SIST EN 13718-1:2008
Medical vehicles and their equipment - Air Ambulances - Part 1: Requirements of medical devices used in air ambulances
Medical vehicles and their equipment - Air Ambulances - Part 1: Requirements of medical devices used in air ambulances
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.
Medizinische Fahrzeuge und ihre Ausrüstung - Luftfahrzeuge zum Patiententransport - Teil 1: Anforderungen an medizinische Geräte, die in Luftfahrzeugen zum Patiententransport verwendet werden
Diese Europäische Norm legt allgemein gültige Leistungsanforderungen für Medizinprodukte fest, die in Luftfahr¬zeugen zum Patiententransport mitgeführt und in diesen sowie außerhalb von Krankenhäusern und Kliniken in Situationen verwendet werden, in denen die Umgebungsbedingungen von den normalen Bedingungen in Gebäuden abweichen können.
Diese Europäische Norm enthält keine Anforderungen zur Abnahme und Registrierung von Luftfahrzeugen zum Patiententransport und für die Ausbildung des Personals, die in der Zuständigkeit der Behörde des Landes liegt in der das Luftfahrzeug registriert ist.
Véhicules sanitaires et leur équipement - Ambulances aériennes - Partie 1 : Exigences pour les dispositifs médicaux utilisés dans les ambulances aériennes
La présente Norme européenne spécifie les exigences générales applicables aux dispositifs médicaux transportés dans des ambulances aériennes où ils sont utilisés et hors des hôpitaux et cliniques dans des situations où les conditions ambiantes diffèrent des conditions intérieures normales.
La présente Norme européenne exclut les exigences relatives à l'approbation et à l'enregistrement du véhicule, ainsi que la formation du personnel qui relève de l'autorité/des autorités du pays dans lequel l'ambulance est enregistrée.
Ambulantna vozila in njihova oprema - Ambulantna zračna vozila - 1. del: Zahteve za medicinsko opremo, ki se uporablja pri ambulantnih zračnih vozilih
General Information
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Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.LOLKMedizinische Fahrzeuge und ihre Ausrüstung - Luftfahrzeuge zum Patiententransport - Teil 1: Anforderungen an medizinische Geräte, die in Luftfahrzeugen zum Patiententransport verwendet werdenVéhicules sanitaires et leur équipement - Ambulances aériennes - Partie 1 : Exigences pour les dispositifs médicaux utilisés dans les ambulances aériennesMedical vehicles and their equipment - Air Ambulances - Part 1: Requirements of medical devices used in air ambulances43.160Vozila za posebne nameneSpecial purpose vehicles11.160First aidICS:Ta slovenski standard je istoveten z:EN 13718-1:2008SIST EN 13718-1:2008en,fr,de01-november-2008SIST EN 13718-1:2008SLOVENSKI
STANDARDSIST EN 13718-1:20021DGRPHãþD
SIST EN 13718-1:2008
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 13718-1August 2008ICS 11.040.01; 11.160; 49.020Supersedes EN 13718-1:2002
English VersionMedical vehicles and their equipment - Air ambulances - Part 1:Requirements for medical devices used in air ambulancesVéhicules sanitaire et leur équipment - Ambulancesaérienne - Partie 1: Exigences pour les dispositifsmédicaux utilisés dans les ambulances aérienneMedizinische Fahrzeuge und ihre Ausrüstung -Luftfahrzeuge zum Patiententransport - Teil 1:Anforderungen an medizinische Geräte, die inLuftfahrzeugen zum Patiententransport verwendet werdenThis 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 EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards 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 translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial 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 STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2008 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 13718-1:2008: ESIST EN 13718-1:2008
EN 13718-1:2008 (E) 2 Contents Page Foreword.3 Introduction.4 1 Scope.5 2 Normative references.5 3 Terms and definitions.6 4 Requirements for medical devices for air ambulances.8 4.1 Patient and personnel safety.8 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 range.8 4.3.2 Humidity.9 4.3.3 Variable atmospheric pressures.9 4.4 Electrical power driven medical devices.9 4.4.1 General.9 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 Inverters.10 4.4.6 Electromagnetic interference of medical devices.10 4.5 Gas supply.10 4.5.1 General.10 4.5.2 Gas leakage.10 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 assemblies.11 4.6 Mechanical strength.11 4.6.1 General.11 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 resistance.11 4.9 Information to be supplied by the manufacturer.12 5 Test methods.12 5.1 General.12 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 standards.13 Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC Medical Devices.16 Bibliography.17
SIST 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. SIST 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. SIST 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 SIST 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 SIST 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. SIST EN 13718-1:2008
EN 13718-1:2008 (E) 8 In HEMS operation one crew member has the function as a HEMS crew member (JAR-OPS 3). National regulations allow different specification/medical qualification of the personnel. 4 Requirements for medical devices for air ambulances 4.1 Patient and personnel safety Risks associated with medical devices shall be minimized, using risk management process in accordance with EN ISO 14971, taking account of the intended application of the devices and of known and foreseeable hazards in both normal and fault conditions. When risk analyses are performed, they shall reflect storage, installation, operation in normal use and maintenance according to the instructions of the manufacturer and the ambient conditions of an air ambulance. 4.2 User interface A medical device designated as "portable" shall be: able to be carried inside and outside the aircraft; able to be carried by one person. NOTE See Directive 90/269/EEC for information. Buttons, switches, indicators, controls etc. shall be accessible and readable under the intended operational conditions. NOTE Intended operational conditions are described as requirement in EN 13718-2. Medical devices with alarms and signals shall provide a clear visual signal under the intended operational conditions. When markings and instructions for the use of medical devices are present they shall conform to EN 1041 and EN 980. Graphical symbols shall be derived from harmonized standards when available. Any other symbols used shall be clear in their intentions, and there shall be a description of the meaning on the label or associated literature. 4.3 Environmental conditions and performance of medical devices intended for use in air ambulances2) 4.3.1 Functional temperature range The medical devices shall function throughout the temperature range from 0 °C to 40 °C and shall function for at least 20 min when placed in an environment at -5 °C after storage at room temperature (20 ± 2) °C. Following storage under extreme temperature conditions ranging from -30 °C to +70 °C, a medical device shall function within 10 min as intended and for at least 20 min when the medical device is returned to room temperature (20 ± 2) °C. Devices which cannot satisfy the above requirements shall be marked appropriately, e.g. by symbol
ISO 7000/0434 “Caution” in combination with symbol ISO 7000/0632 “Temperature limitation”.
2) A comparison of requirements in other standards is provided as information in Annex A. SIST EN 13718-1:2008
EN 13718-1:2008 (E) 9 4.3.2 Humidity Medical devices shall function as intended between 5 % RH to 95 % RH (relative humidity) within the temperature range of 0 °C to 40 °C. ISO 7137 may be used. 4.3.3 Variable atmospheric pressures The medical equipment shall function and present correct data as specified by the manufacturer at pressures between sea level and an altitude of 4 000 m. The operating range shall be stated, and if readings or performance vary, a table of correcting values shall be attached. The table shall state, in accordance with the prevailing atmospheric conditions, the extent of discrepancy between the actual values and the values indicated by the device. NOTE Medical devices intended to endure sub-atmospheric or pressurized chambers should have a table to cover correcting values, the pressure range given should be as appropriate. As an example, for pressures between 600 hPa and 2 500 hPa, the correcting values should be presented in increments of 100 hPa. 4.4 Electrical power driven medical devices 4.4.1 General Electrical power driven medical devices shall conform to EN 60601, all parts. Medical devices shall be IPX4 rated according to EN 60529. Life supporting devices shall be capable of operating with 12 V DC power input. Life supporting equipment shall function as intended during loading, transport and unloading.
Life supporting medical devices shall have changeable batteries or means for external 12 V DC in order to prevent interruption of the power supply. NOTE 1 This requirement is deemed essential to interoperability. NOTE 2 Connectors conforming to MIL-C26482 or EN 60309-1, -2 can be used. NOTE 3 Most equipment will have to meet the requirements of EN 60601-1:2006 and the related collateral and particular standards in EN 60601-1 series and EN 60601-2 series that are relevant to the specific type of equipment. Where the relevant particular standard in the EN 60601-2 series has not yet been revised to relate to EN 60601-1:2006, the previous edition of the general standard EN 60601-1:1990 will apply, together with relevant collateral standards related to that edition. 4.4.2 Medical devices with 12 V DC power input The medical device shall be constructed for a voltage of U = 13,8 V. The internal batteries shall be charged in the voltage range of Uvar = 12,4 V to 15,1 V. It shall operate as specified by the manufacturer independently of voltage fluctuation at shorttime voltage drop to 10 V. NOTE Aircraft can, like vehicles, have a power supply with nominal voltage of 12 V DC. The normal voltage will, typically, fluctuate from 12,4 V to 15,1 V. 13,8 V DC is, for this purpose, identified as the normal voltage. 4.4.3 Medical devices with 24 V DC power input The medical device shall be constructed for a voltage of U = 27,5 V. The internal batteries shall be charged in the voltage range of Uvar = 24,8 V to 30,3 V. It shall operate as specified by the manufacturer independently of voltage fluctuation at shorttime voltage drop to 20 V. SIST EN 13718-1:2008
EN 13718-1:2008 (E) 10 NOTE Aircraft can have a power supply with nominal voltage of 24 V DC. The normal voltages will, typically, fluctuate from 24,8 V to 30,2 V. 27,5 V DC is for this purpose identified as the normal voltage. 4.4.4 Internal electrical power source Medical devices with internal rechargeable batteries shall be rechargeable using power from the aircraft under normal operation conditions. Rechargeable batteries shall be such that, at a temperature of 55 °C, the electrolyte does not flow from a ruptured or cracked case. There should be no free flow of liquid and terminals should be protected from short circuit. NOTE Batteries conforming to IATA, UN 2800-A67, fulfil this requirement. 4.4.5 Inverters A fixed installed electrical inverter shall meet the requirements of EASA part 21. NOTE Electrical inverters intended for use with medical equipment are by law legislated under the Medical Device Directive 93/42/EEC. 4.4.6 Electromagnetic interference of medical devices The electromagnetic emission and susceptibility of medical devices shall conform to ISO 7137. NOTE 1 RTCA DO-160D sections 20 and 21 is equivalent to ISO 7137. NOTE 2 The requirement in 4.4.1 for conformity to EN 60601-1 means that EN 60601-1-2 also applies. 4.5 Gas supply 4.5.1 General Devices requiring gas supply shall be compatible with the installations specified EN 13718-2. 4.5.2 Gas leakage Means shall be provided to minimize the leakage of medical gases into the environment. The permitted leakage from the gas supplied equipment to the atmosphere shall conform to the requirements in EN 737-1, EN ISO 5359 and EN ISO 10297. NOTE Attention is drawn to any national and/or regional requirements regarding the protection of workers. 4.5.3 Pressure regulators and flow metering devices Pressure regulators and pressure regulators with flow metering devices shall conform to EN ISO 10524-1 or EN ISO 10524-3. The pressure regulators shall be directly connected to the source of supply. Flow metering devices for connection to terminal units shall conform to EN 13220. 4.5.4 Pneumatic power supply The range of the nominal distribution pressure for medical gases shall be 4001000+ kPa; the pressure measured at the terminal units (if fitted) shall be within ± 10 % of the nominal distribution pressure at a test flow of 40 l/min. SIST EN 13718-1:2008
EN 13718-1:2008 (E) 11 For vacuum the nominal distribution pressure shall be 60 kPa absolute pressure; the pressure measured at the terminal units (if fitted) shall not rise to more than 60 kPa absolute pressure at a test flow of 25 l/min. The medical equipment shall function during single fault condition in the gas installation, i.e. 10 bar. 4.5.5 Cylinder valves Cylinder valves shall conform to EN ISO 10297. If pin-index valves are used, their outlet connection shall conform to EN ISO 407. 4.5.6 Low pressure hose assemblies Low pressure hose assemblies for connecting medical devices to terminal units shall conform to EN ISO 5359. If flexible hoses are used between the pressure regulators and the terminal units, the requirements of
EN ISO 5359:2008 shall apply, except for 4.4.2.1, 4.4.7, 4.4.8 and 4.4.9. The minimum bursting pressure of such hoses shall be not less than 8 000 kPa at 23 °C and not less than
6 400 kPa at 40 °C. NOTE See also 59.101.1 c) of EN ISO 11197:2004. 4.6 Mechanical strength 4.6.1 General The manufacturer of fixed installations and fixed medical devices shall conform to the strength test procedures of EASA part 21 for the particular aircraft. The medical equipment shall function within its specification after being submitted to tests according to
Clause 5. 4.6.2 Vibration and bump The medical device shall conform to ISO 7137. 4.6.3 Free fall The medical device shall conform to 5.4. NOTE This clause applies to the portable medical equipment only. 4.7 Fixation of medical devices in air ambulances The mounts for fixation of medical device shall conform to EASA part 21. If rail clamps are used they shall conform to EN ISO 19054 with additional fixation requirements according to EASA part 21. Manufacturers of the aircraft installation and/or of the medical devices intended for transport and use within air ambulances shall provide recommendations for the proper attachment of the medical device. The manufacturer of the medical device shall declare the maximum weight for the device. 4.8 Fire resistance All materials should have a burning rate of less than 100 mm/min in accordance with ISO 3795. SIST EN 13718-1:2008
EN 13718-1:2008 (E) 12 NOTE Alternative tests can be found in EASA part 21, depending upon the type of aircraft. 4.9 Information to be supplied by the manufacturer Instructions for use shall include information of the products intended use and the environmental conditions. Instructions for use shall contain all information necessary to use the product in accordance with its specification and shall include an explanation of the function of controls, the sequence of operation and connection and disconnection of detachable parts and accessories. Instructions for use shall give detailed instructions for the safe performance of cleaning, inspection and preventative maintenance to be performed by the operator or by authorized persons, and shall indicate the recommended frequency or interval of such activities. The meaning of figures, symbols, warning statements and abbreviations shall be explained in the instructions for use. A list of recommended spare parts shall be provided. 5 Test methods 5.1 General Medical devices shall be tested according to ISO 7137. 5.2 Ambient conditions The tests shall b
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