Bsi bs en 01789 2007 + a2 2014

BRITISH STANDARD Medical vehicles and their equipment — Road ambulances ICS 11.160; 43.160     BS EN EN 1789:2007 1789:2007 +A2:2014 +A1:2010 BS EN 1789:2007+A2:2014 National foreword This British Standard is the UK implementation of EN 1789:2007+A2:2014 It supersedes BS EN 1789:2007+A1:2010 which is withdrawn The start and finish of text introduced or altered by amendment is indicated in the text by tags Tags indicating changes to CEN text carry the number of the CEN amendment For example, text altered by CEN amendment A1 is indicated by  The UK participation in its preparation was entrusted to Technical Committee CH/239, Rescue systems A list of organizations represented on this committee can be obtained on request to its secretary The 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 from legal obligations This British Standard was published under the authority of the Standards Policy and Strategy Committee on 29 June 2007 © The British Standards Institution 2014 Published by BSI Standards Limited 2014 ISBN 978 580 84270 Amendments/corrigenda issued since publication Date Comments 30 June 2010 Implementation of CEN amendment A1:2010 30 November 2014 Implementation of CEN amendment A2:2014 EUROPEAN STANDARD EN 1789:2007+A2 NORME EUROPÉENNE EUROPÄISCHE NORM September 2014 ICS 11.160; 43.160 Supersedes EN 1789:2007+A1:2010 English Version Medical vehicles and their equipment - Road ambulances Véhicules de transport sanitaire et leurs équipements Ambulances routières Rettungsdienstfahrzeuge und deren Ausrüstung Krankenkraftwagen This European Standard was approved by CEN on 24 February 2007 and includes Amendment approved by CEN on March 2010 and Amendment approved by CEN on 14 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 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 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 members 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, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom EUROPEAN COMMITTEE FOR STANDARDIZATION COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR 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 1789:2007+A2:2014 E BS EN 1789:2007+A2:2014 EN 1789:2007+A2:2014 (E) Contents Page Foreword #Introduction$ Scope Normative references Terms and definitions 4.1 4.1.1 4.1.2 4.1.3 4.2 4.2.1 4.2.2 4.2.3 4.3 4.3.1 4.3.2 4.3.3 4.3.4 4.3.5 4.4 4.4.1 4.4.2 4.4.3 4.4.4 4.4.5 4.4.6 4.5 4.5.1 4.5.2 4.5.3 4.5.4 4.5.5 4.5.6 4.5.7 4.5.8 4.5.9 4.5.10 Requirements 11 General requirements 11 General 11 Maximum overall dimensions 11 Wheel arch clearance 11 #Performance-braking and acceleration$ 11 Acceleration 11 Braking 12 Safety system 12 Electrical requirements 12 General 12 Electromagnetic compatibility (EMC) – Communication equipment 12 Battery and alternator 12 Electrical installation 13 Visual and audible warning system 14 Vehicle body 14 Fire safety 14 Driver's seat configuration 14 Minimum loading capacity 14 Bulkhead 15 Openings (doors, windows, emergency exits) 16 Loading area 17 Patient’s compartment 18 General 18 Patient’s compartment dimensions 19 Patient and attendant seating 23 Ventilation and anaesthetic gas scavenging systems 24 Temperature system 25 Interior lighting 25 Interior noise level 26 Holding system for infusion 26 Mounting systems 26 Mass reserve 27 5.1 5.2 5.2.1 5.2.2 5.2.3 5.3 5.4 5.4.1 Testing 27 General 27 Testing of the interior noise level 27 #Specific measurement conditions$ 27 Measurements 28 Establishment of compliance 29 Testing of the acceleration 30 Testing of maintain systems and fixations of the equipment in the patient’s compartment 30 General 30 BS EN 1789:2007+A2:2014 EN 1789:2007+A2:2014 (E) 5.4.2 5.4.3 5.4.4 5.4.5 5.5 5.5.1 5.5.2 5.6 5.7 5.7.1 5.7.2 5.8 5.8.1 5.8.2 5.9 5.10 5.11 5.12 5.12.1 5.12.2 5.13 5.14 Testing of the stretcher fixations on the vehicle floor 32 Testing of the medical devices fixations 33 Testing of furniture 33 Test procedure 33 #Testing of rounded edges and radius inside the patient's compartment$ 34 #Testing of rounded edges$ 34 Testing of rounded edges and radius inside the patient's compartment 35 Procedure to verify the patient's compartment specifications 35 Procedure to verify the loading area specifications 36 General 36 Procedure to verify the loading angle of 16° 36 Procedure to verify the dimensions of the patient's compartment 37 Type A and B road ambulances 37 Type C road ambulances 37 Procedure to verify the seats dimensions of the patient's compartment 38 Testing of the ventilation system 39 Testing of the heating system 39 Testing of the cooling system 40 Test procedure 40 Testing of independent air conditioning system 40 Testing of interior lighting 41 Testing of infusion holding system 41 6.1 6.2 6.3 6.3.1 6.3.2 6.3.3 6.3.4 6.3.5 6.3.6 6.3.7 6.3.8 6.3.9 6.3.10 6.4 6.4.1 6.4.2 6.5 Medical devices 41 Provision of medical devices 41 Medical devices storage 41 Requirements for medical devices 42 General 42 Temperature 42 Humidity and ingress of liquids 42 Mechanical strength 42 Fixation of devices 43 Electrical safety 43 User interface 43 Gas installation 43 Marking and instructions 45 Maintenance 45 Mechanical strength – Test methods for medical devices for use in road ambulances 45 Vibration and bump test 45 Free fall 46 List of equipment 46 Conformity assessment 53 Requirements to be met for a Certificate of Compliance 53 Annex A (informative) #Test summary$ 55 Annex B (informative) #Definition of ambulance body styles$ 56 B.1 General 56 B.2 Van based Ambulance 56 B.3 Fully independent box body 57 Annex C (informative) #Recognition$ 58 C.1 Recognition and visibility of ambulances 58 C.2 Recognition of personnel 58 BS EN 1789:2007+A2:2014 EN 1789:2007+A2:2014 (E) Annex ZA (informative) !#Relationship between this European Standard and the Essential Requirements of EC Directive 93/42/EEC on Medical Devices and Directive 2007/46/EC of the European Parliament and of the Council of September 2007 establishing a framework for the approval of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles$ 59 Bibliography 60 BS EN 1789:2007+A2:2014 EN 1789:2007+A2:2014 (E) Foreword This document (EN 1789:2007+A2:2014) 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 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 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 includes Amendment 1, approved by CEN on 2010-03-06 and Amendment 2, approved by CEN on 2014-07-14 This document supersedes #EN 1789:2007+A1:2010$ The start and finish of text introduced or altered by amendment is indicated in the text by tags ! " and #$ This document has been prepared under a mandate given to 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 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, 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, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom BS EN 1789:2007+A2:2014 EN 1789:2007+A2:2014 (E) #Introduction In the development of the European standard EN during the 90's, Directive 70/156/EEC has been considered In October 2009, CEN/TC 239 appointed an ad-hoc group to evaluate the impact of the Directive 2007/46/EC which replaces Directive 70/156/EEC, on EN 1789:2007 and to assess its application in different member countries of CEN Moreover the definition of ambulance of the COMMISSION REGULATION (EU) No 678/2011 (14 July 2011 replacing Annex II and amending Annexes IV, IX and XI to Directive 2007/46/EC) refers to EN 1789:2007 The appointed ad-hoc group reported its findings as follows: — EN 1789:2007 has not been applied consistently by notified bodies since the text for verifying compliance is open to interpretation and may cause difficulties to Technical Services (TS) as defined in Directive 2007/46/EC, EN 1789:2007 or local authorities; — these differences can lead to declarations that the same ambulance complies or does not comply with EN 1789:2007; — manufacturers of ambulances may have the same problems of interpretation in the design of their ambulances; — users of ambulances may have the same problems of interpretation that affects their responsibility This second amendment 1) gives an answer to questions concerning the application of EN 1789:2007 and avoids differences in interpretation between such notified bodies to check compliance of vehicles specially adapted to medical transportation (Road ambulances) NOTE Such as the demonstration of compliance to the requirements of 4.5.9 or 4.3.$ 1) #The first amendment published in 2010 only updates Table ZA.1 to consider the revision of Directive 93/42/EEC.$ BS EN 1789:2007+A2:2014 EN 1789:2007+A2:2014 (E) 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 patient’s compartment 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 This European Standard is applicable to road ambulances capable of transporting at least one person on 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 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 Normative references The following referenced documents are indispensable for 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 3-7:2004+A1:2007$, Portable fire extinguishers — Part 7: Characteristics, performance requirements and test methods #EN 420:2003+A1:2009$, Protective gloves — General requirements and test methods #EN 455-1:2000$, Medical gloves for single use — Part 1: Requirements and testing for freedom from holes #EN 455-2:2009+A2:2013$, Medical gloves for single use — Part 2: Requirements and testing for physical properties #deleted text$ 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 #deleted text$ #EN 794-3:1998+A2:2009$, Lung ventilators — Part 3: Particular requirements for emergency and transport ventilators #deleted text$ #EN 1041:2008+A1:2013, Information supplied by the manufacturer of medical devices$ BS EN 1789:2007+A2:2014 EN 1789:2007+A2:2014 (E) Table — Type of patient handling equipment No Device Standard A1 A2 B C Main stretcher/undercarriage #EN 18651:2010$ 1 1 Pick up stretcher #EN 18651:2010$ – – 1 Vacuum mattress #EN 18651:2010$ – – 1 1 X 1 1 – – X X Device for conveying a seated #EN 1865-1:2010 and EN 1865patient a 4:2012$ Carrying mattress Long spinal board complete with head immobilizer and securing straps a Type of road ambulances sheet or transfer #EN 18651:2010$ #EN 18651:2010$ Unless the main stretcher has the function of these devices Table 10 — Type of immobilization equipment No Device Standard Type of road ambulance A1 A2 B C Traction device – – – X X Immobilization, set for fractures – – – 1 Cervical upper spinal immobilization devices Cervical collar-set – – – 1 Extended upper spinal immobilization – – – 1 Extrication devices or short spinal board (one of these) 47 BS EN 1789:2007+A2:2014 EN 1789:2007+A2:2014 (E) Table 11— Type of ventilation/respiration equipment No Device Standard Stationary oxygen a l, Minimum 000 (under normal temperature and pressure), flowmeter/flowgauge with maximum capacity of at least 15 l/min and regulating valve quick connection b Portable oxygen Minimum 400 l, (under normal temperature and pressure), flowmeter/flowgauge with maximum capacity of at least 15 l/min and regulating valve quick connection A2 B C EN 737-1:1998 X X 1 EN 737-1:1998 – – 1 EN 737-1:1998 1 1 EN 737-1:1998 – – 1 X X 1 1 – – – – 1 1 1 Resuscitator with oxygen inlet and masks and airways for all ages and oxygen reservoir – Mouth to mask oxygen inlet – 48 A1 ventilator with Non-manual suction device with a EN minimum pressure of –65 kPa with a ISO 10079-1:19 minimum capacity of l 99 EN ISO 10079-3:19 99 Portable suction device Type of road ambulance EN ISO 10079-2:19 99 a A reduced capacity of 000 l may be fitted in type A1 and A2 road ambulances b A reduced capacity of 200 l may be fitted in type A1 and A2 road ambulances BS EN 1789:2007+A2:2014 EN 1789:2007+A2:2014 (E) Table 12 — Type of diagnostics equipment No Device Standard Type of road ambulance A1 A2 B C – – 1 – – X X #EN ISO 80601-261:2011$ – – 1 Stethoscope – – – 1 Thermometer #EN 124701:2000+A1:2009 $ – – 1 Manual B P Monitor, – Cuff size 10 cm – 66 cm – Automatic B P Monitor, Cuff size 10 cm – 66 cm A doppler type shall operate accurately in the conditions of electrical interference and vibration specified in 4.3.1 and 6.3.4 Oximeter Minimum range 28 °C to 42 °C Device for blood sugar determination – – – 1 Diagnostic light – – – 1 Table 13 — Type of drug No Type of drug Pain relief Standard – Type of road ambulance A1 A2 B C – – X X Table 14 — Type of infusion material or equipment No Device Standard A1 A2 B C – – 4 – – 2 – – – 1 Infusion solutions, litre – Equipment for injections and infusions, set – Infusion system which is designed to allow the administration of fluid warmed to (37 ± 2) °C Type of road ambulance This system is not required to be portable Infusion mounting – 1 2 Pressure infusion device – – – 1 49 BS EN 1789:2007+A2:2014 EN 1789:2007+A2:2014 (E) Table 15 — Type of equipment for managing of life-threatening problems No Device Standard Type of road ambulance A1 A2 B C Defibrillator with rhythm and patient #EN 606012-4:2011$ data recording a 1 1 Cardiac monitor a #EN 606012-4:2011$ – – 1 External cardiac pacing a #EN 606012-4:2011$ – – X – – – – – – – – #EN 135441:2007+A1:20 09$ – – 1 – – – – Portable airways care system (p.a.c.s.) Manual resuscitator Mouth to mask ventilator with oxygen inlet Airways oro- or nasopharyngeal airway Aspirator Suction catheter Portable advanced resuscitation system (p.a.r.s.) Contents of portable airways care system (p.a.c.s.) Infusion equipment – to include suitable venous indwelling cannulae Infusion administration sets Infusion solutions Adhesive fixing materials Intubation equipment – to include laryngoscope handle(s) with suitable blades Magill forceps Insertion stylets Endotracheal tubes with connectors Inflation tube clamp Inflation syringe Tube fixing material Stethoscope Drug administration equipment 50 Nebulization apparatus Thorax drainage kit BS EN 1789:2007+A2:2014 EN 1789:2007+A2:2014 (E) Volumetric infusing device – – – – Central vein catheters – – – – 10 Requirements for transport ventilators #EN 7943:1998+A2:20 09$ – – – 11 PEEP-valve, adjustable or set – – – – 12 Capnometer #EN ISO 80601-255:2011$ – – – a emergency and If desired two or more of these functions can be combined within one device Table 16 — Bandaging and nursing No Device Standard Type of road ambulance A1 A2 B C Bedding equipment – 1 Blankets – 2 Material for treatment of wounds – 1 1 Material for treatment of burns and corrosives – – – 1 Re-plantation container to maintain the internal temperature at (4 ± 2) °C for at least h – – – X X Kidney bowl – 1 Vomiting bag – 1 Bed-pan – X X X X Non-glass urine bottle – 1 10 Sharps container – 1 1 11 Gastric tube with accessories – – – X X X X 5 Sterile surgical gloves, pairs #EN 4551:2000$, #EN 4552:2009+A2:20 13$ 100 100 100 100 13 Non-sterile gloves for single use #EN 4551:2000$, #EN 4552:2009+A2:20 13$ 14 Emergency delivery kit – X X 1 15 Waste bag – 1 1 16 Clinical waste bag – X X X X 17 Non-wovens stretcher sheet – 1 1 12 51 BS EN 1789:2007+A2:2014 EN 1789:2007+A2:2014 (E) Table 17 — Personal protection equipment (for each member of the crew for protection and to identify the staff as road ambulance personnel) No Device Standard Type of road ambulance A1 a A2 a Ba Ca Basic protective clothing including high #EN ISO 20 visibility reflective jacket or tabard 471:2013$ 1 1 Advanced protection wear – – – X X Safety/debris gloves, pairs #EN 420:20 03+A1:2009 $ 1 1 Safety shoes, pairs #EN ISO 20345:20 11$ X X 1 Safety helmet #EN 14052: 2012+A1:2012 $ – – 1 – – – 1 Personal protection equipment against infection a Numbers are quoted per crew member Table 18 — Rescue and protection material No Standard Type of road ambulance A1 A2 B C Cleaning and disinfection material – 1 1 Light rescue tools, set – – – X X Seat belt cutter – 1 1 Warning triangle/lights – 2 2 Spotlight – 1 1 #EN 37:2004+A1:20 07$ 1 1 52 Device Fire extinguisher BS EN 1789:2007+A2:2014 EN 1789:2007+A2:2014 (E) Table 19 — Communication No Device Standard Type of road ambulance A1 A2 B C Mobile radio transceiver – 1 1 Portable radio transceiver – – – 1 Access to the public telephone network e.g via the normal radio transmitter or by mobile (cellular) telephone – – – 1 Portable alerting system, per person – – – 1 1 1 Can be included in portable radio receiver Internal communication between driver and patient compartment – # Conformity assessment Clause and Annex A specify the test summary The means of verification (MoV) to establish a compliance are deliverables or tests to be performed to allow the TS to establish the compliance of the ambulance to this standard: a) b) Documentary: 1) control record (CsD); 2) approval document (FdC); 3) manufacturer certificate (AC) Testing or inspection of vehicles and / or subassemblies: 1) control on vehicle (CsV); 2) testing by third-party (ETP).$ # Requirements to be met for a Certificate of Compliance An ambulance belongs to a vehicle type specially adapted to medical transportation in due regard to this standard, to obtain a certificate of compliance if it has the following features in common: a) base vehicle description (list of TVV declared by the bodybuilder and covered by the multi-stage typeapproval); b) bodybuilder; c) type of ambulance in accordance with this standard (type A1, A2 B or C); 53 BS EN 1789:2007+A2:2014 EN 1789:2007+A2:2014 (E) d) patient's compartment; 1) number of stretcher(s); 2) number of seats in road use; 3) dimension of the patient's compartment or ergonomic space NOTE Under item d) several layouts of the patient's compartment can be covered in the same type of vehicles specially adapted to medical transportation in due regard to this standard.$ 54 BS EN 1789:2007+A2:2014 EN 1789:2007+A2:2014 (E) Annex A (informative) #Test summary This is to certify that ambulance compartment produced by……………………………………………………… on the chassis………………………………………………………………………………………………………… equipped as a (type A B or C) ambulance complies with EN 1789:2007+A2:2014, 4.5.9 and 5.4 Static and/or dynamic tests have been carried from………………… to … ………….………………………(dates) Detailed data are to be found in test report number Authorized designated official (name) Signed Date $ 55 BS EN 1789:2007+A2:2014 EN 1789:2007+A2:2014 (E) Annex B (informative) #Definition of ambulance body styles B.1 General This annex provides a definition and illustration of the various types of ambulance bodies B.2 Van based Ambulance Figure B.1 — Integrated body shell (panelled van) Figure B.2 — Semi integrated box body (Bulkhead integrated to the vehicle) 56 BS EN 1789:2007+A2:2014 EN 1789:2007+A2:2014 (E) Figure B.3 — Semi integrated box body (box body mounted to platform cab and retaining original cab fixed bulkhead) B.3 Fully independent box body Figure B.4 — Fully independent box body mounted on the chassis cab by fixation points (body is a self-supporting unit)$ 57 BS EN 1789:2007+A2:2014 EN 1789:2007+A2:2014 (E) Annex C (informative) #Recognition C.1 Recognition and visibility of ambulances To enhance the recognition and visibility of the vehicle in daylight the base body colour should be yellow (RAL 1016) 11) or white Where the white body option is selected additional fluorescent yellow or yellow (RAL 1016) 11) red (RAL 3024) should be used on the external surface of the vehicles 11) or fluorescent For night time visibility micro-prismatic reflective material should be applied With the exception of Red Cross societies or where the "Star of life" is locally registered, a blue reflective "Star of life" emblem (minimum size 500 mm) together with reflective letters, numerals or a symbol identifying the organization and the vehicle, should be applied to the roof of the ambulance With the exception of Red Cross societies or where the "Star of life" is locally registered, a blue reflective "Star of life" emblem should be applied to the sides and rear of the ambulance The word "ambulance" or equivalent national translation should be applied in reflective upper case letters, a minimum of 100 mm high, in a colour contrasting with the background, to the side and rear of the ambulance and if possible on the front C.2 Recognition of personnel Safety garments should conform to at least class of EN ISO 20471:2013 With the exception of Red Cross societies or where the "Star of life" is locally registered, a blue reflective “Star of Life” emblem should be fixed to the garments The garments should identify the designation of the wearer.$ 11 RAL colour space system, maintained by Deutsches Institut für Gütesicherung und Kennzeichnung e.V 58 BS EN 1789:2007+A2:2014 EN 1789:2007+A2:2014 (E) Annex ZA (informative) !#Relationship between this European Standard and the Essential Requirements of EC Directive 93/42/EEC on Medical Devices and Directive 2007/46/EC of the European Parliament and of the Council of September 2007 establishing a framework for the approval of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles$ This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC on Medical Devices Once this standard is cited in the Official Journal of the European Union under that Directive and has been implemented as a national standard in at least one Member State, compliance with the clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC on Medical #Devices$ # Clause(s)/subclause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 6.3.8 9.1, first sentence only Covered as far as the gas installation is concerned 4.1.1, 6.3.2, 6.3.4, 6.3.5, 6.3.6, 6.3.8, 6.4 9.2, second indent To fully cover this ER, risks connected with reasonably foreseeable environmental conditions shall be removed or minimized as far as possible 4.1.1, 6.3.8 9.3 To fully cover this ER, risks connected with fire or explosion shall be minimized 6.3.4 12.7.1 $ General note: Ambulances are not considered to be medical devices However, ambulances are designed to accommodate medical devices and some clauses of this standard specify requirements for devices carried and used in ambulances Compliance with the clauses listed above and subsequent presumption of conformity with the corresponding ERs of the directive only applies to these medical devices WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard." 59 BS EN 1789:2007+A2:2014 EN 1789:2007+A2:2014 (E) Bibliography [1] Council Directive 70/156/EEC of February 1970 on the approximation of the laws of the Members States relating to the type-approval of motor vehicles and their trailers [2] Council Directive 72/245/EEC of 20 June 1972 on the approximation of the laws of the Members States relating to the suppression of radio interference produced by spark-ignition engines fitted to motor vehicles [3] Council Directive 74/408/EEC of 22 July 1974 on the approximation of the laws of the Member States relating to the interior fittings of motor vehicles (strength of seats and of their anchorages) [4] Council Directive 76/115/EEC of 18 December 1975 on the approximation of the laws of the Member States relating to anchorages for motor-vehicle safety belts [5] Council Directive 77/541/EEC of 28 June 1977 on the approximation of the laws of the Member States relating to safety belts and restraint systems of motor vehicles [6] Council Directive 78/932/EEC of 16 October 1978 on the approximation of the laws of the Member States relating to head restraints of seats of motor vehicles [7] Council Directive 90/269/EEC of 29 May 1990 on the minimum health and safety requirements for the manual handling of loads where there is a risk particularly of back injury to workers (fourth individual Directive within the meaning of Article 16 (1) of Directive 89/391/EEC) [8] Council Directive 92/21/EEC of 31 March 1992 on the masses and dimensions of motor vehicles of category M1 [9] Council Directive 92/22/EEC of 31 March 1992 on safety glazing and glazing materials on motor vehicles and their trailers [10] Council Directive 93/42/EEC of 14 June 1993 concerning medical devices [11] Directive 96/79/EC of the European Parliament and of the Council of 16 December 1996 on the protection of occupants of motor vehicles in the event of a frontal impact and amending Directive 70/156/EEC [12] Commission Directive 2004/104/EC of 14 October 2004 adapting to technical progress Council Directive 72/245/EEC relating to the radio interference (electromagnetic compatibility) of vehicles and amending Directive 70/156/EEC on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers [13] ECE-Regulation No 16; revision 3; uniform provisions concerning the approval of safety-belts and restraint systems for adult occupants of power- driven vehicles [14] EN ISO 7396-2, Medical gas pipeline systems - Part 2: Anaesthetic gas scavenging disposal systems (ISO 7396-2:2007) 60 This page deliberately left blank