1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN 13976-1:2011Rescue systems Transportation of incubatorsPart 1: Interface conditionsBS EN 13976-1:2011 BRITISH STANDARDNational forewordThis British Standard is the UK imple
2、mentation of EN 13976-1:2011.It supersedes BS EN 13976-1:2003 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/239, Rescue systems.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does n
3、ot purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. BSI 2011ISBN 978 0 580 68336 7ICS 11.040.10; 11.160Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authorit
4、y of theStandards Policy and Strategy Committee on 30 June 2011.Amendments issued since publicationDate Text affectedBS EN 13976-1:2011EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 13976-1 May 2011 ICS 11.040.10; 11.160 Supersedes EN 13976-1:2003English Version Rescue systems - Transportation
5、 of incubators - Part 1: Interface conditions Systmes de sauvetage - Transport dincubateurs - Partie 1: Conditions dinterface Rettungssysteme - Inkubatortransport - Teil 1: Anforderungen an Schnittstellen This European Standard was approved by CEN on 14 April 2011. CEN members are bound to comply wi
6、th 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 Mana
7、gement 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 st
8、atus 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, Portug
9、al, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2011 CEN All rights of exploitation in any form and by any means r
10、eserved worldwide for CEN national Members. Ref. No. EN 13976-1:2011: EBS EN 13976-1:2011EN 13976-1:2011 (E) 2 Contents Page Foreword 3Introduction .41 Scope 52 Normative references 53 Terms and definitions .64 Requirements .84.1 Interface between transport incubator system and ambulance .84.1.1 Fix
11、ation .84.1.2 Electricity 84.1.3 Gas supply 9Annex A (informative) Rationale regarding power use 10Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices 11Bibliography . 12BS EN 13976-1:2011EN 13976-1:2011 (E) 3
12、 Foreword This document (EN 13976-1:2011) 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 lates
13、t by November 2011, and conflicting national standards shall be withdrawn at the latest by November 2011. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all
14、such patent rights. This document supersedes EN 13976-1:2003. 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 informativ
15、e Annex ZA, which is an integral part of this document. EN 13976-1:2003 has been technically revised. The following points represent the most important changes in the revision: 1) clarified ambiguous and unclear issues between the two parts (requirements for the transport incubator system interface
16、conditions and system requirements, respectively); 2) proposed items in order to improve fixation, interchangeability and interoperability of the transport incubator system when transported in hospitals and between hospitals using different ambulances and air crafts; 3) adapted the standard to devel
17、opments in neonatal intensive care; 4) excluded proposals on standards for stretchers, vehicles or medical devices. 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 t
18、he 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, Latvi
19、a, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. BS EN 13976-1:2011EN 13976-1:2011 (E) 4 Introduction This European Standard gives the requirements for the interfaces required in the transport of a
20、 transport incubator system. The standard include interfaces between the incubator and the ambulance as well as those between the various items of equipment used to make up the transport incubator system. They are essential in order to ensure interchangeability and a safe and effective function in d
21、ifferent vehicles, allowing the uninterrupted care of patients. Requirements for interface conditions are given in this part 1 (EN 13976-1). 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 st
22、andard interfaces as defined in this document. BS EN 13976-1:2011EN 13976-1:2011 (E) 5 1 Scope This European Standard specifies the requirements for the interface between the ambulance and the incubator and the associated equipment, needed for care and treatment of infants, used in emergency or plan
23、ned transports to ensure interchangeability and interoperability and to provide uninterrupted care of patients. 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 ar
24、e normally combined with other equipment to form a “transport incubator system“. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the r
25、eferenced document (including any amendments) applies. ENV 737-6, Medical gas pipeline systems Part 6: Dimensions and allocation of probes for terminal units for compressed medical gases and vacuum EN 1789, Medical vehicles and their equipment Road ambulances EN 13718-1, Medical vehicles and their e
26、quipment Air Ambulances Part 1: Requirements for medical devices used in air ambulances EN 13718-2, Medical vehicles and their equipment Air Ambulances Part 2: Operational and technical requirements of air ambulances EN 60309-1, Plugs, socket-outlets and couplers for industrial purposes Part 1: Gene
27、ral requirements (IEC 60309-1:1999) EN 60309-2, Plugs, socket-outlets and couplers for industrial purposes Part 2: Dimensional interchangeability requirements for pin and contact-tube accessories (IEC 60309-2:1999) EN 60601-2-20, Medical electrical equipment Part 2-20: Particular requirements for ba
28、sic safety and essential performance of infant transport incubators (IEC 60601-2-20:2009) EN ISO 407, Small medical gas cylinders Pin-index yoke-type valve connections (ISO 407:2004) EN ISO 7396-1:2007, Medical gas pipeline systems Part 1: Pipeline systems for compressed medical gases and vacuum (IS
29、O 7396-1:2007) EN ISO 7396-2:2007, Medical gas pipeline systems Part 2: Anaesthetic gas scavenging disposal systems (ISO 7396-2:2007) EN ISO 9170-1, Terminal units for medical gas pipeline systems Part 1: Terminal units for use with compressed medical gases and vacuum (ISO 9170-1:2008) MS 33601, Tra
30、ck and Stud Fitting for Cargo Transport Aircraft, Standard Dimensions for FSC 1560 BS EN 13976-1:2011EN 13976-1:2011 (E) 6 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 interface means or place of interaction between one or more of the medi
31、cal devices, the ambient conditions, the user, the patient and, when relevant, the ambulance 3.2 transport incubator enclosure intended to contain a baby, and having transparent section(s) which allow(s) for viewing of the baby, provided with means to control the environment of the baby, primarily b
32、y heated air within the enclosure, and suitable for the safe conveyance of a baby EN 60601-2-20:2009 3.3 ambulance 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 EN 1789 3.4 transport
33、incubator system TIS system produced or arranged to serve as a complete unit for the care of an infant during transport NOTE The system typically includes one or more of the following: an incubator, vital signs monitor, ventilator, device(s) for infusion and suction as well as basic supplies of elec
34、tricity and medical gas. In some cases a trolley will form an integral part of the TIS. BS EN 13976-1:2011EN 13976-1:2011 (E) 7 Key 1 transport incubator system based on a self-containing structure with rails attached underneath as specified in 4.1.1.3 2 interface to be used if rails can not be fixe
35、d directly to the stretcher system. If the interface is to be attached to undercarriage, original attachment points on the undercarriage should be used. 3 stretcher system (stretcher/undercarriage/trolley/stretcher support, etc.) 4 rails (grey) 5 syringe pump 6 incubator 7 ventilator 8 monitor NOTE
36、In some cases a trolley (3) will form an integral part of the transport incubator system (1). Figure 1 Transport incubator system with undercarriage fixation 3.5 interoperability facility to connect various medical devices that are fixed to patients, into relevant connections of associated medical d
37、evices including the possibility of connecting powered medical devices to various kinds of ambulances EN 13718-2 3.6 Interchangeability facility to transfer patients between scenes of emergencies, ambulances and hospitals as well as between hospitals, including transport between countries, providing
38、 continuous patient care, treatment and monitoring EN 13718-2 BS EN 13976-1:2011EN 13976-1:2011 (E) 8 4 Requirements 4.1 Interface between transport incubator system and ambulance 4.1.1 Fixation 4.1.1.1 Fixation of the transport incubator system in a road ambulance shall comply with EN 1789 and in a
39、ir ambulances with EN 13718-1 and EN 13718-2, irrespective of whether the transport incubator system is supported by a stretcher, trolley, frame or other supporting construction. 4.1.1.2 Fixation points to the transport incubator system shall be described by the manufacturer, and marked on each tran
40、sport incubator system. 4.1.1.3 If there is a requirement for the incubator to be interchangeable between road ambulances and other vehicles or craft then to ensure interoperability and interchangeability, a rail system as specified in MS 33601 (MIL-standard) shall be used. The mounting points for t
41、he rail shall be (400 0,25) mm between centres and minimum 1300 mm length. This rail system shall be used between the transport incubator system and the stretcher/undercarriage/trolley/stretcher support etc. 4.1.2 Electricity 4.1.2.1 The transport incubator system shall be capable of operating on 12
42、 V DC, 24 V DC and 230 V AC/50 Hz power supplies during transport. It shall comply with EN 13718-1 regarding DC voltages. 4.1.2.2 The total power consumption of the transport incubator system shall not exceed the specifications in the following table when connected to an external power source. Table
43、 1 Electrical power supply Voltage Power 230 V AC 1200 W 24 V DC 720 W 12 V DC 360 W 4.1.2.3 Low voltage (12 V/24 V) electrical connectors on the transport incubator system, which are capable of interfacing with the transport vehicle, shall be lockable, enclosed and constructed to prevent them from
44、being incorrectly connected to different voltages. Plugs and connectors shall comply with EN 60309-1 and EN 60309-2. Coding is required for all accessories having operational voltage not exceeding 50 V. Socket-outlets and connectors for the transport incubator systems shall be coded with their minor
45、 key or keyway at the 8 oclock position. The contact position for 12 V DC is L1 and L2 and the contact position for 24 V DC is L2 and L3. The connectors shall be labelled with the rated voltages. The identification colour for the housing is grey. The 12 V and the 24 V leads shall not be connected at
46、 the same time. If an adapter is used, the adapter shall be labelled with the rated maximum rated current. NOTE An adapter may be used to connect with the electrical supply of the ambulance. BS EN 13976-1:2011EN 13976-1:2011 (E) 9 4.1.2.4 The 230 V connector shall comply with national regulations. N
47、OTE An adapter may be used in cross-border transportation and to connect into the electrical supply of the ambulance. This adapter should also be connected to the earth wiring where applicable. 4.1.3 Gas supply 4.1.3.1 The transport incubator system shall be provided with medical oxygen and medical
48、air for 1 h according to EN 60601-2-20. If a compressor producing medical air substitutes for air cylinders, the European Pharmacopoeia, shall apply. The rated pressure shall be 400 1000kPa with a maximum flow of at least 15 l/min. 4.1.3.2 If Pin-index outlets of cylinder valves are used, they shall
49、 comply with EN ISO 407. 4.1.3.3 Connections and fixation for gas supply shall comply with ENV 737-6, EN 1789, EN ISO 9170-1, EN ISO 7396-1 and EN ISO 7396-2. NOTE An adapter may be used in cross-border transportation and to connect into the gas supply of the ambulance. BS EN 13976-1:2011EN 13976-1:2011 (E) 10 Annex A (informative) Rationale regarding power use From experience it is known that transport incubator systems have an increasing need of electrical power for the safe and adequate care of the pat
