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STANDARD

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ÖNORM EN 868-3

Issue date: 1999 10 01

Packaging materials and systems for medical devices which are to be sterilized - 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 Part of the series of EN 868 provides examples of particular requirements and test methods for paper, used in the manufacture of paper bags (specified in EN 8684) and in the manufacture of pouches and reels (specified in EN 868- 5). It introduces no additional requirements to the general requirements of Part 1 but provides guidance based upon various elements of former, relevant national standards. As such, the particular requirements in 4.2 to 4.5 can be used to demonstrate compliance with one or more but not all of the requirements of Part 1. Paper specified in this part is suitable for use as packaging of medical devices which are to be terminally sterilized.

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General information on ÖNORM EN 868-3

Format

Digital | 15 Pages

Language

German | English | Download GER/ENG

Publisher

Austrian Standards International

Committee 215 Sterilization and disinfection of medical devices

Timeline

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

• ÖNORM EN 868-3

  2025 09 15 Standard ÖNORM EN 868-3, Edition: 2025 09 15

  Packaging for terminally sterilized medical devices - Part 3: Paper for use in the manufacture of pa...
• ÖNORM EN 868-3

  2017 04 15 Standard ÖNORM EN 868-3, Edition: 2017 04 15

  Packaging for terminally sterilized medical devices - Part 3: Paper for use in the manufacture of pa...
• ÖNORM EN 868-3

  2009 09 15 Standard ÖNORM EN 868-3, Edition: 2009 09 15

  Packaging for terminally sterilized medical devices - Part 3: Paper for use in the manufacture of pa...
• ÖNORM EN 868-3

  1999 10 01 Standard ÖNORM EN 868-3, Edition: 1999 10 01

  Packaging materials and systems for medical devices which are to be sterilized - Part 3: Paper for u...

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Frequently Asked Questions about ÖNORM EN 868-3

What is a "Single-User Licence"?

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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 DIN 58953-6	Titel Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized	Ausgabedatum 2025 03	Art Standard	Zur Produktseite
Dokumentnummer ISO 2758:2014	Titel Paper — Determination of bursting strength	Ausgabedatum 2014 08 14	Art Standard	Zur Produktseite
Dokumentnummer ISO 3689:1983	Titel Paper and board — Determination of bursting strength after immersion in water	Ausgabedatum 1983 09 01	Art Standard	Zur Produktseite
Dokumentnummer ISO 3781:2011	Titel Paper and board — Determination of tensile strength after immersion in water	Ausgabedatum 2011 08 17	Art Standard	Zur Produktseite
Dokumentnummer ISO 536:2019	Titel Paper and board — Determination of grammage	Ausgabedatum 2019 11 25	Art Standard	Zur Produktseite
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	Zur Produktseite
Dokumentnummer ISO 6588:1981	Titel Paper, board and pulps — Determination of pH of aqueous extracts	Ausgabedatum 1981 04 01	Art Standard	Zur Produktseite
Dokumentnummer ISO 9197-1:1989	Titel Paper, board and pulps — Determination of water-soluble chlorides — Part 1: General method	Ausgabedatum 1989 06 29	Art Standard	Zur Produktseite
Dokumentnummer ISO 9198:2020	Titel Paper, board and pulp — Determination of water-soluble sulfates	Ausgabedatum 2020 09 18	Art Standard	Zur Produktseite

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