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DIN EN 868-10 E : 2009

Current
Current

The latest, up-to-date edition.

PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 10: ADHESIVE COATED NONWOVEN MATERIALS OF POLYOLEFINES - REQUIREMENTS AND TEST METHODS
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2009

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Information to be supplied by the manufacturer
Annex A (informative) - Details of significant technical
        changes between this European Standard and the
        previous edition
Annex B (normative) - Method for the determination of mass
        per unit area of uncoated nonwoven polyolefine
        materials and adhesive coating
Annex C (normative) - Method for the determination of the
        seal strength and visual inspection of the adhesive
        coating
Bibliography
National Annex NA (informative) - Bibliography

Gives test methods and values for sealable adhesive coated nonwoven materials of polyolefines, manufactured from nonwovens complying with EN 868-9 used for sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use.

DocumentType
Standard
Pages
17
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
Status
Current

Standards Relationship
EN 868-10:2018 Identical
BS EN 868-10:2009 Identical
NS EN 868-10 : 2009 Identical
NBN EN 868-10 : 2009 Identical
UNI EN 868-10 : 2009 Identical
ONORM EN 868-10 : 2009 Identical
SN EN 868-10 : 2009 Identical
I.S. EN 868-10:2009 Identical
NF EN 868-10 : 2009 Identical
UNE-EN 868-10:2009 Identical
NEN EN 868-10 : 2009 Identical
EN 868-10:2009 Identical

ISO 1974:2012 Paper — Determination of tearing resistance — Elmendorf method
DIN ISO 8601:2006-09 DATA ELEMENTS AND INTERCHANGE FORMATS - INFORMATION INTERCHANGE - REPRESENTATION OF DATES AND TIMES
ISO 5636-3:2013 Paper and board — Determination of air permeance (medium range) — Part 3: Bendtsen method
ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
EN 20811 : 1992 TEXTILES - DETERMINATION OF RESISTANCE TO WATER PENETRATION - HYDROSTATIC PRESSURE TEST
ISO 6588-2:2012 Paper, board and pulps Determination of pH of aqueous extracts Part 2: Hot extraction
EN 21974 : 1994 PAPER - DETERMINATION OF TEARING RESISTANCE (ELMENDORF METHOD)
ISO 2758:2014 Paper Determination of bursting strength
EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
EN ISO 1924-2:2008 Paper and board - Determination of tensile properties - Part 2: Constant rate of elongation method (20 mm/min) (ISO 1924-2:2008)
EN ISO 536:2012 Paper and board - Determination of grammage (ISO 536:2012)
ISO 8601:2004 Data elements and interchange formats Information interchange Representation of dates and times
ISO 1924-2:2008 Paper and board — Determination of tensile properties — Part 2: Constant rate of elongation method (20 mm/min)
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 536:2012 Paper and board Determination of grammage
EN ISO 2758:2014 Paper - Determination of bursting strength (ISO 2758:2014)
ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
EN ISO 10993-1:2009/AC:2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)

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Hardcopy - English
PDF - English
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