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FprEN 868-5

Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels constructed of porous materials and plastic film - Requirements and test methods FprEN 868-5

Publication date:   Jan 15, 2026

General information

45.99   Dispatch of FV draft to CCMC   Jul 15, 2026

CEN

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

European Norm

11.080.30   Sterilized packaging

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Draft

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Scope

This document specifies test methods and values for single-use sealable pouches and reels constructed of a porous material as specified in EN 868 part 2, 3, 6, 7, 9 or 10 and a plastic film. These sealable pouches and reels are intended to be 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 series specifies materials, test methods and values that are specific to the products covered by this document.

Life cycle

PREVIOUSLY

PUBLISHED
EN 868-5:2018

NOW

IN_DEVELOPMENT
FprEN 868-5
45.99 Dispatch of FV draft to CCMC
Jul 15, 2026




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