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1、BS EN 13718-2:2008 ICS 11.040.01; 11.160; 49.020 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW BRITISH STANDARD Medical vehicles and their equipment Air ambulances Part 2: Operational and technical requirements of air ambulances Licensed CopyChinese University of Hong Kong,
2、21/10/2008 02:51, Uncontrolled Copy, (c) BSI This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 September 2008 BSI 2008 ISBN 978 0 580 54218 3 Amendments/corrigenda issued since publication DateComments BS EN 13718-2:2008 National foreword Th
3、is British Standard is the UK implementation of EN 13718-2:2008. It supersedes BS EN 13718-2:2002 which is withdrawn. The UK participation in its preparation was entrusted to Technical Committee CH/239, Rescue systems. A list of organizations represented on this committee can be obtained on request
4、to its secretary. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard cannot confer immunity from legal obligations. Licensed CopyChinese University of Hong Kong, 21/10/2008 02:
5、51, Uncontrolled Copy, (c) BSI BS EN 13718-2:2008 EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 13718-2 August 2008 ICS 11.040.01; 11.160; 49.020Supersedes EN 13718-2:2002 English Version Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements of
6、 air ambulances Vhicules sanitaire et leur quipement - Ambulances arienne - Partie 2: Exigences techniques et oprationnelles pour les ambulances ariennes Medizinische Fahrzeuge und ihre Ausrstung - Luftfahrzeuge zum Patiententransport - Teil 2: Operationelle und technische Anforderungen an Luftfahrz
7、euge zum Patiententransport This 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 European Standard the status of a national standard without any alteration. Up-to-date list
8、s and bibliographical references concerning such national standards 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 translation under the resp
9、onsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, I
10、celand, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue
11、 de Stassart, 36 B-1050 Brussels 2008 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 13718-2:2008: E Licensed CopyChinese University of Hong Kong, 21/10/2008 02:51, Uncontrolled Copy, (c) BSI BS EN 13718-2:2008 EN 13718-2:2008 (E)
12、2 Contents Page Foreword4 Introduction.5 1 Scope 6 2 Normative references6 3 Terms and definitions .7 4 General requirements for air ambulances 8 4.1 General8 4.2 Environmental conditions in the patient compartment.8 4.2.1 Temperature and humidity8 4.2.2 Variable atmospheric pressure8 4.2.3 Interior
13、 light8 4.2.4 Ventilation.9 4.2.5 Noise exposure9 4.3 Requirements for electrical power source for medical devices in the patient compartment9 4.4 Electromagnetic interference.10 4.5 Rail systems.10 4.6 Mechanical vibration .10 4.7 Requirements for fixation of medical devices10 4.8 Restraint systems
14、 in the patient compartment 10 4.9 Patient compartment.11 4.9.1 General11 4.9.2 Patient loading and unloading .11 4.9.3 Communication systems 11 4.9.4 Fire safety requirements.12 4.9.5 Emergency exit 12 4.10 Lists of equipment.12 5 Air ambulances, operation and performance requirements .12 5.1 Perso
15、nnel12 5.1.1 Flight crew12 5.1.2 Medical crew.12 5.2 Specific requirements for helicopters operated in Helicopter Emergency Medical Service (HEMS)12 5.2.1 General12 5.2.2 Patient compartment.13 5.3 Specific requirements for HICAMS13 5.3.1 General13 5.3.2 Patient compartment.13 5.4 Specific requireme
16、nts for fixed wing air ambulances .15 5.4.1 General15 5.4.2 Patient compartment.15 6 Gas installations in air ambulances.16 6.1 System components16 6.2 General requirements16 6.2.1 Capacity and pressure operating range16 6.2.2 Continuity of supply16 6.3 Supply systems with gas cylinders.16 6.4 Suppl
17、y systems for compressed medical air .17 6.5 Supply systems with air compressor17 6.6 Pipeline distribution system.18 6.7 Marking and colour coding.18 Licensed CopyChinese University of Hong Kong, 21/10/2008 02:51, Uncontrolled Copy, (c) BSI BS EN 13718-2:2008 EN 13718-2:2008 (E) 3 6.8 Alarms.19 6.9
18、 Testing19 6.9.1 General .19 6.9.2 Test for mechanical integrity for compressed medical gas systems19 6.9.3 Test for leakage on all pipeline systems and for mechanical integrity of vacuum pipeline systems 19 6.9.4 Leakage from the compressed medical gas pipelines19 6.9.5 Test for cross connection.19
19、 6.10 Maintenance.20 Annex A (normative) Medical devices in air ambulances.21 A.1 Patient transfer devices21 A.2 Isolated extremity and upper spinal immobilisation devices.21 A.3 Ventilation and respiration devices.22 A.4 Medical devices for diagnosis and monitoring23 A.5 Devices for injection and i
20、nfusion.23 A.6 Devices managing of life-threatening problems24 A.7 Bandaging and nursing devices24 A.8 Additional equipment24 Annex B (normative) Medicinal products and equipment additional to medical devices in air ambulances25 B.1 Medicinal products (drugs) 25 B.2 Rescue and protection equipment e
21、tc26 B.3 Communication equipment for medical personnel .27 Bibliography28 Licensed CopyChinese University of Hong Kong, 21/10/2008 02:51, Uncontrolled Copy, (c) BSI BS EN 13718-2:2008 EN 13718-2:2008 (E) 4 Foreword This document (EN 13718-2:2008) has been prepared by Technical Committee CEN/TC 239 “
22、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 identical text or by endorsement, at the latest by February 2009, and conflicting national standards shall be withdrawn at the latest by Febr
23、uary 2009. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN 13718-2:2002. EN 13718 Medical vehicles and the
24、ir equipment Air ambulances consists of the following parts: Part 1: Requirements of medical devices used in air ambulances; Part 2: Operational and technical requirements of air ambulances. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following coun
25、tries are bound to implement this European Standard: 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, Spa
26、in, Sweden, Switzerland and the United Kingdom. Licensed CopyChinese University of Hong Kong, 21/10/2008 02:51, Uncontrolled Copy, (c) BSI BS EN 13718-2:2008 EN 13718-2:2008 (E) 5 Introduction This European Standard provides requirements for air ambulances, and in particular covers requirements for
27、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 ambulances are provided in EN 13718-1 Medical vehicles and their equipment Air ambulances P
28、art 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 ambu
29、lance 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
30、 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 r
31、equirements 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,
32、 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. Th
33、e 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 requirement
34、s are based on the state of the art of today and common practice in Europe. Licensed CopyChinese University of Hong Kong, 21/10/2008 02:51, Uncontrolled Copy, (c) BSI BS EN 13718-2:2008 EN 13718-2:2008 (E) 6 1 Scope This European Standard specifies the requirements for design, performance and equipp
35、ing of air ambulances used for the transport and treatment of sick or injured persons. This European Standard is applicable to air ambulances capable of transporting at least one person on a stretcher. NOTE Requirements are specified for categories of air ambulances based on the different intended u
36、se. These are the helicopter emergency medical service (HEMS) the helicopter intensive care medical service (HICAMS) and the fixed wing air ambulance (FWAA). 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only t
37、he edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. EN 143:2000, Respiratory protective devices Particle filters Requirements, testing, marking EN ISO 5359, Low-pressure hose assemblies for use with medical gases EN 1865
38、, Specifications for stretchers and other patient handling equipment used in road ambulances EN 13718-1, Medical vehicles and their equipment Air ambulances Part 1: Requirements for medical devices used in air ambulance EN 13976-1, Rescue systems Transportation of incubators Part 1: Interface condit
39、ions EN 13976-2, Rescue systems Transportation on incubators Part 2: System requirements EN ISO 7396-1:2007, Medical gas pipeline systems Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2007) EN ISO 10524 (all parts), Pressure regulators for use with medical gases (ISO 1
40、0524) EN ISO 18777, Transportable liquid oxygen systems for medical use Particular requirements (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
41、 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 an
42、d 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 f
43、or Large Rotorcraft 1) 1) http:/www.easa.eu.int/home/index.html Licensed CopyChinese University of Hong Kong, 21/10/2008 02:51, Uncontrolled Copy, (c) BSI BS EN 13718-2:2008 EN 13718-2:2008 (E) 7 Joint Aviation Authorities, JAR-OPS (Joint Aviation Regulations-Operational Specifications) 3 Commercial
44、 Air Transportation (Helicopters) (publication available at Information Handling Services, Global Engineering Documents, 15 Inverness Way East, Englewood, Colorado 80112-5776, USA) 2) 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 air ambula
45、nce aircraft designed to be normally staffed by two medically trained personnel equipped and intended for the transportation of at least one stretcher patient who will receive medical treatment during transport 3.2 medical device instrument, apparatus, appliance, material or other article, whether u
46、sed alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of diagnosis, prevention, monitoring, treatment or alleviation of disease and injury 3.3 helicopter emergency medical service flight HEMS
47、flight flight by a helicopter operating under a HEMS approval, the purpose of which is to facilitate emergency medical assistance, where immediate and rapid transportation is essential, by carrying: medical personnel and/or medical supplies (equipment, blood, organs, drugs) and/or ill or injured per
48、sons and other persons directly involved 3.4 helicopter intensive care medical service flight HICAMS flight flight by a helicopter operating under a HEMS approval, especially staffed and equipped for the transportation, medical treatment and care of patients requiring intensive care treatment, mainl
49、y in inter-hospital transfers 3.5 fixed wing air ambulance FWAA aircraft especially equipped for transportation, medical treatment and care of patients, including patients requiring intensive care treatment 3.6 interface means or place of interaction between one or more of the medical devices, the ambient conditions, the user, the patient, and when relevant, the various kinds of ambulances 3.7 interoperability facility to connect various medical devices that are fixed to patients, into connections of associated medical devices in