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Sterilization of medical devices. Requirements for medical devices to be designated "STERILE" - Part 1. Requirements for terminally sterilized medical devices Ingestion-build-146508 Informative on the influence ofBS EN 556 1: 2001 Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Requirements for terminally sterilized medical devices BS EN 556 1 is the standard that specifies the requirements for a terminally sterilized medical device to be designated STERILE. BS EN 556 2 specifies the requirements for an aseptically processed medical device to be designated STERILE. Designation of a medical device as STERILE is