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  • EN 1282-2:2005+A1:2009

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Tracheostomy tubes - Part 2: Paediatric tubes (ISO 5366-3:2001, modified)

    Available format(s): 

    Superseded date:  26-10-2016

    Language(s): 

    Published date:  12-08-2009

    Publisher:  Comite Europeen de Normalisation

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

    Foreword
    Introduction
    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
    9 Adaptor
    Annex A (normative) - Test for security of attachment of
                          permanently attached connector, if
                          provided, and neck-plate to tracheostomy
                          tube
    Annex B (normative) - Test method for determining the
                          resting diameter of the cuff
    Annex C (informative) - Guidance on materials and 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)

    This European Standard specifies requirements for paediatric tracheostomy tubes made of plastics materials and/or rubber having inside diameters from 2,0 mm to 6,0 mm. Requirements for paediatric tracheostomy tube connectors and adaptors are also given.This document is not applicable to specialized tracheostomy tubes.

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

    Committee CEN/TC 215
    Development Note 2005 Edition Re-Issued in August 2009 & incorporates AMD 1 2009. (09/2009)
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Superseded
    Superseded By

    Standards Referenced By This Book - (Show below) - (Hide below)

    12/30266576 DC : 0 BS EN 13718-2 - MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS OF AIR AMBULANCES
    DIN EN 1733:2003-02 SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
    I.S. EN 1733:2002 SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
    EN 1733 : 2002 SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
    BS EN 1733:2002 Suction catheters for use in the respiratory tract

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

    EN ISO 5356-1:2015 Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets (ISO 5356-1:2015)
    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 5366-1:2000 Anaesthetic and respiratory equipment Tracheostomy tubes Part 1: Tubes and connectors for use in adults
    EN ISO 5366-1:2009 Anaesthetic and respiratory equipment - Tracheostomy tubes - Part 1: Tubes and connectors for use in adults (ISO 5366-1:2000)
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    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 20594-1:1993/A1:1997 CONICAL FITTINGS WITH A 6% (LUER) TAPER FOR SYRINGES, NEEDLES AND CERTAIN OTHER MEDICAL EQUIPMENT - 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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