1、BSI Standards PublicationBS EN 13718-2:2015Incorporating corrigendum September 2015BS EN 13718-2:2015Medical vehicles and theirequipment Air ambulancesPart 2: Operational and technicalrequirements for air ambulancesBS EN 13718-2:2015 BRITISH STANDARDNational forewordThis British Standard is the UK i
2、mplementation of EN 13718-2:2015. It supersedes BS EN 13718-2:2008 which is withdrawn.The UK committee recognizes the importance of EN 13718 in setting out minimum standards for the safe and efficient operations of air ambulances within the UK. However, the UK committee has identified concerns that
3、in its current form the provisions in this European Standard for such aircraft are broad but do not fully account for the range of existing aircraft in use in the UK. The same concerns extend to the requirements for specific medical devices, products and equipment on board different types of air amb
4、ulance due to the need for trained and licensed personnel to administer/use them. The UK committee is taking steps to initiate a revision of this standard within CEN. For further information, the AAAs Operational Subcommittee Chairman can be contacted at: Operations Subcommittee Chairman Association
5、 of Air Ambulances 50 High Street Henley-in-Arden Warwickshire B95 5ANThe 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 to its secretary.This publication does not purpor
6、t to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2015. Published by BSI Standards Limited 2015ISBN 978 0 580 91578 9ICS 11.040.01; 11.160; 49.020Compliance with a British Standard cannot confer immunity from
7、 legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 August 2015.Amendments/corrigenda issued since publicationDate Text affected30 September 2015 Additional national foreword text insertedBS EN 13718-2:2015EUROPEAN STANDARD
8、NORME EUROPENNE EUROPISCHE NORM EN 13718-2 March 2015 ICS 11.040.01; 11.160; 49.020 Supersedes EN 13718-2:2008English Version Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances Vhicules sanitaire et leur quipement - Ambulances ar
9、ienne - Partie 2: Exigences techniques et oprationnelles pour les ambulances arienne Medizinische Fahrzeuge und ihre Ausrstung - Luftfahrzeuge zum Patiententransport - Teil 2: Operationelle und technische Anforderungen an Luftfahrzeuge zum Patiententransport This European Standard was approved by CE
10、N on 26 December 2014. 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 lists and bibliographical references concerning such national standar
11、ds may be obtained on application to the CEN-CENELEC 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 responsibility of a CEN member into its own language and noti
12、fied to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Ic
13、eland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Man
14、agement Centre: Avenue Marnix 17, B-1000 Brussels 2015 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 13718-2:2015 EBS EN 13718-2:2015EN 13718-2:2015 (E) 2 Contents Page Foreword 4 Introduction .5 1 Scope 6 2 Normative references
15、6 3 Terms and definitions .9 4 General requirements for air ambulances . 11 4.1 General . 11 4.2 Environmental conditions in the patient compartment 11 4.2.1 Temperature and humidity . 11 4.2.2 Air conditioning system (ACS) 11 4.2.3 Variable atmospheric pressure . 11 4.2.4 Interior light . 11 4.2.5
16、Ventilation 12 4.2.6 Noise exposure . 12 4.3 Requirements for electrical power supply for medical devices in the patient compartment . 12 4.4 Electromagnetic interference 13 4.5 Rail systems 13 4.6 Mechanical vibration 13 4.7 Requirements for fixation of medical devices . 14 4.8 Restraint systems in
17、 the patient compartment . 14 4.9 Patient compartment 14 4.9.1 General . 14 4.9.2 Hygienic . 15 4.9.3 Patient loading and unloading 15 4.9.4 Communication systems . 15 4.9.5 Fire safety requirements 15 4.9.6 Emergency exit . 15 4.10 Patient treatment area 15 4.10.1 General . 15 4.10.2 Dimensions 15
18、4.11 Lists of equipment 17 5 Air ambulances, operation and performance requirements 17 5.1 Personnel . 17 BS EN 13718-2:2015EN 13718-2:2015 (E) 3 5.1.1 Flight crew 17 5.1.2 Medical crew 17 5.2 Specific requirements for helicopters operated in Helicopter Emergency Medical Service (HEMS) 18 5.3 Specif
19、ic requirements for Helicopter Intensive Care Medical Service (HICAMS) . 18 5.4 Specific requirements for Fixed Wing Air Ambulances (FWAA) 18 6 Gas installations in air ambulances 19 6.1 System components . 19 6.2 General requirements . 19 6.2.1 Capacity and pressure operating range 19 6.2.2 Continu
20、ity of supply 20 6.3 Supply systems with gas cylinders . 20 6.4 Supply systems for compressed medical air . 20 6.5 Supply systems with air compressor 21 6.6 Pipeline distribution system. 21 6.7 Marking and colour coding. 22 6.8 Alarms. 22 6.9 Testing 22 6.9.1 General . 22 6.9.2 Test for mechanical i
21、ntegrity for compressed medical gas systems 22 6.9.3 Test for leakage on all pipeline systems and for mechanical integrity of vacuum pipeline systems 22 6.9.4 Leakage from the compressed medical gas pipelines 23 6.9.5 Test for cross connection. 23 6.10 Maintenance . 23 Annex A (normative) Medical de
22、vices in air ambulances . 24 A.1 Introduction 24 A.2 Additional equipment 28 Annex B (normative) Medicinal products and equipment additional to medical devices in air ambulances 29 B.1 Introduction 29 Annex C (informative) Adeviations 32 C.1 Deviation in Germany 32 C.1.1 Additional specifications fo
23、r the medical crew 32 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC . 33 Bibliography 34 BS EN 13718-2:2015EN 13718-2:2015 (E) 2 Contents Page Foreword 4 Introduction .5 1 Scope 6 2 Normative references 6 3 Terms and defin
24、itions .9 4 General requirements for air ambulances . 11 4.1 General . 11 4.2 Environmental conditions in the patient compartment 11 4.2.1 Temperature and humidity . 11 4.2.2 Air conditioning system (ACS) 11 4.2.3 Variable atmospheric pressure . 11 4.2.4 Interior light . 11 4.2.5 Ventilation 12 4.2.
25、6 Noise exposure . 12 4.3 Requirements for electrical power supply for medical devices in the patient compartment . 12 4.4 Electromagnetic interference 13 4.5 Rail systems 13 4.6 Mechanical vibration 13 4.7 Requirements for fixation of medical devices . 14 4.8 Restraint systems in the patient compar
26、tment . 14 4.9 Patient compartment 14 4.9.1 General . 14 4.9.2 Hygienic . 15 4.9.3 Patient loading and unloading 15 4.9.4 Communication systems . 15 4.9.5 Fire safety requirements 15 4.9.6 Emergency exit . 15 4.10 Patient treatment area 15 4.10.1 General . 15 4.10.2 Dimensions 15 4.11 Lists of equip
27、ment 17 5 Air ambulances, operation and performance requirements 17 5.1 Personnel . 17 BS EN 13718-2:2015EN 13718-2:2015 (E) 3 5.1.1 Flight crew 17 5.1.2 Medical crew 17 5.2 Specific requirements for helicopters operated in Helicopter Emergency Medical Service (HEMS) 18 5.3 Specific requirements for
28、 Helicopter Intensive Care Medical Service (HICAMS) . 18 5.4 Specific requirements for Fixed Wing Air Ambulances (FWAA) 18 6 Gas installations in air ambulances 19 6.1 System components . 19 6.2 General requirements . 19 6.2.1 Capacity and pressure operating range 19 6.2.2 Continuity of supply 20 6.
29、3 Supply systems with gas cylinders . 20 6.4 Supply systems for compressed medical air . 20 6.5 Supply systems with air compressor 21 6.6 Pipeline distribution system. 21 6.7 Marking and colour coding. 22 6.8 Alarms. 22 6.9 Testing 22 6.9.1 General . 22 6.9.2 Test for mechanical integrity for compre
30、ssed medical gas systems 22 6.9.3 Test for leakage on all pipeline systems and for mechanical integrity of vacuum pipeline systems 22 6.9.4 Leakage from the compressed medical gas pipelines 23 6.9.5 Test for cross connection. 23 6.10 Maintenance . 23 Annex A (normative) Medical devices in air ambula
31、nces . 24 A.1 Introduction 24 A.2 Additional equipment 28 Annex B (normative) Medicinal products and equipment additional to medical devices in air ambulances 29 B.1 Introduction 29 Annex C (informative) Adeviations 32 C.1 Deviation in Germany 32 C.1.1 Additional specifications for the medical crew
32、32 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC . 33 Bibliography 34 BS EN 13718-2:2015EN 13718-2:2015 (E) 4 Foreword This document (EN 13718-2:2015) has been prepared by Technical Committee CEN/TC 239 “Rescue systems”, t
33、he 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 September 2015, and conflicting national standards shall be withdrawn at the latest by September 2015. Atten
34、tion 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 13718-2:2008. This document has been prepared under a mandate g
35、iven to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). For relationship with EU Directive(s), see informative Annex ZA which is an integral part of this document. EN 13718-2:2008 has been technically revised. The follow
36、ing points represent the most important changes in the revision: a) clarified unclear issues in this part of the standard and between the two parts of the standard (for example requirements for patients compartment illumination); b) changed text related to enhancing safety related to the risk from r
37、otors on helicopters; c) clarified the requirements for the patient compartment; d) the standard has been modified/integrated to meet the Medical Devices Directive 93/42/EEC requirements. EN 13718 consists of the following parts, under the general title: Medical vehicles and their equipment Air ambu
38、lance: Part 1: Requirements for medical devices used in air ambulances; Part 2: Operational and technical requirements for air ambulances. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard:
39、 Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
40、Sweden, Switzerland, Turkey and the United Kingdom. BS EN 13718-2:2015EN 13718-2:2015 (E) 5 Introduction 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 w
41、ell 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 o
42、rder 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 giv
43、es 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
44、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 o
45、f 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
46、 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 medi
47、cal 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
48、. The standards work was called for by the EU Commission by a mandate linked with the Medical Devices Directive (see Annex ZA and Bibliography 1). This European Standard is supplementary to several other European Standards and gives requirements for medical devices when used in situations where the
49、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. Medical devices need to conform to the applicable essential requirements in the Medical Devices Directive, 93/42/EEC. The essential requirements are listed in Annex I of the Medical Devices Directive. Annex ZA in this European Standard lists the essential requirements that are
