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  • AAMI ISO 5362 : 2006

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

    ANAESTHETIC RESERVOIR BAGS

    Available format(s):  Hardcopy, PDF

    Withdrawn date:  09-04-2024

    Language(s):  English

    Published date:  01-01-2006

    Publisher:  Association for the Advancement of Medical Instrumentation

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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 by the
      manufacture
    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 for use with anaesthetic apparatus or lung-ventilator breathing systems.

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

    Development Note Issued by AAMI in January 2015. (01/2015)
    Document Type Standard
    Publisher Association for the Advancement of Medical Instrumentation
    Status Withdrawn

    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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