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ONORM EN 556-1:2024
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
This document specifies the requirements for a medical device sterilized in the final packaging and marked as "STERILE". EN 556-2 specifies the requirements for an aseptically manufactured medical device that is labeled “STERILE”.
Austrian Standards Institute [on]