BS EN 13718-1-2014 Medical vehicles and their equipment Air ambulances Requirements for medical devices used in air ambulances《医疗车辆及其设备 空中救护机 用于空中救护机的医疗装置要求》.pdf

1、BSI Standards PublicationBS EN 13718-1:2014Medical vehicles and theirequipment Air ambulancesPart 1: Requirements for medical devicesused in air ambulancesBS EN 13718-1:2014 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN 13718-1:2014.It supersedes BS EN 13718-1

2、:2008 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/239, Rescue systems.A list of organizations represented on this committee can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 not purport to include all the necessaryprovisions of a c

3、ontract. Users are responsible for its correctapplication. The British Standards Institution 2014. Published by BSI StandardsLimited 2014ISBN 978 0 580 81504 1ICS 11.040.01; 11.160; 49.020Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was publis

4、hed under the authority of theStandards Policy and Strategy Committee on 30 September 2014.Amendments issued since publicationDate Text affectedBS EN 13718-1:2014EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 13718-1 September 2014 ICS 11.040.01; 11.160; 49.020 Supersedes EN 13718-1:2008Englis

5、h Version Medical vehicles and their equipment - Air ambulances - Part 1: Requirements 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 u

6、nd ihre Ausrstung - Luftfahrzeuge zum Patiententransport - Teil 1: Anforderungen 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 w

7、hich 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 Management Centre or to any CEN member. This

8、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 status as the official versions. CEN member

9、s 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, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal

10、, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. 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

11、and by any means reserved worldwide for CEN national Members. Ref. No. EN 13718-1:2014 EBS EN 13718-1:2014EN 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

12、6 4.2 Patient and personnel safety 7 4.3 User interface .7 4.4 Environmental conditions and performance 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

13、.1 General 8 4.5.2 Medical devices with 12 V DC power input .8 4.5.3 Medical devices with 24 V DC 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 Me

14、dical gas supply 9 4.6.1 General 9 4.6.2 Gas leakage 9 4.6.3 Pressure regulators and flow metering 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 F

15、ixation of medical devices in air ambulances . 10 4.9 Fire resistance . 10 4.10 Information to be 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)

16、 Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices 13 Bibliography . 15 BS EN 13718-1:2014EN 13718-1:2014 (E) 3 Foreword This document (EN 13718-1:2014) has been prepared by Technical Committee CEN/TC 239 “Rescue systems”, the sec

17、retariat 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 March 2015, and conflicting national standards shall be withdrawn at the latest by March 2015. Attention is drawn

18、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 13718-1:2008. This document has been prepared under a mandate given to CEN by

19、 the European Commission and the European Free Trade Association, and supports essential requirements 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 repre

20、sent the most important changes in the revision: a) normative references were updated; b) the following 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“, 3.1

21、0 “interchangeability“, 3.11 “flight crew“, 3.12 “medical crew“; c) a new Subclause 4.5.4 “Medical 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 resi

22、stance“ (now Subclause 4.9) was revised; g) unclear issues were clarified in this part of the standard 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

23、 requirements. EN 13718 consists of the following parts, under the general title: Medical vehicles 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 Inte

24、rnal 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, I

25、reland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. BS EN 13718-1:2014EN 13718-1:2014 (E) 4 Introduction This part of EN 13718 gives minimum requirements for interfaces and

26、 compatibility of medical devices used in air ambulances. The standards work was called for 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 medi

27、cal 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 that are set are carefully selected to ensure

28、 interoperability and continuous patient care. The medical devices are being used by the services 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 essentia

29、l requirements in the Medical Devices Directive. The essential requirements are listed in Annex 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

30、 used in air ambulances are different from those expected in a normal hospital environment. 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 disturba

31、nces between the air ambulances and the medical device. BS EN 13718-1:2014EN 13718-1:2014 (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 ca

32、n differ from normal indoor conditions. This European Standard does not cover the requirements 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 refer

33、ences The following documents, in whole 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. E

34、N 1041:2008+A1:2013, Information supplied by the manufacturer of medical devices EN 13718-2:2008,1)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 s

35、hocks, primarily for equipment-type specimens (IEC 60068-2-31:2008) EN 60529:1991, Degrees 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

36、connections (ISO 407:2004) EN ISO 5359:2008, Low-pressure hose assemblies for use with medical 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

37、 1: Pressure regulators and pressure regulators with flow-metering devices (ISO 10524-1:2006) 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 mana

38、gement to medical devices (ISO 14971:2007, Corrected version 2007-10-01) EN ISO 15002:2008, 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 inform

39、ation to be supplied Part 1: General requirements (ISO 15223-1:2012) ISO 7000:2012, Graphical symbols for use on equipment Registered symbols 1) EN 13718-2:2008 is bound to be superseded with a new edition. BS EN 13718-1:2014EN 13718-1:2014 (E) 6 RTCA DO-160G:2010,2)Environmental Conditions and Test

40、 Procedures for Airborne Equipment 3 Terms and definitions For the purposes of this document, 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

41、who will receive medical treatment during transport 3.2 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 various kinds of ambulances 3.3 interoperability facility to connect various medical devic

42、es 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

43、the software necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of diagnosis, prevention, monitoring, treatment or alleviation of disease and injury 3.5 portable term referring to transportable equipment that, once installed and placed into

44、 service, is intended to be moved from one location to another while being carried by one or more persons Note 1 to entry: Equipment can refer to accessories or equipment parts. Note 2 to entry: See the taxonomy in the rationale for Definition 3.63 in EN 60601-1:2006/A1:2013. SOURCE: EN 60601-1:2006

45、/A1:2013, 3.85, modified The wording of Note 2 to entry has been slightly modified. 4 Requirements for medical devices for air ambulances 4.1 General The manufacturers of all medical devices intended to be used in air ambulances shall ensure that the requirements of this standard are met. 2) This do

46、cument is a material copyrighted by RTCA, Inc. and used with permission: RTCA, Inc. 1150 18th Street NW Suite 910 Washington, DC 20036 (202) 833-9339 http:/www.rtca.org/ It is available on the RTCA store: http:/www.rtca.org/store_product.asp?prodid=770. BS EN 13718-1:2014EN 13718-1:2014 (E) 7 4.2 Pa

47、tient and personnel safety Risks associated with medical devices shall be minimized, using risk management process in accordance with EN ISO 14971:2012, taking account of the intended application of the devices and of known and foreseeable hazards in both normal and fault conditions. When risk analy

48、ses are performed, they shall reflect storage, installation, operation in normal use and maintenance according to the instructions of the manufacturer and the ambient conditions of an air ambulance. 4.3 User interface The user interface of the medical device shall be easy to use in an air ambulance.

49、 NOTE 1 See EN 62366:2008 and EN 6060116:2010 for detailed information on how to design an easy to use medical device. A medical device designated as portable shall be: able to be carried inside and outside the aircraft; able to be carried by one person. NOTE 2 See Directive 90/269/EEC for information. The manufacturer of the medical device shall carry out a risk assessment of the manual handling of the medical device inside and outside of an air ambulance. NOTE 3 There are several accepted risk assessments methods to use e.g. K