1、December 2014 Translation by DIN-Sprachendienst.English price group 22No 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 11.160; 43.160!%1o“2271476www.din.deDDIN EN 1789Medical vehicles and their equipment Road ambulances;English version EN 1789:2007+A2:2014,English translation of DIN EN 1789:2014-12Rettungsdienstfahrzeuge und deren Ausrstung Krankenkraftwagen;Englische Fassung EN 1789:2007+A2:2014,Englische berset
3、zung von DIN EN 1789:2014-12Vhicules de transport sanitaire et leurs quipements Ambulances routires;Version anglaise EN 1789:2007+A2:2014,Traduction anglaise de DIN EN 1789:2014-12SupersedesDIN EN 1789:2010-11www.beuth.deDocument comprises 64 pagesIn case of doubt, the German-language original shall
4、 be considered authoritative.11.14 DIN EN 1789:2014-12 2 A comma is used as the decimal marker. National foreword This document (EN 1789:2007+A2:2014) has been prepared by Technical Committee CEN/TC 239 “Rescue systems” (Secretariat: DIN, Germany). The responsible German body involved in its prepara
5、tion was the DIN-Normenausschuss Rettungsdienst und Krankenhaus (DIN Standards Committee Rescue Services and Hospital), Working Committee NA 053-01-02 AA Krankenkraftwagen und deren medizinische und technische Ausstattung. This second Amendment gives an answer to questions concerning the application
6、 of EN 1789:2007 and avoids differences in interpretation among notified bodies when checking the compliance of vehicles specially adapted to medical transportation (road ambulances). In the previous edition, DIN EN 1789:2007-08, (and in this edition) reference is made to “high performance industria
7、l helmets” as in DIN EN 14052 as regards lateral loads. The German experts recommend that road ambulances include a helmet as in DIN EN 443, as specified in DIN EN 1789:2003-08. Amendments This standard differs from DIN EN 1789:2010-11 as follows: a) normative references have been updated; b) in Sub
8、clause 3 “Terms and definitions”, “3.5 permissible gross vehicle mass” has been deleted and the following terms and definitions have been added: “3.5 ambulance loading capacity”, “3.8 Technical Service”, “3.9 means of verification (MoV), 3.10 non equipped ambulance”; c) requirements for the “visual
9、and audible warning system” have been added (Subclause 4.3.5); d) Subclause 4.5.10 “Mass reserve” has been added; e) requirements for the measurement of the interior noise level have been specified (Subclauses 5.2.2 and 5.2.3); f) requirements for the dynamic test have been specified (Subclause 5.4.
10、1); g) requirements for the “testing of the stretcher fixations on the vehicle floor” have been added (Subclause 5.4.2); h) requirements for the “testing of the medical devices fixations” have been added (Subclause 5.4.3); i) requirements for the “testing of furniture” have been added (Subclause 5.4
11、.4); j) requirements for the test procedure” have been specified (Subclause 5.4.5); k) Subclause 5.5 “Testing of rounded edges and radius inside the patients compartment” has been specified; l) Subclause 5.6 “Procedure to verify the patients compartment specifications” has been added; DIN EN 1789:20
12、14-12 3 m) Subclause 5.7 “Procedure to verify the loading area specifications” has been added; n) Subclause 5.8 “Procedure to verify the dimensions of the patients compartment” has been added; o) Subclause 5.9 “Procedure to verify the seats dimensions of the patients compartment” has been added; p)
13、Subclause 5.10 “Testing of the ventilation system” has been specified; q) Subclause 5.11 “Testing of the heating system” has been specified; r) Subclause 5.12 “Testing of the cooling system” has been specified; s) Subclause 5.13 “Testing of interior lighting” has been specified; t) Subclause 5.14 “T
14、esting of infusion holding system” has been specified; u) Clause 7 “Conformity assessment” has been added; v) Clause 8 “Requirements to be met for a Certificate of Compliance” has been added; w) the former Annex C (informative) “Certificate of compliance” has been deleted; x) Annex B (informative) “
15、Definition of ambulance body styles” has been added; y) Annex ZA has been updated. Previous editions DIN FANOK 20 = DIN 13020: 1931-09 DIN FANOK 26 = DIN 13026: 1933-09 DIN 75080: 1955-07, 1960-08 DIN 75080-1: 1967-07, 1977-02, 1987-05 DIN 75080-2: 1967-07, 1982-07, 1989-01 DIN 75080-3: 1967-07, 198
16、2-06, 1989-01 DIN EN 1789: 1999-12, 2003-08, 2007-08, 2010-11 DIN EN 1789:2014-12 4 This page is intentionally blank 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 equipmen
17、t - Road ambulances Vhicules de transport sanitaire et leurs quipements - Ambulances 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 approv
18、ed 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 sta
19、ndards 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
20、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
21、, 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 COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC
22、 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 EN 1789:2007+A2:2014 (E) 2 Contents Page Foreword 5 #Introduction$ 6 1 Scope 7 2 Normative references 7
23、3 Terms and definitions .9 4 Requirements 11 4.1 General 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 requirement
24、s 12 4.3.1 General . 12 4.3.2 Electromagnetic compatibility (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
25、capacity . 14 4.4.4 Bulkhead 15 4.4.5 Openings (doors, 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
26、 Temperature system . 25 4.5.6 Interior lighting 25 4.5.7 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 Me
27、asurements . 28 5.2.3 Establishment of compliance 29 5.3 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 DIN EN 1789:2014-12 EN 1789:2007+A2:2014 (E) 3 5.4.2 Testing of the stretcher fixations on the ve
28、hicle floor 32 5.4.3 Testing of the medical devices fixations 33 5.4.4 Testing 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 co
29、mpartment 35 5.6 Procedure to verify the patients compartment specifications 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
30、road ambulances . 37 5.8.2 Type C road ambulances 37 5.9 Procedure to verify 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 indepe
31、ndent air conditioning system . 40 5.13 Testing of interior lighting 41 5.14 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 H
32、umidity and ingress of liquids . 42 6.3.4 Mechanical strength 42 6.3.5 Fixation 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
33、 road ambulances . 45 6.4.1 Vibration and bump test . 45 6.4.2 Free fall . 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
34、.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 DIN EN 1789:2014-12 EN 1789:2007+A2:2014 (E) 4 Annex ZA (informative) !#Relationship between this E
35、uropean 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 framework for the approval of motor vehicles and their trailers, and of systems, components and separ
36、ate technical units intended for such vehicles$ . 59 Bibliography . 60 DIN EN 1789:2014-12 EN 1789:2007+A2:2014 (E) 5 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 sh
37、all 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 docume
38、nt 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$. T
39、he start and finish of text introduced or altered by amendment is indicated in the text by tags ! “ and #$. 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 rel
40、ationship 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,
41、 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 U
42、nited Kingdom. DIN EN 1789:2014-12 EN 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
43、 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
44、: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 1789:20
45、07 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 int
46、erpretation 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 check compliance of vehicles specially adapted to medical transportation (Road ambula
47、nces). 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.$ DIN EN 1789:2014-12 EN 1789:2007+A2:2014 (E) 7 1 Scope This European Standard specifies require
48、ments 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 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
