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  • BS EN ISO 5366-1:2004

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 Tubes and connectors for use in adults

    Available format(s):  Hardcopy, PDF

    Superseded date:  30-11-2016

    Language(s):  English

    Published date:  03-08-2004

    Publisher:  British Standards Institution

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

    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
    Bibliography
    Annex ZA (Informative) - Relationship between this European
             Standard and the Essential Requirements of EU
             Directive 93/42/EEC

    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)

    Committee CH/121/5
    Development Note Supersedes BS EN 1282-1 (08/2004)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By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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