EN 13976-2-2018 en Rescue systems - Transportation of incubators - Part 2 System requirements.pdf

1、BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06Rescue systems - Transportation of incubatorsPart 2: System requirementsBS EN 139762:2018EUROPEANSTANDARDNORME EUROPENNE EUROPISCHE NORMEN 13976-2 June 2018ICS 11.040.10; 11.160 Supersedes EN 13976-2:2011EnglishVersionR

2、escue systems - Transportation of incubators - Part 2: System requirementsSystmes de sauvetage - Transport dincubateurs -Partie 2: Exigences relatives ausystmeRettungssysteme - Inkubatortransport - Teil2: Anforderungen an TransportsystemeThis European Standard was approved by CEN on 4 September 2017

3、CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving thisEuropean Standard the status of a national standard without any alteration.Up-to-date lists and bibliographical referencesconcerning such national standards may be obtained on app

4、lication 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 bytranslation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Ma

5、nagementCentre has the same status as the officialversions.CEN members are the nationalstandards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,

6、 Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGCEN-CENELEC Management Centre: Rue de la

7、Science 23, B-1040 Brussels 2018 CEN All rights of exploitation in any form and by any means reservedworldwide for CENnational Members.Ref. No. EN 13976-2:2018 ENational forewordThis British Standard is the UK implementation of EN 139762:2018. It supersedes BS EN 139762:2011, which will be withdrawn

8、 on 31 December 2019.The UK participation in its preparation was entrusted to Technical Committee CH/239, Rescue systems.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a co

9、ntract. Users are responsible for its correct application. The British Standards Institution 2018 Published by BSI Standards Limited 2018ISBN 978 0 580 92494 1ICS 11.040.10; 11.160Compliance with a British Standard cannot confer immunity from legal obligations. This British Standard was published un

10、der the authority of the Standards Policy and Strategy Committee on 31 July 2018.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN 139762:2018EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 13976-2 June 2018 ICS 11.040.10; 11.160 Supersedes EN 13976-2:2011Eng

11、lish Version Rescue systems - Transportation of incubators - Part 2: System requirements Systmes de sauvetage - Transport dincubateurs - Partie 2: Exigences relatives au systme Rettungssysteme - Inkubatortransport - Teil 2: Anforderungen an Transportsysteme This European Standard was approved by CEN

12、 on 4 September 2017. 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 standard

13、s 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 notif

14、ied 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Ice

15、land, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENE

16、LEC Management Centre: Rue de la Science 23, B-1040 Brussels 2018 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 13976-2:2018 EBS EN 139762:2018EN 13976-2:2018 (E) 2 Contents Page European foreword . 3 Introduction 4 1 Scope 5 2 N

17、ormative 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.

18、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

19、10 Bibliography . 11 BS EN 139762:2018EN 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

20、 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

21、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 infor

22、mative 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 restra

23、int 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

24、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

25、 Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. BS EN 139762:2018EN 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 it

26、s 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). BS EN 139762:2018EN 13976-2:2018 (E) 5 1 Scope This European Standard specifies the requirements for a tra

27、nsport 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-

28、) 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 fo

29、r 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 normativel

30、y 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 amb

31、ulances 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

32、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: Interfa

33、ce requirements EN 60529:1991,1Degrees of protection provided by enclosures (IP Code) (IEC 60529:1989 + A1:1999 + A2:2013) EN 60601-1:2006,2Medical 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

34、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) 1As impacted by EN 60529:1991/corrigendum May 1993, EN 60529:1991/A1:2000, EN 60529:1991/A2:2013

35、 and EN 60529:1991/AC:2016-2. 2As 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 BS EN 139762:2018EN 13976-2:2018 (E) 6 EN 60601-1-12:2015, Medical electrical equipment Part 1-12: General requirements for basic

36、 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

37、 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 Aeroplanes3European Aviation Safety Agency (EASA) Certification Specificat

38、ions CS-25, Large Aeroplanes3European Aviation Safety Agency (EASA) Certification Specifications CS-27, Small Rotorcraft3European Aviation Safety Agency (EASA) Certification Specifications CS-29, Large Rotorcraft3RTCA DO 160G:2010, Radio Technical Commission for Aeronautics Environmental conditions

39、and test procedures for airborne equipment43 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

40、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. Al

41、l 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

42、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 137181:2014 and EN 137182:2015 for air ambulances and in EN 1865 series for s

43、tretchers. 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. 3EASA constitutes the European governments transport aircraft airworthiness appr

44、oval Regulations, and can be obtained from: European Aviation Safety Agency (EASA), Otto Platz 1, Postfach 101253, D-50452 Cologne, Germany, or at www.easa.europa.eu. 4Publication available at the RTCA Secretariat, Suite 500, 1425 K Street, N.W. Washington DC, 20005, USA http:/www.rtca.org/ BS EN 13

45、9762:2018EN 13976-2:2018 (E) 7 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 should be at an appropriate speed to ensure the comfort of the infant. High speeds

46、are rarely necessary. 4.3 Temperature conditions 4.3.1 The transport incubator system shall comply with the relevant requirements of EN 60601-2-20:2009 as a minimum standard with regard to controlling the internal temperature. 4.3.2 If the transport incubator system is to be used at extremes of temp

47、erature, 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 liq

48、uids All equipment forming part of the transport incubator system shall comply to IPX3 according to EN 60529:19915. If the equipment complies with this standard with an additional accessory or procedure, the manufacturer shall describe in the accompanying documents how to comply with this standard.

49、4.5 Vibration All equipment forming part of the transport incubator system shall comply with EN 1789:2007+A2:2014 or EN 13718-1:2014. 4.6 Mechanical integrity All equipment forming part of the transport incubator system shall comply with EN 60601-1:20066. EN 60601-2-20:2009 applies for transport incubators. EN 60601-1-12:2015 applies for hand-held equipment. 4.7 EMC All equipment forming part of the transport incubator system shall comply with EN 60601-1-2:2015 and EN 60601-2-20:2009. Equipment used during air tr