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    I.S. EN 13544-2:2002

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    RESPIRATORY THERAPY EQUIPMENT - PART 2: TUBING AND CONNECTORS

    Available format(s):  Hardcopy, PDF

    Superseded date:  08-04-2022

    Language(s):  English

    Published date:  15-11-2002

    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.

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

    Foreword
    1 Scope
    2 Normative references
    3 Nipples
    4 Weight-bearing screw-threaded connectors
    5 Tubing
    6 Marking of tubing, labels and packaging
    7 Packaging
    8 Usability
    9 Clinical evaluation
    Annex A (normative) - Test methods
    Annex B (normative) - Weight-bearing screw-threaded
                          connectors for oxygen and air
    Annex C (informative) - Information on method of testing
                            security of connections
    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 tubing to be used with equipment for the therapeutic administration of respirable gases in domiciliary, ambulance and hospital practice including the interface to the equipment i.e. nipples and screw threaded connectors.

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

    Development Note 2002 Edition Re-Issued in September 2009 & incorporates AMD 1 2009. (10/2009)
    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Superseded
    Superseded By

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

    EN 13220 : 1998 FLOW-METERING DEVICES FOR CONNECTION TO TERMINAL UNITS OF MEDICAL GAS PIPELINE SYSTEMS
    EN 738-1:1997/A1:2002 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PRESSURE REGULATORS AND PRESSURE REGULATORS WITH FLOW METERING DEVICES
    EN 60601-1-6:2010/A1:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY (IEC 60601-1-6:2010/A1:2013)
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    EN 62366 : 2008 AMD 1 2015 MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007/A1:2014)
    EN ISO 10651-4:2009 Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002)
    EN 980:2008 Symbols for use in the labelling of medical devices
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