EN 13718-1:2014
(Main)Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances
Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for 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 an medizinische Geräte fest, die in Luftfahrzeugen 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 an die Ausbildung des Personals, die in der Zuständigkeit der Behörde(n) des Landes liegt, in dem 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 v ambulantnih zračnih vozilih
Ta evropski standard določa splošne zahteve za medicinsko opremo, ki se prevaža v ambulantnih zračnih vozilih in uporablja v teh vozilih ter zunaj bolnišnic in klinik v primerih, v katerih obstaja možnost, da se okoljski pogoji razlikujejo od običajnih notranjih pogojev.
Ta evropski standard ne obravnava zahtev za odobritev in registracijo vozila ter usposabljanje osebja, za kar je odgovoren organ oz. organi v državi, v kateri bo ambulantno vozilo registrirano.
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Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.LKMedizinische 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 for medical devices used in air ambulances49.020Letala in vesoljska vozila na splošnoAircraft and space vehicles in general11.160First aidICS:Ta slovenski standard je istoveten z:EN 13718-1:2014SIST EN 13718-1:2015en,fr,de01-januar-2015SIST EN 13718-1:2015SLOVENSKI
STANDARDSIST EN 13718-1:20081DGRPHãþD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 13718-1
September 2014 ICS 11.040.01; 11.160; 49.020 Supersedes EN 13718-1:2008English Version
Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances
Véhicules sanitaire et leur équipement - 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 werdenThis European Standard was approved by CEN on 25 July 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 © 2014 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 13718-1:2014 ESIST EN 13718-1:2015
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices . 13 Bibliography . 15
normative references were updated; b) the following terms and definitions were deleted: 3.3 "HEMS flight", 3.4 "air ambulance flight", 3.5 "non-dedicated aircraft for patient transportation", 3.6 "HICAMS flight", 3.7 "fixed wing air ambulance", 3.10 "interchangeability", 3.11 "flight crew", 3.12 "medical crew"; c) a new Subclause 4.5.4 "Medical devices with 230 V AC power input" was introduced; d) Subclause 4.4.5 "Inverters" was deleted; e) Subclause 4.5.4 "Pneumatic power supply" (now Subclause 4.6.4) was revised; f) Subclause 4.8 "Fire resistance" (now Subclause 4.9) was revised; g)
unclear issues were clarified in this part of the standard and between the two parts of the standard (requirements for patient's compartment illumination, respectively); h)
the standard was 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 ambulances: — 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. SIST EN 13718-1:2015
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