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DIN 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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Organization: DIN
Publication Date: 1 May 2017
Status: active
Page Count: 23
ICS Code (Sterilized packaging): 11.080.30
scope:

This European Standard specifies test methods and values for paper, used in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) used as 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.

Document History

DIN EN 868-3
May 1, 2017
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 European Standard specifies test methods and values for paper, used in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5)...
DIN EN 868-3
August 1, 2015
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 868-3:2015
A description is not available for this item.
DIN EN 868-3
September 1, 2009
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
A description is not available for this item.
DIN EN 868-3
August 1, 1999
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
A description is not available for this item.

References

This document references:
DIN EN ISO 11607-1 - Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019 + Amd 1:2023) (includes Amendment A1:2023)
Published by DIN on February 1, 2024
A description is not available for this item.
This document references:
DIN EN 1041 - Information supplied by the manufacturer of medical devices (includes Amendment A1:2013)
Published by DIN on December 1, 2013
This European Standard specifies requirements for information to be supplied by a manufacturer for medical devices regulated by Council Directive 90/385/EEC relating to active implantable medical...
This document references:
DIN EN 20187 - Paper, board and pulps; standard atmosphere for conditioning and testing and procedure for monitoring the atmosphere and conditioning of samples (ISO 187:1990); German version EN 20187:1993
Published by DIN on November 1, 1993
A description is not available for this item.
This document references:
DIN EN ISO 11607-1 - Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019 + Amd 1:2023) (includes Amendment A1:2023)
Published by DIN on February 1, 2024
A description is not available for this item.
This document references:
DIN EN ISO 11607-2 - Verpackungen fuer in der Endverpackung zu sterilisierende Medizinprodukte - Teil 2: Validierungsanforderungen an Prozesse der Formgebung, Siegelung und des Zusammenstellens (ISO 11607-2:2019); Deutsche Fassung EN ISO 11607-2:2020
Published by DIN on May 1, 2020
A description is not available for this item.
This document references:
DIN EN ISO 1924-2 - Paper and board - Determination of tensile properties - Part 2: Constant rate of elongation method (20 mm/min) (ISO 1924-2:2008)
Published by DIN on May 1, 2009
A description is not available for this item.
This document is referenced by:
DIN EN 868-4 - Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
Published by DIN on May 1, 2017
This European Standard specifies test methods and values for paper bags manufactured from paper specified in EN 868-3, used as sterile barrier systems and/or packaging systems that are intended to...
This document is referenced by:
DIN EN 868-5 - Verpackungen fuer in der Endverpackung zu sterilisierende Medizinprodukte - Teil 5: Siegelfaehige Klarsichtbeutel und -schlaeuche aus poroesen Materialien und Kunststoff-Verbundfolie - Anforderungen und Pruefverfahren; Deutsche Fassung EN 868-5:2018
Published by DIN on March 1, 2019
Dieses Dokument legt Prüfverfahren und Werte für siegelfähige Klarsichtbeutel und -schläuche aus porösem Material fest, die entweder EN 868 Teil 2, Teil 3, Teil 6, Teil 7, Teil 9 oder Teil 10...
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