SIST EN 13976-2:2011
(Main)Rescue systems - Transportation of incubators - Part 2: System requirements
Rescue systems - Transportation of incubators - Part 2: System requirements
This European Standard specifies the requirements for a transport incubator system needed for care and treatment of infants, used in emergency or planned transport. It specifies the particular requirements needed to ensure the proper function of equipment during transportation (e.g. monitors, respirators, infusion pumps, extra corporeal lung support- (ECLS-) systems, gas supply) and to provide safe transportation for infants and operators.
This European Standard also stipulates that the equipment or systems shall not interfere with the functions of the ambulance providing transportation.
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 2: Anforderungen an Transportsysteme
Diese Europäische Norm legt die Anforderungen an ein Inkubatortransportsystem einschließlich der Wechselbeziehungen zwischen dem Fahrzeug und dem Inkubator sowie der dazugehörigen Ausrüstung fest, die bei Notfall oder geplanten Transporten für die Pflege und Behandlung von Säuglingen erforderlich ist.
Sie legt auch die besonderen Anforderungen fest, die zur Sicherstellung der einwandfreien Funktion der Ausrüstung (z. B. Überwachungsgeräte, Beatmungsgeräte, Infusionspumpen, Systeme zur extrakorporalen Lungenunterstützung (en: extra corporeal lung supportsystem, ECLS), Versorgung mit Gasen) während des Transports und für einen sicheren Transport von Säuglingen und Personal gestellt werden müssen.
In dieser Norm ist auch festgelegt, dass die Ausrüstungen oder Systeme nicht störend in die Funktionen des Fahrzeugs eingreifen dürfen.
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 normalerweise mit anderen Geräten verbunden und bilden ein „Inkubatortransportsystem“.
Systèmes de sauvetage - Transport d'incubateurs - Partie 2: Exigences relatives au système
Reševalni sistemi - Prevoz inkubatorjev - 2. del: Zahteve za sistem
Ta evropski standard določa zahteve za transportni inkubatorski sistem, potreben za nego in zdravljenje dojenčkov, ki se uporablja v urgentnem ali načrtovanem prevozu. Določa posebne zahteve, potrebne za zagotovitev pravilnega delovanja opreme med prevozom (npr. zasloni, respiratorji, infuzijske črpalke, sistemi zunajtelesne mehanske podpore pljuč in srca (ECLS-), oskrba s plinom) ter zagotavljanje varnega prevoza za dojenčke in kirurge.
Ta evropski standard prav tako določa, da oprema ali sistemi ne smejo motiti funkcij reševalnega vozila med prevozom.
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 - 2. del: Zahteve za sistemRettungssysteme - Inkubatortransport - Teil 2: Anforderungen an TransportsystemeSystèmes de sauvetage - Transport d'incubateurs - Partie 2: Exigences relatives au systèmeRescue systems - Transportation of incubators - Part 2: System requirements11.160First aid11.040.10Anestezijska, respiratorna in reanimacijska opremaAnaesthetic, respiratory and reanimation equipmentICS:Ta slovenski standard je istoveten z:EN 13976-2:2011SIST EN 13976-2:2011en,fr,de01-julij-2011SIST EN 13976-2:2011SLOVENSKI
STANDARDSIST EN 13976-2:2004/AC:2005SIST EN 13976-2:20041DGRPHãþD
SIST EN 13976-2:2011
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 13976-2
May 2011 ICS 11.040.10; 11.160 Supersedes EN 13976-2:2003English Version
Rescue systems - Transportation of incubators - Part 2: System requirements
Systèmes de sauvetage - Transport d'incubateurs - Partie 2: Exigences relatives au système
Rettungssysteme - Inkubatortransport - Teil 2: Anforderungen an Transportsysteme 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 13976-2:2011: ESIST EN 13976-2:2011
EN 13976-2:2011 (E) 2 Contents Page Foreword .3Introduction .41 Scope .52 Normative references .53 Terms and definitions .64 General requirements .64.1 System combination .64.2 Suspension/noise/comfort (shock-absorption) .64.3 Temperature conditions .64.4 Ingress of liquids .64.5 Vibration .64.6 Mechanical integrity .64.7 EMC .74.8 Mass .74.9 Electricity .74.10 Fixation of component parts .74.11 Modifications .7Annex A (informative)
Ergonomics .8A.1 Space .8A.2 Loading .8Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices .9Bibliography . 10 SIST EN 13976-2:2011
EN 13976-2:2011 (E) 3 Foreword This document (EN 13976-2:2011) 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 13976-2:2003. 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 13976-2:2003 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 13976-2:2011
EN 13976-2:2011 (E) 4 Introduction This European Standard gives the requirements for a transport incubator system that will ensure its interchangeability as well as its safe and effective function in different vehicles or crafts. Such systems are essential in allowing the uninterrupted care of patients. Requirements for interface conditions are given in part 1 (EN 13976-1). SIST EN 13976-2:2011
EN 13976-2:2011 (E) 5 1 Scope This European Standard specifies the requirements for a transport incubator system needed for care and treatment of infants, used in emergency or planned transport. It specifies the particular requirements needed to ensure the proper function of equipment during transportation (e.g. monitors, respirators, infusion pumps, extra corporeal lung support- (ECLS-) systems, gas supply) and to provide safe transportation for infants and operators. This European Standard also stipulates that the equipment or systems shall not interfere with the functions of the ambulance providing transportation. 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. EN 1789, Medical vehicles and their equipment — Road ambulances EN 1865 (all parts), Patient handling equipment used in 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 13976-1:2011, Rescue systems — Transportation of incubators — Part 1: Interface conditions EN 60601-1, Medical electrical equipment — Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005) EN 60601-1-2, Medical electrical equipment — Part 1-2: General requirements for basic safety and essential performance — Collateral standard: Electromagnetic compatibility — Requirements and tests
(IEC 60601-1-2:2007, modified) 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) RTCA DO 160, Radio Technical Commission for Aeronautics — Environmental conditions and test procedures for airborne equipment (corresponding to EUROCAE ed-14) [publication available at the RTCA Secretariat, Suite 500, 1425 K Street, N.W. Washington DC, 20005, USA] RTCA DO 199, Radio Technical Commission for Aeronautics — Potential interference to aircraft electronic equipment from devices carried on board [publication available at the RTCA Secretariat, Suite 500, 1425 K Street, N.W. Washington DC, 20005, USA] SIST EN 13976-2:2011
EN 13976-2:2011 (E) 6 3 Terms and definitions
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