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
20-Jan-2026
Technical Committee
CEN/TC 239 - Rescue systems
Current Stage
9960 - Withdrawal effective - Withdrawal
Start Date
27-Jun-2018
Completion Date
21-Jan-2026

Relations

Effective Date
21-May-2011
Effective Date
21-May-2011
Effective Date
15-Jul-2018
Effective Date
28-Jan-2026
Effective Date
28-Jan-2026
Effective Date
28-Jan-2026
Effective Date
28-Jan-2026
Effective Date
28-Jan-2026
Effective Date
28-Jan-2026
Effective Date
28-Jan-2026

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Frequently Asked Questions

EN 13976-2:2011 is a standard published by the European Committee for Standardization (CEN). Its full title is "Rescue systems - Transportation of incubators - Part 2: System requirements". This standard covers: 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.

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.

EN 13976-2:2011 is classified under the following ICS (International Classification for Standards) categories: 11.040.10 - Anaesthetic, respiratory and reanimation equipment; 11.160 - First aid. The ICS classification helps identify the subject area and facilitates finding related standards.

EN 13976-2:2011 has the following relationships with other standards: It is inter standard links to EN 13976-2:2003/AC:2004, EN 13976-2:2003, EN 13976-2:2018, EN 1865-3:2012, EN 1865-2:2024, EN 1865-6:2024, EN 1789:2020+A1:2023, EN 1865-4:2012, EN 1865-5:2012, EN 13718-2:2015. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.

EN 13976-2:2011 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC; Standardization Mandates: M/023. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.

EN 13976-2:2011 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.

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

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

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 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.
(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
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