Skip to content
Please enter a keyword to search
  • Preview

    I.S. EN ISO 5366-1:2009

    View superseded by
    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
    View superseded by

    ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEOSTOMY TUBES - PART 1: TUBES AND CONNECTORS FOR USE IN ADULTS

    Available format(s):  Hardcopy, PDF

    Superseded date:  23-07-2013

    Language(s):  English

    Published date:  01-01-2009

    Publisher:  National Standards Authority of Ireland

    For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
    Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

    Dates of withdrawal of national standards are available from NSAI.

    Add To Cart

    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 the requirements for tracheostomy tubes made of plastics materials and/or rubber having inside diameters of or greater.

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

    Development Note Supersedes I.S. EN 1282-1 (10/2004)
    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Superseded
    Superseded By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
    View more information

    • Access your standards online with a subscription

      Features

      • Simple online access to standards, technical information and regulations
      • Critical updates of standards and customisable alerts and notifications
      • Multi - user online standards collection: secure, flexibile and cost effective