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  • DIN EN 13718-2:2015-05

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES

    Available format(s):  Hardcopy, PDF

    Superseded date:  30-10-2020

    Language(s):  English, German

    Published date:  01-01-2015

    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 General requirements for air ambulances
    5 Air ambulances, operation and performance
      requirements
    6 Gas installations in air ambulances
    Annex A (normative) - Medical devices in air
            ambulances
    Annex B (normative) - Medicinal products and
            equipment additional to medical devices in
            air ambulances
    Annex C (informative) - A - deviations
    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 standard is included in DIN Handbook 257.

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

    Development Note Together with DIN EN 13718-1 and DIN 13230-10; supersedes DIN 13230-1, -2, -3, -4 and -5. (05/2003) Supersedes DIN 13230-10. (11/2008) DRAFT AMD 1 issued in April 2018. (04/2018)
    Document Type Standard
    Publisher German Institute for Standardisation (Deutsches Institut für Normung)
    Status Superseded
    Supersedes

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

    ISO 11070:2014 Sterile single-use intravascular introducers, dilators and guidewires
    EN ISO 5367:2014 Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2014)
    EN 60601-2-34:2014 Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment
    EN 374-1:2003 Protective gloves against chemicals and micro-organisms - Part 1: Terminology and performance requirements
    EN 455-1:2000 MEDICAL GLOVES FOR SINGLE USE - PART 1: REQUIREMENTS AND TESTING FOR FREEDOM FROM HOLES
    ISO 5364:2016 Anaesthetic and respiratory equipment — Oropharyngeal airways
    EN 60601-2-31:2008/A1:2011 MEDICAL ELECTRICAL EQUIPMENT - PART 2-31: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF EXTERNAL CARDIAC PACEMAKERS WITH INTERNAL POWER SOURCE
    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 18777:2009 Transportable liquid oxygen systems for medical use - Particular requirements (ISO 18777:2005)
    EN ISO 407:2004 Small medical gas cylinders - Pin-index yoke-type valve connections (ISO 407:2004)
    ISO 7376:2009 Anaesthetic and respiratory equipment Laryngoscopes for tracheal intubation
    EN 60601-2-24:2015 Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers
    EN ISO 7886-2 : 1997 STERILE HYPODERMIC SYRINGES FOR SINGLE USE - SYRINGES FOR USE WITH POWER-DRIVEN SYRINGE PUMPS
    EN 1618 : 1997 CATHETERS OTHER THAN INTRAVASCULAR CATHETERS - TEST METHODS FOR COMMON PROPERTIES
    EN 1865-1:2010+A1:2015 Patient handling equipment used in road ambulances - Part 1: General stretcher systems and patient handling equipment
    ISO 15002:2008 Flow-metering devices for connection to terminal units of medical gas pipeline systems
    ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin
    EN ISO 19054:2006/A1:2016 RAIL SYSTEMS FOR SUPPORTING MEDICAL EQUIPMENT (ISO 19054:2005/AMD 1:2016)
    EN 13718-1:2014 Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances
    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)
    EN ISO 81060-1:2012 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type (ISO 81060-1:2007)
    EN ISO 5356-1:2015 Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets (ISO 5356-1:2015)
    ISO 13688:2013 Protective clothing — General requirements
    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
    EN ISO 7376:2009 Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation (ISO 7376:2009)
    ISO 80601-2-56:2017 Medical electrical equipment — Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
    ISO 81060-1:2007 Non-invasive sphygmomanometers — Part 1: Requirements and test methods for non-automated measurement type
    EN 3-9:2006/AC:2007 PORTABLE FIRE EXTINGUISHERS - PART 9: ADDITIONAL REQUIREMENTS T0 EN 3-7 FOR PRESSURE RESISTANCE OF CO[2] EXTINGUISHERS
    ISO 5356-1:2015 Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
    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 ISO 10079-2:2014 Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:2014)
    EN 1865-2:2010+A1:2015 (edition 2) Patient handling equipment used in road ambulances - Part 2: Power assisted stretcher
    EN 794-3:1998+A2:2009 Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators
    EN ISO 10524-4:2008 Pressure regulators for use with medical gases - Part 4: Low-pressure regulators (ISO 10524-4:2008)
    EN 455-3:2015 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
    ISO 7886-2:1996 Sterile hypodermic syringes for single use Part 2: Syringes for use with power-driven syringe pumps
    ISO 18777:2005 Transportable liquid oxygen systems for medical use — Particular requirements
    EN ISO 10555-3:2013 Intravascular catheters - Sterile and single-use catheters - Part 3: Central venous catheters (ISO 10555-3:2013)
    ISO 7396-2:2007 Medical gas pipeline systems Part 2: Anaesthetic gas scavenging disposal systems
    EN ISO 6009:2016 Hypodermic needles for single use - Colour coding for identification (ISO 6009:2016)
    ISO 5356-2:2012 Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors
    ISO 10079-1:2015 Medical suction equipment Part 1: Electrically powered suction equipment
    IEC 60601-2-34:2011 Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment
    EN 3-10:2009 Portable fire extinguishers - Part 10: Provisions for evaluating the conformity of a portable fire extinguisher to EN 3-7
    EN ISO 23328-2:2009 Breathing system filters for anaesthetic and respiratory use - Part 2: Non-filtration aspects (ISO 23328-2:2002)
    EN 60601-2-27:2014 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
    EN ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016)
    ISO 3795:1989 Road vehicles, and tractors and machinery for agriculture and forestry — Determination of burning behaviour of interior materials
    IEC 60601-2-31:2008+AMD1:2011 CSV Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
    IEC 60601-2-4:2010 Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
    ISO 5367:2014 Anaesthetic and respiratory equipment — Breathing sets and connectors
    ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
    ISO 5359:2014 Anaesthetic and respiratory equipment Low-pressure hose assemblies for use with medical gases
    ISO 10524-3:2005 Pressure regulators for use with medical gases Part 3: Pressure regulators integrated with cylinder valves
    ISO 23328-2:2002 Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration aspects
    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 80601-2-30:2010/A1:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-30: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATED NON-INVASIVE SPHYGMOMANOMETERS (IEC 80601-2-30:2009/A1:2013)
    EN ISO 10555-5:2013 Intravascular catheters - Sterile and single-use catheters - Part 5: Over-needle peripheral catheters (ISO 10555-5:2013)
    EN 13976-2:2011 Rescue systems - Transportation of incubators - Part 2: System requirements
    EN ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2016)
    EN ISO 5364:2016 Anaesthetic and respiratory equipment - Oropharyngeal airways (ISO 5364:2016)
    ISO 81060-2:2013 Non-invasive sphygmomanometers Part 2: Clinical investigation of automated measurement type
    ISO 5366-1:2000 Anaesthetic and respiratory equipment Tracheostomy tubes Part 1: Tubes and connectors for use in adults
    EN ISO 7396-1:2016 Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2016)
    EN ISO 81060-2:2014 Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type (ISO 81060-2:2013)
    ISO 7864:2016 Sterile hypodermic needles for single use — Requirements and test methods
    IEC 80601-2-30:2009+AMD1:2013 CSV Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
    EN ISO 5356-2:2012 Anaesthetic and respiratory equipment - Conical connectors - Part 2: Screw-threaded weight-bearing connectors (ISO 5356-2:2012)
    EN ISO 5366-1:2009 Anaesthetic and respiratory equipment - Tracheostomy tubes - Part 1: Tubes and connectors for use in adults (ISO 5366-1:2000)
    IEC 60601-2-27:2011 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
    ISO 10555-3:2013 Intravascular catheters — Sterile and single-use catheters — Part 3: Central venous catheters
    EN ISO 9360-1:2009 Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 1: HMEs for use with minimum tidal volumes of 250 ml (ISO 9360-1:2000)
    EN 1865-3:2012+A1:2015 (edition 2) Patient handling equipment used in road ambulances - Part 3: Heavy duty stretcher
    ISO 10555-1:2013 Intravascular catheters — Sterile and single-use catheters — Part 1: General 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
    EN 3-8:2006/AC:2007 PORTABLE FIRE EXTINGUISHERS - PART 8: ADDITIONAL REQUIREMENTS TO EN 3-7 FOR THE CONSTRUCTION, RESISTANCE TO PRESSURE AND MECHANICAL TESTS FOR EXTINGUISHERS WITH A MAXIMUM ALLOWABLE PRESSURE EQUAL TO OR LOWER THAN 30 BAR
    ISO 80601-2-55:2011 Medical electrical equipment Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
    ISO 2631-1:1997 Mechanical vibration and shock — Evaluation of human exposure to whole-body vibration — Part 1: General requirements
    EN 143:2000/A1:2006 RESPIRATORY PROTECTIVE DEVICES - PARTICLE FILTERS - REQUIREMENTS, TESTING, MARKING
    EN ISO 5361:2016 Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2016)
    ISO 10079-3:2014 Medical suction equipment Part 3: Suction equipment powered from a vacuum or positive pressure gas source
    EN ISO 13688:2013 Protective clothing - General requirements (ISO 13688:2013)
    IEC 60601-2-24:2012 Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers
    ISO 407:2004 Small medical gas cylinders Pin-index yoke-type valve connections
    ISO 23328-1:2003 Breathing system filters for anaesthetic and respiratory use — Part 1: Salt test method to assess filtration performance
    ISO 7137:1995 Aircraft — Environmental conditions and test procedures for airborne equipment
    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)
    ISO 9360-1:2000 Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for humidifying respired gases in humans — Part 1: HMEs for use with minimum tidal volumes of 250 ml
    EN 1789:2007+A2:2014 Medical vehicles and their equipment - Road ambulances
    EN 14605:2005+A1:2009 Protective clothing against liquid chemicals - performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only (Types PB [3] and PB [4])
    ISO 5361:2016 Anaesthetic and respiratory equipment — Tracheal tubes and connectors
    ISO 9170-1:2017 Terminal units for medical gas pipeline systems — Part 1: Terminal units for use with compressed medical gases and vacuum
    EN ISO 9170-1:2008 Terminal units for medical gas pipeline systems - Part 1: Terminal units for use with compressed medical gases and vacuum (ISO 9170-1:2008)
    EN ISO 7396-2:2007 Medical gas pipeline systems - Part 2: Anaesthetic gas scavenging disposal systems (ISO 7396-2:2007)
    EN 60601-2-12:2006 Medical electrical equipment - Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators
    EN ISO 80601-2-56:2017 Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (ISO 80601-2-56:2017)
    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 60601-2-12:2001 Medical electrical equipment - Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators
    EN 20594-1:1993/A1:1997 CONICAL FITTINGS WITH A 6% (LUER) TAPER FOR SYRINGES, NEEDLES AND CERTAIN OTHER MEDICAL EQUIPMENT - 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)
    96/98/EC : 1996 COR 3 2015 COUNCIL DIRECTIVE 96/98/EC OF 20 DECEMBER 1996 ON MARINE EQUIPMENT
    ISO 6009:2016 Hypodermic needles for single use Colour coding for identification
    EN 1707 : 1996 CONICAL FITTINGS WITH A 6 % (LUER) TAPER FOR SYRINGES, NEEDLES AND CERTAIN OTHER MEDICAL EQUIPMENT - LOCK FITTINGS
    ISO 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements
    ISO 10555-5:2013 Intravascular catheters — Sterile and single-use catheters — Part 5: Over-needle peripheral catheters
    EN ISO 23328-1:2008 Breathing system filters for anaesthetic and respiratory use - Part 1: Salt test method to assess filtration performance (ISO 23328-1:2003)
    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
    ISO 10524-2:2005 Pressure regulators for use with medical gases Part 2: Manifold and line pressure regulators
    ISO 7396-1:2016 Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum
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