EN 13976-1-2018 en Rescue systems - Transportation of incubators - Part 1 Interface requirements.pdf

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1、BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06Rescue systems - Transportation of incubatorsPart 1: Interface requirementsBS EN 139761:2018EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 13976-1 June 2018 ICS 11.040.10; 11.160 Supersedes EN 13976-1:2011English

2、Version Rescue systems - Transportation of incubators - Part 1: Interface requirements Systmes de sauvetage - Transport dincubateurs - Partie 1: Exigences dinterface Rettungssysteme - Inkubatortransport - Teil 1: Schnittstellenanforderungen This European Standard was approved by CEN on 10 January 20

3、18. 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

4、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-CEN

5、ELEC 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, Iceland, Ireland, Ita

6、ly, 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-CENELEC Management Cen

7、tre: 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 13976-1:2018 ENational forewordThis British Standard is the UK implementation of EN 139761:2018. It supersedes BS EN 139761:2011, which

8、 will be withdrawn on 31 December 2019.The UK participation in its preparation was entrusted to Technical Committee CH/239, Rescue systems.A list of organizations represented on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

9、provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2018 Published by BSI Standards Limited 2018ISBN 978 0 580 92495 8ICS 11.040.10; 11.160Compliance with a British Standard cannot confer immunity from legal obligations. This British Standar

10、d was published under the authority of the Standards Policy and Strategy Committee on 31 July 2018.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN 139761:2018EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 13976-1 June 2018 ICS 11.040.10; 11.160 Supersedes

11、EN 13976-1:2011English Version Rescue systems - Transportation of incubators - Part 1: Interface requirements Systmes de sauvetage - Transport dincubateurs - Partie 1: Exigences dinterface Rettungssysteme - Inkubatortransport - Teil 1: Schnittstellenanforderungen This European Standard was approved

12、by CEN on 10 January 2018. 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 sta

13、ndards 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

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

15、, Iceland, 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

16、-CENELEC 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 13976-1:2018 EBS EN 139761:2018EN 13976-1:2018 (E) 2 Contents Page European foreword . 3 Introduction 4 1 Scope

17、5 2 Normative references 5 3 Terms and definitions . 5 4 Requirements . 7 4.1 Fixation . 7 4.2 Electricity . 8 4.3 Gas supply . 10 Annex A (informative) Rationale regarding power use 12 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive

18、93/42/EEC OJ L 169 aimed to be covered 13 Bibliography . 14 BS EN 139761:2018EN 13976-1:2018 (E) 3 European foreword This document (EN 13976-1:2018) 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 th

19、e 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

20、 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 relat

21、ionship with EU Directive(s), see informative Annex ZA which is an integral part of this document. This document supersedes EN 13976-1:2011. The following point represents the most important technical change in the revision: clarified ambiguous and unclear issues in order to improve interchangeabili

22、ty and interoperability of the transport incubator system when transported in hospitals and between hospitals using different ambulances and air crafts, by specifying the interface for mechanical fixation, gas connector and electrical connector EN 13976 consists of the following parts, under the gen

23、eral 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, Bulga

24、ria, 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, Switzerl

25、and, Turkey and the United Kingdom. BS EN 139761:2018EN 13976-1:2018 (E) 4 Introduction This European Standard gives the requirements for the interfaces required in the transport of a transport incubator system. The standard includes interfaces between the incubator and the ambulance as well as thos

26、e between the various items of equipment used to form the transport incubator system. They are essential in order to ensure interchangeability and a safe and effective function in different vehicles, allowing the uninterrupted care of infants. Interface requirements are given in this part 1 (EN 1397

27、6-1). Requirements for the system are given in part 2 (EN 13976-2). Fixation, monitoring, supply of gas and electricity are maintained through the use of the same standard interfaces as defined in this document. BS EN 139761:2018EN 13976-1:2018 (E) 5 1 Scope This European Standard specifies the requ

28、irements for the interface between the ambulance and the incubator and the associated equipment, needed for care and treatment of infants, used in emergency or planned transports to ensure interchangeability and interoperability and to provide uninterrupted care of infants. This European Standard do

29、es 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

30、 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. ENV 737-6:2003, Medical gas pipeline sys

31、tems Part 6: Dimensions and allocation of probes for terminal units for compressed medical gases and vacuum EN 1789:2007+A2:2014, Medical vehicles and their equipment Road ambulances EN 13718-1:2014, Medical vehicles and their equipment Air ambulances Part 1: Requirements for medical devices used in

32、 air ambulances EN 13718-2:2015, Medical vehicles and their equipment Air ambulances Part 2: Operational and technical requirements for air ambulances EN 60601-2-20:2009, Medical electrical equipment Part 2-20: Particular requirements for the basic safety and essential performance of infant transpor

33、t incubators (IEC 60601-2-20:2009) EN ISO 407:2004, Small medical gas cylinders Pin-index yoke-type valve connections (ISO 407:2004) EN ISO 7396-1:2016, Medical gas pipeline systems Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2016) EN ISO 7396-2:2007, Medical gas pip

34、eline systems Part 2: Anaesthetic gas scavenging disposal systems (ISO 7396-2:2007) EN ISO 9170-1:2008, Terminal units for medical gas pipeline systems Part 1: Terminal units for use with compressed medical gases and vacuum (ISO 9170-1:2008) ISO 7166:1985, Aircraft Rail and stud configuration for pa

35、ssenger equipment and cargo restraint MIL-DTL-5015H, Detail Specification: Connectors, Electrical, Circular Threaded, An Type, General Specification for (18 May 2000) (Superseding MIL-C-5015G) 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 a

36、mbulance vehicle or craft intended to be crewed by a minimum of two appropriately trained staff for the provision of care and transport of at least one stretchered patient BS EN 139761:2018EN 13976-1:2018 (E) 6 SOURCE: EN 1789:2007+A2:2014, 3.2 3.2 interchangeability facility to transfer patients be

37、tween scenes of emergencies, ambulances and hospitals as well as between hospitals, including transport between countries, providing continuous patient care, treatment and monitoring SOURCE: EN 13718-2:2015, 3.6 3.3 interface means or place of interaction between one or more of the medical devices,

38、the ambient conditions, the user, the patient and, when relevant, the ambulance 3.4 interoperability facility to connect various medical devices that are fixed to patients, into relevant connections of associated medical devices including the possibility of connecting powered medical devices to vari

39、ous kinds of ambulances SOURCE: EN 13718-2:2015, 3.8 3.5 transport incubator device with an enclosure intended to contain an infant with transparent section/s to allow observation of the infant and provide a safe, secure and temperature controlled environment while being transported for medical care

40、 and it needs to be possible to provide care and medical intervention should this be required during the journey 3.6 transport incubator system TIS system produced or arranged to serve as a complete unit for the care of an infant during transport, see Figure 1 BS EN 139761:2018EN 13976-1:2018 (E) 7

41、Key 1 Transport incubator system NOTE Example of components that could be included in a TIS: 1.1 Incubator 1.2 Syringe pump 1.3 Ventilator 1.4 Monitor 2 Track system 2.1 Track studs 2.2 Track rails 3 Interface to be used if track rails cannot be fixed directly to the stretcher system. If the interfa

42、ce is to be attached to undercarriage, original fixation points on the undercarriage should be used 4 Stretcher system (stretcher/undercarriage/stretcher support, etc.) NOTE When a TIS is permanently fixed to an undercarriage, the undercarriage will form an integral part of the TIS. Figure 1 Transpo

43、rt incubator system with undercarriage fixation 4 Requirements 4.1 Fixation 4.1.1 Fixation of the transport incubator system in a road ambulance shall comply with EN 1789:2007+A2:2014 and in air ambulances with EN 13718-1:2014 and EN 13718-2:2015, irrespective of whether the transport incubator syst

44、em is supported by a stretcher system. BS EN 139761:2018EN 13976-1:2018 (E) 8 4.1.2 Fixation points to the transport incubator system shall be described by the manufacturer, and marked on each transport incubator system. 4.1.3 If there is a requirement for the incubator to be interchangeable between

45、 road ambulances and other vehicles or craft then to ensure interoperability and interchangeability, a track system as specified in ISO 7166:1985 shall be used. The fixation points for the studs (Figure 1, 2.1) on the TIS shall be (382,5 0,25) mm between centres and maximum 1250 mm of length. The fi

46、xation points for the tracks (Figure 1, 2.2) on the interface or stretcher system shall be (382,5 0,25) mm between centres and minimum 1300 mm of length. The locking studs shall have a function for quick release without the use of tools. This track rail system shall be used between the transport inc

47、ubator system and the stretcher system. 4.2 Electricity 4.2.1 The transport incubator system shall be capable of operating on 12 V DC, 24 V DC and 230 V AC/50 Hz power supplies during transport. It shall comply with EN 13718-1:2014 regarding DC voltages. 4.2.2 The total power consumption of the tran

48、sport incubator system shall not exceed the specifications in Table 1 when connected to an external power source. Table 1 Electrical power supply Voltage Power 230 V AC 1200 W 24 V DC 720 W 12 V DC 360 W 4.2.3 Low voltage (12 V/24 V) electrical connectors on the transport incubator system, which are

49、 capable of interfacing with the transport vehicle, shall be lockable, enclosed and constructed to prevent them from being incorrectly connected to different voltages. There shall be a four pole connector according to MIL-DTL-5015H with the following specific requirements: Reverse Bayonet coupling; shell key (insert arrangement): 18 to 10; voltage class A = 700 V (nominal voltage); nominal current: 23 Amp; Maximum cable diameter: 2 mm to 3,3 mm; Service Rating: A; Number of Contacts: 4;