Medical vehicles and their equipment - Road ambulances

This European Standard specifies requirements for the design, testing, performance and equipping of road ambulances used for the transport, monitoring, treatment and care of patients. It contains requirements for the patient’s compartment in terms of the working environment, ergonomic design and the safety of the crew and patients.This European Standard does not cover 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 and excludes the transportation of hospital beds.
This standard also specifies requirements for ambulances intended to carry transport incubator systems.
The European Standard covers the specific requirements of each type of road ambulance which are
designated according to the patient condition e.g. patient transport road ambulance types A1, A2, B and 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.

Rettungsdienstfahrzeuge und deren Ausrüstung - Krankenkraftwagen

Dieses Dokument legt Anforderungen an Gestaltung, Prüfung, Ausführung und Ausrüstung für Krankenkraftwagen fest, die für den Transport, die Überwachung, die Behandlung und die Versorgung von Patienten genutzt werden. Es enthält Anforderungen an den Patientenraum im Hinblick auf die Arbeitsumgebung, die ergonomische Gestaltung und die Sicherheit des Personals und der Patienten. Dieses Dokument behandelt nicht die Ausbildung des Personals. Dafür ist die Behörde/ sind die Behörden des Landes zuständig, in dem der Krankenkraftwagen registriert ist.
Dieses Dokument gilt für Krankenkraftwagen, in denen mindestens ein Patient liegend auf einer Krankentrage transportiert werden kann. Es schließt den Transport von Krankenbetten aus.
Dieses Dokument legt auch die Anforderungen für Krankenkraftwagen fest, die für den Transport von Transportinkubatorsystemen vorgesehen sind.
Dieses Dokument behandelt die besonderen Anforderungen an jeden Typ von Krankenkraftwagen, die entsprechend dem Patientenzustand bezeichnet sind.
Dieses Dokument enthält allgemeine Anforderungen an Medizinprodukte (Geräte), die in Krankenkraftwagen befördert und im Krankenkraftwagen sowie außerhalb von Krankenhäusern und Kliniken verwendet werden, wo sich die Umgebungsbedingungen von den normalen Innenraumbedingungen unterscheiden können.

Véhicules de transport sanitaire et leurs équipements - Ambulances routières

Ce document précise les exigences relatives à la conception, aux essais, aux performances et à l'équipement des ambulances routières utilisées pour le transport, le suivi, le traitement et les soins des patients. Il contient des exigences pour la cellule sanitaire en termes d'environnement de travail, d'ergonomie et de sécurité de l'équipage et des patients. Ce document ne couvre pas la formation de l'équipage qui relève de la responsabilité de l'autorité ou des autorités du pays où l'ambulance doit être enregistrée.
Le présent document s'applique aux ambulances routières capables de transporter au moins une personne sur un brancard et exclut le transport de lits d'hôpital.
Ce document précise également les exigences relatives aux ambulances destinées à transporter des systèmes d'incubateurs.
Ce document couvre les exigences spécifiques de chaque type d'ambulance routière qui sont définis en fonction de l'état du patient.
Le présent document énonce les exigences générales applicables aux dispositifs médicaux transportés dans les ambulances routières et utilisés à l'intérieur et à l'extérieur des hôpitaux et des cliniques dans des situations où les conditions ambiantes peuvent différer des conditions intérieures normales.

Medicinska vozila in pripadajoča oprema - Cestna reševalna vozila

General Information

Status
Published
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
02-Sep-2020
Completion Date
02-Sep-2020

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SLOVENSKI STANDARD
SIST EN 1789:2020
01-december-2020
Nadomešča:
SIST EN 1789:2007+A2:2015
Medicinska vozila in pripadajoča oprema - Cestna reševalna vozila
Medical vehicles and their equipment - Road ambulances
Rettungsdienstfahrzeuge und deren Ausrüstung - Krankenkraftwagen
Véhicules de transport sanitaire et leurs équipements - Ambulances routières
Ta slovenski standard je istoveten z: EN 1789:2020
ICS:
11.160 Prva pomoč First aid
43.160 Vozila za posebne namene Special purpose vehicles
SIST EN 1789:2020 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 1789:2020
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SIST EN 1789:2020
EN 1789
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2020
EUROPÄISCHE NORM
ICS 11.160; 43.160 Supersedes EN 1789:2007+A2:2014
English Version
Medical vehicles and their equipment - Road ambulances

Véhicules de transport sanitaire et leurs équipements - Rettungsdienstfahrzeuge und deren Ausrüstung -

Ambulances routières Krankenkraftwagen
This European Standard was approved by CEN on 13 April 2020.

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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,

Poland, Portugal, Republic of North Macedonia, Romania, Serbia, 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: Rue de la Science 23, B-1040 Brussels

© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 1789:2020 E

worldwide for CEN national Members.
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SIST EN 1789:2020
EN 1789:2020 (E)
Contents Page

European foreword ....................................................................................................................................................... 4

Introduction .................................................................................................................................................................... 5

1 Scope .................................................................................................................................................................... 6

2 Normative references .................................................................................................................................... 6

3 Terms and definitions ................................................................................................................................... 9

4 Requirements ................................................................................................................................................ 10

4.1 General requirements ................................................................................................................................ 10

4.2 Electrical requirements ............................................................................................................................. 10

4.2.1 General ............................................................................................................................................................. 10

4.2.2 Electromagnetic compatibility (EMC) ................................................................................................... 11

4.2.3 Battery and alternator ............................................................................................................................... 11

4.2.4 Electrical installation .................................................................................................................................. 12

4.2.5 Visual warning system and audible warning system (siren) ....................................................... 13

4.2.6 Reversing systems ....................................................................................................................................... 13

4.2.7 Exterior illumination lights ...................................................................................................................... 13

4.3 Vehicle body ................................................................................................................................................... 14

4.3.1 Fire safety ........................................................................................................................................................ 14

4.3.2 Driver's seat configuration ....................................................................................................................... 14

4.3.3 Minimum passenger capacity .................................................................................................................. 14

4.3.4 Bulkhead ......................................................................................................................................................... 15

4.3.5 Openings (doors, windows, emergency exits) ................................................................................... 15

4.3.6 Loading area................................................................................................................................................... 16

4.4 Patient’s compartment ............................................................................................................................... 18

4.4.1 General ............................................................................................................................................................. 18

4.4.2 Safety ................................................................................................................................................................ 18

4.4.3 Hygiene ............................................................................................................................................................ 18

4.4.4 Patient’s compartment dimensions ...................................................................................................... 19

4.4.5 Patient and crew seating ........................................................................................................................... 24

4.4.6 Ventilation and anaesthetic gas scavenging systems ...................................................................... 25

4.4.7 Temperature control system ................................................................................................................... 25

4.4.8 Interior lighting ............................................................................................................................................ 26

4.4.9 Interior noise level ...................................................................................................................................... 26

4.4.10 Holding system for infusion ..................................................................................................................... 26

4.4.11 Retention, fixation and restraint systems ........................................................................................... 27

4.4.12 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

5.3 Testing of retention systems and fixation of the equipment in the patient’s

compartment ................................................................................................................................................. 28

5.3.1 General ............................................................................................................................................................. 28

5.3.2 Testing of the stretcher fixation on the vehicle floor ...................................................................... 30

5.3.3 Testing of the medical devices fixation ................................................................................................ 30

5.3.4 Testing of furniture ..................................................................................................................................... 30

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SIST EN 1789:2020
EN 1789:2020 (E)

5.3.5 Test procedure .............................................................................................................................................. 31

5.4 Testing of rounded edges and radius inside the patient's compartment................................. 32

5.4.1 Testing of rounded edges ........................................................................................................................... 32

5.4.2 Testing of radius inside the patient's compartment ........................................................................ 33

5.5 Procedure to verify the patient's compartment specifications ................................................... 33

5.6 Procedure to verify the loading area specifications ........................................................................ 33

5.6.1 General ............................................................................................................................................................. 33

5.6.2 Procedure to verify the loading angle of 16° ...................................................................................... 33

5.7 Procedure to verify the dimensions of the patient's compartment ........................................... 35

5.7.1 Type A and B road ambulances................................................................................................................ 35

5.7.2 Type C road ambulances ............................................................................................................................ 35

5.8 Procedure to verify the seats dimensions of the patient's compartment ................................ 36

5.9 Testing of the ventilation system ............................................................................................................ 36

5.10 Testing of the heating system ................................................................................................................... 37

5.11 Testing of the cooling system ................................................................................................................... 37

5.11.1 Test procedure .............................................................................................................................................. 37

5.11.2 Testing of independent air conditioning system .............................................................................. 38

5.12 Testing of interior lighting ........................................................................................................................ 38

5.13 Testing of infusion holding system ........................................................................................................ 38

6 Equipment and medical devices .............................................................................................................. 39

6.1 Provision of medical devices .................................................................................................................... 39

6.2 Medical devices storage.............................................................................................................................. 39

6.3 Requirements for medical devices ......................................................................................................... 39

6.3.1 General ............................................................................................................................................................. 39

6.3.2 Temperature .................................................................................................................................................. 39

6.3.3 Humidity and ingress of liquids .............................................................................................................. 39

6.3.4 Mechanical strength .................................................................................................................................... 39

6.3.5 Fixation of devices ........................................................................................................................................ 40

6.3.6 Electrical safety ............................................................................................................................................. 40

6.3.7 User interface ................................................................................................................................................. 40

6.3.8 Gas installation .............................................................................................................................................. 40

6.3.9 Marking and instructions .......................................................................................................................... 42

6.3.10 Maintenance ................................................................................................................................................... 42

6.4 List of equipment .......................................................................................................................................... 42

Annex A (informative) Test summary ................................................................................................................ 52

Annex B (informative) Recognition ..................................................................................................................... 53

B.1 Recognition and visibility of ambulances ............................................................................................ 53

B.2 Recognition of crew ..................................................................................................................................... 53

Annex C (informative) Hygiene ............................................................................................................................. 54

Annex D (informative) A–deviations .................................................................................................................. 55

D.1 Deviation in Spain......................................................................................................................................... 55

Annex ZA (informative) Relationship between this European Standard and the essential

requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered .................................... 56

Bibliography ................................................................................................................................................................. 57

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SIST EN 1789:2020
EN 1789:2020 (E)
European foreword

This document (EN 1789:2020) 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 February 2021, and conflicting national standards

shall be withdrawn at the latest by March 2022.

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CEN shall not be held responsible for identifying any or all such patent rights.

This document supersedes EN 1789:2007+A2:2014.

This document has been prepared under a standardization request 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 organisations of the

following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,

Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,

Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of

North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the

United Kingdom.
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SIST EN 1789:2020
EN 1789:2020 (E)
Introduction

Road ambulances are subject to a higher risk in use. The exact circumstances of operation cannot

always be planned or anticipated in detail.

Vehicles are designed so as to be safe. Design requirements can be derived from European and national

occupational safety and health legislation.

Under EU law, employers are responsible for carrying out a risk assessment (89/391/EEC, OSH

framework directive) and for provision of safe work equipment (89/655/EEC, use of work equipment

directive) that allows employees to work without their health being at risk.

The document was first developed in the late 1990s to define a common approach to requirements to

enhance patient and crew safety. The document has evolved and matured through several amendments

and revisions.
This latest revision work of EN 1789 has had two key objectives:

— The first objective was to revise the technical side of the document with more manageable

verification in mind, while maintaining the high quality and strict nature of the requirements.

— The second objective was to check all the references and regulations, paying special attention to EU

regulations and updated standardization rules.

Testing of special purpose vehicle, such as an ambulance, is complex. Multiple functions (e.g. fixations,

maintain systems, noise, illumination, heating, cooling etc.) may require numerous tests, which can be

destructive. In this edition, carefully planned tests according to worst-case scenario strategies have

reduced the number of destructive tests without sacrificing test qualities.

The previous edition of this standard (EN 1789:2007+A2:2014) contained a number of direct

references to EU regulations. According to CEN Internal Regulations Part 3:2017 and to avoid

duplication as well as outdated references and to enable use of this standard independently of the ECE

rules, EU regulations and directives, these references have now been removed from the normative

section of the standard.

This document is a reference document which can be used in support of regulations.

For the purpose of verification of an ambulance according to EU vehicle approval process, a section of

EN 1789:2007+A1:2010+A2:2014 (i.e. patient’s compartment) has been referenced directly in

Regulation (EU) 2018/858.

CEN/TC 239 has agreed to a transition period of a maximum of 18 months in order to accommodate the

different organisational structures that are necessary for the transport of patients are responsible for

providing sufficient time for the technical implementation. At the date of publication of EN 1789, the

presumption of conformity of the superseded standard has not yet been established in the Official

Journal of the European Union. Users of the standard are invited to check the date in the Official Journal

of the European Union against the transition period established by CEN/TC 239.
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SIST EN 1789:2020
EN 1789:2020 (E)
1 Scope

This document specifies requirements for the design, testing, performance and equipping of road

ambulances used for the transport, monitoring, treatment and care of patients. It contains requirements

for the patient’s compartment in terms of the working environment, ergonomic design and the safety of

the crew and patients. This document does not cover the training of the crew, which is the

responsibility of the authority/authorities in the country where the ambulance is to be registered.

This document is applicable to road ambulances capable of transporting at least one patient on a

stretcher and excludes the transportation of hospital beds.

This document also specifies requirements for ambulances intended to carry transport incubator

systems.

This document covers the specific requirements of each type of road ambulance, which are designated

according to the patient condition.

This document 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 documents are referred to in the text in such a way that some or all of their content

constitutes requirements 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.

CEN/TS 16165:2016, Determination of slip resistance of pedestrian surfaces - Methods of evaluation

DIN 51130:2014, Testing of floor coverings - Determination of the anti-slip property - Workrooms and

fields of activities with slip danger - Walking method - Ramp test

EN 3-7:2004+A1:2007, Portable fire extinguishers - Part 7: Characteristics, performance requirements

and test methods
EN 443:2008, Helmets for fire fighting in buildings and other structures

EN 455-1:2020, Medical gloves for single use - Part 1: Requirements and testing for freedom from holes

EN 455-2:2015, Medical gloves for single use - Part 2: Requirements and testing for physical properties

EN 794-3:1998+A2:2009, Lung ventilators - Part 3: Particular requirements for emergency and transport

ventilators

EN 1041:2008+A1:2013, Information supplied by the manufacturer of medical devices

EN 1865-1:2010+A1:2015, Patient handling equipment used in road ambulances - Part 1: General

stretcher systems and patient handling equipment

EN 1865-2:2010+A1:2015, Patient handling equipment used in road ambulances - Part 2: Power assisted

stretcher

EN 1865-4:2012, Patient handling equipment used in road ambulances - Part 4: Foldable patient transfer

chair

EN 1865-5:2012, Patient handling equipment used in road ambulances - Part 5: Stretcher support

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SIST EN 1789:2020
EN 1789:2020 (E)

EN 12470-1:2000+A1:2009, Clinical thermometers - Part 1: Metallic liquid-in-glass thermometers with

maximum device

EN 13544-1:2019, Respiratory therapy equipment - Part 1: Nebulizing systems and their components

EN 13976-1:2018, Rescue systems - Transportation of incubators - Part 1: Interface requirements

EN 60601-1:2006+A1:2013, Medical electrical equipment - Part 1: General requirements for basic safety

and essential performance (IEC 60601-1:2005 + Cor.:2006 + Cor.:2007 + A1:2012)

EN 60601-1-12:2015, Medical electrical equipment - Part 1-12: General requirements for basic safety and

essential performance - Collateral Standard: Requirements for medical electrical equipment and medical

electrical systems intended for use in the emergency medical services environment

EN 60601-2-4:2011, Medical electrical equipment - Part 2-4: Particular requirements for the basic safety

and essential performance of cardiac defibrillators

EN 60601-2-27:2014, Medical electrical equipment - Part 2-27: Particular requirements for the basic

safety and essential performance of electrocardiographic monitoring equipment

EN ISO 407:2004, Small medical gas cylinders - Pin-index yoke-type valve connections (ISO 407:2004)

EN ISO 5359:2014+A1:2017, Anaesthetic and respiratory equipment - Low-pressure hose assemblies for

use with medical gases (ISO 5359:2014 + Amd 1:2017)

EN ISO 9170-1:—, Terminal units for medical gas pipeline systems — Part 1: Terminal units for use with

compressed medical gases and vacuum (ISO/DIS 9170-1:2016)

EN ISO 7396-1:2016+A1:2019, Medical gas pipeline systems - Part 1: Pipeline systems for compressed

medical gases and vacuum (ISO 7396-1:2016 + Amd 1:2017)

EN ISO 10079-1:2015+A1:2019, Medical suction equipment - Part 1: Electrically powered suction

equipment (ISO 10079-1:2015 + Amd 1:2018)

EN ISO 10079-2:2014, Medical suction equipment - Part 2: Manually powered suction equipment (ISO

10079-2:2014)

EN ISO 10079-3:2014, Medical suction equipment - Part 3: Suction equipment powered from a vacuum or

positive pressure gas source (ISO 10079-3:2014)

EN ISO 10524-1:2019, Pressure regulators for use with medical gases - Part 1: Pressure regulators and

pressure regulators with flow-metering devices (ISO 10524-1:2018)

EN ISO 10524-2:2019, Pressure regulators for use with medical gases - Part 2: Manifold and line pressure

regulators (ISO 10524-2:2018)

EN ISO 10524-3:2019, Pressure regulators for use with medical gases - Part 3: Pressure regulators

integrated with cylinder valves (VIPRs) (ISO 10524-3:2019)
EN ISO 11197:2018, Medical supply units (ISO/DIS 11197:2018)
Under preparation. Stage at time of publication: prEN ISO 9170-1:2017
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SIST EN 1789:2020
EN 1789:2020 (E)

EN ISO 14971:2019, Medical devices - Application of risk management to medical devices

(ISO 14971:2019)

EN ISO 15002:2008, Flow-metering devices for connection to terminal units of medical gas pipeline

systems (ISO 15002:2008)

EN ISO 15223-1:2016, Medical devices - Symbols to be used with medical device labels, labelling and

information to be supplied - Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03)

EN ISO 19054:2006+A1:2016, Rail systems for supporting medical equipment (ISO 19054:2005+

Amd1:2016)

EN ISO 20471:2013+A1:2016, High visibility clothing — Test methods and requirements

(ISO 20471:2013, Corrected version 2013-06-01+Amd 1:2016)

EN ISO 21420:2020-06, Protective gloves - General requirements and test methods (ISO 21420:2020)

EN ISO 80601-2-55:2018, Medical electrical equipment - Part 2-55: Particular requirements for the basic

safety and essential performance of respiratory gas monitors (ISO 80601-2-55:2018)

EN ISO 80601-2-61:2019, Medical electrical equipment - Part 2-61: Particular requirements for basic

safety and essential performance of pulse oximeter equipment (ISO 80601-2-61:2017, Corrected version

2018-02)

IEC 60364-7-721:2017, Low-voltage electrical installations — Part 7-721: Requirements for special

installations or locations — Electrical installations in caravans and motor caravans

ISO 3795:1989, Road vehicles, and tractors and machinery for agriculture and forestry — Determination

of burning behaviour of interior materials
ISO 5128:1980, Acoustics — Measurement of noise inside motor vehicles
Under preparation. Stage at time of publication: EN ISO 11197:2018
---------------------- Page: 10 ----------------------
SIST EN 1789:2020
EN 1789:2020 (E)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— IEC Electropedia: available at http://www.electropedia.org/
— ISO Online browsing platform: available at http://www.iso.org/obp
3.1
patient

person whose condition requires appropriately trained personnel to provide medical care and/or

suitable transport
3.2
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
3.3
road ambulance
vehicle intended to be crewed by a minimum
...

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