DIN EN 13718-2-2015 Medical vehicles and their equipment - Air ambulances - Part 2 Operational and technical requirements for air ambulances German version EN 13718-2 2015《医疗交通工具及其.pdf

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1、May 2015 Translation by DIN-Sprachendienst.English price group 16No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11

2、.040.01; 11.160; 49.020!%Bc“2315864www.din.deDDIN EN 13718-2Medical vehicles and their equipment Air ambulances Part 2: Operational and technical requirements for air ambulances;English version EN 13718-2:2015,English translation of DIN EN 13718-2:2015-05Medizinische Fahrzeuge und ihre Ausrstung Luf

3、tfahrzeuge zum Patiententransport Teil 2: Operationelle und technische Anforderungen an Luftfahrzeuge zumPatiententransport;Englische Fassung EN 13718-2:2015,Englische bersetzung von DIN EN 13718-2:2015-05Vhicules sanitaires et leur quipement Ambulances ariennes Partie 2: Exigences techniques et opr

4、ationnelles pour les ambulances ariennes;Version anglaise EN 13718-2:2015,Traduction anglaise de DIN EN 13718-2:2015-05SupersedesDIN EN 13718-2:2010-06www.beuth.deDocument comprises 37 pagesIn case of doubt, the German-language original shall be considered authoritative.04.15 DIN EN 13718-2:2015-05

5、2 A comma is used as the decimal marker. National foreword This document (EN 13718-2:2015) has been prepared by Technical Committee CEN/TC 239 “Rescue systems” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the DIN-Normenausschuss Rettungsdienst und Krankenh

6、aus (DIN Standards Committee Rescue Services and Hospital), Working Committee NA 053-01-03 AA Luftfahrzeuge zum Patiententransport. This standard contains some general and some more specific requirements for the safe operation of aircraft being used as ambulances. The specific requirements are given

7、 for helicopters operated in helicopter emergency medical service (HEMS), helicopter intensive care medical service (HICAMS), and fixed wing air ambulances (FWAA). These requirements are provided to ensure the safe handling of patients and to accommodate continuity of patient care between different

8、kinds of ambulances. Requirements are also given to ensure the safe use and handling of medical devices. The legal provisions regarding medical crew for air ambulances in Germany are included as a national A-deviation in this standard. In addition to the legal units of measurement, this standard als

9、o uses the unit “ft”. It should, however, be noted that the Gesetz ber Einheiten im Messwesen (German Law on units in metrology) prohibits the use of this unit for official and commercial purposes in Germany. Conversion: Non-SI unit SI unit Conversion ft m 1 ft = 0,304 8 m Amendments This standard d

10、iffers from DIN EN 13718-2:2010-06 as follows: a) unclear issues have been clarified in this part of the standard and between the two parts of the standard (requirements for patients compartment illumination, respectively); b) text related to enhancing safety related to the risk from rotors on helic

11、opters has been changed; c) requirements for the patients compartment have been clarified; d) Annex C includes the A-deviation for Germany; e) the standard has been modified/integrated to meet the Medical Devices Directive 93/42/EEC requirements. Previous editions DIN 13230-1: 1980-10, 1988-03, 1996

12、-04 DIN 13230-2: 1982-10, 1989-05, 1997-01 DIN 13234-1: 1987-12 DIN 13234-2: 1987-12 DIN 13230-3: 1996-04 DIN 13230-4: 1997-01 DIN 13230-5: 1998-01 DIN EN 13718-2: 2002-11, 2008-11, 2010-06 DIN 13230-10: 2003-05 EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 13718-2 March 2015 ICS 11.040.01; 1

13、1.160; 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 sanitaires et leur quipement - Ambulances ariennes - Partie 2: Exigences techniques et oprationnelles pour les am

14、bulances ariennes Medizinische Fahrzeuge und ihre Ausrstung - Luftfahrzeuge zum Patiententransport - Teil 2: Operationelle und technische Anforderungen an Luftfahrzeuge zum Patiententransport This European Standard was approved by CEN on 26 December 2014. CEN members are bound to comply with the CEN

15、/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 standards may be obtained on application to the CEN-CENELEC Management Cen

16、tre 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 notified to the CEN-CENELEC Management Centre has the same status as th

17、e 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, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Nether

18、lands, 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 Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CEN All righ

19、ts of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 13718-2:2015 EEN 13718-2:2015 (E) 2 Contents Page Foreword 4 Introduction .5 1 Scope 6 2 Normative references 6 3 Terms and definitions .9 4 General requirements for air ambulances . 11 4.1 Gener

20、al . 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 4.2.6 Noise exposure . 12 4.3 Requirements for electrical power supply

21、 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 compartment . 14 4.9 Patient compartment 14 4.9.1 General . 14 4.9.2 Hyg

22、ienic . 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 equipment 17 5 Air ambulances, operation and performance requirements 1

23、7 5.1 Personnel . 17 DIN EN 13718-2:2015-05 EN 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 Helicopter Intensive Care Medical Service (HICAMS) . 18 5.4

24、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 6.3 Supply systems with gas cylinders . 20 6.4 Supply systems f

25、or 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 compressed medical gas systems 22 6.9.3 Test for leakage on all pip

26、eline 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 ambulances . 24 A.1 Introduction 24 A.2 Additional equipment 28 Ann

27、ex 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 Annex ZA (informative) Relationship between this European

28、Standard and the Essential Requirements of EU Directive 93/42/EEC . 33 Bibliography 34 DIN EN 13718-2:2015-05 EN 13718-2:2015 (E) 4 Foreword This document (EN 13718-2:2015) has been prepared by Technical Committee CEN/TC 239 “Rescue systems”, the secretariat of which is held by DIN. This European St

29、andard 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. Attention is drawn to the possibility that some of the elemen

30、ts 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 given to CEN by the European Commission and the European

31、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 following points represent the most important changes in the r

32、evision: 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 rotors on helicopters; c) clarified the requirements for

33、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 ambulance: Part 1: Requirements for medical devices used in

34、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: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Repu

35、blic, 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, Sweden, Switzerland, Turkey and the United Kingdom. DIN

36、EN 13718-2:2015-05 EN 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 well as drugs and rescue equipment to be used by med

37、ical 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 monitor

38、ing 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

39、 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 airc

40、raft 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 p

41、atient 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 medica

42、l 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 othe

43、r 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 Commi

44、ssion 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 ambient conditions differ from the normal indoor co

45、nditions 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

46、 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 covered by the identified clauses of this European Standard. The environmental co

47、nditions 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

48、and electromagnetic disturbances between the air ambulances and the medical device. DIN EN 13718-2:2015-05 EN 13718-2:2015 (E) 6 1 Scope This part of EN 13718 specifies the requirements for performance and equipping for air ambulances, including requirements for interfaces to medical devices used for the transport and treatment of sick or injured persons. This part of EN 13718 is applicable to air ambulances capable of transporting at least one person on a stretcher. NOTE Requirements are specified for categories of air ambulance