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FprEN 868-6

Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods

Publication date:   Dec 19, 2024

General information

50.20 Proof sent to secretariat or FDIS ballot initiated: 8 weeks   Dec 19, 2024

CEN

CEN/TC 102 Sterilizers and associated equipment for processing of medical devices

European Norm

11.080.30   Sterilized packaging

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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.

Life cycle

PREVIOUSLY

PUBLISHED
EN 868-6:2017

NOW

IN_DEVELOPMENT
FprEN 868-6
50.20 Proof sent to secretariat or FDIS ballot initiated: 8 weeks
Dec 19, 2024