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SRPS EN 868-5:2019

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

Apr 24, 2019

General information

90.92     Nov 11, 2024

ISS

Z076

European Norm

11.080.30  

English  

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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WITHDRAWN
SRPS EN 868-5:2011

NOW

PUBLISHED
SRPS EN 868-5:2019
90.92 Standard to be revised
Nov 11, 2024

REVISED BY

PROJECT
naSRPS EN 868-5:2024

Related project

Adopted from EN 868-5:2018