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    I.S. EN ISO 5364:2016

    Current The latest, up-to-date edition.

    ANAESTHETIC AND RESPIRATORY EQUIPMENT - OROPHARYNGEAL AIRWAYS (ISO 5364:2016)

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2016

    Publisher:  National Standards Authority of Ireland

    For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
    Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

    Dates of withdrawal of national standards are available from NSAI.

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

    National Foreword
    European foreword
    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
    Annex ZA (informative) - Relationship between this
             European Standard and the Essential Requirements
             of EU Directive 93/42/EEC

    Abstract - (Show below) - (Hide below)

    Provides 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 I.S. EN 12181. (07/2011)
    Document Type Standard
    Publisher National Standards Authority of Ireland
    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
    EN 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
    EN ISO 10993-1:2009/AC:2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)
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