SIST EN 13976-2:2018

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 . 8 4.11 Infant restraint system. 8 4.12 Modifications . 8 Annex A (informative)
Ergonomics . 9 A.1 Space . 9 A.2 Loading. 9 Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered . 10 Bibliography . 11
SIST EN 13976-2:2018



EN 13976-2:2018 (E) 3 European foreword This document (EN 13976-2:2018) 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 December 2018, and conflicting national standards shall be withdrawn at the latest by December 2019. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN not be held responsible for identifying any or all such patent rights. 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. This document supersedes EN 13976-2:2011. The following points represent the most important technical changes in the revision: a) clarified unclear issues about mass of the transport incubator system; b) a requirement for the infant restraint system was included. EN 13976 consists of the following parts, under the general title Rescue systems — Transportation of incubators: — Part 1: Interface requirements — 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. SIST EN 13976-2:2018



EN 13976-2:2018 (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 infants. Interface requirements are given in part 1 (EN 13976-1). SIST EN 13976-2:2018



EN 13976-2:2018 (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 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”. 2 Normative references The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. EN 1789:2007+A2:2014, Medical vehicles and their equipment — Road ambulances EN 1865-1:2010+A1:2015, Patient handling equipment used in road ambulances — Part 1: General stretcher systems and patient handling equipment EN 1865-2:2010+A1:2015, Patient handling equipment used in road ambulances — Part 2: Power assisted stretcher EN 13718-1:2014, Medical vehicles and their equipment — Air ambulances — Part 1: Requirements for medical devices used in air ambulances EN 13718-2:2015, Medical vehicles and their equipment — Air ambulances — Part 2: Operational and technical requirements for air ambulances EN 13976-1:2018, Rescue systems — Transportation of incubators — Part 1: Interface requirements EN 60529:1991,1 Degrees of protection provided by enclosures (IP Code) (IEC 60529:1989 + A1:1999 + A2:2013) EN 60601-1:2006,2 Medical electrical equipment — Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005+Cor.:2006+Cor.:2007+A1:2012) EN 60601-1-2:2015, Medical electrical equipment — Part 1-2: General requirements for basic safety and essential performance — Collateral Standard: Electromagnetic disturbances — Requirements and tests (IEC 60601-1-2:2014)
1 As impacted by EN 60529:1991/corrigendum May 1993, EN 60529:1991/A1:2000, EN 60529:1991/A2:2013 and EN 60529:1991/AC:2016-2. 2 As impacted by EN 60601-1:2006/corrigendum Mar. 2010, EN 60601-1:2006/A1:2013, EN 60601-1:2006/A1:2013/AC:2014 and EN 60601-1:2006/A12:2014 SIST EN 13976-2:2018



EN 13976-2:2018 (E) 6 EN 60601-1-12:2015, Medical electrical equipment — Part 1-12: General requirements for basic safety and essential performance — Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment (IEC 60601-1-12:2014) EN 60601-2-20:2009, Medical electrical equipment — Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators (IEC 60601-2-20:2009) European Aviation Safety Agency (EASA) Certification Specifications CS-23, Normal, Utility, Aerobatic, and Commuter Category Aeroplanes3 European Aviation Safety Agency (EASA) Certification Specifications CS-25, Large Aeroplanes3 European Aviation Safety Agency (EASA) Certification Specifications CS-27, Small Rotorcraft3 European Aviation Safety Agency (EASA) Certification Specifications CS-29, Large Rotorcraft3 RTCA DO 160G:2010, Radio Technical Commission for Aeronautics — Environmental conditions and test procedures for airborne equipment4 3 Terms and definitions For the purposes of this document, the terms and definitions given in EN 13976-1:2018 apply. 4 General requirements 4.1 System combination Requirements for interfaces are found in EN 13976-1:2018 and basic requirements for transport incubators are described in EN 60601-2-20:2009. Any medical device which is part of the transport incubator system shall be designed for use with neonates and infants and for use during transportation. The transport should be performed minimizing manual lifting, lowering or carrying by personnel. All of the equipment that is part of the system shall be tested according to the existing standards relevant to the type of vehicle in which it is to be used. Equipment that is part of the transport incubator system shall be specified by the manufacturer as having an intended use in transportation by road and air ambulances and labelled according to the standard. NOTE Basic requirements for vehicles used as ambulances and medical devices in these vehicles are described in EN 1789:2007+A2:2014 for road ambulances, in EN 13718–1:2014 and EN 13718–2:2015 for air ambulances and in EN 1865 series 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 specified in EN 60601-2-20:2009.
3 EASA constitutes the European g
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