BS-EN-13718-1-2008.pdf
BS EN 13718-1:2008 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 1: Requirements for medical devices used in air ambulances Licensed CopyChinese University of Hong Kong, 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 54217 6 Amendments/corrigenda issued since publication DateComments BS EN 13718-1:2008 National foreword This British Standard is the UK implementation of EN 13718-1:2008. It supersedes BS EN 13718-1:2002 which is withdrawn.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 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 02:51, Uncontrolled Copy, (c) BSI BS EN 13718-1:2008 EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM EN 13718-1 August 2008 ICS 11.040.01; 11.160; 49.020Supersedes EN 13718-1:2002 English Version Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances Véhicules sanitaire et leur équipment - Ambulances aérienne - Partie 1: Exigences pour les dispositifs médicaux utilisés dans les ambulances aérienne Medizinische Fahrzeuge und ihre Ausrüstung - Luftfahrzeuge zum Patiententransport - Teil 1: Anforderungen an medizinische Geräte, die in Luftfahrzeugen zum Patiententransport verwendet werden 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 lists 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 responsibility 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, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG Management Centre: rue 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 13718-1:2008: E Licensed CopyChinese University of Hong Kong, 21/10/2008 02:51, Uncontrolled Copy, (c) BSI BS EN 13718-1:2008 EN 13718-1:2008 (E) 2 Contents Page Foreword3 Introduction.4 1 Scope 5 2 Normative references5 3 Terms and definitions .6 4 Requirements for medical devices for air ambulances.8 4.1 Patient and personnel safety8 4.2 User interface.8 4.3 Environmental conditions and performance of medical devices intended for use in air ambulances).8 4.3.1 Functional temperature range8 4.3.2 Humidity9 4.3.3 Variable atmospheric pressures9 4.4 Electrical power driven medical devices.9 4.4.1 General9 4.4.2 Medical devices with 12 V DC power input.9 4.4.3 Medical devices with 24 V DC power input.9 4.4.4 Internal electrical power source.10 4.4.5 Inverters10 4.4.6 Electromagnetic interference of medical devices10 4.5 Gas supply10 4.5.1 General10 4.5.2 Gas leakage10 4.5.3 Pressure regulators and flow metering devices.10 4.5.4 Pneumatic power supply 10 4.5.5 Cylinder valves.11 4.5.6 Low pressure hose assemblies11 4.6 Mechanical strength11 4.6.1 General11 4.6.2 Vibration and bump.11 4.6.3 Free fall .11 4.7 Fixation of medical devices in air ambulances 11 4.8 Fire resistance11 4.9 Information to be supplied by the manufacturer12 5 Test methods12 5.1 General12 5.2 Ambient conditions .12 5.3 Test method for durability of markings and colour coding 12 5.4 Free fall .12 Annex A (informative) Comparative military standards13 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC Medical Devices.16 Bibliography17 Licensed CopyChinese University of Hong Kong, 21/10/2008 02:51, Uncontrolled Copy, (c) BSI BS EN 13718-1:2008 EN 13718-1:2008 (E) 3 Foreword This document (EN 13718-1:2008) 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 February 2009, and conflicting national standards shall be withdrawn at the latest by February 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 13718-1:2002. 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 Medical vehicles and their equipment Air ambulances consists of the following parts: Part 1: Requirements for medical devices used in air ambulance; Part 2: Operational and technical requirements of 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, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Licensed CopyChinese University of Hong Kong, 21/10/2008 02:51, Uncontrolled Copy, (c) BSI BS EN 13718-1:2008 EN 13718-1:2008 (E) 4 Introduction 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 from the Medical Device Directive (see Bibliography and Annex ZA). 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 being used by the services in air ambulances. Air ambulances carry medical devices as well as medicinal products and rescue equipment to be used by medical personnel. Medical devices need to conform to the applicable essential requirements. The essential requirements are listed in Annex I to the Medical Device Directive (MDD). Annex ZA indicates related essential requirements that are addressed in 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. Licensed CopyChinese University of Hong Kong, 21/10/2008 02:51, Uncontrolled Copy, (c) BSI BS EN 13718-1:2008 EN 13718-1:2008 (E) 5 1 Scope This European Standard specifies general requirements for medical devices carried in air ambulances and used therein and outside hospitals and clinics in situations where the ambient conditions can differ from normal indoor conditions. This European Standard does not cover the requirements for approval and registration of the vehicle and the training of the staff which is the responsibility of the authority/authorities in the country where the ambulance is to be registered. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. EN 737-1, Medical gas pipeline systems Part 1: Terminal units for compressed medical gases and vacuum EN 980, Symbols for use in the labelling of medical devices EN 1041, Information supplied by the manufacturer with medical devices EN 13220, Flow-metering devices for connection to terminal units of medical gas pipeline systems EN 13718-2, Medical vehicles and their equipment Air ambulances Part 2: Operational and technical requirements of air ambulances EN 60601 (all parts), Medical electrical equipment EN 60529, Degrees of protection provided by enclosures (IP code) (IEC 60529:1989) EN 60068-2-32:1993, Basic environmental testing procedures Part 2: Tests Test Ed: Free fall (IEC 60068-2-32:1975 + A1:1982 + A2:1990) EN ISO 407, Small medical gas cylinders Pin-index yoke-type valve connections (ISO 407:2004) EN ISO 5359:2008, Low-pressure hose assemblies for use with medical gases (ISO 5359:2008) EN ISO 10297, Transportable gas cylinders Cylinder valves Specification and type testing (ISO 10297:2006) EN ISO 10524-1, Pressure regulators for use with medical gases Part 1: Pressure regulators and pressure regulators with flow-metering devices (ISO 10524-1:2006) EN ISO 10524-3, Pressure regulators for use with medical gases Part 3: Pressure regulators integrated with cylinder valves (ISO 10524-3:2005) EN ISO 14971, Medical devices Application of risk management to medical devices (ISO 14971:2007) EN ISO 19054, Rail systems for supporting medical equipment (ISO 19054:2005) ISO 3795, Road vehicles, and tractors and machinery for agriculture and forestry Determination of burning behaviour of interior materials ISO 7000, Graphical symbols for use on equipment Index and synopsis Licensed CopyChinese University of Hong Kong, 21/10/2008 02:51, Uncontrolled Copy, (c) BSI BS EN 13718-1:2008 EN 13718-1:2008 (E) 6 ISO 7137, Aircraft Environmental conditions and test procedures for airborne equipment European Aviation Safety Agency, EASA Part 21: Certification of aircraft and related products, parts and appliances, and of design and production organisations 1) 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 air ambulance aircraft designed to be normally staffed by two medical 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 used 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 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 persons and other persons directly involved 3.4 air ambulance flight usually planned flight with an aircraft which is equipped with medical devices and installations, which are to facilitate medical assistance, where immediate and rapid transportation is not essential by carrying: medical personnel and/or medical supplies (equipment, blood, organs, drugs) and/or ill or injured persons and other persons directly involved 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 13718-1:2008 EN 13718-1:2008 (E) 7 3.5 non-dedicated aircraft for patient transportation aircraft equipped and staffed mainly for technical rescue, evacuation and/or transportation purposes, not specifically designed and equipped to provide adequate medical treatment, monitoring and continuity of patient care NOTE For example SAR (Search and Rescue) units covered by IMO (International Maritime Organization), ICAO (International Civil Aviation Organization). 3.6 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, mainly in inter-hospital transfers 3.7 fixed wing air ambulance FWAA aircraft especially equipped for transportation, medical treatment and care of patients, including patients requiring intensive care treatment 3.8 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 3.9 interoperability facility to connect various medical devices that are fixed to patients, into relevant connections of associated medical devices including the possibility of connecting powered medical devices to various kinds of ambulances 3.10 interchangeability facility to transfer patients between scenes of emergencies, ambulances and hospitals as well as between hospitals, including transport between countries, providing continuous patient care, treatment and monitoring 3.11 flight crew member of the crew intended to operate the aircraft NOTE See JAR-OPS 1 or 3, JAR-FCL 1 or 2. 3.12 medical crew members of the crew intended to provide patient care NOTE The medical crew normally consists of two persons, one as a specially trained physician and/or medical practitioner. In fixed wing air ambulances the medical crew normally consists of a physician and specially trained nurse or medical practitioner in addition if needed. Licensed CopyChinese University of Hong Kong, 21/10
