BS EN 13718-2-2015

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BSEN13718 2015
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BSI Standards Publication BS EN 13718-2:2015 Medical vehicles and their equipment — Air ambulances Part 2: Operational and technical requirements for air ambulancesBS EN 13718-2:2015 BRITISH STANDARD National foreword This British Standard is the UK implementation of EN 13718-2:2015. It supersedes BS EN 13718-2:2008 which is withdrawn.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 to its secretary. This publication does not purport 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 2015 ISBN 978 0 580 79616 6 ICS 11.040.01; 11.160; 49.020 Compliance with a British Standard cannot confer immunity from legal obligations. This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 August 2015. Amendments issued since publication Date Text affectedBS EN 13718-2:2015EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM EN 13718-2 March 2015 ICS 11.040.01; 11.160; 49.020 Supersedes EN 13718-2:2008 English Version Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances Véhicules sanitaire et leur équipement - Ambulances aérienne - Partie 2: Exigences techniques et opérationnelles pour les ambulances aérienne Medizinische Fahrzeuge und ihre Ausrüstung - 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/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 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 notified 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, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG CEN-CENELEC Management 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 13718-2:2015 EN 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 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 4.2.6 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 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 4.11 Lists of equipment 17 5 Air ambulances, operation and performance requirements 17 5.1 Personnel . 17 BS EN 13718-2:2015 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 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 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 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 devices 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) A–deviations 32 C.1 Deviation in Germany 32 C.1.1 Additional specifications for 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 13718-2:2015 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 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. 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 13718-2:2008. This document has been prepared under a mandate given 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 following 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 patient's compartment illumination); b) changed text related to enhancing safety related to the risk from rotors 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 ambulance: — 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: 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, Sweden, Switzerland, Turkey and the United Kingdom. BS EN 13718-2:2015 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 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 (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 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 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. BS EN 13718-2:2015 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 ambulances based on the different intended use. 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 documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. EN 3-7:2004+A1:2007, Portable fire extinguishers — Part 7: Characteristics, performance requirements and test methods EN 3-8:2006, Portable fire extinguishers — Part 8: Additional requirements to EN 3-7 for the construction, resistance to pressure and mechanical tests for extinguishers with a maximum allowable pressure equal to or lower than 30 bar EN 3-9:2006, Portable fire extinguishers — Part 9: Additional requirements to EN 3-7 for pressure resistance of CO2 extinguishers EN 3-10:2009, Portable fire extinguishers — Part 10: Provisions for evaluating the conformity of a portable fire extinguisher to EN 3-7 EN 143:2000, Respiratory protective devices — Particle filters — Requirements, testing, marking EN 374-1:2003, Protective gloves against chemicals and micro-organisms — Part 1: Terminology and performance requirements EN 455-1:2000, Medical gloves for single use — Part 1: Requirements and testing for freedom from holes EN 455-2:2009+A2:2013, Medical gloves for single use — Part 2: Requirements and testing for physical properties EN 455-3:2006, Medical gloves for single use — Part 3: Requirements and testing for biological evaluation EN 794-3:1998+A2:2009, Lung ventilators — Part 3: Particular requirements for emergency and transport ventilators EN 1618:1997, Catheters other than intravascular catheters — Test methods for common properties EN 1707:1996, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment — Lock fittings EN 1865-1:2010, Patient handling equipment used in road ambulances — Part 1: General stretcher systems and patient handling equipment EN 13718-1:2014, Medical vehicles and their equipment — Air ambulances — Part 1: Requirements for medical devices used in air ambulances BS EN 13718-2:2015 EN 13718-2:2015 (E) 7 EN 13976-1:2011, Rescue systems — Transportation of incubators — Part 1: Interface conditions EN 13976-2:2011, Rescue systems — Transportation of incubators — Part 2: System requirements EN 14605:2005+A1:2009, Protective clothing against liquid chemicals — Performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only (Types PB [3] and PB [4
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