EN 13718-2:2008

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Medizinische Fahrzeuge und ihre Ausrüstung - Luftfahrzeuge zum Patiententransport - Teil 2: Operationelle und technische Anforderungen an Luftfahrzeuge zum PatiententransportVéhicules sanitaires et leur équipement - Ambulances aériennes - Partie 2 : Exigences opérationnelles et techniques pour les ambulances aériennesMedical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements of air ambulances43.160Vozila za posebne nameneSpecial purpose vehicles11.160First aidICS:Ta slovenski standard je istoveten z:EN 13718-2:2008SIST EN 13718-2:2008en,fr,de01-november-2008SIST EN 13718-2:2008SLOVENSKI
STANDARDSIST EN 13718-2:20021DGRPHãþD

EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 13718-2August 2008ICS 11.040.01; 11.160; 49.020Supersedes EN 13718-2:2002
English VersionMedical vehicles and their equipment - Air ambulances - Part 2:Operational and technical requirements of air ambulancesVéhicules sanitaire et leur équipement - Ambulancesaérienne - Partie 2: Exigences techniques etopérationnelles pour les ambulances aériennesMedizinische Fahrzeuge und ihre Ausrüstung -Luftfahrzeuge zum Patiententransport - Teil 2:Operationelle und technische Anforderungen anLuftfahrzeuge zum PatiententransportThis European Standard was approved by CEN on 11 July 2008.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 CEN 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 CEN Management Centre has the same status as theofficial versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2008 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 13718-2:2008: ESIST EN 13718-2:2008

Medical devices in air ambulances.21 A.1 Patient transfer devices.21 A.2 Isolated extremity and upper spinal immobilisation devices.21 A.3 Ventilation and respiration devices.22 A.4 Medical devices for diagnosis and monitoring.23 A.5 Devices for injection and infusion.23 A.6 Devices managing of life-threatening problems.24 A.7 Bandaging and nursing devices.24 A.8 Additional equipment.24 Annex B (normative)
Medicinal products and equipment additional to medical devices in air ambulances.25 B.1 Medicinal products (drugs).25 B.2 Rescue and protection equipment etc.26 B.3 Communication equipment for medical personnel.27 Bibliography.28
EN 13718-1 Medical vehicles and their equipment — Air ambulances — Part 1: Requirements for medical devices used in air ambulances. This standard is supplementary to several European Standards as well as laws and regulations providing the requirements for aircraft in order to provide continuous patient care and monitoring during transport in and between various ambulance types and hospitals. The requirements sets covers ambulance flights in general. Several national and regional rules and regulations apply to aircrafts being used as ambulances. This European Standard gives information on these in the annexes and in notes throughout the text. Provisions for the safety and care both of the patient as well as of the crew and the medical personnel are contained in existing national and international laws, regulations and guidelines. This European Standard provides some general requirements for the safe operation of aircrafts being used as ambulances. These requirements are not covered by the scope of the Medical Device Directive or by international agreements for craft, transportation and traffic. They are provided in order to secure the safe handling of patients. In order to accommodate continuity of patient care between different kinds of ambulances, some specific requirements are given. Requirements are set in order to secure safe use and handling of medical devices. Aircraft being used as ambulances are equipped with medical devices, medicinal products and rescue equipment to enable the medical personnel to provide continuous patient care. The minima for the medical devices are specified in Annex A. The requirements set out in this European Standard give the minimum provisions for an ambulance service to provide satisfactory care and medical attention to emergency patients as well as other patients during transportation. The requirements are based on the state of the art of today and common practice in Europe. SIST EN 13718-2:2008

(ISO 18777:2005) EN ISO 19054, Rail systems for supporting medical equipment (ISO 19054:2005) ISO 3795:1989, Road vehicles, and tractors and machinery for agriculture and forestry — Determination of burning behaviour of interior materials European Aviation Safety Agency, EASA Part 21 Certification of aircraft and related products, parts and appliances, and of design and production organisations 1) European Aviation Safety Agency, EASA CS-23 Certification Specification for Normal, Utility, Aerobatic and Commuter Category Aeroplanes 1) European Aviation Safety Agency, EASA CS-25 Certification Specification for Large Aeroplanes 1) European Aviation Safety Agency, EASA CS-27 Certification Specification for Small Rotorcraft 1) European Aviation Safety Agency, EASA CS-29 Certification Specifications for Large Rotorcraft 1)
1) http://www.easa.eu.int/home/index.html SIST EN 13718-2:2008

2) http://www.jaa.nl/publications/publications.html SIST EN 13718-2:2008

NOTE
See JAR-OPS 1 or 3, JAR-FCL 1 or 2. 3.10 medical crew members of the crew intended to provide patient care NOTE The medical crew normally consists of two persons, one as a specially trained physician and/or medical practitioner. In fixed wing air ambulances the medical crew normally consists of a physician and specially trained nurse or medical practitioner in addition if needed. In HEMS operation one crew member has the function as a HEMS crew member (JAR-OPS 3). National regulations allow different specification/medical qualification of the personnel. 4 General requirements for air ambulances 4.1 General Air ambulances should be designed to enable fast and safe access of medical personnel to people in need of medical attention at sites outside hospitals and between hospitals. Intensive care patients transportation usually requires specially trained personnel. Air ambulances should be designed to accommodate the personnel, creating the safe and effective working environment. Air ambulances should allow treatment for at least one stretcher patient. Air ambulances shall be equipped with medical devices in accordance with Annex A and other life supporting equipment in accordance with Annex B, in order to provide continuous patient care. Equipment and systems should be selected and designed to enable interoperability and interchangeability (see 3.7 and 3.8). 4.2 Environmental conditions in the patient compartment 4.2.1 Temperature and humidity A heating system shall be provided capable of raising the temperature in the patient compartment from 0 °C to + 18 °C within 20 min, when the outside air temperature is 0 °C. NOTE 1 There should be an auxiliary system to heat/cool the patient compartment when stationary. NOTE 2 Normal ambient humidity conditions for patient treatment should be aimed at. 4.2.2 Variable atmospheric pressure Air ambulances which operate regularly at flight altitude above 15 000 feet shall have a pressurized cabin system. The operating pressure in the patient compartment above 15 000 feet shall be equivalent to the operating pressure at 3 500 feet. 4.2.3 Interior light Lighting shall be provided in accordance with Table 1. SIST EN 13718-2:2008

Means shall be provided to switch the lighting level down to 10 lx. 4.2.4 Ventilation Means shall be provided for a vented patient compartment. Ventilation systems shall be designed to prevent draught to the patient(s) and crew. 4.2.5 Noise exposure If noise exposure to the patient compartment during transport exceeds 85 dB(A), protection to both patient(s) and personnel shall be established and available. NOTE 1 Patients, in particular children, can need specially designed protection. NOTE 2 Specific requirements for sound protection in a working environment exist in some countries or regions. Sound protection shall allow communication between the medical personnel, the pilot and the patient(s) when experiencing ambient noise conditions greater than 85 dB(A). 4.3 Requirements for electrical power source for medical devices in the patient compartment The patient compartment shall have available a minimum of four 12 V DC outlets. Optionally one additional outlet may be supplied by a separate battery, dedicated to medical devices. The outlets shall be available 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. Outlets should have a visible indication under intended operational conditions in order to show if the power is switched on. If main voltage (AC) is provided by an inverter and available for use with medical device, the requirements on the AC and the inverter given in EN 13718-1 shall be fulfilled. The inverter is to be considered as an accessory to the medical device. Supply mains for medical devices with 24 V DC power input should be constructed for a nominal voltage of Unom = 27,5 V. The internal batteries should be charged in the voltage range of Uvar = 24,8
V to 30,3 V. Functioning according to the manufacturer’s specifications should remain at a minimum voltage of
Umin = 20,0 V. Electrical outlets for medical devices shall have connectors that are lockable. Connectors shall be designed to prevent short-circuiting under the environmental conditions prevailing in the air ambulances. NOTE Connectors conforming to MIL-C26482 may be used (see EN 13718-1). There shall be an externally mounted connector to enable charging of rechargeable batteries in medical devices. When the aircraft is connected to mains on the ground means should be provided to prevent earth leak currents. SIST EN 13718-2:2008

Cardiopulmonary resuscitation shall be possible during the flight. Elevating the patient’s upper body and/or the legs should be possible during the flight. The patient compartment including the aircraft storage areas, shall be designed and constructed to accommodate the devices listed in Annexes A and B. The medical device and its position in the patient compartment shall allow free access and interaction by medical personnel in a treatment, monitoring and care situation. 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 fixed lockable container available for the storage of classified drugs. Means shall be provided for keeping temperature sensitive drugs cool. Windows in the patient compartment shall be positioned or screened to ensure the privacy of patients when required. The interior of the patient compartment shall be designed to minimize the risk of injury. Drawers shall be secured to prevent self-opening. The ceiling, the interior walls and the doors of the patient compartment shall be fully lined. The edges of surfaces shall be designed and/or sealed in such a way that no fluid can infiltrate. NOTE Open shelves should be constructed with rounded edges and made from energy absorbent material. The floor shall be sealed to the structure of the aircraft and designed to allow fluids to drain. Floor coverings, also when wet, shall provide adequate grip for the attendant and shall be durable and easy to clean and disinfect. 4.9.2 Patient loading and unloading The safe loading and unloading of patients shall be possible under all operational conditions. NOTE 1 For manual loading and unloading, a maximum lifting or lowering height not exceeding 1 200 mm with a loading angle of 16° between the patient's sagital axis and the horizontal position will take care of this provision. NOTE 2 An upright position of the personnel during manual loading and unloading should be possible. There shall be a sufficient space from the top of the stretcher mattress to the top of the door opening where the patient is loaded to avoid implications to the patient. Transfer of patients shall be undertaken using one or more of the medical devices listed in Annex A, Table A.1. Stretchers and other patient handling equipment shall conform to EN 1865. NOTE 3 Specific aircrafts can require stretchers of other dimensions than those specified in EN 1865. 4.9.3 Communication systems Air ambulances shall be equipped with a communication system accessible to medical personnel. NOTE Attention is drawn to national and/or regional legislation regarding communication systems. SIST EN 13718-2:2008

JAR-FCL 1 or 2. NOTE Flight crew should be able to assist the medical personnel. 5.1.2 Medical crew All medical personnel who work regularly with Helicopter Emergency Medical Service and Fixed Wing air ambulance services shall be classified as “crew member”.
NOTE The flight training and duty times of medical personnel are not regulated by aviation authorities. 5.2 Specific requirements for helicopters operated in Helicopter Emergency Medical Service (HEMS) 5.2.1 General Sufficient space shall be available for emergency treatment to be administered from the patient extended head end. Helicopters operated in Helicopter Emergency Medical Service (HEMS) shall have the capacity to carry the medical devices and other equipment and medical products listed in Annexes A and B. To provide a safe working area the main rotor blades shall have a minimum ground clearance of 2,2 m irrespective of rotor speed. When required, rotors shall come to a complete stop at the earliest possible time, e.g. by using rotor brake. Tail rotor systems shall allow operation in confined areas. Tail rotor systems shall have a ground clearance of at least 1,85 m or designed as a protected tail rotor system. HEMS helicopters shall meet all the requirements in JAR-OPS 3. SIST EN 13718-2:2008

1 200 mm; (head, chest, abdomen, pelvis). (See Figure 1.)  width:
1 300 mm;  length:
2 650 mm. A minimum height of 700 mm for the whole patient compartment shall be provided. The available space for the medical personnel to attend the patient shall be at least 600 mm from one side of the patient, preferably the upper body part (head, chest, abdomen and pelvis) (see Figure 1). The emergency exit shall be free from obstruction.
Figure 1 — Patient Compartment Horizontal
Figure 2 — Patient Compartment Vertical
Table 2 — Dimensions for Air Ambulances SIST EN 13718-2:2008

Dimensions in millimetres
HEMS HICAMS FWAA Clause 5.2.2 5.3.2 5.4.2 A 400 650 650 B 700 700 700 C 2 400 2 650 2 650 D 700 700 700 E 1 150 1 200 1 200 F 750 1 300 1 300 G 250 600 600/400 H 50 50 50 I 750 750 750 NOTE 1 If G is 600 H can be 0. If H is 600 G can be 0. NOTE 2 When fixed wing and more than one stretcher, G or H can be 400. 5.4 Specific requirements for fixed wing air ambulances 5.4.1 General Sufficient space shall be available for emergency treatment to be administered from the patient extended head end. Fixed wing air ambulances shall have more than one engine and a pressurized cabin and shall have the capacity to carry the flight crew and medical crew according to their mission, the medical devices, other equipment and medicinal products as listed in Annexes A and B. Fixed wing air ambulances should have a minimum endurance of three hours flight time. The choice of aircraft should be based on the capacity of the aircraft to: a) minimize the time taken for entire flight; b) limit the number of ground stops; c) ensure comfort for patient, crew and escort. 5.4.2 Patient compartment The patient compartment shall be large enough to provide free space for the patient on a stretcher, the minimum dimensions being: height: 1 200 mm; width: 1 300 mm; length: 2 650 mm. (See Table 2.) The available space for the medical personnel to attend the patient shall be at least 600 mm from one side of the patient, preferably the upper body part. The compartment shall be arranged so that there is sufficient space available for resuscitation procedures. SIST EN 13718-2:2008

1,43 times the maximum pressure which can be applied to that section in single fault condition. The maximum pressure during single fault condition shall never exceed 10 Bar. The capacity of any supply system shall be determined using risk management principles. NOTE The expected range of transportation distance, the gas consumption and the possibility of exchange of gas cylinders should be considered when determining the capacity. Air ambulances equipped with compressed medical gas system using terminal units shall have following requirements:  the range of operating pressure shall be: 400 1000+ ;  the maximum allowable pressure change between the source of supply and the terminal units shall be
1 Bar at a flow of 10 l/min. 6.2.2 Continuity of supply The supply system shall be designed to achieve continuity of system design flow at a distribution pressure conforming to 6.2.1 to the terminal units in normal condition and single fault condition. NOTE Loss of electrical power or breakdown of one of the air ambulance engine is a single fault condition. 6.3 Supply systems with gas cylinders A supply system with gas cylinders shall comprise: SIST EN 13718-2:2008
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