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

Abstract

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.

Begin

2024-11-28

WI

00102189

Planned document number

DIN EN 868-5

Project number

17600126

Responsible national committee

NA 176-03-07 AA - Sterile supply  

Responsible european committee

CEN/TC 102/WG 4 - Packaging  

previous edition(s)

Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods; German version EN 868-5:2018
2019-03

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