that the medical devices reprocessed (cleaned, disinfected, packed, sterilized, stored) in the hospital setting or in other healthcare establishments are endowed with the same level of safety with respect to sterility as that of industrially produced and marketed sterile medical devices.