SIST EN 1789:2020
(Main)Medical vehicles and their equipment - Road ambulances
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
Relations
Standards Content (Sample)
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.
5
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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
6
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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)
1
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)
2
EN ISO 11197:2018, Medical supply units (ISO/DIS 11197:2018)
1
Under preparation. Stage at time of publication: prEN ISO 9170-1:2017
7
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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
2
Under preparation. Stage at time of publication: EN ISO 11197:2018
8
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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
...
SLOVENSKI STANDARD
oSIST prEN 1789:2019
01-marec-2019
0HGLFLQVNDYR]LODLQSULSDGDMRþDRSUHPD&HVWQDUHãHYDOQDYR]LOD
Medical vehicles and their equipment - Road ambulances
Rettungsdienstfahrzeuge und deren Ausrüstung - Krankenkraftwagen
Ta slovenski standard je istoveten z: prEN 1789
ICS:
11.160 3UYDSRPRþ First aid
43.160 Vozila za posebne namene Special purpose vehicles
oSIST prEN 1789:2019 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN 1789:2019
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oSIST prEN 1789:2019
DRAFT
EUROPEAN STANDARD
prEN 1789
NORME EUROPÉENNE
EUROPÄISCHE NORM
December 2018
ICS Will supersede EN 1789:2007+A2:2014
English Version
Medical vehicles and their equipment - Road ambulances
Rettungsdienstfahrzeuge und deren Ausrüstung -
Krankenkraftwagen
This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee
CEN/TC 239.
If this draft becomes a European Standard, 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.
This draft European Standard was established by CEN 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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are
aware and to provide supporting documentation.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without
notice and shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 1789:2018 E
worldwide for CEN national Members.
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oSIST prEN 1789:2019
prEN 1789:2018 (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 light and audible siren warning system. 13
4.2.6 Audible reversing alarm . 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 loading 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 . 17
4.4.1 General . 17
4.4.2 Safety . 17
4.4.3 Hygiene . 18
4.4.4 Patient’s compartment dimensions . 18
4.4.5 Patient and crew seating . 23
4.4.6 Ventilation and anaesthetic gas scavenging systems . 24
4.4.7 Temperature control system . 24
4.4.8 Interior lighting . 24
4.4.9 Interior noise level . 25
4.4.10 Holding system for infusion . 25
4.4.11 Retention, fixation and restraint systems . 25
4.4.12 Mass reserve . 26
5 Testing . 26
5.1 General . 26
5.2 Testing of the interior noise level . 26
5.2.1 Specific measurement conditions . 26
5.2.2 Measurements . 27
5.3 Testing of retention systems and fixation of the equipment in the patient’s
compartment . 27
5.3.1 General . 27
5.3.2 Testing of the stretcher fixation on the vehicle floor . 29
5.3.3 Testing of the medical devices fixation . 29
2
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oSIST prEN 1789:2019
prEN 1789:2018 (E)
5.3.4 Testing of furniture . 30
5.3.5 Test procedure . 30
5.4 Testing of rounded edges and radius inside the patient's compartment. 31
5.4.1 Testing of rounded edges . 31
5.4.2 Testing of rounded edges and radius inside the patient's compartment. 32
5.5 Procedure to verify the patient's compartment specifications . 32
5.6 Procedure to verify the loading area specifications . 32
5.6.1 General . 32
5.6.2 Procedure to verify the loading angle of 16° . 32
5.7 Procedure to verify the dimensions of the patient's compartment . 34
5.7.1 Type A and B road ambulances. 34
5.7.2 Type C road ambulances . 34
5.8 Procedure to verify the seats dimensions of the patient's compartment . 35
5.9 Testing of the ventilation system . 36
5.10 Testing of the heating system . 36
5.11 Testing of the cooling system . 36
5.11.1 Test procedure . 36
5.11.2 Testing of independent air conditioning system . 37
5.12 Testing of interior lighting . 37
5.13 Testing of infusion holding system . 38
6 Equipment and medical devices . 38
6.1 Provision of medical devices . 38
6.2 Medical devices storage. 38
6.3 Requirements for medical devices . 38
6.3.1 General . 38
6.3.2 Temperature . 38
6.3.3 Humidity and ingress of liquids . 38
6.3.4 Mechanical strength . 39
6.3.5 Fixation of devices . 39
6.3.6 Electrical safety . 39
6.3.7 User interface . 39
6.3.8 Gas installation . 39
6.3.9 Marking and instructions . 41
6.3.10 Maintenance . 41
6.4 List of equipment . 41
Annex A (informative) Test summary . 49
Annex B (informative) Recognition . 50
B.1 Recognition and visibility of ambulances . 50
B.2 Recognition of crew . 50
Annex C (informative) Hygiene . 51
Annex ZA (informative) Relationship between this European Standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered . 52
Bibliography . 53
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European foreword
This document (prEN 1789:2018) has been prepared by Technical Committee CEN/TC 239 “Rescue
systems”, the secretariat of which is held by DIN.
This document is currently submitted to the CEN Enquiry.
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.
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Introduction
The document was first developed in the late 1990s to define a common approach to requirements to
enhance patient and crew safety. The standard 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+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 standard 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 Directive
2007/46/EC (Annex XI).
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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 person 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 420:2003+A1:2009, Protective gloves - General requirements and test methods
EN 443:2008, Helmets for fire fighting in buildings and other structures
EN 455-1:2000, 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 1865-3:2012+A1:2015, Patient handling equipment used in road ambulances - Part 3: Heavy duty
stretcher
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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
EN 12470-1:2000+A1:2009, Clinical thermometers - Part 1: Metallic liquid-in-glass thermometers with
maximum device
EN 13544-1:2007+A1:2009, 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/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 (IEC 60601 2 4:2010)
EN 60601-2-27:2014, Medical electrical equipment - Part 2-27: Particular requirements for the basic
safety and essential performance of electrocardiographic monitoring equipment (IEC 60601 2 27:2011 +
Corrigendum May 2012)
EN ISO 407:2004, Small medical gas cylinders - Pin-index yoke-type valve connections (ISO 407:2004)
EN ISO 5359:2014, Anaesthetic and respiratory equipment - Low-pressure hose assemblies for use with
medical gases (ISO 5359:2014)
prEN ISO 9170-1:2017, Terminal units for medical gas pipeline systems — Part 1: Terminal units for use
with compressed medical gases and vacuum (ISO/DIS 9170-1:2017)
EN ISO 7396-1:2016, Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases
and vacuum (ISO 7396-1:2016)
EN ISO 10079-1:2015, Medical suction equipment - Part 1: Electrically powered suction equipment (ISO
10079-1:2015)
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)
prEN ISO 10524-1:2017, Pressure regulators for use with medical gases — Part 1: Pressure regulators
and pressure regulators with flow-metering devices (ISO/FDIS 10524-1:2017)
prEN ISO 10524-2:2017, Pressure regulators for use with medical gases - Part 2: Manifold and line
pressure regulators (ISO/FDIS 10524-2:2017)
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prEN ISO 10524-3:2017, Pressure regulators for use with medical gases — Part 3: Pressure regulators
integrated with cylinder valves (ISO/DIS 10524-3:2017)
prEN ISO 11197:2018, Medical supply units (ISO/DIS 11197:2018)
EN ISO 14971:2012, Medical devices - Application of risk management to medical devices (ISO
14971:2007, Corrected version 2007-10-01)
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 20345:2011, Personal protective equipment - Safety footwear (ISO 20345:2011)
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 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)
prEN ISO 80601-2-61:2017, Medical electrical equipment — Part 2-61: Particular requirements for basic
safety and essential performance of pulse oximeter equipment (ISO/DIS 80601-2-61:2017)
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
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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 and emergency patient
3.1.1
patient
person whose condition requires appropriately trained personnel to provide medical care and/or
suitable transport
3.1.2
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
3.2
road ambulance
vehicle intended to be crewed by a minimum of two appropriately trained crew members for the
provision of care and transport of at least one stretchered patient
3.3
types of road ambulances
3.3.1
type A
patient transport ambulance
road ambulance designed and equipped for the transport of patients who are not expected to become
emergency patients
Note 1 to entry: Two types of patient transport ambulance exist:
— type A : suitable for transport of a single patient;
1
— type A2: suitable for transport of one or more patient(s) (on stretcher(s) and seat(s)).
3.3.2
type B
emergency ambulance
road ambulance designed and equipped for the transport, basic treatment and monitoring of patients
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3.3.3
type C
mobile intensive care unit
road ambulance designed and equipped for the transport, advanced treatment and monitoring of
patients
3.4
net vehicle mass
net mass of the road ambulance including the driver taken as 75 kg, 90% fuel tank and all fixed
installations
Note 1 to entry: Loose portable patient handling, sanitary, medical and technical equipment are not included in
net vehicle mass.
3.5
road ambulance loading capacity
difference between the permissible gross vehicle mass and the net vehicle mass of the road ambulance
including the driver taken as 75 kg and all fixed installations, mass reserve and all passengers
Note 1 to entry: This represents the mass that may be distributed on the road ambulance such that the
permissible axle loads are not exceeded.
3.6
fixation system
system or device to ensure the permanent fixation of medical devices or other equipment into the road
ambulance
3.7
retention system
bracket or other interface device used to secure a mobile or transportable item of equipment or medical
device in the road ambulance without the use of tools
3.8
patient compartment
interior section of an road ambulance for patient treatment and/or transport
4 Requirements
4.1 General requirements
Road ambulances equipment shall, when operated in normal use and maintained according to the
instructions of the manufacturer, cause no safety hazard which could reasonably be foreseen using risk
management procedures, e.g. in accordance with EN ISO 14971:2012, and which is connected with their
intended application, in normal condition and in single fault condition.
4.2 Electrical requirements
4.2.1 General
Elec
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