EN 13976-2:2018

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 specifies that the equipment or systems shall not interfere with the functions of the road and air 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 das Transportsysteme

Diese Europäische Norm legt die Anforderungen an ein Inkubatortransportsystem für die Pflege und Behandlung von Säuglingen fest, die bei Notfall- oder geplanten Transporten erforderlich sind.
Sie legt 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 Europäischen Norm ist auch festgelegt, dass die Ausrüstungen oder Systeme nicht die Funktionen des Rettungsdienstfahrzeugs behindern dürfen.
In dieser Europäischen Norm sind keine Anforderungen an die Fahrzeuge, Luftfahrzeuge, Geräte oder Inkubatoren selbst festgelegt, diese Anforderungen finden sich in anderen Normen. Transportinkubatoren sind jedoch üblicherweise mit anderen Geräten verbunden und bilden ein „Inkubatortransportsystem“.

Systèmes de secours - Transport d'incubateurs - Partie 2 : Exigences relatives au système

Reševalni sistemi - Prevoz inkubatorjev - 2. del: Zahteve za sistem

Ta evropski standard določa zahteve za sistem za transport inkubatorja, nujnega za nego in zdravljenje dojenčkov, ki se uporablja pri reševalnih ali načrtovanih prevozih. Določa posebne zahteve za zagotovitev pravilnega delovanja opreme med prevozov (npr. zaslonov, respiratorjev, infuzijskih črpalk, sistemov za zunajtelesno podporo pljuč (ECLS), oskrbe s plinom) in za zagotavljanje varnega prevoza dojenčkov in operaterjev. Ta evropski standard prav tako določa, da oprema ali sistemi ne smejo vplivati na delovanje reševalnega vozila, ki se uporablja za prevoz. Ta evropski standard ne podaja zahtev za sama vozila, objekte, naprave ali inkubatorje; te zahteve so navedene v drugih standardih. Vendar pa se transportni inkubatorji običajno uporabljajo skupaj z drugo opremo, ki sestavlja sistem za transport inkubatorja.

General Information

• Status: Published
• Publication Date: 26-Jun-2018
• Withdrawal Date: 30-Dec-2019
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• ICS: 11.160 - First aid
• Technical Committee: CEN/TC 239 - Rescue systems
• Drafting Committee: CEN/TC 239/WG 4 - Transportation of incubators
• 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 13976-2:2018 - Rescue systems - Transportation of incubators - Part 2: System requirements

Relations

• Replaces: EN 13976-2:2011 - Rescue systems - Transportation of incubators - Part 2: System requirements
• Effective Date: 15-Jul-2018

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 13976-2:2018SIST EN 13976-2:2018en,fr,de01-september-2018SIST EN 13976-2:2018SLOVENSKI
STANDARDSIST EN 13976-2:20111DGRPHãþD



SIST EN 13976-2:2018



EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 13976-2
June
t r s z ICS
s sä r v rä s râ
s sä s x r Supersedes EN
s u { y xæ tã t r s sEnglish Version
Rescue systems æ Transportation of incubators æ Part
tã System requirements Systèmes de sauvetage æ Transport d 5incubateurs æ Partie
tã Exigences relatives au système
Rettungssysteme æ Inkubatortransport æ Teil
tã Anforderungen an Transportsysteme This European Standard was approved by CEN on
v September
t r s yä
egulations which stipulate the conditions for giving this European Standard the status of a national standard without any alterationä Upætoædate lists and bibliographical references concerning such national standards may be obtained on application to the CENæCENELEC Management Centre or to any CEN memberä
translation under the responsibility of a CEN member into its own language and notified to the CENæCENELEC Management Centre has the same status as the official versionsä
CEN members are the national standards bodies of Austriaá Belgiumá Bulgariaá Croatiaá Cyprusá Czech Republicá Denmarká Estoniaá Finlandá Former Yugoslav Republic of Macedoniaá Franceá Germanyá Greeceá Hungaryá Icelandá Irelandá Italyá Latviaá Lithuaniaá Luxembourgá Maltaá Netherlandsá Norwayá Polandá Portugalá Romaniaá Serbiaá Slovakiaá Sloveniaá Spainá Swedená Switzerlandá Turkey and United Kingdomä
EUROPEAN COMMITTEE FOR STANDARDIZATION COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre:
Rue de la Science 23,
B-1040 Brussels
9
t r s z CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Membersä Refä Noä EN
s u { y xæ tã t r s z ESIST EN 13976-2:2018



EN 13976-2:2018 (E) 2 Contents Page European foreword . 3 Introduction . 4 1 Scope . 5 2 Normative references . 5 3 Terms and definitions . 6 4 General requirements . 6 4.1 System combination . 6 4.2 Suspension/noise/comfort (shock-absorption) . 6 4.3 Temperature conditions . 7 4.4 Ingress of liquids . 7 4.5 Vibration . 7 4.6 Mechanical integrity . 7 4.7 EMC . 7 4.8 Mass . 7 4.9 Electricity . 8 4.10 Fixation of component parts .
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