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

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

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1   Scope

This document specifies test methods and values for sealable adhesive coated paper manufactured from paper complying with EN 868‑6, used as single-use sterile barrier systems and/or single-use packaging systems for terminally sterilized medical devices by the 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.