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EN 868-9:2018

Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods

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 uncoated nonwoven materials of polyolefines used for 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 European Standard.
The materials specified in this part of EN 868 are intended for single use only.

Life cycle

PREVIOUSLY

WITHDRAWN
EN 868-9:2009

NOW

PUBLISHED
EN 868-9:2018
90.20 Standard under periodical review
Jan 15, 2024