DIN EN 13718-1-2014 Medical vehicles and their equipment - Air ambulances - Part 1 Requirements for medical devices used in air ambulances German version EN 13718-1 2014《医疗交通工具及其设备.pdf

1、December 2014 Translation by DIN-Sprachendienst.English price group 11No 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).I

2、CS 11.040.01; 11.160; 49.020!%O%“2274402www.din.deDDIN EN 13718-1Medical vehicles and their equipment Air ambulances Part 1: Requirements for medical devices used in air ambulances;English version EN 13718-1:2014,English translation of DIN EN 13718-1:2014-12Medizinische Fahrzeuge und ihre Ausrstung

3、Luftfahrzeuge zum Patiententransport Teil 1: Anforderungen an medizinische Gerte, die in Luftfahrzeugen zumPatiententransport verwendet werden;Englische Fassung EN 13718-1:2014,Englische bersetzung von DIN EN 13718-1:2014-12Vhicules sanitaire et leur quipement Ambulances arienne Partie 1: Exigences

4、pour les dispositifs mdicaux utiliss dan les ambulances arienne ;Version anglaise EN 13718-1:2014,Traduction anglaise de DIN EN 13718-1:2014-12SupersedesDIN EN 13718-1:2008-11www.beuth.deIn case of doubt, the German-language original shall be considered authoritative.Document comprises 19 pages 12.1

5、4sss sDIN EN 13718-1:2014-12 2 A comma is used as the decimal marker. National foreword This document (EN 13718-1:2014) has been prepared by Technical Committee CEN/TC 239 “Rescue systems” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the DIN-Normenausschus

6、s Rettungsdienst und Krankenhaus (DIN Standards Committee Rescue Services and Hospital), Working Committee NA 053-01-03 AA Luftfahrzeuge zum Patiententransport. This document gives minimum requirements for interfaces and compatibility of medical devices used in air ambulances. It specifies requireme

7、nts for medical devices when used in situations where the ambient conditions differ from the normal indoor conditions prevailing within the health care system. Several specific requirements are related to the conditions prevailing in air ambulances. The requirements set are carefully selected to ens

8、ure interoperability and continuous patient care. Amendments This standard differs from DIN EN 13718-1:2008-11 as follows: a) normative references have been updated; b) the following terms and definitions have been deleted: 3.3 “HEMS flight”, 3.4 “air ambulance flight”, 3.5 “non-dedicated aircraft f

9、or patient transportation”, 3.6 “HICAMS flight”, 3.7 “fixed wing air ambulance”, 3.10 “interchangeability”, 3.11 “flight crew”, 3.12 “medical crew”; c) a new Subclause 4.5.4 “Medical devices with 230 V AC power input” has been introduced; d) the former Subclause 4.4.5 “Inverters” has been deleted; e

10、) Subclause 4.5.4 “Pneumatic power supply” (now Subclause 4.6.4) has been revised; f) Subclause 4.8 “Fire resistance” (now Subclause 4.9) has been revised; g) unclear issues have been clarified in this part of the standard and between the two parts of the standard (requirements for patient s compart

11、ment illumination, respectively); h) the standard has been modified/integrated to meet the requirements of Directive 93/42/EEC on medical devices. Previous editions DIN 13230-1: 1980-10, 1988-03, 1996-04 DIN 13230-2: 1982-10, 1989-05, 1997-01 DIN 13230-3: 1996-04 DIN 13230-4: 1997-01 DIN 13230-5: 19

12、98-01 DIN 13234-1: 1987-12 DIN 13234-2: 1987-12 DIN EN 13718-1: 2002-11, 2008-11 EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 13718-1 September 2014 ICS 11.040.01; 11.160; 49.020 Supersedes EN 13718-1:2008English Version Medical vehicles and their equipment - Air ambulances - Part 1: Require

13、ments for medical devices used in air ambulances Vhicules sanitaire et leur quipement - Ambulances arienne - Partie 1 : Exigences pour les dispositifs mdicaux utiliss dans les ambulances arienne Medizinische Fahrzeuge und ihre Ausrstung - Luftfahrzeuge zum Patiententransport - Teil 1: Anforderungen

14、an medizinische Gerte, die in Luftfahrzeugen zum Patiententransport verwendet werdenThis European Standard was approved by CEN on 25 July 2014. 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 n

15、ational standard without any alteration. Up-to-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

16、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 status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cypru

17、s, 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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United King

18、dom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2014 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 13718-1

19、:2014 EsssEN 13718-1:2014 (E) 2 Contents Page Foreword 3 Introduction .4 1 Scope 5 2 Normative references 5 3 Terms and definitions .6 4 Requirements for medical devices for air ambulances .6 4.1 General 6 4.2 Patient and personnel safety 7 4.3 User interface .7 4.4 Environmental conditions and perf

20、ormance of medical devices intended for use in air ambulances 7 4.4.1 Functional temperature range 7 4.4.2 Humidity 8 4.4.3 Variable atmospheric pressures 8 4.5 Electrically-powered medical devices .8 4.5.1 General 8 4.5.2 Medical devices with 12 V DC power input .8 4.5.3 Medical devices with 24 V D

21、C power input .8 4.5.4 Medical devices with 230 V AC power input .9 4.5.5 Short time voltage drop 9 4.5.6 Internal electrical power source .9 4.5.7 Electromagnetic interference of medical devices 9 4.6 Medical gas supply 9 4.6.1 General 9 4.6.2 Gas leakage 9 4.6.3 Pressure regulators and flow meteri

22、ng devices .9 4.6.4 Pneumatic power 10 4.6.5 Cylinder valves 10 4.6.6 Low pressure hose assemblies . 10 4.7 Mechanical strength . 10 4.7.1 General . 10 4.7.2 Vibration and bump 10 4.7.3 Free fall 10 4.8 Fixation of medical devices in air ambulances . 10 4.9 Fire resistance . 10 4.10 Information to b

23、e supplied by the manufacturer . 11 5 Test methods . 11 5.1 General . 11 5.2 Ambient conditions 11 5.3 Test method for durability of markings and colour coding . 11 5.4 Free fall 11 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/4

24、2/EEC on Medical Devices 13 Bibliography . 15 DINEN 13718-1:2014-12EN 13718-1:2014(E)3 Foreword This document (EN 13718-1:2014) 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 nationa

25、l standard, either by publication of an identical text or by endorsement, at the latest by March 2015, and conflicting national standards shall be withdrawn at the latest by March 2015. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent righ

26、ts. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN 13718-1:2008. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requir

27、ements of EU Directive(s). For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document. EN 13718-1:2008 has been technically revised. The following points represent the most important changes in the revision: a) normative references were updated; b) the f

28、ollowing terms and definitions were deleted: 3.3 “HEMS flight“, 3.4 “air ambulance flight“, 3.5 “non-dedicated aircraft for patient transportation“, 3.6 “HICAMS flight“, 3.7 “fixed wing air ambulance“, 3.10 “interchangeability“, 3.11 “flight crew“, 3.12 “medical crew“; c) a new Subclause 4.5.4 “Medi

29、cal devices with 230 V AC power input“ was introduced; d) Subclause 4.4.5 “Inverters“ was deleted; e) Subclause 4.5.4 “Pneumatic power supply“ (now Subclause 4.6.4) was revised; f) Subclause 4.8 “Fire resistance“ (now Subclause 4.9) was revised; g) unclear issues were clarified in this part of the s

30、tandard and between the two parts of the standard (requirements for patients compartment illumination, respectively); h) the standard was modified/integrated to meet the Medical Devices Directive 93/42/EEC requirements. EN 13718 consists of the following parts, under the general title: Medical vehic

31、les and their equipment Air ambulances: Part 1: Requirements for medical devices used in air ambulances; Part 2: Operational and technical requirements for air ambulances. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to

32、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, Poland, Portugal, Rom

33、ania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. DINEN 13718-1:2014-12EN 13718-1:2014 (E) 4 Introduction This part of EN 13718 gives minimum requirements for interfaces and compatibility of medical devices used in air ambulances. The standards work was called for

34、by the EU Commission by a mandate from the Medical Devices Directive (see Bibliography and Annex ZA). This part of EN 13718 is supplementary to several other European Standards and gives requirements for medical devices when used in situations where the ambient conditions differ from the normal indo

35、or conditions prevailing within the health care system. Several specific requirements are related to the conditions prevailing in air ambulances. The requirements that are set are carefully selected to ensure interoperability and continuous patient care. The medical devices are being used by the ser

36、vices in air ambulances. Air ambulances carry medical devices as well as medicinal products and rescue equipment to be used by medical personnel. The medical devices need to conform to the applicable essential requirements in the Medical Devices Directive. The essential requirements are listed in An

37、nex I of the Medical Devices Directive (MDD). Annex ZA lists the essential requirements that are addressed by the identified clauses of this European Standard. The environmental conditions for medical devices used in air ambulances are different from those expected in a normal hospital environment.

38、In particular, this implies environmental conditions such as temperature and humidity, vibration and shock caused by movement of the air ambulances, variable atmospheric pressures and electromagnetic disturbances between the air ambulances and the medical device. DIN EN 13718-1:2014-12 EN 13718-1:20

39、14(E)5 1 Scope This European Standard specifies general requirements for medical devices carried in air ambulances and used therein and outside hospitals and clinics in situations where the ambient conditions can differ from normal indoor conditions. This European Standard does not cover the require

40、ments for approval and registration of the vehicle and the training of the staff which is the responsibility of the authority/authorities in the country where the ambulance is to be registered. 2 Normative references The following documents, in whole or in part, are normatively referenced in this do

41、cument 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 1041:2008+A1:2013, Information supplied by the manufacturer of medical devices EN 13718

42、-2:2008,1)Medical vehicles and their equipment Air ambulances Part 2: Operational and technical requirements of air ambulances EN 60068-2-31:2008, Environmental testing Part 2-31: Tests Test Ec: Rough handling shocks, primarily for equipment-type specimens (IEC 60068-2-31:2008) EN 60529:1991, Degree

43、s of protection provided by enclosures (IP Code) (IEC 60529:1989) EN 60601 (all parts), Medical electrical equipment (IEC 60601, all parts) EN ISO 407:2004, Small medical gas cylinders Pin-index yoke-type valve connections (ISO 407:2004) EN ISO 5359:2008, Low-pressure hose assemblies for use with me

44、dical gases (ISO 5359:2008) EN ISO 10297:2006, Transportable gas cylinders Cylinder valves Specification and type testing (ISO 10297:2006) EN ISO 10524-1:2006, Pressure regulators for use with medical gases Part 1: Pressure regulators and pressure regulators with flow-metering devices (ISO 10524-1:2

45、006) EN ISO 10524-3:2006, Pressure regulators for use with medical gases Part 3: Pressure regulators integrated with cylinder valves (ISO 10524-3:2005) EN ISO 14971:2012, Medical devices Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) EN ISO 15002:200

46、8, Flow-metering devices for connection to terminal units of medical gas pipeline systems (ISO 15002:2008) EN ISO 15223-1:2012, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements (ISO 15223-1:2012) ISO 7000:2012, Graph

47、ical symbols for use on equipment Registered symbols 1) EN 13718-2:2008 is bound to be superseded with a new edition. DINEN 13718-1:2014-12EN 13718-1:2014 (E) 6 RTCA DO-160G:2010,2)Environmental Conditions and Test Procedures for Airborne Equipment 3 Terms and definitions For the purposes of this do

48、cument, the following terms and definitions apply. 3.1 air ambulance aircraft designed to be normally staffed by two medical personnel equipped and intended for the transportation of at least one stretcher patient who will receive medical treatment during transport 3.2 interface means or place of in

49、teraction between one or more of the medical devices, the ambient conditions, the user, the patient, and when relevant, the various kinds of ambulances 3.3 interoperability facility to connect various medical devices that are fixed to patients into connections of associated medical devices including the possibility of connecting powered medical devices to various kinds of ambulances 3.4 medical device instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software nec