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PREN 868-7 : DRAFT 2015

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 7: ADHESIVE COATED PAPER FOR LOW TEMPERATURE STERILIZATION PROCESSES - REQUIREMENTS AND TEST METHODS
Superseded date

01-02-2017

Published date

18-08-2015

Publisher

Comite Europeen de Normalisation

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 draft 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

Gives 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.

Committee
TC 102
DocumentType
Draft
PublisherName
Comite Europeen de Normalisation
Status
Superseded
SupersededBy

Standards Relationship
15/30325864 DC : 0 Identical
07/30167327 DC : DRAFT AUG 2007 Identical

BS EN 867-2:1997 Non-biological systems for use in sterilizers Process indicators (Class A)
BS EN 868-1:1997 Packaging materials and systems for medical devices which are to be sterilized General requirements and test methods

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 2758:2014 Paper Determination of bursting strength
EN 20535 : 1994 PAPER AND BOARDS - DETERMINATION OF WATER ABSORPTIVENESS - COBB METHOD
EN 868-6:2017 Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
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)
ASTM F 88/F88M : 2015 : REDLINE Standard Test Method for Seal Strength of Flexible Barrier Materials
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 2470-2:2008 Paper, board and pulps — Measurement of diffuse blue reflectance factor — Part 2: Outdoor daylight conditions (D65 brightness)
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
ISO 5725-2:1994 Accuracy (trueness and precision) of measurement methods and results Part 2: Basic method for the determination of repeatability and reproducibility of a standard measurement method
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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