• EN ISO 5366:2016

    Current The latest, up-to-date edition.

    Anaesthetic and respiratory equipment - Tracheostomy tubes and connectors (ISO 5366:2016)

    Available format(s): 

    Language(s): 

    Published date:  26-10-2016

    Publisher:  Comite Europeen de Normalisation

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

    European foreword
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 General requirements for TRACHEOSTOMY TUBES
      and connectors
    5 Materials
    6 Design requirements for TRACHEOSTOMY TUBES
      and connectors
    7 Requirements for TRACHEOSTOMY TUBES supplied sterile
    8 Information supplied by the manufacturer
    Annex A (informative) - Rationale
    Annex B (normative) - Test method for the security of
            attachment of a fitted connector and NECK-PLATE
            TO THE TRACHEOSTOMY TUBE
    Annex C (normative) - Test method for determining the
            diameter of the CUFF
    Annex D (normative) - Test method for cuff herniation
    Annex E (normative) - Test method for determining kink
            resistance
    Annex F (informative) - Guidance on materials and design
    Annex G (informative) - Hazard identification for
            risk assessment
    Bibliography

    Abstract - (Show below) - (Hide below)

    ISO 5366:2016 specifies requirements for adult and paediatric tracheostomy tubes and connectors. Such tubes are primarily designed for patients who require anaesthesia, artificial ventilation or other respiratory support.ISO 5366:2016 is also applicable to specialized tracheostomy tubes that share common attributes, for example, those without a connector at the machine end intended for spontaneously breathing patients and those with reinforced walls or tubes made of metal or tubes with shoulders, tapering tubes, tubes with provision for suctioning or monitoring or delivery of drugs or other gases.Flammability of tracheostomy tubes is a well recognized hazard (for example, when electrosurgical units or lasers are used with flammable anaesthetic agents in oxidant-enriched atmospheres) that is addressed by appropriate clinical management and is outside the scope of this International Standard.NOTE ISO/TR 11991 gives guidance on avoidance of airway fires.

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

    Committee CEN/TC 215
    Development Note Supersedes EN ISO 5366-1. (11/2016) Supersedes EN 1282-2. (04/2017)
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Current
    Supersedes

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

    ASTM F 2503 : 2013 : REDLINE Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
    ISO 5356-1:2015 Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
    ISO 18190:2016 Anaesthetic and respiratory equipment — General requirements for airways and related equipment
    ASTM F 2052 : 2015 : REDLINE Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
    ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications Part 7: Connectors for intravascular or hypodermic applications
    ISO 5361:2016 Anaesthetic and respiratory equipment — Tracheal tubes and connectors
    ISO/TR 11991:1995 Guidance on airway management during laser surgery of upper airway
    ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
    ASTM F 640 : 2012 : REDLINE Standard Test Methods for Determining Radiopacity for Medical Use
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