Project

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; German and English version prEN 868-3:2024

Abstract

This document specifies test methods and values for paper, used in the manufacture of single-use paper bags (specified in EN 868-4) and in the manufacture of single-use pouches and reels (specified in EN 868-5) 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, this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this document.

Begin

2023-03-03

WI

00102178

Planned document number

DIN EN 868-3

Project number

06302212

Responsible national committee

NA 176-03-07 AA - Sterile supply  

Responsible european committee

CEN/TC 102/WG 4 - Packaging  

draft standard

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; German and English version prEN 868-3:2024
2024-05
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previous edition(s)

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; German version EN 868-3:2017
2017-05

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Contact

M.Sc.

Maximilian Rasser

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10787 Berlin

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Fax: +49 30 2601-42572

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