STANDARD

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ÖNORM EN 868-3

Issue date: 2025 09 15

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

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.

General information on ÖNORM EN 868-3

Format
Digital | 26 Pages
Language
German | English | Download GER/ENG
Publisher
Austrian Standards International

Timeline

An overview of the development of ÖNORM EN 868-3 from 1999 til today.

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Normative References

Here you will find an extract of the normative references. Please refer to the document itself for the full list.

Dokumentnummer Titel Ausgabedatum Art Link
Dokumentnummer
ISO 2470-2:2008
Titel
Paper, board and pulps — Measurement of diffuse blue reflectance factor — Part 2: Outdoor daylight conditions (D65 brightness)
Ausgabedatum
2008 10 22
Art
Standard
Dokumentnummer
ISO 3689:1983
Titel
Paper and board — Determination of bursting strength after immersion in water
Ausgabedatum
1983 09 01
Art
Standard
Dokumentnummer
ISO 3781:2011
Titel
Paper and board — Determination of tensile strength after immersion in water
Ausgabedatum
2011 08 17
Art
Standard
Dokumentnummer
ISO 5636-3:2013
Titel
Paper and board — Determination of air permeance (medium range) — Part 3: Bendtsen method
Ausgabedatum
2013 10 16
Art
Standard
Dokumentnummer
ISO 8601-1:2019
Titel
Date and time — Representations for information interchange — Part 1: Basic rules
Ausgabedatum
2019 02 25
Art
Standard
Dokumentnummer
ISO 9197:2016
Titel
Paper, board and pulps — Determination of water-soluble chlorides
Ausgabedatum
2016 08 17
Art
Standard
Dokumentnummer
ISO 9198:2020
Titel
Paper, board and pulp — Determination of water-soluble sulfates
Ausgabedatum
2020 09 18
Art
Standard

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ÖNORM EN 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

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