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I.S. EN 868-10:2009

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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

Hardcopy , PDF

Superseded date

01-25-2019

Language(s)

English

Published date

01-01-2009

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

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

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
15
PublisherName
National Standards Authority of Ireland
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
ONORM EN 868-10 : 2009 Identical
SN EN 868-10 : 2009 Identical
NEN EN 868-10 : 2009 Identical
NF EN 868-10 : 2009 Identical
UNE-EN 868-10:2009 Identical
BS EN 868-10:2009 Identical
NS EN 868-10 : 2009 Identical
NBN EN 868-10 : 2009 Identical
DIN EN 868-10:2009-09 Identical
UNI EN 868-10 : 2009 Identical
DIN EN 868-10 E : 2009 Identical
EN 868-10:2009 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
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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