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!$sve“1808366www.din.deDDIN EN 13976-2Rescue systems Transportation of incubators Part 2: System requirementsEnglish translation of DIN EN 13976-2:2011-08Rettungssysteme Inkubatortransport Teil 2: Anforderungen an TransportsystemeEnglische bersetzung von DIN EN 13976-2:2011-08Systme
3、s de sauvetage Transport dincubateurs Partie 2: Exigences relatives au systmeTraduction anglaise de DIN EN 13976-2:2011-08SupersedesDIN EN 13976-2:2004-03 andDIN EN 13976-2 Corrigendum1:2006-11www.beuth.deDocument comprises pagesIn case of doubt, the German-language original shall be considered auth
4、oritative.1307.11 DIN EN 13976-2:2011-08 A comma 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
5、 its preparation was the Normenausschuss Rettungsdienst 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
6、set out in EU Directive 93/42/EEC on medical devices (see Annex ZA). Amendments This standard differs from DIN EN 13976-2:2004-03 and DIN EN 13976-2 Corrigendum 1:2006-11 as follows: a) Annex A (normative) “Medical devices used in conjunction with transport incubators” has been deleted; b) the forme
7、r informative Annex B is now Annex A with two subclauses: A.1 “Space” and A.2 “Loading”; c) Annex ZA (informative) concerning the relationship between this European Standard and the essential requirements of EU Directive 93/42/EEC on medical devices has been updated on the basis of EU Directive 2007
8、/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 States 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
9、of biocidal products; d) the standard has been editorially revised. Previous editions DIN 13072: 1997-01 DIN EN 13976-2: 2004-03 DIN EN 13976-2 CORRIGENDUM 1: 2006-11 2 EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 13976-2 May 2011 ICS 11.040.10; 11.160 Supersedes EN 13976-2:2003English Versi
10、on Rescue systems - Transportation of incubators - Part 2: System requirements Systmes de sauvetage - Transport dincubateurs - Partie2: Exigences relatives au systme Rettungssysteme - Inkubatortransport - Teil 2: Anforderungen an Transportsysteme This European Standard was approved by CEN on 14 Apri
11、l 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-date lists and bibliographical references concerning such national standards may be obtai
12、ned 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
13、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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg,
14、Malta, Netherlands, Norway, Poland, Portugal, 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 e
15、xploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 13976-2:2011: EEN 13976-2:2011 (E) 2 Contents Page Foreword 3Introduction .41 Scope 52 Normative references 53 Terms and definitions .64 General requirements 64.1 System combination 64.2 Suspension/nois
16、e/comfort (shock-absorption) 64.3 Temperature conditions 64.4 Ingress of liquids .64.5 Vibration .64.6 Mechanical integrity 64.7 EMC .74.8 Mass 74.9 Electricity 74.10 Fixation of component parts 74.11 Modifications 7Annex A (informative) Ergonomics .8A.1 Space 8A.2 Loading .8Annex ZA (informative) R
17、elationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices .9Bibliography . 10DIN EN 13976-2:2011-08 EN 13976-2:2011 (E) 3 Foreword This document (EN 13976-2:2011) has been prepared by Technical Committee CEN/TC 239 “Rescue systems”, the se
18、cretariat 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 November 2011, and conflicting national standards shall be withdrawn at the latest by November 2011. Attention is
19、 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 such patent rights. This document supersedes EN 13976-2:2003. This document has been prepared under a mandate given to
20、 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. EN 13976-2:2003 has been technically revised. The following po
21、ints 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 conditions and system requirements, respectively); 2) proposed items in order to improve fixation, interchangeability
22、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 developments in neonatal intensive care; 4) excluded proposals on standards for stretchers, vehicles or medical devices. EN
23、 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 the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to impl
24、ement this European Standard: Austria, Belgium, Bulgaria, Croatia, 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, Sw
25、itzerland and the United Kingdom. DIN EN 13976-2:2011-08 EN 13976-2:2011 (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
26、are essential in allowing the uninterrupted care of patients. Requirements for interface conditions are given in part 1 (EN 13976-1). DIN EN 13976-2:2011-08 EN 13976-2:2011 (E) 5 1 Scope This European Standard specifies the requirements for a transport incubator system needed for care and treatment
27、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 transportat
28、ion for infants and operators. This European Standard also stipulates that the equipment or systems shall not interfere with the functions of the ambulance providing transportation. This European Standard does not give requirements for the vehicles, crafts, devices or incubators as such, these requi
29、rements 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 application of this document. For dated references, only the edit
30、ion cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. EN 1789, Medical vehicles and their equipment Road ambulances EN 1865 (all parts), Patient handling equipment used in road ambulances EN 13718-1, Medical vehicles and their eq
31、uipment 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 13976-1:2011, Rescue systems Transportation of incubators Part 1: Interface condi
32、tions EN 60601-1, Medical electrical equipment Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005) EN 60601-1-2, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral standard: Electromagnetic compatib
33、ility Requirements and tests (IEC 60601-1-2:2007, modified) 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) RTCA DO 160, Radio Technical Commission for Aeronautics Environme
34、ntal conditions and test procedures for airborne equipment (corresponding to EUROCAE ed-14) publication available at the RTCA Secretariat, Suite 500, 1425 K Street, N.W. Washington DC, 20005, USA RTCA DO 199, Radio Technical Commission for Aeronautics Potential interference to aircraft electronic eq
35、uipment from devices carried on board publication available at the RTCA Secretariat, Suite 500, 1425 K Street, N.W. Washington DC, 20005, USA DIN EN 13976-2:2011-08 EN 13976-2:2011 (E) 6 3 Terms and definitions For the purposes of this document, the terms and definitions given in EN 13976-1:2011 app
36、ly. 4 General requirements 4.1 System combination Requirements for interfaces are found in part 1 of this standard (EN 13976-1) and basic requirements for transport incubators are described in EN 60601-2-20. Any medical device which is part of the transport incubator system shall be designed for use
37、 with neonates and infants and for use in transport settings. All of the equipment that is integrated or 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 employed as part of transport incubator system shall be
38、 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 for road ambulances, in EN 13718-1 and
39、EN 13718-2 for air ambulances and in EN 1865 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 set by EN 60601-2-20. NOTE Vibration and noise can interfere wi
40、th the general comfort and well-being of infants. Therefore the vibration to which they are exposed should be as low as possible. The transportation of the baby should be at an appropriate speed to ensure the comfort of the baby. High speeds are rarely necessary. 4.3 Temperature conditions 4.3.1 The
41、 transport incubator system shall comply with the relevant requirements of EN 60601-2-20 as a minimum standard with regard to controlling the internal temperature. 4.3.2 Where the transport incubator system is to be used at extremes of temperature, additional test data shall be supplied in the accom
42、panying 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 liquids All equipment forming part of the transport incubator s
43、ystem shall be drip-proof according to EN 60601-2-20. If the equipment complies with this standard only with an additional accessory or procedure, the manufacturer shall describe in the accompanying documents how to comply with this standard. 4.5 Vibration All equipment forming part of the transport
44、 incubator system shall comply with EN 1789 or EN 13718-1 and EN 13718-2. 4.6 Mechanical integrity All equipment forming part of the transport incubator system shall comply with EN 60601-1. DIN EN 13976-2:2011-08 EN 13976-2:2011 (E) 7 EN 60601-2-20 applies for transport incubators. The free fall tes
45、t in EN 1789 applies (i.e. 0,75 m) for hand-held equipment. 4.7 EMC All equipment forming part of the transport incubator system shall comply with EN 60601-1-2 and EN 60601-2-20. Equipment used during air transportation shall comply with RTCA DO 160. For equipment used for transportation, each user
46、shall carry out mutual compatibility assessments when required to ensure that all medical equipment functions correctly in each mode of transport and with every type of equipment for communication and/or navigation to be used during the transport. NOTE The manufacturer should include the requirement
47、 for mutual compatibility assessments in the instructions for use. 4.8 Mass The mass of the transport incubator system including its rail parts shall not exceed 140 kg. The requirement for stretchers defined in EN 1865 is 150 kg minimum loading capacity, a margin of 10 kg for the interface is used.
48、The TIS shall be marked with its weight. NOTE 1 This clause does not apply for cases where the trolley is an integral part of the TIS. NOTE 2 In all cases the mass should be as low as possible. In cases where the TIS has to be transported in air ambulances more restrictive weight limits may apply. 4
49、9 Electricity The transport incubator system shall be capable of operating on 12 V DC, 24 V DC or, 24VDC and 230 V AC/50 Hz power supplies during transport. The electrical system shall be designed to prevent the vehicle from draining electrical power from the transport incubator system or its interface equipment. 4.10 Fixation of component parts All component parts of the transport incubator system shall be securely fixed in road ambulances in conformity with EN 1789 and test criteri
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