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DIN EN 868-4:2017-05

DIN EN 868-4:2017-05

Current

Current

The latest, up-to-date edition.

PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 4: PAPER BAGS - 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
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 pH value, chloride and sulphate in paper bags
Annex C (normative) - Method for the determination
        of the tensile strength of the back seam joint in
        paper bags
Annex D (informative) - Repeatability and
        Reproducibility of test methods
Bibliography

Defines test methods and values for paper bags manufactured from paper specified in EN 868-3, 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
18
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
Status
Current

Standards Relationship
UNE-EN 868-4:2009 Identical
SN EN 868-4:2017 Identical
NS EN 868-4 : 2017 Identical
I.S. EN 868-4:2017 Identical
NEN EN 868-4 : 2017 Identical
EN 868-4:2017 Identical
NF EN 868-4 : 2017 Identical
NBN EN 868-4 : 2009 Identical
BS EN 868-4:2017 Identical
UNI EN 868-4 : 2009 Identical

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
ISO 9197:2016 Paper, board and pulps Determination of water-soluble chlorides
EN 868-3:2017 Packaging for terminally sterilized medical devices - Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methods
EN ISO 11140-1:2014 Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014)
ISO 11140-1:2014 Sterilization of health care products Chemical indicators Part 1: General requirements
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)
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 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
ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
ISO 9198:2001 Paper, board and pulp Determination of water-soluble sulfates

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