SIST EN 13718-2:2002
(Main)Air, water and difficult terrain ambulances - Part 2: Operational and technical requirements for the continuity of patient care
Air, water and difficult terrain ambulances - Part 2: Operational and technical requirements for the continuity of patient care
This European standard specifies minimum requirements for ambulance services, covering air, water and difficult terrain vehicles and craft in particular. Exclusions: Requirements for road ambulances are excluded from this standard. Non-dedicated vehicles and craft are excluded from this standard.
Patiententransportmittel in der Luft, auf dem Wasser und in schwierigem Gelände - Teil 2: Operationelle und technische Anforderungen für die kontinuierliche Patientenbetreuung
Diese Europäische Norm legt Mindestanforderungen für den Betrieb von besonders dafür vorgesehenen Patiententransportmitteln fest, wobei besonders Luftfahrzeuge, Schiffe und Fahrzeuge für schwieriges Gelände behandelt werden.
Ausschlusskriterien:
Diese Norm enthält keine Anforderungen an Krankenkraftwagen. Fahrzeuge und Schiffe, die nicht für den besonderen Zweck vorgesehen sind, sind nicht Gegenstand dieser Norm.
Ambulances aériennes, maritimes et de terrain difficile - Partie 2: Exigences opérationnelles et techniques assurant la continuité des soins
La présente Norme européenne spécifie les exigences minimales pour les services d'ambulance couvrant en particulier les véhicules et les engins a moteur aériens, maritimes et de terrain difficile.
Exclusions :
Les exigences relatives aux ambulances routieres sont exclues de la présente Norme européenne. Les véhicules et engins a moteur non dédiés sont exclus de la présente Norme européenne, telles que les unités de recherche ou de sauvetage.
Ambulantna vozila za zrak, vodo in težke terene - 2. del: Oprerativne in tehnične zahteve za nenehno oskrbo bolnikov
General Information
Relations
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Patiententransportmittel in der Luft, auf dem Wasser und in schwierigem Gelände - Teil 2: Operationelle und technische Anforderungen für die kontinuierliche PatientenbetreuungAmbulances aériennes, maritimes et de terrain difficile - Partie 2: Exigences opérationnelles et techniques assurant la continuité des soinsAir, water and difficult terrain ambulances - Part 2: Operational and technical requirements for the continuity of patient care43.160Vozila za posebne nameneSpecial purpose vehicles11.160First aidICS:Ta slovenski standard je istoveten z:EN 13718-2:2002SIST EN 13718-2:2002en01-november-2002SIST EN 13718-2:2002SLOVENSKI
STANDARD
SIST EN 13718-2:2002
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 13718-2August 2002ICS 11.040.01; 11.160English versionAir, water and difficult terrain ambulances - Part 2: Operationaland technical requirements for the continuity of patient careAmbulances aériennes, maritimes et de terrain difficile -Partie 2: Exigences opérationnelles et techniques assurantla continuité des soinsPatiententransportmittel in der Luft, auf dem Wasser und inschwierigem Gelände - Teil 2: Operationelle und technischeAnforderungen für die kontinuierliche PatientenbetreuungThis European Standard was approved by CEN on 23 June 2002.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the Management Centre or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2002 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 13718-2:2002 ESIST EN 13718-2:2002
EN 13718-2:2002 (E)2ContentspageForeword.3Introduction.41Scope.52Normative references.53Terms and definitions.54General requirements for interchangeability between air, water, and difficult terrainambulances.64.1General.64.2Environmental conditions in the patient compartment.64.3Requirements for electrical power source for medical devices in the patient compartment.74.4Electromagnetic interference.84.5Gas supply.84.6Rail systems.84.7Mechanical vibration.84.8Requirements for fixing of medical devices.94.9Restraint systems in the patient compartment.94.10Patient compartment.94.11Operation and maintenance of medical devices.104.12Lists of equipment.115Ambulance performance requirements.115.1Specific requirements for emergency helicopter ambulance.115.2Specific requirements for air ambulance.125.3Specific requirements for water ambulance.135.4Specific requirements for difficult terrain ambulance.14Annex A
(normative)
Medical devices in air, water, and difficult terrain ambulances.15Annex B
(normative)
Medicinal products and equipment additional to medical devices inair, water, and difficult terrain ambulances.21Bibliography.24SIST EN 13718-2:2002
EN 13718-2:2002 (E)3ForewordThis document EN 13718-2:2002 has been prepared by Technical Committee CEN/TC 239 "Rescue systems",the secretariat of which is held by DIN.This European Standard shall be given the status of a national standard, either by publication of an identicaltext or by endorsement, at the latest by February 2003, and conflicting national standards shall be withdrawn atthe latest by February 2003.The annexes A and B are normative.According to the CEN/CENELEC Internal Regulations, the national standards organizations of the followingcountries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark,Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal,Spain, Sweden, Switzerland and the United Kingdom.SIST EN 13718-2:2002
EN 13718-2:2002 (E)4IntroductionThis European Standard provides requirements for air, water, and difficult terrain vehicles, and in particularcovers requirements for the ambulance role of these vehicles and craft when in operation.Air, water, and difficult terrain ambulances are equipped with medical devices as well as drugs and rescueequipment to be used by medically trained personnel. Requirements for interfaces for medical devices intendedfor use in ambulances are provided in prEN 13718-1 Air, water, and difficult terrain ambulances – Part 1:Medical device interface requirements for the continuity of patient care. Specific interface requirements formedical devices to be used in road ambulances as well as performance requirements for road ambulances areprovided by EN 1789 (see Bibliography).This standard is supplementary to several European Standards as well as laws and regulations providing thenecessary requirements for the vehicles or craft in order to provide continuous patient care and monitoringduring transport in and between various ambulance types and hospitals. The requirements set cover bothemergency (primary missions) and prepared activities (secondary missions). Several specific requirementsrelate to the conditions prevailing in air, water, and difficult terrain ambulances. Several national and regionalrules and regulations apply to air, water, and difficult terrain ambulances. This standard gives information onthese in the annexes and in notes throughout the text. Provisions for the safety and care both to the patient aswell as to the crew and the medical personnel are contained in existing national and international laws,regulations and guidelines.This standard provides some general requirements for the safe operation of air, water, and difficult terrainambulances. These requirements are not covered by the scope of the Medical Device Directive or byinternational agreements for craft and vessels, transportation and traffic. They are provided in order to securethe safe handling of patients. In order to accommodate continuity of patient care between different kinds ofambulances, some specific requirements are given. Requirements are set in order to secure safe use andhandling of medical devices.Air, water, and difficult terrain ambulances are equipped with medical devices, drugs, and rescue equipment toenable the medically trained personnel to provide continuous patient care. The recommended minima for therelevant devices are listed in annex A. The requirements set out in this part of the standard give the necessaryminimum provisions for an ambulance service to provide satisfactory care and medical attention to emergencypatients as well as other patients during transport. The requirements are based on the state of the art of todayand common practice in Europe.SIST EN 13718-2:2002
EN 13718-2:2002 (E)51 ScopeThis European Standard specifies minimum requirements for dedicated ambulance services covering air, water,and difficult terrain vehicles and craft in particular.Exclusions:requirements for road ambulances are excluded from this standard. Non-dedicated vehicles and craft areexcluded from this standard, such as search and/or rescue units.2 Normative referencesThis European Standard incorporates by dated or undated reference, provisions from other publications. Thesenormative references are cited at the appropriate places in the text, and the publications are listed hereafter.For dated references, subsequent amendments to or revisions of any of these publications apply to thisEuropean Standard only when incorporated in it by amendment or revision. For undated references the latestedition of the publication referred to applies (including amendments).prEN 13718-1, Air, water, and difficult terrain ambulances – Part 1: Medical device interface requirements forthe continuity of patent care.EN 737-1, Medical gas pipeline systems – Part 1: Terminal units for compressed medical gases and vacuum.EN 738-1, Pressure regulators for use with medical gases – Part 1: Pressure regulators and pressureregulators with flow metering devices.EN 12218, Rail systems for supporting medical equipment.EN 1865, Specifications for stretchers and other patient handling equipment used in road ambulances.EN 60601-2-19, Medical electrical equipment – Part 2: Particular requirements for the safety of baby incubators(IEC 60601-2-19:1990).3 Terms and definitionsFor the purposes of this European Standard, the following terms and definitions apply.3.1primary missionimmediate medical assistance to scenes of emergencies where rapid treatment and/or transportation isessential in order to convey medically trained personnel, equipment and/or supplies, as well as transport of illand/or injured patients to places where appropriate further treatment can be received3.2secondary missiontransport of a patient, usually planned in advance, normally between sites of hospitals, to provide medicalassistance and the appropriate equipment in order to maintain continuity of patient care, including intensivecare treatment3.3air, water, and difficult terrain ambulancededicated vehicle or craft, which under operational conditions accommodates appropriate treatment,monitoring, care and transport and are designed and constructed to gain access to locations not possible orpracticable to reach by road ambulances3.4emergency helicopter ambulancerotor wing (RW) aircraft specifically designed and equipped to provide “Helicopter Emergency Medical Service”(HEMS) operating mainly on primary missionsNOTERequirements for HEMS flights are given in JAR-OPS 3 subpart B, Appendix 1 (see Bibliography).SIST EN 13718-2:2002
EN 13718-2:2002 (E)63.5air ambulanceemergency helicopter ambulance or a fixed wing (FW) aircraft ambulance especially those equipped anddesigned for the transportation, medical treatment and care of patients mainly on secondary missions, includingpatients requiring intensive care treatment3.6water ambulancevessel or craft designed and equipped to transport patients in coastal areas and on inland lakes and rivers, toconvey medically trained personnel to scenes of emergencies for the rapid treatment and/or transportation ofcritically ill and/or injured persons3.7difficult terrain ambulancevehicle specifically designed and equipped to operate in off-road locations, to convey medically trainedpersonnel to scenes of emergencies for the rapid treatment and/or transportation of critically ill and/or injuredpersons3.8non-dedicated vehicles or craftvehicle or craft equipped and staffed mainly for rescue and/or transportation purposes, not specifically designedand equipped to provide adequate medical treatment, monitoring and continuity of patient careNOTEFor example SAR (Search and Rescue ) units covered by IMO (International Maritime Organization) and ICAO(International Civil Aviation Organization), (see Bibliography).3.9interchangeabilityfacility to transfer patients between scenes of emergencies, ambulances and hospitals as well as betweenhospitals, including transport between countries, providing continuous patient care, treatment and monitoring4 General requirements for interchangeability between air, water, and difficult terrainambulances4.1 GeneralAttention is drawn to the need for vehicles and craft intended for ambulance services in the air, on water or inoff-road locations, to conform to the relevant rules and regulations pertaining to each vehicle or craft.Ambulances shall be constructed to enable fast and safe access of medically trained personnel to people inneed of medical attention at sites outside hospitals and between hospitals.Air, water, and difficult terrain ambulances shall be equipped with medical devices and other life supportingequipment in order to provide continuous patient care. These ambulances shall be capable of carrying twoappropriately medically trained personnel and at least one stretcher patient within the patient compartment.The ambulance shall be designed and constructed to accommodate the devices listed under the relevantcolumn in the tables of annex A and annex B.NOTEThere can be circumstances under which the ambulance should operate, and that would permit the trainedpersonnel to act as appropriate using whatever staff and equipment that can be available at that particular moment. This iscovered by any incident deemed as being a ‘force majeure’.4.2 Environmental conditions in the patient compartment4.2.1 TemperatureA heating system shall be provided capable of raising the temperature in the patient compartment from 0 oC to+ 18 oC within 10 min, when the outdoor temperature is 0 oC.SIST EN 13718-2:2002
EN 13718-2:2002 (E)7NOTEThere should be an auxiliary system to heat/cool the patient compartment when stationary and/or to preheat theengine, when relevant.4.2.2 HumidityNo particular requirements are given.NOTENormal ambient humidity conditions for patient treatment should be aimed at.4.2.3 Variable atmospheric pressureNo particular requirements are given.NOTEIt is essential to secure a stable atmospheric pressure within the patient compartment, as applicable, for the vehicleor craft. In the event of any significant deviation an indicating system should be employed.4.2.4 Interior lightLighting shall be provided as set out in Table 1.Table 1 – Interior lightTypeair, water, and difficult terrain ambulancesPatient area, minimum (lux)300 aSurrounding area, minimum (lux)50a Means shall be provided to switch the lighting level down to 10 lux.4.2.5 VentilationMeans shall be provided for a vented patient compartment. Ventilation systems shall be designed to preventdraught to the patient (-s) and crew.4.2.6 Noise exposureIf noise exposure to the patient compartment during transport exceeds 85 dBA, relevant protection to bothpatient(-s) and personnel shall be established and available (see Bibliography).NOTE 1Patients, in particular children, can need specially designed protection.NOTE 2Specific requirements for sound protection in a working environment exist in some countries or regions.When relevant, sound protection shall allow communication between the medically trained personnel, the pilotor driver and the patient (-s) under conditions of high ambient noise, e.g. over 85 dBA.4.3 Requirements for electrical power source for medical devices in the patient compartmentThe patient compartment shall have available a minimum of two available 12 VDC outlets and one additionaloutlet supplying the battery voltage of the vehicle or craft, dedicated to medical devices. The outlets shall beavailable for medical equipment and located in the area of storage and/or use of the medical device.The outlets for the medical devices shall be labelled with the nominal voltage and current rating.NOTE 1Outlets should have a visible indication under intended operational conditions in order to show if thepower is switched on.NOTE 2If mains voltage (AC) is provided and available for use with medical devices, means should be provided tolimit earth leakage current.SIST EN 13718-2:2002
EN 13718-2:2002 (E)8NOTE 3Supply mains for medical devices with 24 VDC power input should be constructed for a nominal voltage ofUnom = 27,5 V. The internal batteries should be charged in the voltage range of Uvar = 24,8 - 30,3 V. Functioning accordingto the manufacturer’s specifications should remain at a minimum voltage of Umin = 20,0.Electrical outlets for medical devices shall have connectors that are lockable.NOTE 4Connectors should be designed to prevent short-circuiting under the environmental conditions prevailingin these ambulances. Connectors complying with MIL-C26482 can be recommended for this purpose (see prEN 13718-1).There shall be an externally mounted connector to enable charging of rechargeable batteries in medicaldevices.4.4 Electromagnetic interferenceElectromagnetic disturbances caused by the vehicle or craft shall not influence the safe operation of themedical devices and vice versa.NOTE 1At present no common specific test method is available, therefore individual operational testingprocedures should be performed.NOTE 2Information on a general electromagnetic compatibility (EMC)-testing of medical devices intended for air,water, and difficult terrain ambulances is provided by prEN 13718-1.NOTE 3Cables can function as antennas and induce disturbances.4.5 Gas supply4.5.1 Outlet connectorsTerminal units or gas-specific connection points shall conform to EN 737-1.4.5.2 Stationary oxygen supplyPressure regulators with flow metering devices shall comprise of a source with a capacity of at least 2 000 l, atStandard Temperature and Pressure, with a maximum flow of at least 15 l/min and be in conformance withEN 738-1.NOTERequirements for the oxygen supply to be “stationary”, i.e. not necessarily a permanent installation, isbased on the need to obtain sufficient oxygen supply during transportation.4.5.3 Portable oxygen supplyThe portable oxygen supply shall comprise of a source with a capacity of at least 400 l, at StandardTemperature and Pressure, and a pressure regulator with flow metering device with a maximum flow of at least15 l/min.4.6 Rail systemsIf rail systems for supporting medical devices are used, they shall conform to EN 12218, see alsoprEN 13718-1.4.7 Mechanical vibrationKnowledge of the relationship between vibration, its effects during different human health conditions and thephysical vibration values is insufficient, and for safety reasons mechanical vibration shall be kept to a minimum.NOTEShock-absorbing devices can prove useful both for patient(-s) and personnel. Relevant requirements can be foundin ISO 2631-1 (see Bibliography).SIST EN 13718-2:2002
EN 13718-2:2002 (E)94.8 Requirements for fixing of medical devicesThe medical devices shall be fitted as applicable to the vehicle or craft.All medical devices required for a set procedure shall be stowed in a specified location. Essential medicaldevices for the management of vital functions, including airway management and ventilation shall be in reach ofthe attendant whilst seated. Essential medical devices required for use outside the vehicle shall be easilyaccessible. All medical devices shall be securely and safely stowed to prevent damage or injury whilst thevehicle is in motion.The devices shall be restrained within the vehicle or craft and g-load requirements shall be those applicable tothe particular class or certification of the craft or vehicle.Mountings shall be provided to support at least two vertically positioned infusion devices at the maximumavailable height above the patient(-s) whilst allowing sufficient infusions rates.4.9 Restraint systems in the patient compartmentDuring transport, restraint systems shall be available to secure the patient (-s) and personnel, as well as themedical devices and other equipment.Provisions shall be made to enable the medically trained personnel to be seated in an unimpeded manner.Means shall be provided for the personnel to grip and hold on to during transport, such as handles or similarobjects.NOTE 1For information on the provisions for safety of workplaces, see Council Directive of 12 June 1989 (seeBibliography).There shall be a security arrangement to prevent intrusion of items into the pilot’s or the driver’s area.NOTE 2A security wall or grid behind the driver’s seat of at least 700 mm width could provide protection for thepilot or driver.4.10 Patient compartment4.10.1 GeneralThe compartment shall be constructed to enable free access by the medically trained personnel to the patient(-s)'s vital body parts, e.g. head, chest and abdomen, in order to ensure adequate treatment, monitoring andcare.The patient compartment including the vehicle storage areas, shall be designed and constructed toaccommodate the devices listed in annexes A and B in such a way that they may be used as appropriate, see4.12. The positioning of medical devices shall allow the operation of the device without obstructing aisles,emergency exits or patient loading and unloading sites.There shall be a lockable compartment available for the storage of drugs.Windows in the patient compartment shall be positioned or screened to ensure the privacy of patients whenrequired.The interior of the patient compartment shall be designed to minimise the risk of injury. Drawers shall besecured to prevent self-opening. The ceiling, the interior walls and the doors of the patient compartment shallbe fully lined. The edges of surfaces shall be designed and/or sealed in such a way that no fluid can infiltrate.NOTEOpen shelves should be constructed with rounded edges and made from energy absorbent material.The floor shall be designed to allow fluids to drain. Floor coverings, also when wet, shall provide adequate gripfor the attendant and shall be durable and easy to clean.4.10.2 Patient loading and unloadingThe safe loading and unloading of patients shall be possible under all operational conditions.SIST EN 13718-2:2002
EN 13718-2:2002 (E)10NOTE 1For manual loading and unloading, a maximum lifting or lowering height not exceeding 1 200 mm with aloading angle of 16o between the patient sagital axis and the horizontal position will take care of this provision.NOTE 2An upright position of the personnel during manual loading and unloading should be possible.There shall be a minimum of 750 mm from the top of the stretcher mattress to the top of the door openingwhere the patient is loaded. This measurement shall be taken from the top of the door to the normal headposition of the stretcher in flat position.NOTE 3Current design features in some present day helicopters preclude conformity with this requirement (see5.1 and 5.2).Transfer of patients shall be provided by one or more of the medical devices listed in annex A, Table A.1.Stretchers and other relevant handling equipment shall conform to EN 1865 as applicable.NOTE 4Specific vehicles can require stretchers of other dimensions than those specified in EN 1865.4.10.3 Communication systemsAmbulances shall be equipped with a communication system accessible to medical personnel, which conformsto current national regulations or requirements (see annex B, Table B.3).4.10.4 Fire safety requirementsInterior materials shall be flame resistant. Requirements are deemed to have been met if the main parts have aburning rate of less than 100 mm/min when tested in accordance with ISO 3795 (see Bibliography).NOTEFire safety requirements for medical devices are covered by the requirements in the Medical DeviceDirective (93/42/EEC) and relevant standards for electrically powered medical devices.4.10.5 Emergency exitThere shall be an alternative exit from the patient compartment which permits the evacuation of patient(-s) andpersonnel.4.11 Operation and maintenance of medical devicesThe operator shall provide a documentation system assuring the proper quality of the medical devices for theirintended use within air, water, and difficult terrain ambulances, using operating and maintenance instructions asprovided by the relevant manufacturer of the medical device.The documentation system shall contain provisions to enable the personnel to choose and use the medicaldevices as appropriate.NOTE 1Appropriately trained personnel should be provided with the relevant information to enable them to takewith them the necessary medical devices, relevant equipment, and medicinal products. This shall be provided in a way thatwould facilitate the use when there is extremely limited time available, such as when going out on a mission.User manuals, when relevant, are provided with the product. These shall be made available to the user.NOTE 2In some regions this is covered by regulations.To ensure that powered medical devices used in air, water, and difficult terrain ambulances are appropriate forthe environment in which they are to operate, an indication system shall be provided.NOTE 3A marking or labelling system indicating the release to service and the relevant ambulance can proveuseful.SIST EN 13718-2:2002
EN 13718-2:2002 (E)114.12 Lists of equipmentThe ambulances shall have medical devices according to annex A.NOTE 1Minimum requirements for medical devices are listed in annex A as generic device groups. The minimumrequirements are based on the “today’s state of the art” in order to provide proper medical attention and continuation ofpatient care.The ambulances shall have the additional medicinal products and equipment given in annex B.Incubators shall conform to EN 60601-2-19 and prEN 13718-1.NOTE 2Specific requirements for transport incubator interfaces should be found in prEN 13976-1 and –2, (seeBibliography).The total mass of the medical devices shall not compromise the function of the vehicle or craft.5 Ambulance performance requirements5.1 Specific requirements for emergency helicopter ambulance5.1.1 GeneralEmergency helicopter ambulances shall have the capacity to carry at least one stretcher patient, together withtwo medically trained personnel and the medical devices and other relevant equipment and medical productslisted in annexes A and B.NOTE 1One of the medically trained personnel can be the HEMS crew member.NOTE 2Performance requirements for emergency helicopter ambulances are contained in Appendix 1 to JAR-OPS 3.005(d) and in Subparts G, H and I to JAR-OPS 3 (see Bibliography).NOTE 3The choice of type of aircraft shall ensure comfort as appropriate for normal passenger transport.The specific motion abilities, e.g. hovering of emergency helicopter ambulances, shall be achievable under theintended operational conditions.NOTE 4Emergency helicopter ambulances should be able to take off two minutes after the flight crew has entered,with the weight of the 4 persons and the equipment. It should be capable of flying for a minimum 1,5 h with a cruise speedof 200 km/h plus the required fuel reserve. Relevant requirements are provided by JAR-OPS 3.005, Appendix 1 (seeBibliography).Emergency helicopter ambulance shall be able to land on hard soil, i.e. sloping or rough grounds.NOTE 5Landing on ground sloping at a minimum of 8o should be possible.In the interest of providing a safe working area, the main rotor blades shall be a minimum of 2,2 m in heightabove level ground irrespective of rotor speed. If required, rotors shall become stationary at the earliestpossible time, e.g. by using rotor brakes.5.1.2 Pat
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