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DIN EN 868-10

Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods; German version EN 868-10:2018

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Organization: DIN
Publication Date: 1 March 2019
Status: active
Page Count: 19
ICS Code (Sterilized packaging): 11.080.30
scope:

Dieses Dokument legt Prüfverfahren und Werte für klebemittelbeschichtete Faservliesmaterialien aus Polyolefinen fest, hergestellt aus Faservliesmaterialien nach EN 868-9, und die dazu bestimmt sind, als Sterilbarrieresysteme und/oder Verpackungssysteme die Sterilität von in der Endverpackung sterilisierten Medizinprodukten bis zum Anwendungszeitpunkt zu erhalten.

Im Gegensatz zu den allgemeinen Anforderungen, welche durch EN ISO 11607-1 und EN ISO 11607-2 festgelegt sind, legt dieser Teil der EN 868 Materialien, Prüfverfahren und Werte fest, welche spezifisch für die in diesem Dokument betrachteten Produkte sind.

Die nach diesem Teil von EN 868 festgelegten Materialien sind nur für den einmaligen Gebrauch vorgesehen.

Document History

DIN EN 868-10
March 1, 2019
Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods; German version EN 868-10:2018
Dieses Dokument legt Prüfverfahren und Werte für klebemittelbeschichtete Faservliesmaterialien aus Polyolefinen fest, hergestellt aus Faservliesmaterialien nach EN 868-9, und die dazu bestimmt sind,...
DIN EN 868-10
August 1, 2017
Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods; Version allemande et anglaise prEN 868-10:2017
A description is not available for this item.
DIN EN 868-10
September 1, 2009
Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods; German version EN 868-10:2009
A description is not available for this item.
DIN EN 868-10
October 1, 2007
Packaging materials for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines for use in the manufacture of sealable pouches, reels and lids - Requirements and test methods; German version prEN 868-10:2007
A description is not available for this item.
DIN EN 868-10
March 1, 2000
Packaging materials and systems for medical devices which are to be sterilized - Part 10: Adhesive coated nonwoven materials of polyolefines for use in the manufacture of heat sealable pouches, reels and lids; requirements and test methods; German version EN 868-10:2000
A description is not available for this item.
DIN EN 868-10
August 1, 1998
Packaging materials and systems for medical devices which are to be sterilized - Part 10: Adhesive coated nonwoven materials of polyolefines for use in the manufacture of heat sealable pouches, reels and lids; requirements and tests methods; German version prEN 868-10:1998
A description is not available for this item.
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References

This document references:
ASTM D2724 - Standard Test Method for Bond Strength of Bonded, Fused, and Laminated Apparel Fabrics
Published by ASTM on January 1, 2019
This test method covers procedures for characterizing the bond strength of bonded, fused, and laminated apparel fabrics before or after drycleaning and laundering. The values stated in SI units are...
This document references:
F88/F88M - Standard Test Method for Seal Strength of Flexible Barrier Materials
May 1, 2023
This test method covers the measurement of the strength of seals in flexible barrier materials. The test may be conducted on seals between a flexible material and another flexible material, a rigid...
This document references:
DIN EN ISO 10993-1 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system (ISO 10993-1:2009); German version EN ISO 10993-1:2009
Published by DIN on April 1, 2010
A description is not available for this item.
This document references:
DIN EN ISO 11607-1 - Verpackungen fuer in der Endverpackung zu sterilisierende Medizinprodukte - Teil 1: Anforderungen an Materialien, Sterilbarrieresysteme und Verpackungssysteme (ISO 11607-1:2019); Deutsche Fassung EN ISO 11607-1:2020
Published by DIN on May 1, 2020
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.
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