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

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

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1   Scope

This document specifies the requirements for a terminally sterilizedmedical device to be designated ‘STERILE’. Part 2 of EN 566 specifies the requirements for an aseptically processed medical device to be designated “STERILE”.