EN 13718-1:2008

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• Status: Withdrawn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: 16-Sep-2014
• ICS: 11.040.01 - Medical equipment in general
• ICS: 11.160 - First aid
• ICS: 49.020 - Aircraft and space vehicles in general
• 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
• Completion Date: 17-Sep-2014
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN 13718-1:2008 - Medical vehicles and their equipment - Air Ambulances - Part 1: Requirements of medical devices used in air ambulances

Relations

• Replaces: EN 13718-1:2002 - Air, water and difficult terrain ambulances - Part 1: Medical device interface requirements for the continuity of patient care
• Effective Date: 22-Dec-2008
• Replaced By: EN 13718-1:2014 - Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances
• Effective Date: 24-Sep-2014

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
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