EN 13976-2:2011

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 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 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

• Status: Withdrawn
• Publication Date: 17-May-2011
• Withdrawal Date: 26-Jun-2018
• 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
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 27-Jun-2018
• 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 13976-2:2011 - Rescue systems - Transportation of incubators - Part 2: System requirements

Relations

• Replaces: EN 13976-2:2003/AC:2004 - Rescue systems - Transportation of incubators - Part 2: System requirements
• Effective Date: 21-May-2011
• Replaces: EN 13976-2:2003 - Rescue systems - Transportation of incubators - Part 2: System requirements
• Effective Date: 21-May-2011
• Replaced By: EN 13976-2:2018 - 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 13976-2:2011SIST 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 .
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