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  • UNI EN ISO 5366-1 : 2009

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEOSTOMY TUBES - PART 1: TUBES AND CONNECTORS FOR USE IN ADULTS

    Available format(s): 

    Superseded date:  15-02-2017

    Language(s): 

    Published date:  31-12-2008

    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 and finish
    7 Requirements for tracheostomy tubes supplied sterile
    8 Marking and labelling
    Annexes
      A Test method for the security of attachment of connector
        and neck-plate to tracheostomy tube
        A.1 Principle
        A.2 Apparatus
        A.3 Procedure
        A.4 Expression of results
      B Test method for determining the resting diameter of the
        cuff
        B.1 Principle
        B.2 Apparatus
        B.3 Procedure
        B.4 Expression of results
      C Guidance on materials and design
        C.1 Materials
        C.2 Design
    Annex ZA (Informative) Relationship between this European
             Standard and the Essential Requirements of EU
             Directive 93/42/EEC
    Bibliography

    Abstract - (Show below) - (Hide below)

    Describes requirements for tracheostomy tubes made of plastics materials and/or rubber having inside diameters of 6,5 mm or greater.

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

    Development Note Supersedes UNI EN 1282-1. (11/2004)
    Document Type Standard
    Publisher Ente Nazionale Italiano di Unificazione (UNI)
    Status Superseded
    Superseded By
    Supersedes

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

    EN 556:1994 + A1:1998 STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR TERMINALLY-STERILIZED MEDICAL DEVICES TO BE LABELLED "STERILE"
    ISO 5356-1:2015 Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
    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 5366-3:2001 Anaesthetic and respiratory equipment Tracheostomy tubes Part 3: Paediatric tracheostomy tubes
    ISO 11607:2003 Packaging for terminally sterilized medical devices
    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
    EN 980:2008 Symbols for use in the labelling of medical devices
    ISO 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements
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