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EN 868-4:2025

Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods

Publication date:   Jun 16, 2025

General information

60.60   Standard published   Apr 30, 2025

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 single-use paper bags manufactured from paper specified in EN 868-3, used as sterile barrier systems and/or packaging systems for terminally sterilized medical devices.
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.

Life cycle

PREVIOUSLY

WITHDRAWN
EN 868-4:2017

NOW

PUBLISHED
EN 868-4:2025
60.60 Standard published
Apr 30, 2025