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  • CAN/CSA-ISO 5364:16

    Current The latest, up-to-date edition.

    ANAESTHETIC AND RESPIRATORY EQUIPMENT - OROPHARYNGEAL AIRWAYS

    Available format(s):  Hardcopy, PDF

    Language(s):  English, French

    Published date:  01-09-2016

    Publisher:  Canadian Standards Association

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Size designation and dimensions
    5 Materials
    6 Design
    7 Performance requirements
    8 Sterility assurance
    9 Packaging of oropharyngeal airways supplied sterile
    10 Marking
    11 Information to be supplied by the manufacturer
    Annex A (informative) - Rationale
    Annex B (normative) - Test method for resistance to
            collapse of the buccal portion
    Annex C (normative) - Test method for patency of lumen
    Annex D (informative) - Guidance on materials and design
    Bibliography

    Abstract - (Show below) - (Hide below)

    This International Standard specifies requirements for oropharyngeal airways of plastics materials and/or rubber, including those with a reinforcement insert made of plastics materials and/or metal.

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

    Committee ISO/TC 12
    Document Type Standard
    Publisher Canadian Standards Association
    Status Current
    Supersedes

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

    ISO 11712:2009 Anaesthetic and respiratory equipment — Supralaryngeal airways and connectors
    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/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 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
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
    EN 980:2008 Symbols for use in the labelling of medical devices
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