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CEN
PREN 868-4 : DRAFT 2015

PREN 868-4 : 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Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 4: PAPER BAGS - 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Superseded date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
        pH value, chloride and sulfate 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

Gives 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.

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Superseded

Standards Relationship
15/30325861 DC : 0 Identical
07/30166930 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 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 868-5:2009 Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods
EN 868-4:2017 Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
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 9198:2001 Paper, board and pulp Determination of water-soluble sulfates

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