BS EN 868-10 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 10: ADHESIVE COATED NONWOVEN MATERIALS OF POLYOLEFINES - REQUIREMENTS AND TEST METHODS

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Hardcopy , PDF

Language(s)

English

Publisher

British Standards Institution

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
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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