Sterilization of medical devices. Requirements for medical devices to be designated "STERILE" - Part 1. Requirements for terminally sterilized medical devices

Sterilization of medical devices. Requirements for medical devices to be designated "STERILE" - Part 1. Requirements for terminally sterilized medical devices

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BS 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 only permissible when a validated sterilization process has been applied.

Also available for sterilization of medical devices:

BS EN 556-2:2015 Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Requirements for aseptically processed medical devices