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I.S. EN 868-7:2017

Current

Current

The latest, up-to-date edition.

PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 7: ADHESIVE COATED PAPER FOR LOW TEMPERATURE STERILIZATION PROCESSES - REQUIREMENTS AND TEST METHODS

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2017

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.


Dates of withdrawal of national standards are available from NSAI.

€37.00
Excluding VAT

National Foreword
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 water repellency
Annex C (normative) - Method for the determination
        of pore size
Annex D (normative) - Method for the determination
        of regularity of seal adhesive coatings on paper
Annex E (normative) - Method for the determination
        of mass per unit area of uncoated paper and
        adhesive coating
Annex F (normative) - Method for the determination
        of seal strength and mode of specimen failure
Annex G (informative) - Repeatability and reproducibility
        of test methods
Bibliography

Defines test methods and values for sealable adhesive coated paper manufactured from paper complying with EN 868-6, used as 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
30
PublisherName
National Standards Authority of Ireland
Status
Current
Supersedes

Standards Relationship
SN EN 868-7:2017 Identical
UNE-EN 868-7:2009 Identical
BS EN 868-7:2017 Identical
NS EN 868-7 : 2017 Identical
NEN EN 868-7 : 2017 Identical
UNI EN 868-7 : 2009 Identical
EN 868-7:2017 Identical
NF EN 868-7 : 2017 Identical
NBN EN 868-7 : 2009 Identical
UNE-EN 868-7:2017 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
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 1974:1990)
ISO 2758:2014 Paper Determination of bursting strength
EN 20535:1994 Paper and board - Determination of water absorptiveness - Cobb method (ISO 535:1991)
ISO 187:1990 Paper, board and pulps — Standard atmosphere for conditioning and testing and procedure for monitoring the atmosphere and conditioning of samples
ISO 9197:2016 Paper, board and pulps Determination of water-soluble chlorides
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)
EN 20187:1993 Paper, board and pulps - Standard atmosphere for conditioning and testing and procedure for monitoring the atmosphere and conditioning of samples (ISO 187:1990)
ISO 3781:2011 Paper and board — Determination of tensile strength after immersion in water
ISO 536:2012 Paper and board Determination of grammage
ISO 3689:1983 Paper and board — Determination of bursting strength after immersion in water
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
ISO 535:2014 Paper and board — Determination of water absorptiveness — Cobb method
ISO 9198:2001 Paper, board and pulp Determination of water-soluble sulfates

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