SIST EN 13976-1:2011
(Main)Rescue systems - Transportation of incubators - Part 1: Interface conditions
Rescue systems - Transportation of incubators - Part 1: Interface conditions
This European Standard specifies the requirements for the interface between the ambulance and the incubator and the associated equipment, needed for care and treatment of infants, used in emergency or planned transports to ensure interchangeability and interoperability and to provide uninterrupted care of patients. This European Standard does not give requirements for the vehicles, crafts, devices or incubators as such; these requirements are found in other standards. However, transport incubators are normally combined with other equipment to form a "transport incubator system".
Rettungssysteme - Inkubatortransport - Teil 1: Anforderungen an Schnittstellen
Diese Europäische Norm legt die Anforderungen an die Schnittstellen zwischen dem Fahrzeug oder Luftfahrzeug und dem Inkubator sowie der dazugehörigen Ausrüstung fest, die bei Notfall oder geplanten Transporten für die Pflege und Behandlung von Säuglingen erforderlich ist.
In dieser Norm sind keine Anforderungen an die Fahrzeuge, Luftfahrzeuge, Geräte oder Inkubatoren selbst festgelegt, diese Anforderungen finden sich in anderen Normen. Transportinkubatoren sind jedoch üblicher-weise mit anderen Geräten verbunden und bilden ein „Inkubatortransportsystem“.
Systèmes de sauvetage - Transport d'incubateurs - Partie 1: Conditions d'interface
La présente Norme européenne spécifie les exigences pour l'interface entre l'ambulance et l'incubateur et les équipements associés, nécessaires pour les soins et le traitement des nourrissons, utilisés dans les transports d'urgence ou prévues pour assurer l'interchangeabilité et l'interopérabilité et fournir des soins sans interruption aux patients.
La présente Norme européenne ne donne pas de prescriptions pour les véhicules, les embarcations, les dispositifs ou les incubateurs en tant que tels, ces exigences se trouvent dans d'autres normes. Toutefois, les incubateurs de transport sont généralement combinés avec d'autres équipements pour former un "système d’incubateur de transport".
Reševalni sistemi - Prevoz inkubatorjev - 1. del: Vmesni pogoji
Ta evropski standard določa zahteve za vmesnik med reševalnim vozilom in inkubatorjem ter pripadajočo opremo, potrebno za nego in zdravljenje dojenčkov, uporabljeno v urgentnih ali načrtovanih prevozih, za zagotavljanje zamenljivosti in interoperabilnosti ter za neprekinjeno nego bolnika. Ta evropski standard ne podaja zahtev za vozila, plovila, naprave ali inkubatorje kot take; te zahteve so v drugih standardih. Vendar so transportni inkubatorji po navadi kombinirani z drugo opremo, da tvorijo »transportni inkubatorski sistem«.
General Information
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Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Reševalni sistemi - Prevoz inkubatorjev - 1. del: Vmesni pogojiRettungssysteme - Inkubatortransport - Teil 1: Anforderungen an SchnittstellenSystèmes de sauvetage - Transport d'incubateurs - Partie 1: Conditions d'interfaceRescue systems - Transportation of incubators - Part 1: Interface conditions11.160First aid11.040.10Anestezijska, respiratorna in reanimacijska opremaAnaesthetic, respiratory and reanimation equipmentICS:Ta slovenski standard je istoveten z:EN 13976-1:2011SIST EN 13976-1:2011en,fr,de01-julij-2011SIST EN 13976-1:2011SLOVENSKI
STANDARDSIST EN 13976-1:20041DGRPHãþD
SIST EN 13976-1:2011
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 13976-1
May 2011 ICS 11.040.10; 11.160 Supersedes EN 13976-1:2003English Version
Rescue systems - Transportation of incubators - Part 1: Interface conditions
Systèmes de sauvetage - Transport d'incubateurs - Partie 1: Conditions d'interface
Rettungssysteme - Inkubatortransport - Teil 1: Anforderungen an Schnittstellen This European Standard was approved by CEN on 14 April 2011.
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, 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 STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2011 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 13976-1:2011: ESIST EN 13976-1:2011
EN 13976-1:2011 (E) 2 Contents Page Foreword .3Introduction .41 Scope .52 Normative references .53 Terms and definitions .64 Requirements .84.1 Interface between transport incubator system and ambulance .84.1.1 Fixation .84.1.2 Electricity .84.1.3 Gas supply .9Annex A (informative)
Rationale regarding power use . 10Annex ZA
(informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices . 11Bibliography . 12 SIST EN 13976-1:2011
EN 13976-1:2011 (E) 3 Foreword This document (EN 13976-1:2011) has been prepared by Technical Committee CEN/TC 239 “Rescue systems”, the secretariat 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 or by endorsement, at the latest by November 2011, and conflicting national standards shall be withdrawn at the latest by November 2011. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights. This document supersedes EN 13976-1:2003. This document has been prepared under a mandate given to CEN by the European Commission and the European Free 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. EN 13976-1:2003 has been technically revised. The following points represent the most important changes in the revision: 1) clarified ambiguous and unclear issues between the two parts (requirements for the transport incubator system interface conditions and system requirements, respectively); 2) proposed items in order to improve fixation, interchangeability and interoperability of the transport incubator system when transported in hospitals and between hospitals using different ambulances and air crafts; 3) adapted the standard to developments in neonatal intensive care; 4) excluded proposals on standards for stretchers, vehicles or medical devices. EN 13976 consists of the following parts, under the general title: Rescue systems — Transportation of incubators: Part 1: Interface conditions Part 2: System requirements. 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom.
SIST EN 13976-1:2011
EN 13976-1:2011 (E) 4 Introduction This European Standard gives the requirements for the interfaces required in the transport of a transport incubator system. The standard include interfaces between the incubator and the ambulance as well as those between the various items of equipment used to make up the transport incubator system. They are essential in order to ensure interchangeability and a safe and effective function in different vehicles, allowing the uninterrupted care of patients. Requirements for interface conditions are given in this part 1 (EN 13976-1). Requirements for the system are given in part 2 (EN 13976-2). Fixation, monitoring, supply of gas and electricity are maintained through the use of the same standard interfaces as defined in this document.
SIST EN 13976-1:2011
EN 13976-1:2011 (E) 5 1 Scope This European Standard specifies the requirements for the interface between the ambulance and the incubator and the associated equipment, needed for care and treatment of infants, used in emergency or planned transports to ensure interchangeability and interoperability and to provide uninterrupted care of patients. This European Standard does not give requirements for the vehicles, crafts, devices or incubators as such; these requirements are found in other standards. However, transport incubators are normally combined with other equipment to form a "transport incubator system". 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ENV 737-6, Medical gas pipeline systems — Part 6: Dimensions and allocation of probes for terminal units for compressed medical gases and vacuum EN 1789, Medical vehicles and their equipment — Road ambulances EN 13718-1, Medical vehicles and their equipment — Air Ambulances — Part 1: Requirements for medical devices used in air ambulances EN 13718-2, Medical vehicles and their equipment — Air Ambulances — Part 2: Operational and technical requirements of air ambulances EN 60309-1, Plugs, socket-outlets and couplers for industrial purposes — Part 1: General requirements
(IEC 60309-1:1999) EN 60309-2, Plugs, socket-outlets and couplers for industrial purposes — Part 2: Dimensional interchangeability requirements for pin and contact-tube accessories (IEC 60309-2:1999) EN 60601-2-20, Medical electrical equipment — Part 2-20: Particular requirements for basic safety and essential performance of infant transport incubators (IEC 60601-2-20:2009) EN ISO 407, Small medical gas cylinders — Pin-index yoke-type valve connections (ISO 407:2004) EN ISO 7396-1:2007, Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2007) EN ISO 7396-2:2007, Medical gas pipeline systems — Part 2: Anaesthetic gas scavenging disposal systems (ISO 7396-2:2007) EN ISO 9170-1, Terminal units for medical gas pipeline systems — Part 1: Terminal units for use with compressed medical gases and vacuum (ISO 9170-1:2008) MS 33601, Track and Stud Fitting for Cargo Transport Aircraft, Standard Dimensions for FSC 1560
SIST EN 13976-1:2011
EN 13976-1:2011 (E) 6 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 interfa
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