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1、BRITISH STANDARD BS EN 1789:2007 Medical vehicles and their equipment Road ambulances The European Standard EN 1789:2007 has the status of a British Standard ICS 11.160; 43.160 ? BS EN 1789:2007 This British Standard was published under the authority of the Standards Policy and Strategy Committee on
2、 29 June 2007 BSI 2007 ISBN 978 0 580 52922 1 National foreword This British Standard was published by BSI. It is the UK implementation of EN 1789:2007. It supersedes BS EN 1789:2000 which is withdrawn. The UK participation in its preparation was entrusted to Technical Committee CH/239, Rescue syste
3、ms. A list of organizations represented on this committee can be obtained on request to its secretary. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard cannot confer immunity
4、 from legal obligations. Amendments issued since publication Amd. No. DateComments EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 1789 May 2007 ICS 11.160; 43.160Supersedes EN 1789:1999 English Version Medical vehicles and their equipment - Road ambulances Vhicules de transport sanitaire et le
5、urs quipements - Vhicule dambulances Rettungsdienstfahrzeuge und deren Ausrstung - Krankenkraftwagen This European Standard was approved by CEN on 24 February 2007. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Stand
6、ard 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 Management Centre or to any CEN member. This European Standard exists in three official versions (English, French
7、, 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 Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, C
8、zech 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 United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT E
9、UROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2007 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 1789:2007: E EN 1789:2007 (E) 2 Contents Page Foreword4 1 Scope 5 2 N
10、ormative references5 3 Terms and definitions .7 4 Requirements.8 4.1 General requirements8 4.1.1 General8 4.1.2 Maximum overall dimensions.8 4.1.3 Wheel arch clearance9 4.2 Performance.9 4.2.1 Acceleration .9 4.2.2 Braking9 4.2.3 Safety system.9 4.3 Electrical requirements.9 4.3.1 General9 4.3.2 Ele
11、ctromagnetic compatibility (EMC)9 4.3.3 Battery and alternator .10 4.3.4 Electrical installation.11 4.4 Vehicle body.12 4.4.1 Fire safety.12 4.4.2 Drivers seat configuration .12 4.4.3 Minimum loading capacity12 4.4.4 Bulkhead.12 4.4.5 Openings (doors, windows, emergency exits).12 4.4.6 Loading area.
12、13 4.5 Patients compartment14 4.5.1 General14 4.5.2 Patients compartment dimensions.15 4.5.3 Patient and attendant seating.21 4.5.4 Ventilation and anaesthetic gas scavenging systems.21 4.5.5 Temperature system22 4.5.6 Interior lighting.22 4.5.7 Interior noise level.23 4.5.8 Holding system for infus
13、ion.23 4.5.9 Mounting systems .23 5 Testing24 5.1 Testing of the interior noise level 24 5.2 Testing of the acceleration.24 5.3 Testing of maintain systems and fixations of the equipment in the patients compartment 24 5.4 Testing of rounded edges.26 6 Medical devices27 6.1 Provision of medical devic
14、es .27 6.2 Medical devices storage .27 6.3 Requirements for medical devices 28 6.3.1 General28 6.3.2 Temperature.28 6.3.3 Humidity and ingress of liquids.28 6.3.4 Mechanical strength28 6.3.5 Fixation of devices.29 EN 1789:2007 (E) 3 6.3.6 Electrical safety.29 6.3.7 User interface.29 6.3.8 Gas instal
15、lation29 6.3.9 Marking and instructions31 6.3.10 Maintenance.31 6.4 Mechanical strength Test methods for medical devices for use in road ambulances .31 6.4.1 Vibration and bump test .31 6.4.2 Free fall.32 6.5 List of equipment.32 Annex A (informative) Recognition.39 A.1 Recognition and visibility of
16、 ambulances.39 A.2 Recognition of personnel.39 Annex B (informative) Test summary .40 Annex C (informative) Certificate of compliance.41 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC concerning medical devices42 Bibliograp
17、hy43 EN 1789:2007 (E) 4 Foreword This document (EN 1789:2007) 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 endor
18、sement, at the latest by November 2007, and conflicting national standards shall be withdrawn at the latest by November 2007. This document supersedes EN 1789:1999. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and su
19、pports essential requirements of EU Directive(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement thi
20、s European Standard: Austria, Belgium, Bulgaria, 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 Unit
21、ed Kingdom. EN 1789:2007 (E) 5 1 Scope This European Standard specifies requirements for the design, testing, performance and equipping of road ambulances used for the transport and care of patients. It contains requirements for the patients compartment. This European Standard does not cover the req
22、uirements 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. This European Standard is applicable to road ambulances capable of transporting at least one person on
23、 a stretcher. Requirements are specified for categories of road ambulances based in increasing order of the level of treatment that can be carried out. These are the patient transport ambulance (types A1 A2), the emergency ambulance (type B) and the mobile intensive care unit (type C). This European
24、 Standard gives general requirements for medical devices carried in road ambulances and used therein and outside hospitals and clinics in situations where the ambient conditions can differ from normal indoor conditions. 2 Normative references The following referenced documents are indispensable for
25、the application 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. EN 3-7, Portable fire extinguishers Part 7: Characteristics, performance requirements and test methods EN
26、420, Protective gloves General requirements and test methods EN 455-1, Medical gloves for single use Part 1: Requirements and testing for freedom from holes EN 455-2, Medical gloves for single use Part 2: Requirements and testing for physical properties EN 471:2003, High-visibility warning clothing
27、for professional use Test methods and requirements EN 737-1:1998, Medical gas pipeline systems Part 1: Terminal units for compressed medical gases and vacuum EN 737-3:1998, Medical gas pipeline systems Part 3: Pipelines for compressed medical gases and vacuum EN 739, Low-pressure hose assemblies for
28、 use with medical gases EN 794-3, Lung ventilators Part 3: Particular requirements for emergency and transport ventilators EN 980, Graphical symbols for use in the labelling of medical devices EN 1041, Information supplied by the manufacturer with medial devices EN 1865, Specifications for stretcher
29、s and other patient handling equipment used in road ambulances EN 12470-1, Clinical thermometers Part 1: Metallic liquid-in-glass thermometers with maximum device EN 13544-1, Respiratory therapy equipment Part 1: Nebulizing systems and their components EN 14052, High performance industrial helmets E
30、N 1789:2007 (E) 6 EN 60068-2-6, Environmental testing Part 2: Tests Tests Fc: Vibration (sinusoidal) (IEC 60068-2-6:1995 + Corrigendum 1995) EN 60068-2-29, Basic environmental testing procedures Part 2: Tests; test Eb and guidance: bump (IEC 60068-2-29:1987) EN 60068-2-32, Basic environmental testin
31、g procedures Part 2: Tests; test Ed: free fall (IEC 60068-2- 32:1975 + A1:1982 + A2:1990) EN 60068-2-64, Environmental testing Part 2: Test methods Test Fh: Vibration, broad-band random (digital control) and guidance (IEC 60068-2-64:1993 + Corrigendum 1993) EN 60601-1 (all parts), Medical electrical
32、 equipment EN 60601-2 (all parts), Medical electrical equipment EN 60601-2-4, Medical electrical equipment Part 2-4: Particular requirements for the safety of cardiac defibrillators (IEC 60601-2-4:2002) EN ISO 407, Small medical gas cylinders Pin-index yoke- type valve connections (ISO 407:2004) EN
33、ISO 9919, Medical electrical equipment Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use (ISO 9919:2005) EN ISO 10079-1:1999, Medical suction equipment Part 1: Electrically powered suction equipment Safety requirements (ISO 10079-1:199
34、9) EN ISO 10079-2:1999, Medical suction equipment Part 2: Manually powered suction equipment (ISO 10079-2:1999) EN ISO 10079-3:1999, Medical suction equipment Part 3: Suction equipment powered from a vacuum or pressure source (ISO 10079-3:1999) EN ISO 10524-1, Pressure regulators for use with medica
35、l gases Part 1: Pressure regulators and pressure regulators with flow-metering devices (ISO 10524-1:2006) EN ISO 10524-3, Pressure regulators for use with medical gases Part 3: Pressure regulators integrated with cylinder valves (ISO 10524-3:2005) EN ISO 11197:2004, Medical supply units (ISO 11197:2
36、004) EN ISO 14971, Medical devices Application of risk management to medical devices (ISO 14971:2007) prEN ISO 15002, Flow-metering devices for connection to terminal units of medical gas pipeline systems (ISO/DIS 15002:2006) EN ISO 19054, Rail systems for supporting medical equipment (ISO 19054:200
37、5) EN ISO 20345, Personal protective equipment Safety footwear (ISO 20345:2004) EN ISO 21647, Medical electrical equipment Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 21647:2004) EN 1789:2007 (E) 7 IEC 60364-7-708, Electrical installations
38、of buildings Part 7: Requirements for special installations or locations. Section 708 Electrical installations in caravan parks and caravans1) ISO 3795, Road vehicles, and tractors and machinery for agriculture and forestry Determination of burning behaviour of interior materials ISO 5128:1980, Acou
39、stics Measurement of noise inside motor vehicles 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 patient and emergency patient 3.1.1 patient person whose condition requires appropriately trained personnel to provide medical care and/or suitab
40、le transport 3.1.2 emergency patient patient who through sickness, injury or other circumstances is in immediate or imminent danger to life unless emergency treatment and/or monitoring and suitable transport to diagnostic facilities or medical treatment is provided 3.2 ambulance vehicle or craft int
41、ended to be crewed by a minimum of two appropriately trained staff for the provision of care and transport of at least one stretchered patient 3.3 types of road ambulances2) 3.3.1 type A: patient transport ambulance road ambulance designed and equipped for the transport of patients who are not expec
42、ted to become emergency patients. Two types of patient transport ambulance exist: type A1: suitable for transport of a single patient; type A2: suitable for transport of one or more patient(s) (on stretcher(s) and/or chair(s) 3.3.2 type B: emergency ambulance road ambulance designed and equipped for
43、 the transport, basic treatment and monitoring of patients 1) IEC/TC 64 “Electrical installations and protection against electric shock” is developing the revision of IEC 60364-7-708. The draft is presently at the DIS stage. The standard, when ready, will be published as the first edition of the new
44、 section 7-721 “Electrical installations in caravans and motor caravans”. 2) Road ambulances are road vehicles which comply with type approval for special use vehicles according to Directive 70/156/EEC in the last applicable amended version. EN 1789:2007 (E) 8 3.3.3 type C: mobile intensive care uni
45、t road ambulance designed and equipped for the transport, advanced treatment and monitoring of patients 3.4 net vehicle mass unloaded mass vehicle mass according to 92/21/EEC modified of the road ambulance including the driver taken as 75 kg and all fixed installations NOTE Loose portable patient ha
46、ndling, sanitary, medical and technical equipment are not included in net vehicle mass. 3.5 permissible gross vehicle mass permissible total mass vehicle mass comprising the net vehicle mass, the mass of sanitary, medical and technical equipment, the mass of passengers, taken as 75 kg per person, an
47、d any reserve mass NOTE The permissible gross vehicle mass should be specified by the chassis manufacturer in accordance with Directive 70/156/EEC. 3.6 loading capacity difference between the gross vehicle mass and the net vehicle mass NOTE This represents the mass that may be distributed on the roa
48、d ambulance such that the permissible axle loads are not exceeded. 3.7 fixation system system or device to ensure the permanent fixation of medical devices or other equipment into the ambulance 3.8 maintain system bracket or other interface device used to secure a mobile or transportable item of equ
49、ipment or medical device of the vehicle without the use of tools 4 Requirements 4.1 General requirements 4.1.1 General The road ambulance shall comply with the requirements of Directive 70/156/EEC, and separate Directives, for ambulances or corresponding national requirements for approval of vehicles. Road ambulances equipment shall, when operated in normal use and maintained according to the instructions of the manufacturer, c