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    I.S. EN 1789:2007

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    MEDICAL VEHICLES AND THEIR EQUIPMENT - ROAD AMBULANCES

    Available format(s):  Hardcopy, PDF

    Superseded date:  29-09-2020

    Language(s):  English

    Published date:  01-01-2007

    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
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Requirements
    5 Testing
    6 Medical devices
    7 Conformity assessment
    8 Requirements to be met for a Certificate of Compliance
    Annex A (informative) - Test summary
    Annex B (informative) - Definition of ambulance body styles
    Annex C (informative) - Recognition
    Annex ZA (informative) - Relationship between this European
             Standard and the Essential Requirements of
             EC Directive 93/42/EEC on Medical Devices
             and Directive 2007/46/EC of the European
             Parliament and of the Council of 5 September
             2007 establishing a framework for the approval
             of motor vehicles and their trailers, and of systems,
             components and separate technical units intended for
             such vehicles
    Bibliography

    Abstract - (Show below) - (Hide below)

    Defines requirements for the design, testing, performance and equipping of road ambulances used for the transport and care of patients.

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

    Development Note 2007 Edition Re-issued in September 2014 & incorporates AMD 2 2014. (10/2014)
    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Superseded
    Superseded By
    Supersedes

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

    EN 455-1:2000 MEDICAL GLOVES FOR SINGLE USE - PART 1: REQUIREMENTS AND TESTING FOR FREEDOM FROM HOLES
    EN ISO 11197:2016 Medical supply units (ISO 11197:2016)
    EN ISO 80601-2-61:2011 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (ISO 80601-2-61:2011)
    EN ISO 407:2004 Small medical gas cylinders - Pin-index yoke-type valve connections (ISO 407:2004)
    EN 14052:2012+A1:2012 High performance industrial helmets
    EN 1865-1:2010+A1:2015 Patient handling equipment used in road ambulances - Part 1: General stretcher systems and patient handling equipment
    EN 13544-1:2007+A1:2009 Respiratory therapy equipment - Part 1: Nebulizing systems and their components
    ISO 15002:2008 Flow-metering devices for connection to terminal units of medical gas pipeline systems
    EN ISO 19054:2006/A1:2016 RAIL SYSTEMS FOR SUPPORTING MEDICAL EQUIPMENT (ISO 19054:2005/AMD 1:2016)
    EN ISO 10524-3:2006/A1:2013 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 3: PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVES (ISO 10524-3:2005/AMD 1:2013)
    EN ISO 15002:2008 Flow-metering devices for connection to terminal units of medical gas pipeline systems (ISO 15002:2008)
    EN 1865-4:2012 Patient handling equipment used in road ambulances - Part 4: Foldable patient transfer chair
    ISO 19054:2005 Rail systems for supporting medical equipment
    EN ISO 10079-2:2014 Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:2014)
    EN 60068-2-64:2008 ENVIRONMENTAL TESTING - PART 2-64: TESTS - TEST FH: VIBRATION, BROADBAND RANDOM AND GUIDANCE
    EN 1865-2:2010+A1:2015 (edition 2) Patient handling equipment used in road ambulances - Part 2: Power assisted stretcher
    EN ISO 20471:2013/A1:2016 HIGH VISIBILITY CLOTHING - TEST METHODS AND REQUIREMENTS (ISO 20471:2013/AMD 1:2016)
    EN 794-3:1998+A2:2009 Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators
    EN 737-1 : 1998 MEDICAL GAS PIPELINE SYSTEMS - TERMINAL UNITS FOR COMPRESSED MEDICAL GASES AND VACUUM
    EN 737-3:1998/A1:1999 MEDICAL GAS PIPELINE SYSTEMS - PIPELINES FOR COMPRESSED MEDICAL GASES AND VACUUM
    ISO 7396-2:2007 Medical gas pipeline systems Part 2: Anaesthetic gas scavenging disposal systems
    IEC 60068-2-64:2008 Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance
    ISO 10079-1:2015 Medical suction equipment Part 1: Electrically powered suction equipment
    IEC 60601-2-4:2010 Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
    ISO 5359:2014 Anaesthetic and respiratory equipment Low-pressure hose assemblies for use with medical gases
    ISO 5128:1980 Acoustics — Measurement of noise inside motor vehicles
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    ISO 10524-3:2005 Pressure regulators for use with medical gases Part 3: Pressure regulators integrated with cylinder valves
    IEC 60364-7-721:2017 Low-voltage electrical installations - Part 7-721: Requirements for special installations or locations - Electrical installations in caravans and motor caravans
    EN 420:2003+A1:2009 Protective gloves - General requirements and test methods
    ISO 11197:2016 Medical supply units
    EN 12470-1:2000+A1:2009 Clinical thermometers - Part 1: Metallic liquid-in-glass thermometers with maximum device
    ISO 10079-2:2014 Medical suction equipment Part 2: Manually powered suction equipment
    EN 3-7:2004+A1:2007 Portable fire extinguishers - Part 7: Characteristics, performance requirements and test methods
    EN ISO 20345:2011 Personal protective equipment - Safety footwear (ISO 20345:2011)
    ISO 20471:2013 High visibility clothing — Test methods and requirements
    EN 455-2:2015 Medical gloves for single use - Part 2: Requirements and testing for physical properties
    ISO 80601-2-61:2011 Medical electrical equipment Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
    ISO 80601-2-55:2011 Medical electrical equipment Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
    EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
    EN 60068-2-29:1993 Environmental testing - Part 2: Tests - Test Eb and guidance: Bump
    ISO 10079-3:2014 Medical suction equipment Part 3: Suction equipment powered from a vacuum or positive pressure gas source
    ISO 407:2004 Small medical gas cylinders Pin-index yoke-type valve connections
    EN 60068-2-6:2008 Environmental testing - Part 2-6: Tests - Test Fc: Vibration (sinusoidal)
    ISO 20345:2011 Personal protective equipment Safety footwear
    IEC 60068-2-29:1987 Environmental testing. Part 2: Tests. Test Eb and guidance: Bump
    EN ISO 7396-2:2007 Medical gas pipeline systems - Part 2: Anaesthetic gas scavenging disposal systems (ISO 7396-2:2007)
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    EN ISO 10524-1:2006 Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow-metering devices (ISO 10524-1:2006)
    EN 60068-2-32:1993 Basic environmental testing procedures - Part 2: Tests - Test Ed: Free fall
    ISO 10524-1:2006 Pressure regulators for use with medical gases Part 1: Pressure regulators and pressure regulators with flow-metering devices
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
    EN ISO 10079-3:2014 Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source (ISO 10079-3:2014)
    EN 1865-5:2012 Patient handling equipment used in road ambulances - Part 5: Stretcher support
    EN 60601-2-4:2011 Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
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