Packaging for terminally sterilized medical devices - Paper for low temperature sterilization processes. Requirements and test methods

Packaging for terminally sterilized medical devices - Paper for low temperature sterilization processes. Requirements and test methods

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1   Scope

This document specifies test methods and values for paper used in the manufacture of single-use preformed sterile barrier systems and/or packaging systems for terminally sterilized medical devices by means of low temperature sterilization processes.
Other than the general requirements as specified in EN ISO 11607‑1 and EN ISO 11607‑2 [2], this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this document.