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  • DIN EN ISO 5366 E : 2017

    Current The latest, up-to-date edition.

    ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEOSTOMY TUBES AND CONNECTORS (ISO 5366:2016)

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2017

    Publisher:  German Institute for Standardisation (Deutsches Institut für Normung)

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

    National foreword
    National Annex NA (informative) - Bibliography
    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)

    Describes requirements for adult and paediatric TRACHEOSTOMY TUBES and connectors.

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

    Development Note Supersedes DIN EN ISO 5366-1 E and DIN EN 1282-2 E. (04/2017)
    Document Type Standard
    Publisher German Institute for Standardisation (Deutsches Institut für Normung)
    Status Current

    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
    DIN EN ISO 80369-7 E : 2017 SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 7: CONNECTORS FOR INTRAVASCULAR OR HYPODERMIC APPLICATIONS (ISO 80369-7:2016, CORRECTED VERSION 2016-12-01)
    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
    DIN EN ISO 4135:2002-03 Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:2001); Trilingual version EN ISO 4135:2001
    ASTM F 640 : 2012 : REDLINE Standard Test Methods for Determining Radiopacity for Medical Use
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