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  • DIN EN 13718-1:2014-12

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES

    Available format(s):  Hardcopy, PDF

    Superseded date:  28-10-2020

    Language(s):  English, German

    Published date:  01-12-2014

    Publisher:  German Institute for Standardisation (Deutsches Institut für Normung)

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

    National foreword
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Requirements for medical devices for air ambulances
    5 Test methods
    Annex ZA (informative) - Relationship between this
             European Standard and the Essential
             Requirements of EU Directive 93/42/EEC
             on Medical Devices
    Bibliography

    Abstract - (Show below) - (Hide below)

    This standard is included in DIN Handbook 257.

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

    Committee TC 239
    Development Note Together with DIN EN 13718-2 and DIN 13230-10; supersedes DIN 13230-1, -2, -3, -4 and -5. (05/2003) DRAFT AMD 1 issued in April 2018. (04/2018)
    Document Type Standard
    Publisher German Institute for Standardisation (Deutsches Institut für Normung)
    Status Superseded
    Superseded By
    Supersedes

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

    EN ISO 11197:2016 Medical supply units (ISO 11197:2016)
    EN ISO 407:2004 Small medical gas cylinders - Pin-index yoke-type valve connections (ISO 407:2004)
    MIL-STD-704 Revision F:2004 AIRCRAFT ELECTRIC POWER CHARACTERISTICS
    EN 1865-1:2010+A1:2015 Patient handling equipment used in road ambulances - Part 1: General stretcher systems and patient handling equipment
    IEC 61000-4-4 : 3.0EN+(REDLINE+VERSION) ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-4: TESTING AND MEASUREMENT TECHNIQUES - ELECTRICAL FAST TRANSIENT/BURST IMMUNITY TEST
    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)
    ISO 7637-1:2015 Road vehicles — Electrical disturbances from conduction and coupling — Part 1: Definitions and general considerations
    MIL-DTL-26482 Revision H:2007 Connectors, Electrical, Circular, Miniature, Quick Disconnect, Environment Resisting, Receptacles and Plugs, General Specification for
    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)
    MIL-STD-810 Revision G:2008 ENVIRONMENTAL ENGINEERING CONSIDERATIONS AND LABORATORY TESTS
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    EN ISO 15002:2008 Flow-metering devices for connection to terminal units of medical gas pipeline systems (ISO 15002:2008)
    ISO 10524-4:2008 Pressure regulators for use with medical gases — Part 4: Low-pressure regulators
    ISO 7637-2:2011 Road vehicles Electrical disturbances from conduction and coupling Part 2: Electrical transient conduction along supply lines only
    IEC 60601-1-6:2010+AMD1:2013 CSV Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
    EN 1005-2:2003+A1:2008 Safety of machinery - Human physical performance - Part 2: Manual handling of machinery and component parts of machinery
    EN 1865-4:2012 Patient handling equipment used in road ambulances - Part 4: Foldable patient transfer chair
    ISO 9170-2:2008 Terminal units for medical gas pipeline systems — Part 2: Terminal units for anaesthetic gas scavenging systems
    ISO 19054:2005 Rail systems for supporting medical equipment
    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
    IEC 61000-4-4:2012 RLV Electromagnetic compatibility (EMC) - Part 4-4: Testing and measurement techniques - Electrical fast transient/burst immunity test
    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 ISO 10524-4:2008 Pressure regulators for use with medical gases - Part 4: Low-pressure regulators (ISO 10524-4:2008)
    EN 61000-4-2:2009 Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test
    RTCA DO 199 VOL II : 1988 Potential Interference to Aircraft Electronic Equipment from Devices Carried Aboard (Vol II)
    IEC 60068-2-31:2008 Environmental testing - Part 2-31: Tests - Test Ec: Rough handling shocks, primarily for equipment-type specimens
    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
    IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
    IEC 61000-4-6 : 4.0 ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-6: TESTING AND MEASUREMENT TECHNIQUES - IMMUNITY TO CONDUCTED DISTURBANCES, INDUCED BY RADIO-FREQUENCY FIELDS
    IEC 61000-4-6:2013 Electromagnetic compatibility (EMC) - Part 4-6: Testing and measurement techniques - Immunity to conducted disturbances, induced by radio-frequency fields
    EN 61000-4-3 : 2006 AMD 2 2010 ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-3: TESTING AND MEASUREMENT TECHNIQUES - RADIATED, RADIO-FREQUENCY, ELECTROMAGNETIC FIELD IMMUNITY TEST
    ISO 10297:2014 Gas cylinders — Cylinder valves — Specification and type testing
    ISO 5359:2014 Anaesthetic and respiratory equipment Low-pressure hose assemblies for use with medical gases
    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
    ISO 11197:2016 Medical supply units
    IEC 60529:1989+AMD1:1999+AMD2:2013 CSV Degrees of protection provided by enclosures (IP Code)
    MIL-STD-461 Revision G:2015 REQUIREMENTS FOR THE CONTROL OF ELECTROMAGNETIC INTERFERENCE CHARACTERISTICS OF SUBSYSTEMS AND EQUIPMENT
    EN 13976-2:2011 Rescue systems - Transportation of incubators - Part 2: System requirements
    IEC 61000-4-2:2008 Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test
    IEC 61000-4-3:2006+AMD1:2007+AMD2:2010 CSV Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test
    RTCA DO 199 VOL I : 1988 Potential Interference to Aircraft Electronic Equipment from Devices Carried Aboard (Vol I)
    EN 62366 : 2008 AMD 1 2015 MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007/A1:2014)
    EN 1865-3:2012+A1:2015 (edition 2) Patient handling equipment used in road ambulances - Part 3: Heavy duty stretcher
    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 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)
    EN ISO 10297:2014/A1:2017 GAS CYLINDERS - CYLINDER VALVES - SPECIFICATION AND TYPE TESTING (ISO 10297:2014/AMD 1:2017)
    EN ISO 9170-2:2008 Terminal units for medical gas pipeline systems - Part 2: Terminal units for anaesthetic gas scavenging systems (ISO 9170-2:2008)
    EN 1789:2007+A2:2014 Medical vehicles and their equipment - Road ambulances
    EN 61000-4-4:2012 ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-4: TESTING AND MEASUREMENT TECHNIQUES - ELECTRICAL FAST TRANSIENT/BURST IMMUNITY TEST (IEC 61000-4-4:2012)
    CISPR 11:2015 RLV Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement
    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)
    EN 61000-4-6:2014/AC:2015 ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-6: TESTING AND MEASUREMENT TECHNIQUES - IMMUNITY TO CONDUCTED DISTURBANCES, INDUCED BY RADIO-FREQUENCY FIELDS (IEC 61000-4-6:2013)
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    EN 60529:1991/AC:2016-12 DEGREES OF PROTECTION PROVIDED BY ENCLOSURES (IP CODE) (IEC 60529 EDITION 2.2 CORRIGENDUM 2:2015)
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    EN ISO 10524-2:2006 Pressure regulators for use with medical gases - Part 2: Manifold and line pressure regulators (ISO 10524-2:2005)
    EN 13976-1:2011 Rescue systems - Transportation of incubators - Part 1: Interface conditions
    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)
    ISO 10524-1:2006 Pressure regulators for use with medical gases Part 1: Pressure regulators and pressure regulators with flow-metering devices
    IEC 60309-1:1999+AMD1:2005+AMD2:2012 CSV Plugs, socket-outlets and couplers for industrial purposes - Part 1: General requirements
    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 60309-2:1999/A2:2012 PLUGS, SOCKET-OUTLETS AND COUPLERS FOR INDUSTRIAL PURPOSES - PART 2: DIMENSIONAL INTERCHANGEABILITY REQUIREMENTS FOR PIN AND CONTACT-TUBE ACCESSORIES (IEC 60309-2:1999/A2:2012)
    IEC 60309-2:1999+AMD1:2005+AMD2:2012 CSV Plugs, socket-outlets and couplers for industrial purposes - Part 2: Dimensional interchangeability requirements for pin and contact-tube accessories
    EN 1865-5:2012 Patient handling equipment used in road ambulances - Part 5: Stretcher support
    ISO 10524-2:2005 Pressure regulators for use with medical gases Part 2: Manifold and line pressure regulators
    EN 60068-2-31:2008 ENVIRONMENTAL TESTING - PART 2-31: TESTS - TEST EC: ROUGH HANDLING SHOCKS, PRIMARILY FOR EQUIPMENT-TYPE SPECIMENS
    EN 60309-1:1999/A1:2007/AC:2014 PLUGS, SOCKET-OUTLETS AND COUPLERS FOR INDUSTRIAL PURPOSES - PART 1: GENERAL REQUIREMENTS (IEC 60309-1:1999/A2:2012)
    EN 13718-2:2015 Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances
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