SIST EN 13718-1:2002
(Main)Air, water and difficult terrain ambulances - Part 1: Medical device interface requirements for the continuity of patient care
Air, water and difficult terrain ambulances - Part 1: Medical device interface requirements for the continuity of patient care
This European standard specifies minimum performance requirements for interfaces of medical devices used within ambulance services, covering medical devices intended for air, water and difficult terrain ambulances in particular. Exclusions: The standard specifically excludes consideration of the design and ergonomic requirements of the vehicle or craft. Specific requirements for permanent outdoor use and storage of medical devices are excluded from this standard.
Patiententransportmittel in der Luft, auf dem Wasser und in schwierigem Gelände - Teil 1: Besondere Anforderungen an die Schnittstellen von Medizinprodukten für die kontinuierliche Patientenbetreuung
Diese Europäische Norm legt Mindest-Leistungsanforderungen für Schnittstellen von Medizinprodukten fest, die in Patiententransportmitteln in der Luft, auf dem Wasser und in schwierigem Gelände angewendet werden.
Ausschlusskriterien:
Die Norm schließt spezifisch die Berücksichtigung der Anforderungen an Gestaltung und Ergonomie für das Fahrzeug oder Schiff aus. Spezifische Anforderungen hinsichtlich der ständigen Verwendung und Lagerung von Medizinprodukten im Freien werden in dieser Norm nicht behandelt.
ANMERKUNG Anforderungen an Krankenkraftwagen und Luft-, Wasser- und Geländefahrzeuge sind in EN 1789 und prEN 13718-2 zu finden (siehe Literaturhinweise).
Ambulances aériennes, maritimes et de terrain difficile - Partie 1: Exigences relatives a l'interface de dispositifs médicaux assurant la continuité des soins
La présente Norme européenne spécifie les exigences de performance minimales pour les interfaces de dispositifs médicaux utilisés dans les ambulances aériennes, maritimes et de terrain difficile.
Exclusions :
Cette norme exclut spécifiquement les exigences relatives a la conception et a l'ergonomie du véhicule ou de l'engin a moteur. Les exigences spécifiques pour une utilisation en extérieur permanente et le stockage des dispositifs médicaux ne sont pas traitées dans la présente norme.
NOTE Les exigences relatives aux ambulances routieres et aux ambulances aériennes, maritimes et de terrain difficile sont énoncées dans l'EN 1789 et l'EN 13718-2 (voir la bibliographie).
Ambulantna vozila za zrak, vodo in težke terene - 1. del: Zahteve za povezave medicinske opreme za nenehno oskrbo bolnikov
General Information
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Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Ambulantna vozila za zrak, vodo in težke terene - 1. del: Zahteve za povezave medicinske opreme za nenehno oskrbo bolnikovPatiententransportmittel in der Luft, auf dem Wasser und in schwierigem Gelände - Teil 1: Besondere Anforderungen an die Schnittstellen von Medizinprodukten für die kontinuierliche PatientenbetreuungAmbulances aériennes, maritimes et de terrain difficile - Partie 1: Exigences relatives a l'interface de dispositifs médicaux assurant la continuité des soinsAir, water and difficult terrain ambulances - Part 1: Medical device interface requirements for the continuity of patient care43.160Vozila za posebne nameneSpecial purpose vehicles11.160First aidICS:Ta slovenski standard je istoveten z:EN 13718-1:2002SIST EN 13718-1:2002en01-november-2002SIST EN 13718-1:2002SLOVENSKI
STANDARD
SIST EN 13718-1:2002
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 13718-1August 2002ICS 11.040.01; 11.160English versionAir, water and difficult terrain ambulances - Part 1: Medicaldevice interface requirements for the continuity of patient careAmbulances aériennes, maritimes et de terrain difficile -Partie 1: Exigences relatives à l'interface de dispositifsmédicaux assurant la continuité des soinsPatiententransportmittel in der Luft, auf dem Wasser und inschwierigem Gelände - Teil 1: Besondere Anforderungenan die Schnittstellen von Medizinprodukten für diekontinuierliche PatientenbetreuungThis European Standard was approved by CEN on 23 June 2002.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 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 Management Centre has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2002 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 13718-1:2002 ESIST EN 13718-1:2002
EN 13718-1:2002 (E)2ContentspageForeword.4Introduction.51Scope.62Normative references.63Terms and definitions.74General requirements for interfaces of medical devices with air, water and difficult terrainambulances.74.1General.74.1.1User interface.74.2Environmental conditions and performance of medical devices.84.2.1General requirements.84.2.2Functional temperature range.84.2.3Humidity and ingress.84.2.4Variable atmospheric pressures.84.3Electrical power driven medical devices.84.3.1Medical devices with 12 VDC power input.94.3.2Medical devices with 24 V power input.94.3.3Internal electrical power source.94.4Electromagnetic interference of medical devices.94.5Gas-supply.94.5.1General.94.5.2Source of supply.94.5.3Gas leakage.94.5.4Pressure regulators and flow metering devices.104.5.5Terminal units.104.5.6Pneumatic power supply.104.5.7Test pressure.104.5.8Cylinder valves.104.5.9Low pressure hose assemblies.104.5.10Alarms.104.6Rail systems.104.7Mechanical strength.114.7.1General.114.7.2Vibration and bump.114.7.3Free fall.114.8Fixing of medical devices in the ambulances.115Specific additional requirements for interfaces of medical devices with air, water anddifficult terrain ambulances.115.1Specific additional requirements for medical devices in air ambulances.115.1.1Requirements for electrically powered medical devices.115.1.2Fire resistance.115.2Specific additional requirements for medical devices in ambulance boats.115.2.1Requirements for electrically powered medical devices.115.3Specific additional requirements for medical devices in difficult terrain ambulances.12Annex A
(normative)
Test methods for mechanical strength of medical devices.13A.1Vibration and bump test.13A.2Free fall test.13SIST EN 13718-1:2002
EN 13718-1:2002 (E)3Annex B
(informative)
Minimum electromagnetic compatibility (EMC) requirements and testingprocedures for electrically powered and/or electronically controlled medical devices.14B.1General.14B.2Magnetic effect.14B.3Immunity.14B.4Emission.15Annex C
(informative)
Comparison between relevant requirements offered by other series ofstandards.16Annex ZA
(informative)
Clauses of this European Standard addressing essential requirementsor other provisions of EU Directives.20Bibliography.21SIST EN 13718-1:2002
EN 13718-1:2002 (E)4ForewordThis document EN 13718-1:2002 has been prepared by Technical Committee CEN/TC 239 "Rescue systems", thesecretariat 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 orby endorsement, at the latest by February 2003, and conflicting national standards shall be withdrawn at the latestby February 2003.This document has been prepared under a mandate given to CEN by the European Commission and the EuropeanFree 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.Annex A is normative. The annexes B and C are informative.According to the CEN/CENELEC Internal Regulations, the national standards organizations of the followingcountries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland,France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain,Sweden, Switzerland and the United Kingdom.SIST EN 13718-1:2002
EN 13718-1:2002 (E)5IntroductionThis European Standard gives requirements for interfaces of medical devices intended for air, water and difficultterrain ambulances. The standards work was called for by the EU Commission by a mandate from the MedicalDevice Directive (see Bibliography and annex ZA).This standard is supplementary to several other European Standards and gives requirements for medical deviceswhen used in situations where the ambient conditions differ from the normal indoor conditions prevailing within thehealth care system. Several specific requirements are related to the conditions prevailing in air, water, and difficultterrain ambulances. The requirements set are carefully selected to ensure interoperability and continuous patientcare.This standard was derived from the work developed during the establishment of requirements for the vehicles orcrafts being used as air, water and difficult terrain ambulances. The scope covers interface requirements formedical devices intended to be used in pre-hospital and ambulatory activities. The medical devices are being usedby the services in air, water and difficult terrain ambulances as well as on special units such as motorcycles,bicycles and other transport vehicles as deemed practical.Requirements for physical design are given as performance requirements in this standard.Several national and regional rules and regulations apply to air, water, and difficult terrain ambulances. Thisstandard gives information on these in the annexes and in notes throughout the text.In general, the manufacturer of a medical device is responsible for the device as presented to the market, andusers should ensure that devices are used in compliance with manufacturer’s instructions and in accordance withtheir intended use. According to the Medical Device Directive (93/42/EEC), the responsibility of the manufacturer isassumed by a person, who permits unauthorised adjustments, repairs and use of a medical device.Medical devices shall conform to the essential requirements that are relevant. The essential requirements are listedin Annex I to the Medical Device Directive (MDD). Annex ZA indicates related essential requirements that areaddressed in identified clauses of this standard.The environmental conditions for medical devices in air, water, and difficult terrain vehicles are different from thoseexpected in a normal hospital environment. In particular, this implies environmental conditions such as temperatureand humidity, vibration and shock caused by movement of the vehicles, variable atmospheric pressures andelectromagnetic disturbances between the vehicle and the medical device.At present, no common test requirements exist for the testing of electromagnetic compatibility (EMC) betweenmedical devices and the particularly aircraft. An ad hoc group of EMC experts has developed a suggestion for amerger of test requirements deriving from European Standards and regulations covering aircraft operations in orderto establish common and applicable testing routines.SIST EN 13718-1:2002
EN 13718-1:2002 (E)61 ScopeThis European Standard specifies minimum performance requirements for interfaces of medical devices usedwithin air, water, and difficult terrain ambulances.Exclusions:the standard specifically excludes consideration of the design and ergonomic requirements of the vehicle or craft.Specific requirements for permanent outdoor use and storage of medical devices are excluded from this standard.NOTERequirements for road ambulances and air, water and difficult terrain ambulances can be found in EN 1789 and prEN13718-2 (see Bibliography).2 Normative referencesThis European Standard incorporates by dated or undated reference, provisions from other publications. Thesenormative references are cited at the appropriate places in the text, and the publications are listed hereafter. Fordated references, subsequent amendments to or revisions of any of these publications apply to this EuropeanStandard only when incorporated in it by amendment or revision. For undated references the latest edition of thepublication referred to applies (including amendments).EN 737-1, Medical gas pipeline systems – Part 1: Terminal units for compressed medical gases and vacuum.EN 737-3, Medical gas pipeline systems – Part 3: Pipelines for compressed medical gases and vacuum.EN 738-1, Pressure regulators for use with medical gases – Part 1: Pressure regulators and pressure regulatorswith flow metering devices.EN 738-3, Pressure regulators for use with medical gases – Part 3: Pressure regulators integrated with cylindervalves.EN 739:1998, Low-pressure hose assemblies for use with medical gases.EN 849, Transportable gas cylinders - Cylinder valves - Specification and type testing.EN 850, Transportable gas cylinders - Pin-index, yoke-type valve outlet connections for medical use.EN 980, Graphical symbols for use in the labelling of medical devices.EN 1041, Information supplied by the manufacturer with medical devices.EN 12218, Rail systems for supporting medical equipment.EN 13220, Flow-metering devices for connection to terminal units of medical gas pipeline systems.EN 60601-1:1990, Medical electrical equipment - Part 1: General requirements for safety (IEC 60601-1:1988).EN 60529, Degrees of protection provided by enclosures (IP code) (IEC 60529:1989).EN 60068-2-6, Environmental testing - Part 2: Tests - Tests Fc: Vibration (sinusoidal) (IEC 60068-2-6:1995 +Corrigendum 1995).EN 60068-2-29, Basic environmental testing procedures - Part 2: Tests - Test Eb and guidance: Bump (IEC 60068-2-29:1987).EN 60068-2-32, Basic environmental testing procedures - Part 2: Tests - Test Ed: Free fall (IEC 60068-2-32:1975 +A1:1982 + A2:1990).EN 60068-2-64, Environmental testing - Part 2: Test methods - Test Fh: Vibration, broad-band random (digitalcontrol) and guidance (IEC 60068-2-64:1993 + Corrigendum 1993).ISO 7137, Aircraft – Environmental conditions and test procedures for airborne equipment.SIST EN 13718-1:2002
EN 13718-1:2002 (E)73 Terms and definitionsFor the purposes of this European Standard, the following terms and definitions apply.3.1ambulanceroad, air, water and difficult terrain vehicle intended to be staffed by at least two medically trained personnel toaccommodate at least one stretcher patient3.2medical deviceany instrument, apparatus, appliance, material or other article, whether used alone or in combination, including thesoftware necessary for its proper application intended by the manufacturer to be used for human beings for thepurpose of:-diagnosis, prevention, monitoring, treatment or alleviation of disease;-diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap;-investigation, replacement or modification of the anatomy or of a physiological process;-control of conception;and which does not achieve its principal intended action in or on the human body by pharmacological,immunological or metabolic means, but which may be assisted in its function by such means3.3interfacemeans or place of interaction between one or more of the medical devices, the ambient conditions, the user, thepatient, and when relevant, the vehicle or craft3.4interoperabilityfacility to connect various medical devices that are fixed to patients, into relevant connections of associated medicaldevices including the possibility of connecting powered medical devices to various kinds of ambulances4 General requirements for interfaces of medical devices with air, water and difficultterrain ambulances4.1 GeneralThis part of the standard provides requirements for interfaces of medical devices intended for use within air, waterand difficult terrain ambulances. The ambient conditions are characterised by conditions prevailing inside theambulances under transport and in situations outside hospitals and clinics, differing from normal indoor conditions.Specific additional requirements relevant to performance within various types of ambulances, are provided inclause 5.NOTEA major consideration when selecting medical devices, intended by their manufacturer to be suitable for use in air,water, and difficult terrain ambulances, is the advantage of such devices having been designed with a lowest weight andsmallest size as possible. These considerations are of particular importance when considering suitability for use in emergencyhelicopter ambulances.4.1.1 User interfaceIf a medical device is designated as "portable" it shall be possible for it to be carried by one person, and if needed itshall be capable of normal functioning whilst being carried.SIST EN 13718-1:2002
EN 13718-1:2002 (E)8If powered, it shall have its own built-in power supply, and if needed it shall be capable of being used outside theambulance.NOTERelevant requirements can be found in EN 60601-1.Buttons, switches, indicators, controls etc. shall be easily accessible and clearly readable under all intendedoperational conditions.Medical devices with alarms and signals shall provide a clear visual signal under the intended operationalconditions.When markings and instructions for the use of medical devices are present they shall conform to EN 1041 andEN 980. Graphical symbols shall be derived from Harmonised Standards when available. Any other symbols usedshall be clear in their intentions, and there shall be a description of the meaning on the label or associatedliterature.4.2 Environmental conditions and performance of medical devices4.2.1 General requirementsThe medical devices shall conform to the requirements below.NOTEA comparison of requirements in other standards is provided as information in annex C.4.2.2 Functional temperature rangeThe devices shall function throughout the temperature range from 0 oC to 40 oC and shall function for at least20 min when placed in an environment at -5 oC after storage at room temperature (20 ± 2) oC, unless the device isotherwise marked.Following storage under extreme temperature conditions ranging from -30 oC to +70 oC, a medical device shallfunction within 10 min as intended, for at least 20 min when the device is returned to room temperature (20 ± 2) oC.NOTEParticular medical devices, not complying with these requirements, can be evident. If these medical devices are beingused, information on applicability should be provided.4.2.3 Humidity and ingressMedical devices shall conform to clauses 10 and 44 of EN 60601-1:1990 and other standards in the series EN60601-2 when applicable.Medical devices shall function as intended at between 5 % to 95 % RH within the temperature range of 0 oC to40 oC, unless otherwise marked on the device.4.2.4 Variable atmospheric pressuresThe operating range shall be stated, and if readings vary, a table of correcting values shall be attached. The tableshall state, in accordance with the prevailing atmospheric conditions, the extent of discrepancy between the actualvalues and the values indicated by the device.NOTEMedical devices intended to endure sub-atmospheric or pressurised chambers should have a table to cover correctingvalues, the pressure range given should be as appropriate. As an example, for pressures between 600 hPa and 2 500 hPa, thecorrecting values should be presented in increments of 100 hPa.4.3 Electrical power driven medical devicesMedical devices shall be IPX4 rated according to EN 60529, unless the device is otherwise marked.Life supporting devices shall be capable of operating with 12 VDC power input, see also EN 60601-1.NOTE 1This requirement is deemed essential to interoperability.SIST EN 13718-1:2002
EN 13718-1:2002 (E)9Electrical power driven medical devices shall have a connector that is lockable in order to prevent the risk of short-circuiting.NOTE 2Connectors complying with MIL-C26482 or EN 60309-1, -2 are recommended for this use.The requirements of EN 60601-1 shall apply. In addition the following requirements apply:4.3.1 Medical devices with 12 VDC power inputThe medical device shall be constructed for a voltage of U = 13,8 V. The internal batteries shall be charged in thevoltage range of Uvar = 12,4 V to 15,1 V. It shall operate as specified by the manufacturer.4.3.2 Medical devices with 24 V power inputThe device shall be constructed for a voltage of U = 27,5 V. The internal batteries shall be charged in the voltagerange of Uvar = 24,8 V to 30,3 V. It shall operate as specified by the manufacturer.4.3.3 Internal electrical power sourceMedical devices with internal rechargeable batteries shall be rechargeable using power from the vehicle or craft.NOTE 1Requirements for vehicle or craft are provided in prEN 13718-2 and EN 1789 (see Bibliography).Rechargeable batteries for medical devices shall be “non dangerous”.NOTE 2Batteries are considered to be “non dangerous”, if at a temperature of 55 oC, the electrolyte does not flow from aruptured or cracked case. There should be no free flow of liquid and terminals should be protected from short circuit.NOTE 3Batteries conforming to IATA, UN 2800-A67 fulfil this requirement.4.4 Electromagnetic interference of medical devicesThe level of electromagnetic energy from medical devices shall be specified by the manufacturer (see alsoIntroduction).NOTE 1Relevant minimum requirements for electromagnetic compatibility testing of medical devices intended for ambulancesare provided by annex B. Complying with these tests would allow a comparable compliance to relevant requirements forelectronically powered equipment within aircraft, thereby establishing common test requirements (see 5).NOTE 2Cables can function as antennas and induce disturbances.NOTE 3Relevant requirements for the vehicles and crafts are provided by EN 1789 and prEN 13718-2 (see Bibliography).4.5 Gas-supply4.5.1 GeneralMedical devices supplying medical gases shall conform to relevant European Standards (see clause 2).4.5.2 Source of supplyThe sources of supply for medical gases and vacuum shall conform to relevant clauses of EN 737-3 (as far asapplicable), see also 4.7 and annex A.4.5.3 Gas leakageMeans shall be provided to minimise the leakage of medical gases and vacuum into the environment. Thepermitted leakage from the components of the supply systems to the atmosphere shall be as specified in therelevant European Standards (see clause 2).NOTE
National and/or regional requirements for the protection of workers can be applicable (see Bibliography).SIST EN 13718-1:2002
EN 13718-1:2002 (E)104.5.4 Pressure regulators and flow metering devicesPressure regulators and pressure regulators with flow metering devices shall conform to EN 738-1 orEN 738-3. The pressure regulators shall be directly connected to the source of supply.Flow metering devices for connection to terminal units shall conform to EN 13220.4.5.5 Terminal unitsTerminal units for medical gases or vacuum shall conform to EN 737-1.NOTETerminal units are the outlet assemblies (inlet assemblies for vacuum) at which the operator makes connections anddisconnections.4.5.6 Pneumatic power supplyThe range of the nominal distribution pressure for medical gases shall be 4001000+ kPa; the pressure measured atthe terminal units (if fitted) shall be within ± 10 % of the nominal distribution pressure at a test flow of 40 l/min.For vacuum the nominal distribution pressure shall be 60 kPa absolute pressure; the pressure measured at theterminal units (if fitted) shall not rise to more than 60 kPa absolute pressure at a test flow of25 l/min.4.5.7 Test pressureThe components of the supply systems for medical gases downstream of the pressure regulators shallwithstand a pressure of 1 000 kPa, i.e. twice the maximum nominal distribution pressure of 500 kPa (see4.5.6).NOTEThis pressure is the maximum pressure supplied by pressure regulators conforming with EN 738-1 orEN 738-3 in single fault condition.4.5.8 Cylinder valvesCylinder valves shall conform to EN 849. If pin-index valves are used, their outlet connection shall conform toEN 850.4.5.9 Low pressure hose assembliesLow pressure hose assemblies for connecting medical devices to terminal units shall conform to EN 739. If flexiblehoses are used between the pressure regulators and the terminal units, the requirements ofEN 739:1998 shall apply, except of 5.4.2.1, 5.4.7, 5.4.8 and 5.4.9. The minimum bursting pressure of such hosesshall be not less than 8 000 kPa at 23 oC and not less than 6 400 kPa at 40 oC (see also 59.101.1 b) of EN 793).4.5.10 AlarmsIf alarms are provided as part of the supply systems for medical gases and vacuum, they shall conform to therelevant clauses of EN 737-3 (as far as applicable).4.6 Rail systemsIf rail systems are used, they shall conform to EN 12218.NOTEA typical rail system consists of for example rail supports, rail, rail clamps, equipment mount holders, equipmentmounts and equipment pin holders and equipment mount pins.SIST EN 13718-1:2002
EN 13718-1:2002 (E)114.7 Mechanical strength4.7.1 GeneralWhere no stronger requirements for mechanical strength of medical devices exist, the following requirements shallapply:4.7.2 Vibration and bumpAfter vibration tests and bump test according to annex A, A.1, the medical device shall function within thetolerances specified by the manufacturer.4.7.3 Free fallIf the medical device is fixed, as defined in EN 60601-1:1990, 2.2.12, it is exempted
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