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  • CSA ISO 5362 : 2014

    View superseded by
    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    ANAESTHETIC RESERVOIR BAGS

    Available format(s):  Hardcopy, PDF

    Superseded date:  25-06-2019

    Language(s):  French, English

    Published date:  01-01-2014

    Publisher:  Canadian Standards Association

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    Table of Contents - (Show below) - (Hide below)

    1 Scope
    2 Normative references
    3 Terms and definitions
    4 General requirements
    5 Prevention of electrostatic charges
    6 Requirements for bags supplied sterile
    7 Marking
    8 Information to be supplied by the manufacturer
    Annex A (informative) - Test for leakage
    Annex B (normative) - Determination of capacity
    Annex C (normative) - Test for security of attachment of plain
            neck to 22 mm male conical connector
    Annex D (normative) - Test for security of attachment of adaptor
            of assembled neck to bag
    Annex E (normative) - Test for resistance to pressure required
            to distend the bag (pressure/volume)
    Annex F (informative) - Test for resistance to pressure required
     to distend the bag using air (pressure/volume)
    Annex G (informative) - Recommendations for materials
    Bibliography

    Abstract - (Show below) - (Hide below)

    Defines requirements for antistatic and non-antistatic reservoir bags for use with anaesthetic apparatus or lung-ventilator breathing systems.

    General Product Information - (Show below) - (Hide below)

    Document Type Standard
    Publisher Canadian Standards Association
    Status Superseded
    Superseded By

    Standards Referencing This Book - (Show below) - (Hide below)

    EN 556:1994 + A1:1998 STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR TERMINALLY-STERILIZED MEDICAL DEVICES TO BE LABELLED "STERILE"
    ISO 4287:1997 Geometrical Product Specifications (GPS) — Surface texture: Profile method — Terms, definitions and surface texture parameters
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    ISO 5356-1:2015 Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
    ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
    EN 980:2008 Symbols for use in the labelling of medical devices
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