• UNI EN ISO 5364 : 2011

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    ANAESTHETIC AND RESPIRATORY EQUIPMENT - OROPHARYNGEAL AIRWAYS

    Available format(s): 

    Superseded date:  14-09-2022

    Language(s): 

    Published date:  31-12-2010

    Publisher:  Ente Nazionale Italiano di Unificazione (UNI)

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

    Foreword
    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 (normative) - Test method for resistance to
            collapse of the buccal portion
    Annex B (normative) - Test method for patency of lumen
    Annex C (informative) - Guidance on materials and design
    Bibliography

    Abstract - (Show below) - (Hide below)

    Describes 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)

    Development Note Supersedes UNI EN 12181. (09/2011)
    Document Type Standard
    Publisher Ente Nazionale Italiano di Unificazione (UNI)
    Status Superseded
    Superseded By
    Supersedes

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

    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
    EN 980:2008 Symbols for use in the labelling of medical devices
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