EN 1789-2007 en Medical vehicles and their equipment - Road ambulances (Incorporates Amendment A2 2014)《医疗车辆及其设备 道路救护车》.pdf

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1、BRITISH STANDARDBS EN 1789:2007+A1:2010Medical vehicles and their equipment Road ambulancesICS 11.160; 43.160g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3

2、g47g36g58BS EN +A2:2014BS EN 1789:2007+A2:2014ISBN 978 0 580 84270 2Amendments/corrigenda issued since publicationDate Comments30 June 2010 Implementation of CEN amendment A1:201030 November 2014 Implementation of CEN amendment A2:2014This British Standard was published under the authority of the St

3、andards Policy and Strategy Committee on 29 June 2007 The British Standards Institution 2014. Published by BSI Standards Limited 2014National forewordThis 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 It supersedes BS EN 1789:2007+A1:2010 which is withdrawn.The start and finish

4、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,

5、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

6、immunity from legal obligations.EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 1789:2007+A2 September 2014 ICS 11.160; 43.160 Supersedes EN 1789:2007+A1:2010 English Version Medical vehicles and their equipment - Road ambulances Vhicules de transport sanitaire et leurs quipements - Ambulances

7、routires Rettungsdienstfahrzeuge und deren Ausrstung - Krankenkraftwagen This European Standard was approved by CEN on 24 February 2007 and includes Amendment 1 approved by CEN on 6 March 2010 and Amendment 2 approved by CEN on 14 July 2014. CEN members are bound to comply with the CEN/CENELEC Inter

8、nal 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

9、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 ver

10、sions. 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,

11、 Poland, Portugal, 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 exploita

12、tion in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 1789:2007+A2:2014 E EN 1789:2007+A2:2014 (E) 2 Contents Page Foreword 5 #Introduction$ 6 1 Scope 7 2 Normative references 7 3 Terms and definitions .9 4 Requirements 11 4.1 General requirements . 11 4.1.1 Gene

13、ral . 11 4.1.2 Maximum overall dimensions 11 4.1.3 Wheel arch clearance . 11 4.2 #Performance-braking and acceleration$ . 11 4.2.1 Acceleration 11 4.2.2 Braking . 12 4.2.3 Safety system 12 4.3 Electrical requirements 12 4.3.1 General . 12 4.3.2 Electromagnetic compatibility (EMC) Communication equip

14、ment 12 4.3.3 Battery and alternator 12 4.3.4 Electrical installation 13 4.3.5 Visual and audible warning system 14 4.4 Vehicle body 14 4.4.1 Fire safety 14 4.4.2 Drivers seat configuration 14 4.4.3 Minimum loading capacity . 14 4.4.4 Bulkhead 15 4.4.5 Openings (doors, windows, emergency exits) 16 4

15、.4.6 Loading area 17 4.5 Patients compartment . 18 4.5.1 General . 18 4.5.2 Patients compartment dimensions 19 4.5.3 Patient and attendant seating 23 4.5.4 Ventilation and anaesthetic gas scavenging systems 24 4.5.5 Temperature system . 25 4.5.6 Interior lighting 25 4.5.7 Interior noise level 26 4.5

16、.8 Holding system for infusion 26 4.5.9 Mounting systems 26 4.5.10 Mass reserve . 27 5 Testing . 27 5.1 General . 27 5.2 Testing of the interior noise level . 27 5.2.1 #Specific measurement conditions$ . 27 5.2.2 Measurements . 28 5.2.3 Establishment of compliance 29 5.3 Testing of the acceleration

17、30 5.4 Testing of maintain systems and fixations of the equipment in the patients compartment . 30 5.4.1 General . 30 BS EN 1789:2007+A2:2014EN 1789:2007+A2:2014 (E) 2 Contents Page Foreword 5 #Introduction$ 6 1 Scope 7 2 Normative references 7 3 Terms and definitions .9 4 Requirements 11 4.1 Genera

18、l requirements . 11 4.1.1 General . 11 4.1.2 Maximum overall dimensions 11 4.1.3 Wheel arch clearance . 11 4.2 #Performance-braking and acceleration$ . 11 4.2.1 Acceleration 11 4.2.2 Braking . 12 4.2.3 Safety system 12 4.3 Electrical requirements 12 4.3.1 General . 12 4.3.2 Electromagnetic compatibi

19、lity (EMC) Communication equipment 12 4.3.3 Battery and alternator 12 4.3.4 Electrical installation 13 4.3.5 Visual and audible warning system 14 4.4 Vehicle body 14 4.4.1 Fire safety 14 4.4.2 Drivers seat configuration 14 4.4.3 Minimum loading capacity . 14 4.4.4 Bulkhead 15 4.4.5 Openings (doors,

20、windows, emergency exits) 16 4.4.6 Loading area 17 4.5 Patients compartment . 18 4.5.1 General . 18 4.5.2 Patients compartment dimensions 19 4.5.3 Patient and attendant seating 23 4.5.4 Ventilation and anaesthetic gas scavenging systems 24 4.5.5 Temperature system . 25 4.5.6 Interior lighting 25 4.5

21、.7 Interior noise level 26 4.5.8 Holding system for infusion 26 4.5.9 Mounting systems 26 4.5.10 Mass reserve . 27 5 Testing . 27 5.1 General . 27 5.2 Testing of the interior noise level . 27 5.2.1 #Specific measurement conditions$ . 27 5.2.2 Measurements . 28 5.2.3 Establishment of compliance 29 5.

22、3 Testing of the acceleration 30 5.4 Testing of maintain systems and fixations of the equipment in the patients compartment . 30 5.4.1 General . 30 EN 1789:2007+A2:2014 (E) 3 5.4.2 Testing of the stretcher fixations on the vehicle floor 32 5.4.3 Testing of the medical devices fixations 33 5.4.4 Test

23、ing of furniture 33 5.4.5 Test procedure . 33 5.5 #Testing of rounded edges and radius inside the patients compartment$ 34 5.5.1 #Testing of rounded edges$ . 34 5.5.2 Testing of rounded edges and radius inside the patients compartment 35 5.6 Procedure to verify the patients compartment specification

24、s 35 5.7 Procedure to verify the loading area specifications 36 5.7.1 General . 36 5.7.2 Procedure to verify the loading angle of 16 36 5.8 Procedure to verify the dimensions of the patients compartment 37 5.8.1 Type A and B road ambulances . 37 5.8.2 Type C road ambulances 37 5.9 Procedure to verif

25、y the seats dimensions of the patients compartment . 38 5.10 Testing of the ventilation system 39 5.11 Testing of the heating system 39 5.12 Testing of the cooling system 40 5.12.1 Test procedure . 40 5.12.2 Testing of independent air conditioning system . 40 5.13 Testing of interior lighting 41 5.1

26、4 Testing of infusion holding system . 41 6 Medical devices . 41 6.1 Provision of medical devices . 41 6.2 Medical devices storage . 41 6.3 Requirements for medical devices 42 6.3.1 General . 42 6.3.2 Temperature . 42 6.3.3 Humidity and ingress of liquids . 42 6.3.4 Mechanical strength 42 6.3.5 Fixa

27、tion of devices 43 6.3.6 Electrical safety . 43 6.3.7 User interface . 43 6.3.8 Gas installation 43 6.3.9 Marking and instructions 45 6.3.10 Maintenance . 45 6.4 Mechanical strength Test methods for medical devices for use in road ambulances . 45 6.4.1 Vibration and bump test . 45 6.4.2 Free fall .

28、46 6.5 List of equipment . 46 7 Conformity assessment 53 8 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 .

29、 57 Annex C (informative) #Recognition$ 58 C.1 Recognition and visibility of ambulances. 58 C.2 Recognition of personnel . 58 BS EN 1789:2007+A2:2014EN 1789:2007+A2:2014 (E) 4 Annex ZA (informative) !#Relationship between this European Standard and the Essential Requirements of EC Directive 93/42/EE

30、C on Medical Devices and Directive 2007/46/EC of the European Parliament and of the Council of 5 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 B

31、S EN 1789:2007+A2:2014EN 1789:2007+A2:2014 (E) 4 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 5 September 2007 establishing a

32、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 EN 1789:2007+A2:2014 (E) 5 Foreword This document (EN 1789:2007+A2:2014) has been prepared by Technical Committee CEN/TC 239 “Re

33、scue 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 201

34、5. 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,

35、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 T

36、rade 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 ar

37、e 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, Po

38、rtugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. BS EN 1789:2007+A2:2014EN 1789:2007+A2:2014 (E) 6 #Introduction In the development of the European standard EN during the 90s, Directive 70/156/EEC has been considered. In October 2009, CEN/TC 239 appoint

39、ed 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 An

40、nex 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 di

41、fficulties 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 t

42、he design of their ambulances; users of ambulances may have the same problems of interpretation that affects their responsibility. This second amendment1)gives an answer to questions concerning the application of EN 1789:2007 and avoids differences in interpretation between such notified bodies to c

43、heck 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:

44、2007+A2:2014EN 1789:2007+A2:2014 (E) 6 #Introduction In the development of the European standard EN during the 90s, 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,

45、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

46、-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

47、; 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 affect

48、s their responsibility. This second amendment1)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

49、 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.$ EN 1789:2007+A2:2014 (E) 7 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 requirements for approval and registration of the vehicle and t