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17/30360912 DC : 0

NA

NA

Status of Standard is Unknown

BS EN 868-10 - 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

€23.37
Excluding VAT

European 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
        seal strength and mode of specimen failure
Bibliography

BS EN 868-10.

Committee
CH/198
DocumentType
Draft
Pages
15
PublisherName
British Standards Institution
Status
NA

Standards Relationship
PREN 868-10 : DRAFT 2017 Identical

ISO 1974:2012 Paper — Determination of tearing resistance — Elmendorf method
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
ISO 2758:2014 Paper Determination of bursting strength
EN ISO 1974:2012 Paper - Determination of tearing resistance - Elmendorf method (ISO 1974:2012)
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)
ASTM F 88/F88M : 2015 : REDLINE Standard Test Method for Seal Strength of Flexible Barrier Materials
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

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