EN 13718-1:2008
(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 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
- Status
- Withdrawn
- Publication Date
- 12-Aug-2008
- Withdrawal Date
- 13-Apr-2025
- Technical Committee
- CEN/TC 239 - Rescue systems
- Drafting Committee
- CEN/TC 239/WG 5 - Air, water and difficult terrain ambulances
- Current Stage
- 9960 - Withdrawal effective - Withdrawal
- Start Date
- 17-Sep-2014
- Completion Date
- 14-Apr-2025
Relations
- Effective Date
- 22-Dec-2008
- Effective Date
- 24-Sep-2014
Frequently Asked Questions
EN 13718-1:2008 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 13718-1:2008 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 13718-1:2008 has the following relationships with other standards: It is inter standard links to EN 13718-1:2002, EN 13718-1:2014. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 13718-1:2008 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.
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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
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
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
(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
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
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
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
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The article discusses EN 13718-1:2008, a European Standard that outlines the requirements for medical devices used in air ambulances. These requirements apply to situations where the ambient conditions differ from normal indoor conditions. It's important to note that the standard does not cover the approval and registration of the vehicle or the training of the staff, as these responsibilities fall under the authority/authorities in the country where the ambulance is being registered.
記事のタイトル：EN 13718-1:2008 - 医療車両とその装備 - エアアンブランス - 第1部：エアアンブランス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、エアアンブランスで搬送され、および通常の屋内条件と異なる状況で使用される医療機器の一般的な要件を定めています。 この欧州規格は、車両の承認および登録の要件やスタッフの訓練については扱っていません。これらの責任は、アンブランスが登録される国の当局/機関に帰属します。
기사 제목: EN 13718-1:2008 - 의료차량 및 그 장비 - 항공 구급차 - 제 1부: 항공 구급차에서 사용되는 의료 장비에 대한 요구 사항 기사 내용: 이 유럽 표준은 항공 구급차에 탑재되고 그 안에서 사용되는 의료 장비에 대한 일반 요구 사항을 명시합니다. 이 요구 사항은 주변 조건이 일반 실내 조건과 다를 수 있는 병원 및 클리닉 외부에서 사용되는 상황을 대상으로 합니다. 이 유럽 표준은 차량의 승인 및 등록 요구 사항 및 임직원의 교육을 다루지 않습니다. 차량 등록을 담당하는 국가의 권한 기관의 책임입니다.
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