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 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«.
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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
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
NOTE Basic requirements for vehicles used as ambulances and medical devices in these vehicles are described in EN 1789 for road ambulances, in EN 13718-1 and EN 13718-2 for air ambulances and in EN 1865 for stretchers. 4.2 Suspension/noise/comfort (shock-absorption) Ear defenders for the infants shall be used during all transports. Noise from additional equipment shall not exceed 60 dB(A) as set by EN 60601-2-20. NOTE Vibration and noise can interfere with the general comfort and well-being of infants. Therefore the vibration to which they are exposed should be as low as possible. The transportation of the baby should be at an appropriate speed to ensure the comfort of the baby. High speeds are rarely necessary. 4.3 Temperature conditions 4.3.1 The transport incubator system shall comply with the relevant requirements of EN 60601-2-20 as a minimum standard with regard to controlling the internal temperature. 4.3.2 Where the transport incubator system is to be used at extremes of temperature, additional test data shall be supplied in the accompanying documents. These should include, where relevant, information about operation during exposure up to + 40 °C for 15 min and –30 °C for 15 min. The effect of wind chill at intermediate temperatures should be considered. 4.4 Ingress of liquids All equipment forming part of the transport incubator system shall be drip-proof according to EN 60601-2-20. If the equipment complies with this standard only with an additional accessory or procedure, the manufacturer shall describe in the accompanying documents how to comply with this standard. 4.5 Vibration All equipment forming part of the transport incubator system shall comply with EN 1789 or EN 13718-1 and EN 13718-2. 4.6 Mechanical integrity All equipment forming part of the transport incubator system shall comply with EN 60601-1.
The manufacturer should include the requirement for mutual compatibility assessments in the instru
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