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  • CSA Z5361 : 2003

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS

    Available format(s):  Hardcopy, PDF

    Superseded date:  01-02-2014

    Language(s):  English

    Published date:  01-01-2003

    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 for tracheal tubes and tracheal
      tube connectors
      4.1 Size designation
      4.2 Dimensions
      4.3 Materials
      4.4 Bevel
      4.5 Cuff
      4.6 Inflating tubes for cuffs
      4.7 Curvature of tube
    5 Additional requirements for tracheal tubes with a Murphy eye
      5.1 Size of the Murphy eye
      5.2 Location of the Murphy eye
    6 Requirements for tracheal tubes with tracheal tube connector
      supplied sterile
      6.1 Sterility assurance
      6.2 Packaging for tracheal tubes and tracheal tube connectors
          supplied sterile
    7 Marking
      7.1 Use of symbols
      7.2 Tracheal tubes
      7.3 Tracheal tube connectors
    Annex A (normative) Determination of cuff resting diameter
    Annex B (normative) Test method for tube collapse
    Annex C (normative) Test method for cuff herniation
    Annex D (informative) Guidance on materials and design
    Bibliography

    Abstract - (Show below) - (Hide below)

    Specifies requirements for the dimensions, basic properties and method of size designation of the most commonly used types of oro-tracheal and naso-tracheal tube made of plastics materials and/or rubber (plain and cuffed), and requirements for tracheal tube connectors.

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

    Document Type Standard
    Publisher Canadian Standards Association
    Status Superseded
    Superseded By
    Supersedes

    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 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 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 11607:2003 Packaging for terminally sterilized medical devices
    ISO/TR 11991:1995 Guidance on airway management during laser surgery of upper airway
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
    EN 980:2008 Symbols for use in the labelling of medical devices
    ISO 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements
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