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FprEN 868-2

Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods FprEN 868-2

Publication date:   Apr 11, 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 sterilization wrap made of
- single-use creped paper
- single-use nonwoven materials
- reusable woven textile materials
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 specifies materials, test methods and values that are specific to the products covered by this document.

Life cycle

PREVIOUSLY

PUBLISHED
EN 868-2:2017

NOW

IN_DEVELOPMENT
FprEN 868-2
50.20 Proof sent to secretariat or FDIS ballot initiated: 8 weeks
Dec 19, 2024