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DIN
DIN EN 868-6:2017-05

DIN EN 868-6:2017-05

Current

Current

The latest, up-to-date edition.

PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 6: PAPER FOR LOW TEMPERATURE STERILIZATION PROCESSES - REQUIREMENTS AND TEST METHODS

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2017

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

National foreword
National Annex NA (informative) - Bibliography
European foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
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 (informative) - Repeatability and
        reproducibility of test methods
Bibliography

Defines test methods and values for paper used in the manufacture of preformed 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
23
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
Status
Current

Standards Relationship
UNE-EN 868-6:2009 Identical
NBN EN 868-6 : 2009 Identical
SN EN 868-6 : 2017 Identical
I.S. EN 868-6:2017 Identical
BS EN 868-6:2017 Identical
NEN EN 868-6 : 2017 Identical
UNI EN 868-6 : 2009 Identical
EN 868-6:2017 Identical
NF EN 868-6 : 2017 Identical
NS EN 868-6 : 2017 Identical

ISO 1974:2012 Paper — Determination of tearing resistance — Elmendorf method
DIN ISO 3689:1994-07 PAPER AND BOARD - DETERMINATION OF BURSTING STRENGTH AFTER IMMERSION IN WATER
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
DIN ISO 5725-2:2002-12 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 (ISO 5725-2:1994 including Technical Corrigendum 1:2002)
ISO 6588-2:2012 Paper, board and pulps Determination of pH of aqueous extracts Part 2: Hot extraction
EN ISO 535:2014 Paper and board - Determination of water absorptiveness - Cobb method (ISO 535:2014)
ISO 2758:2014 Paper Determination of bursting strength
ISO 187:1990 Paper, board and pulps — Standard atmosphere for conditioning and testing and procedure for monitoring the atmosphere and conditioning of samples
EN ISO 1974:2012 Paper - Determination of tearing resistance - Elmendorf method (ISO 1974:2012)
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 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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