Packaging for terminally sterilized medical devices - Re-usable sterilization containers for steam sterilizers conforming to EN 285. Requirements and test methods

Packaging for terminally sterilized medical devices - Re-usable sterilization containers for steam sterilizers conforming to EN 285. Requirements and test methods

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What is this standard about?

This document specifies test methods and values for re-usable containers used as sterile barrier systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use. These containers are intended to be used in steam sterilizers conforming to EN 285.

Other than the general requirements as specified in EN ISO 11607‑1 and EN ISO 11607‑2 this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this document.