1、August 2011 Translation by DIN-Sprachendienst.English price group 9No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS
2、11.040.10; 11.160!$snK“1807540www.din.deDDIN EN 13976-1Rescue systems Transportation of incubators Part 1: Interface conditionsEnglish translation of DIN EN 13976-1:2011-08Rettungssysteme Inkubatortransport Teil 1: Anforderungen an SchnittstellenEnglische bersetzung von DIN EN 13976-1:2011-08Systmes
3、 de sauvetage Transport dincubateurs Partie 1: Conditions dinterfaceTraduction anglaise de DIN EN 13976-1:2011-08SupersedesDIN EN 13976-1:2004-03www.beuth.deDocument comprises pagesIn case of doubt, the German-language original shall be considered authoritative.1407.11 DIN EN 13976-1:2011-08 2 A com
4、ma is used as the decimal marker. National foreword This standard has been prepared by Technical Committee CEN/TC 239 “Rescue systems” (Secretariat: DIN, Germany), Working Group WG 4 “Transportation of incubators”. The responsible German body involved in its preparation was the Normenausschuss Rettu
5、ngsdienst und Krankenhaus (Rescue Services and Hospital Standards Committee), Working Committee NA 053-01-02 AA Krankenkraftwagen und deren medizinische und technische Ausstattung. This standard contains specifications meeting the essential requirements set out in EU Directive 93/42/EEC on medical d
6、evices (see Annex ZA). Amendments This standard differs from DIN EN 13976-1:2004-03 as follows: a) normative references have been updated; b) Subclause 4.1.1 “vehicles” has been deleted; c) Subclauses 4.1.2 “Loading” and 4.1.3 “Placement” have been deleted and are now dealt with in DIN EN 13976-2:20
7、11-08; d) Subclause 4.2.4 “General requirements gases (transportation)” has been deleted; the normative references have been included in Subclause 4.1.3 “Gas supply”; e) Annex A “Rationale regarding power use” has been added; f) Annex ZA (informative) concerning the relationship between this Europea
8、n Standard and the essential requirements of EU Directive 93/42/EEC on medical devices has been updated on the basis of EU Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directives 90/385/EEC on the approximation of the laws of the Member Stat
9、es relating to active implantable medical devices and 93/42/EEC on medical devices and EU Directive 98/8/EC on the placing on the market of biocidal products; g) the standard has been editorially revised. Previous editions DIN 13072: 1997-01 DIN EN 13976-1: 2004-03 EUROPEAN STANDARD NORME EUROPENNE
10、EUROPISCHE NORM EN 13976-1 May 2011 ICS 11.040.10; 11.160 Supersedes EN 13976-1:2003English Version Rescue systems - Transportation of incubators - Part 1: Interface conditions Systmes de sauvetage - Transport dincubateurs - Partie 1: Conditions dinterface Rettungssysteme - Inkubatortransport - Teil
11、 1: Anforderungen an Schnittstellen 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-
12、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 translati
13、on 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, F
14、rance, 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 COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE
15、 FR 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 13976-1:2011: EEN 13976-1:2011 (E) 2 Contents Page Foreword 3Introduction .41 Scope 52 Normative references 53 Te
16、rms and definitions .64 Requirements .84.1 Interface between transport incubator system and ambulance .84.1.1 Fixation .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 Req
17、uirements of EU Directive 93/42/EEC on medical devices 11Bibliography . 12DIN EN 13976-1:2011-08 EN 13976-1:2011 (E) 3 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
18、be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest 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 docu
19、ment may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all 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 Asso
20、ciation, 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. EN 13976-1:2003 has been technically revised. The following points represent the most important changes in the revision: 1) cl
21、arified ambiguous and unclear issues between the two parts (requirements for the transport incubator system interface conditions and system requirements, respectively); 2) proposed items in order to improve fixation, interchangeability and interoperability of the transport incubator system when tran
22、sported in hospitals and between hospitals using different ambulances and air crafts; 3) adapted the standard to developments 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:
23、 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, Croati
24、a, 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. DIN EN 13976-1:2011-08 EN 1397
25、6-1:2011 (E) 4 Introduction This European Standard gives the requirements for the interfaces required in the transport of a 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
26、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 patients. Requirements for interface conditions are given in this part 1 (EN 13976-1). Requirements for the system are give
27、n 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. DIN EN 13976-1:2011-08 EN 13976-1:2011 (E) 5 1 Scope This European Standard specifies the requirements for the interface between t
28、he 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 patients. This European Standard does not give requirements for the ve
29、hicles, 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 referenced documents are indispensable for the applica
30、tion of this document. 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, Medical gas pipeline systems Part 6: Dimensions and allocation of probes for terminal units for compressed
31、 medical gases and vacuum EN 1789, Medical vehicles and their equipment Road ambulances EN 13718-1, Medical vehicles and their equipment 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
32、and technical requirements of air ambulances EN 60309-1, Plugs, socket-outlets and couplers for industrial purposes Part 1: General requirements (IEC 60309-1:1999) EN 60309-2, Plugs, socket-outlets and couplers for industrial purposes Part 2: Dimensional interchangeability requirements for pin and c
33、ontact-tube accessories (IEC 60309-2:1999) 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) EN ISO 407, Small medical gas cylinders Pin-index yoke-type valve connections (ISO
34、 407:2004) EN ISO 7396-1:2007, Medical gas pipeline systems Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 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 medi
35、cal gas pipeline systems Part 1: Terminal units for use with compressed medical gases and vacuum (ISO 9170-1:2008) MS 33601, Track and Stud Fitting for Cargo Transport Aircraft, Standard Dimensions for FSC 1560 DIN EN 13976-1:2011-08 EN 13976-1:2011 (E) 6 3 Terms and definitions For the purposes of
36、this document, the following terms and definitions apply. 3.1 interface means or place of interaction between one or more of the medical 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 t
37、ransparent section(s) which allow(s) for viewing of the baby, provided with means to control the environment of the baby, primarily by 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
38、of two appropriately trained staff for the provision of care and transport of at least one stretchered patient EN 1789 3.4 transport 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
39、of the following: an incubator, vital signs monitor, ventilator, device(s) for infusion and suction as well as basic supplies of electricity and medical gas. In some cases a trolley will form an integral part of the TIS. DIN EN 13976-1:2011-08 EN 13976-1:2011 (E) 7 Key 1 transport incubator system b
40、ased 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 fixed directly to the stretcher system. If the interface is to be attached to undercarriage, original attachment points on the undercarriage should be used. 3 stretch
41、er system (stretcher/undercarriage/trolley/stretcher support, etc.) 4 rails (grey) 5 syringe pump 6 incubator 7 ventilator 8 monitor NOTE 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
42、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 various kinds of ambulances EN 13718-2 3.6 Interchangeability facility to transfer patie
43、nts between scenes of emergencies, ambulances and hospitals as well as between hospitals, including transport between countries, providing continuous patient care, treatment and monitoring EN 13718-2 DIN EN 13976-1:2011-08 EN 13976-1:2011 (E) 8 4 Requirements 4.1 Interface between transport incubato
44、r 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 air 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 sup
45、porting construction. 4.1.1.2 Fixation points to the transport incubator system shall be described by the manufacturer, and marked on each transport 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
46、 ensure interoperability and interchangeability, a rail system as specified in MS 33601 (MIL-standard) shall be used. The mounting points for the 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 stre
47、tcher/undercarriage/trolley/stretcher support etc. 4.1.2 Electricity 4.1.2.1 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 regarding DC voltages. 4.1.2.2 The total power consumption
48、 of the transport incubator system shall not exceed the specifications in the following table 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 4.1.2.3 Low voltage (12 V/24 V) electrical connectors on the transport i
49、ncubator system, which are capable of interfacing with the transport vehicle, shall be lockable, enclosed and constructed to prevent them from 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 key or keyway at the 8 oclock position. The contact pos
