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
1) EN 13718-2:2008 is bound to be superseded with a new edition. SIST EN 13718-1:2015
2) This document is a material copyrighted by RTCA, Inc. and used with permission: RTCA, Inc. 1150 18th Street NW Suite 910 Washington, DC 20036 (202) 833-9339 http://www.rtca.org/ It is available on the RTCA store: http://www.rtca.org/store_product.asp?prodid=770. SIST EN 13718-1:2015
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Frequently Asked Questions
EN 13718-1:2014 is a standard published by the European Committee for Standardization (CEN). Its full title is "Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances". This standard covers: 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.
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.
EN 13718-1:2014 is classified under the following ICS (International Classification for Standards) categories: 11.040.01 - Medical equipment in general; 11.160 - First aid; 49.020 - Aircraft and space vehicles in general. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 13718-1:2014 has the following relationships with other standards: It is inter standard links to EN 13718-1:2008, EN 13718-1:2014+A1:2020, EN 13718-1:2014/FprA1. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 13718-1:2014 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC; Standardization Mandates: M/023. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
You can purchase EN 13718-1:2014 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of CEN standards.
記事のタイトル：EN 13718-1:2014 - 医療車両およびその装置 - 航空救急 - 第1部：航空救急で使用される医療機器の要件 記事の内容：この欧州規格は、航空救急で携行され、医療機器として使用される機器の一般的な要件を定めています。また、病院やクリニック以外での使用や、通常の室内環境とは異なる環境条件下での使用にも適用されます。 ただし、車両の承認と登録の要件やスタッフの訓練については、救急車両が登録される国の機関の責任であり、この規格では取り扱われていません。
The article discusses EN 13718-1:2014, a European Standard that outlines the requirements for medical devices used in air ambulances. These requirements apply to devices used both inside and outside of hospitals and clinics, taking into consideration the differing ambient conditions in air ambulances. However, it does not cover the approval and registration process for the vehicles, nor the training of staff, which are the responsibilities of the authorities in the respective countries where the ambulances will be registered.
제목: EN 13718-1:2014 - 의료 차량 및 그들의 장비 - 공중 구급차 - 제1부: 공중 구급차에서 사용되는 의료 기기에 대한 요구 사항 내용: 이 유럽 표준은 공중 구급차에 운반되고 그 안에서 사용되는 의료 기기에 대한 일반적인 요구 사항을 명시합니다. 또한 이 표준은 실내 조건과 다른 주변 환경 조건이 있는 병원과 성소 내외에서 사용될 경우에 적용됩니다. 이 유럽 표준은 구급차의 승인 및 등록 요건, 그리고 승무원의 교육에 대한 요구 사항을 다루지 않습니다. 이러한 사항들은 구급차가 등록될 국가의 관계 권한 기관의 책임이 있습니다.
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