Irish Standard

I.S. EN 1789:2007+A2:2014

Medical vehicles and their equipment - Road

ambulances
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 I.S. EN 1789:2007+A2:2014

Incorporating amendments/corrigenda/National Annexes issued since publication:

The National Standards Authority of Ireland (NSAI) produces the following categories of formal documents:
I.S. xxx: Irish Standard — national specification based on the consensus of an expert panel and subject to public consultation.

S.R. xxx: Standard Recommendation — recommendation based on the consensus of an expert panel and subject to public consultation.
SWiFT xxx: A rapidly developed recommendatory document based on the consensus of the participants of an NSAI workshop.
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This document replaces/revises/consolidates the NSAI adoption of the document(s) indicated on the
CEN/CENELEC cover/Foreword and the following National document(s):

NOTE: The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC
document.

This document is based on: Published:

EN 1789:2007+A2:2014 2014-09-10

This document was published ICS number:

under the authority of the NSAI
and comes into effect on: 11.160
43.160
2014-09-27

NOTE: If blank see CEN/CENELEC cover page

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Údarás um Chaighdeáin Náisiúnta na hÉireann

 I.S. EN 1789:2007+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 - Rettungsdienstfahrzeuge und deren Ausrüstung -

Ambulances routières Krankenkraftwagen
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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 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 Ref. No. EN 1789:2007+A2:2014 E
worldwide for CEN national Members.
 I.S. EN 1789:2007+A2:2014
EN 1789:2007+A2:2014 (E)

Contents Page

Foreword ..............................................................................................................................................................5
#Introduction$ ..............................................................................................................................................6
1 Scope ......................................................................................................................................................7
2 Normative references ............................................................................................................................7
3 Terms and definitions ...........................................................................................................................9
4 Requirements ...................................................................................................................................... 11
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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 requirements ...................................................................................................................... 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 Driver's seat configuration ................................................................................................................ 14
4.4.3 Minimum loading capacity ................................................................................................................. 14
4.4.4 Bulkhead .............................................................................................................................................. 15
4.4.5 Openings (doors, windows, emergency exits) ................................................................................ 16
4.4.6 Loading area........................................................................................................................................ 17
4.5 Patient’s compartment ....................................................................................................................... 18
4.5.1 General ................................................................................................................................................. 18
4.5.2 Patient’s 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
4.5.8 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 ................................................................................................................ 30
5.4 Testing of maintain systems and fixations of the equipment in the patient’s compartment ..... 30
5.4.1 General ................................................................................................................................................. 30

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 I.S. EN 1789:2007+A2:2014
EN 1789:2007+A2:2014 (E)

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 Testing of furniture.............................................................................................................................. 33
5.4.5 Test procedure ..................................................................................................................................... 33
5.5 #Testing of rounded edges and radius inside the patient's compartment$ .......................... 34
5.5.1 #Testing of rounded edges$ ....................................................................................................... 34
5.5.2 Testing of rounded edges and radius inside the patient's compartment ...................................... 35
5.6 Procedure to verify the patient's 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 patient's compartment ................................................ 37
5.8.1 Type A and B road ambulances ......................................................................................................... 37
5.8.2 Type C road ambulances .................................................................................................................... 37
5.9 Procedure to verify the seats dimensions of the patient's compartment ..................................... 38
5.10 Testing of the ventilation system ...................................................................................................... 39
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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
5.14 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 Humidity 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 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.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

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 I.S. 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 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
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 I.S. 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.
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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.

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 I.S. 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
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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.$

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 I.S. EN 1789:2007+A2:2014
EN 1789:2007+A2:2014 (E)

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 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
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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.

2 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$

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