DIN EN 13718-2:2015-05

This document has been prepared by Technical Committee CEN/TC 239 "Rescue systems" (secretariat: DIN, Germany) of the European Committee for Standardization (CEN) in collaboration with German experts from Working Committee NA 053-01-03 AA "Luftfahrzeuge zum Patiententransport" ("Air ambulances"). This part of EN 13718 provides requirements for air ambulances, and in particular covers requirements for the ambulance role of the aircraft. Air ambulances are equipped with medical devices as well as drugs and rescue equipment to be used by medical personnel. Requirements for medical devices intended for use in air ambulances are provided in EN 13718-1. 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 cover ambulance flights in general. Several national and regional rules and regulations apply to aircraft being used as ambulances. This part of EN 13718 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 part of EN 13718 provides some general requirements for the safe operation of aircraft being used as ambulances. These requirements are not covered by the scope of the Medical Devices Directive or by international agreements for craft, transportation and traffic. They are provided in order to secure the safe and secure 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 part of EN 13718 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. This European Standard gives minimum requirements for interfaces and compatibility of medical devices used in air ambulances. The standards work was called for by the EU Commission by a mandate linked with the Medical Devices Directive. This European Standard is supplementary to several other European Standards and gives requirements for medical devices when used in situations where the ambient conditions differ from the normal indoor conditions prevailing within the health care system. Several specific requirements are related to the conditions prevailing in air ambulances. The requirements set are carefully selected to ensure interoperability and continuous patient care. The medical devices are used in aircraft for patient transport. Patient transport aircraft transport medical devices as well as pharmaceuticals and rescue equipment for use by medical personnel. This document contains requirements for environmental conditions and important interfaces between medical devices and aircraft for patient transport. Medical devices need to conform to the applicable essential requirements in the Medical Devices Directive. The essential requirements are listed in Annex ZA of the Medical Devices Directive. Annex ZA lists the essential requirements that are covered by the identified clauses of this European Standard. The environmental conditions for medical devices used in air ambulances are different from those expected in a normal hospital environment. In particular, this implies environmental conditions such as temperature and humidity, vibration and shock caused by movement of the air ambulances, variable atmospheric pressures and electromagnetic disturbances between the air ambulances and the medical device.