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FprEN 868-3

Packaging for terminally sterilized medical devices - Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methods FprEN 868-3

Publication date:   Dec 19, 2024

General information

50.20 Proof sent to secretariat or FDIS ballot initiated: 8 weeks   Dec 19, 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 paper used in the manufacture of single-use paper bags (specified in EN 868 4 [3]) and in the manufacture of single-use pouches and reels (specified in EN 868 5 [4]) used as sterile barrier systems and/or packaging systems for terminally sterilized medical devices by means of sterilization processes that require properties specific to higher temperature sterilization, such as moist heat sterilization used in healthcare facilities.
Other than the general requirements as specified in EN ISO 11607 1 and EN ISO 11607 2 [1], this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this document.

Life cycle

PREVIOUSLY

PUBLISHED
EN 868-3:2017

NOW

IN_DEVELOPMENT
FprEN 868-3
50.20 Proof sent to secretariat or FDIS ballot initiated: 8 weeks
Dec 19, 2024