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EN 868-5:2018

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

Publication date:   Mar 14, 2019

General information

90.20 Standard under periodical review   Jan 15, 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 sealable pouches and reels manufactured from porous materials complying with either EN 868 part 2, 3, 6, 7, 9 or 10 and plastic film complying with Clause 4. These sealable pouches and reels are used as sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use.
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.
The materials specified in this part of EN 868 are intended for single use only.

Life cycle

PREVIOUSLY

WITHDRAWN
EN 868-5:2009

NOW

PUBLISHED
EN 868-5:2018
90.20 Standard under periodical review
Jan 15, 2024