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
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
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
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
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.
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.
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
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
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
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 of two appropriately trained crew members for the
provision of care and transport of at least one stretchered patient
3.4
type A road ambulance
patient transport ambulance
vehicle 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 A1: suitable for transport of a single patient;
— type A : suitable for transport of one or more patient(s) (on stretcher(s) and seat(s)).
3.5
type B road ambulance
emergency ambulance
vehicle designed and equipped for the transport, basic treatment and monitoring of patients
3.6
type C road ambulance
mobile intensive care unit
vehicle designed and equipped for the transport, advanced treatment and monitoring of patients
3.7
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.
3.8
road ambulance loading capacity
difference between the permissible gross vehicle mass and the net vehicle mass of the road ambulance
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.
3.9
fixation system
system or device to ensure the permanent fixation of medical devices or other equipment into the road
ambulance
3.10
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
3.11
restraint system
device or combination of devices that minimize movement of the vehicle occupants during crash or
major deceleration (e.g. seat belts)
3.12
patient compartment
interior section of an road ambulance for patient treatment and/or transport
4 Requirements
4.1 General requirements
Road ambulances and 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 14971:2019, and which is connected with their
intended application, in normal condition and in single fault condition.
4.2 Electrical requirements
4.2.1 General
Electrical installations added to the base vehicle shall comply with those clauses of
IEC 60364-7-721:2017 which are applicable to road ambulances. For the supply system of the medical
equipment EN 60601-1:2006+A1:2013 and EN 60601-1-12:2015, Clause 11 shall apply.
4.2.2 Electromagnetic compatibility (EMC)
In order to minimize the risk to the safe operation of the complete road ambulance and any of the
equipment operated on or in the vehicle from the effects of electromagnetic influences:
— Communication equipment (e.g. radio installation) shall comply with national and/or European
regulations.
— The complete operational vehicle shall consist of components, equipment or sub systems that
comply or are certified as conforming to the respective industry EMC regulations.
A road ambulance as supplied and certified may not be fully equipped and therefore some
responsibility for added equipment after conversion rests with the customer/user.
4.2.3 Battery and alternator
Batteries shall be positioned to allow maintenance without removing the battery from its securing
device. The construction of the battery and all connections to it shall be such as to prevent any
possibility of an inadvertent short circuit.
For types A2, B and C road ambulances the electrical system shall be capable of holding a reserve of
electrical power for restarting the engine.The characteristics of the alternator, the starter batteries as
well as additional batteries, if fitted, shall comply with Table 1.
Additional batteries may be required to power the medical devices carried on board and the intended
use of the road ambulance.
Table 1 — Minimum capacity/power
Type of road ambulance
A A B C
1 2
Nominal 54 Ah 54 Ah up to 80 Ah 80 Ah
voltage 4 seats and 80
12 V Ah for more than
4 seats in the
Starter
patient
battery(ies)
compartment
Nominal – – 63 Ah 63 Ah
voltage (2 × 12 V) (2 × 12 V)
24 V
Nominal – – a 80 Ah
80 Ah
voltage
12 V
Additional
b
battery(ies)
Nominal – – a 63 Ah
63 Ah
voltage (2 × 12 V)
(2 × 12 V)
24 V
Alternator power 700 W 700 W 1 200 W 1 200 W
a
Recommended for special operational conditions.
b
Additional batteries shall have high cyclic stability (e.g. gel batteries) and shall be of a sealed type.
When the engine is idling electrical stability should be maintained between electrical load and
alternator output. In order to achieve this it may be necessary to fit an electrical load prioritization
device to the vehicle.
4.2.4 Electrical installation
4.2.4.1 In type B and C road ambulances there shall be a recessed externally mounted power
connector to enable external power to be provided for operations such as the following:
— charging battery(ies);
— operating medical devices, when installed;
— operating a patient compartment heater, when installed;
— operating an engine preheater, when installed.
The connector for 110 V or 220/240 V shall be a male connector and not interfere with the electrical
and mechanical safety.
It shall not be possible to start the engine whilst it is connected to an external power supply unless an
automatic mechanical disconnection is fitted.
If no automatic mechanical disconnection is fitted, the connector shall be on the driver’s side.
The 110 V or 220/240 V circuit shall be protected either by an “earth leakage device” with a maximum
setting of 30 mA or by a separate transformer. If the protection is given only by an “earth leakage
device” there shall be a label near the plug that reads as follows: “CAUTION! CONNECT ONLY TO AN
AUTHORISED SOCKET.”
4.2.4.2 A minimum number of separately protected 12 V DC outlets shall be available according to
Table 2. The outlets shall be available for medical devices, located in the area of use and in the storage
area. The nominal voltage shall be 13,8 V. Voltage fluctuations shall not exceed the range of 12,4 V and
15,1 V.
The power supply shall continuously supply the medical devices with electrical power with the engine
running. The outlets for the medical devices shall be labelled with the nominal voltage and current
rating. The outlets shall have a visible indication under intended operational conditions in order to
show if there is voltage on the outlet.
If the road ambulance is intended to carry a transport incubator system it shall have a four-pole
connector as specified in EN 13976-1:2018, subclause 4.2.3, Figure 2. In that case the nominal current
needs to be assessed (minimum 23 Amp according to EN 13976-1:2018, subclause 4.1.3).
Table 2 — 12 V connections for medical devices in patient’s compartment
Type of road ambulance
A A B C
1 2
1 1 1 1 3 1 3 1
Minimum number of
connections
10 15 10 15 10 15 10 15
Minimum capacity in
Ampere
4.2.4.3 Any additional electrical systems fitted to the base vehicle shall be separate from the base
vehicle electrical system and the body or chassis shall not be used as an earth return for additional
circuits.
All circuits in the additional system(s) shall have separate overload protection. All circuits shall be well
identified and cables clearly marked at the connection points and at a maximum of 1 m intervals along
its length.
NOTE Overload protection can consist of either fuses or so called Electronic Management Control systems.
The system shall have enough circuits and be so constructed that when/if a circuit fails the patient
treatment area shall remain illuminated and at least one power supply source for medical technical
equipment shall still work.
Every power socket in the patient compartment shall be fitted with a permanently visible indicator light
to confirm that there is power to the socket.
4.2.4.4 No wiring shall be located in or pass through conduit intended for medical gas installation.
The wiring shall not be loaded higher than that stated by the wire manufacturer.
4.2.4.5 Where there are different voltage systems, the connections shall be non-interchangeable.
4.2.5 Visual warning system and audible warning system (siren)
4.2.5.1 General
The road ambulance shall be fitted with a visual warning and audible warning system (in accordance
with national regulations) to alert other road vehicles and pedestrians of its approach, in order to
expedite its journey through traffic, whilst being used for emergency operation.
4.2.5.2 Visual warning system
The vehicle shall have 360-degree visibility of warning lights around the vehicle.
Recommended additional warning lights for type B and type C road ambulances are:
— additional warning lights facing forward, sideways of the vehicle (front and rear corner) and facing
backwards to ensure traffic safety and high visibility in heavy traffic.
4.2.5.3 Audible warning systems (siren)
The vehicle shall have an audible warning system additional to the warning lights. The audible warning
system shall activate the visual warning light.
The audible alarm can only be in function if the visible alarm is in operation.
4.2.6 Reversing systems
The ambulance shall be fitted with an audible reversing warning alarm, activated by the selection of the
reverse gear. This function shall be possible to disable from the driver seating position, with default
back to on, when reverse gear is engaged the next time.
There shall be a system enabling the driver to detect obstacles behind.
4.2.7 Exterior illumination lights
Exterior lighting with a minimum of 5 lx illuminating the surrounding the patient compartment area
according to Figure 1 shall be provided on type B and type C vehicles. Illumination shall be measured at
ground level.
Dimensions in millimetres
Key
Grey area Area of illumination of at least 5 lx
Figure 1 — Exterior lighting for type B and type C
4.3 Vehicle body
4.3.1 Fire safety
All interior materials shall have a burning rate of less than 100 mm/minute when tested in accordance
with ISO 3795:1989.
4.3.2 Driver's seat configuration
For all types of road ambulances the ergonomic space of the driver’s compartment and of the seat
adjustment as approved by the base manufacturer shall not be reduced.
4.3.3 Minimum passenger capacity
The minimum passenger capacity shall be in accordance with Table 3.
NOTE Passenger includes crew, patient and accompanying persons.
Table 3 — Minimum passenger capacity
Type of road ambulance
A A B C
1 2
Number of passengers on seats
and/or stretchers (in addition to 3 4 3
a
the driver)
a
With two stretchers.
A notice shall be displayed in the drivers' compartment stating the maximum number of seated and
stretcher passengers that can be carried.
The notice shall be supplied by the manufacturer taking into account the maximum weight capacity of
the vehicle.
4.3.4 Bulkhead
A full bulkhead or a bulkhead with a door shall separate the driver’s compartment from the patient’s
compartment. Where a door is fitted, it shall not be possible to drive the vehicle with the door in the
open position. This door shall be secured against opening if the road ambulance is in motion.
NOTE A bulkhead is also called a “partition wall”.
One or two windows with a minimum separation of 100 mm shall be provided in the bulkhead. The
windows shall allow direct visual contact with the driver. The opening area of the window shall have a
maximum area of 0,2 m . It shall be secured against self-opening and shall have an adjustable blind or
other means of preventing the driver being disturbed by the light of the patient’s compartment.
4.3.5 Openings (doors, windows, emergency exits)
4.3.5.1 General
The patient compartment shall have at least two openings. One at the rear (door/tailgate) and one at
the side.
All openings shall have seals to protect against the ingress of water.
All openings shall comply with the minimum dimensions according to Table 4.
Table 4 — Minimum opening dimensions in the patient's compartment
Type of road ambulance
a a
B C
A A
1 2
mm mm
mm mm
c b 800 1 200 1 400
Height
Side opening
600 660 660
c
Width
Height 900 900 1 200 1 500
Rear opening
Width 900 900 1 050 1 050
a
Corner radius of conversions which reduce the opening area by less than 10 % are permitted.
b
The dimensions provided by the original manufacturer shall not be reduced.
c
If it is a window, the height and width dimensions may be interchanged.
4.3.5.2 Emergency exits
The patient compartment shall have at least two emergency exits on different sides of the vehicle. One
of the emergency exits can be on the roof. The emergency exits shall be easy to open from the inside.
The side door and rear door can be used as emergency exits. The free minimum size shall be 500 mm x
700 mm.
4.3.5.3 Doors
There shall be a central locking system which shall be possible to operate from the driver and patient
compartment.
Each external door allowing direct access to the patient’s compartment shall be fitted with a security
system which enables the following:
a) lock and unlock from inside without use of a key;
b) lock and unlock from outside with use of a key;
c) unlock from the outside using a key when the door is locked from the inside;
NOTE 1 This security system can be integrated with an optional central locking system.
NOTE 2 The key can be a mechanical or non-mechanical device.
The patient’s compartment doors shall be capable of being positively restrained in the open position.
An audible and/or visual signal shall warn the driver when any external door including those not
allowing direct access to the patient's compartment, is not completely closed when the vehicle is in
motion.
Handles and/or handrails of all access points shall be accessible from the outside.
4.3.5.4 Windows
In the patient’s compartment, there shall be a minimum of two external windows. There shall be one on
each side or one on one side and the rear.
The windows shall be positi
...
Frequently Asked Questions
SIST EN 1789:2020 is a standard published by the Slovenian Institute for Standardization (SIST). Its full title is "Medical vehicles and their equipment - Road ambulances". This standard covers: 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.
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.
SIST EN 1789:2020 is classified under the following ICS (International Classification for Standards) categories: 11.160 - First aid; 43.160 - Special purpose vehicles. The ICS classification helps identify the subject area and facilitates finding related standards.
SIST EN 1789:2020 has the following relationships with other standards: It is inter standard links to SIST EN 1789:2007+A2:2015, SIST EN 1789:2020+A1:2024, SIST EN 1789:2020/oprA1:2023. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
SIST EN 1789:2020 is associated with the following European legislation: EU Directives/Regulations: 2022-01-0296, 93/42/EEC, EUR-PUB; Standardization Mandates: M/023. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
You can purchase SIST EN 1789:2020 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of SIST standards.
기사 제목: SIST EN 1789:2020 - 의료차량 및 그 장비 - 도로 구급차 기사 내용: 이 유럽 표준은 환자의 운송, 감시, 치료 및 간호에 사용되는 도로 구급차량의 디자인, 테스트, 성능 및 장비에 대한 요구 사항을 명시합니다. 이는 환자 구획에 대한 작업 환경, 인체공학적 설계 및 승무원과 환자의 안전에 대한 요구 사항을 포함합니다. 이 유럽 표준은 구급차량의 등록 국가의 기관/기관의 책임인 직원 교육을 다루지는 않습니다. 이 유럽 표준은 적어도 한 명의 환자를 연결할 수 있는 스트레처를 이용하는 도로 구급차량에 적용되며, 병원 침대의 운송은 제외됩니다. 이 표준은 수송 관에 장착된 구급차량에 대한 요구 사항도 명시합니다. 유럽 표준은 환자 상태에 따라 지정된 각 유형의 도로 구급차량의 특정 요구 사항을 다룹니다. 예를 들어, 환자 운송 도로 구급차량 유형 A1, A2, B 및 C입니다. 이 유럽 표준은 도로 구급차량에 실려서 사용되는 의료 기기와 병원 및 클리닉 외부에서 정상 실내 조건과 다를 수있는 상황에서 사용되는 기기에 대한 일반 요구 사항을 제공합니다.
The article is about the European Standard EN 1789:2020, which outlines the requirements for road ambulances and their equipment. The standard focuses on the design, testing, performance, and equipping of ambulances used for transporting, monitoring, treating, and caring for patients. It includes specifications for the patient compartment, ensuring a safe and ergonomic working environment for the crew and patients. However, it does not cover staff training, as that falls under the responsibility of the authorities in each country. The standard applies to ambulances capable of transporting at least one person on a stretcher, but excludes the transportation of hospital beds. It also includes requirements for ambulances equipped to transport incubator systems. Additionally, the standard addresses the specific requirements for different types of road ambulances, designated according to the patient condition. Finally, it provides general requirements for medical devices carried in road ambulances, taking into account that the ambient conditions may differ from normal indoor conditions.
記事のタイトル: SIST EN 1789:2020 - 医療車両及びその装備 - 道路救急車 記事内容: この欧州標準は、患者の運搬、監視、治療、ケアに使用される道路救急車両の設計、テスト、性能、装備に関する要件を規定しています。乗員と患者の安全性を考慮した作業環境、人間工学的な設計についての患者区画の要件を含みます。ただし、救急車両の登録国の機関/当局が担当するスタッフの教育についてはカバーしていません。 この欧州標準は、ストレッチャーに少なくとも1人の患者を搬送することができる道路救急車両に適用され、病院ベッドの輸送は除外されます。 この規格では、輸送インキュベーターシステムを搭載した救急車両の要件も規定しています。 また、患者の状態に応じて指定される各種道路救急車両の特定の要件もカバーしています。例えば、A1、A2、B、Cなどの患者輸送道路救急車両のタイプに応じた要件です。 この欧州標準は、道路救急車両に搭載され、通常の室内条件と異なる状況で使用される医療機器の一般的な要件も提供しています。
The article discusses the European Standard EN 1789:2020, which outlines requirements for the design, testing, performance, and equipment of road ambulances. The standard focuses on the patient compartment, including the working environment, ergonomic design, and safety of both the crew and patients. However, it does not cover staff training, which is the responsibility of the relevant authority in each country. The standard applies to road ambulances capable of transporting at least one person on a stretcher, excluding hospital beds. It also includes requirements for ambulances intended to carry transport incubator systems. The standard categorizes road ambulances based on the patient condition and provides general requirements for medical devices carried in the ambulances, considering different ambient conditions outside hospitals and clinics.
記事タイトル:SIST EN 1789:2020 - 医療車両とその装置- 道路救急車 記事内容:この欧州規格は、患者の輸送、モニタリング、治療、ケアに使用される道路救急車の設計、試験、性能、装備に関する要件を規定しています。乗務員と患者の安全性を含む、作業環境、人間工学的設計に関する要件を患者区画に対して含みます。ただし、救急車の登録に関する権限/当局が責任を持つスタッフのトレーニングについては扱っていません。 この欧州規格は、少なくとも一人の患者をストレッチャーで運べる道路救急車に適用され、病院のベッドの輸送は除外されます。この規格では、運搬飼育器システムを搭載する救急車に対する要件も定められています。 この欧州規格は、患者の状態に応じて指定された各種の道路救急車に対する特定の要件をカバーしています。たとえば、A1型、A2型、B型、C型のように、患者輸送の道路救急車のタイプに基づいています。 この欧州規格は、道路救急車に搭載され、通常の屋内条件とは異なる環境条件で病院やクリニック外で使用される医療機器に対する一般的な要件も示しています。
제목: SIST EN 1789:2020 - 의료 차량 및 그 장비 - 도로 구급차 내용: 이 유럽 표준은 환자의 운반, 모니터링, 치료 및 간호에 사용되는 도로 구급차의 설계, 테스트, 성능 및 장비에 대한 요구 사항을 명시합니다. 이는 작업 환경, 인체공학적 설계 및 승무원 및 환자의 안전에 관한 요구 사항에 대한 환자 구획에 대한 요구 사항을 포함합니다. 이 유럽 표준은 구급차가 등록될 국가의 당국/정부의 책임인 직원 교육을 다루지 않습니다. 이 유럽 표준은 적어도 한 명의 환자를 연속된 치료대에 운반할 수 있는 도로 구급차에 적용되며, 병원 침대는 운반하지 않습니다. 이 표준은 수송 보온기 시스템을 탑재한 구급차에 대한 요구 사항도 명시합니다. 이 유럽 표준은 환자 상태에 따라 지정된 각 유형의 도로 구급차에 대한 특정 요구 사항을 다룹니다. 예를 들어, 환자 운반을 위한 도로 구급차 유형 A1, A2, B 및 C입니다. 이 유럽 표준은 도로 구급차에 수반되고 내외부에서 병원 및 클리닉과 달리 환경 조건이 일반적인 실내 조건과 다를 수 있는 상황에서 사용되는 의료 장비에 대한 일반 요구 사항을 제공합니다.
기사 제목: SIST EN 1789:2020 - 의료 차량과 그 장비 - 도로 구급차 기사 내용: 이 유럽 표준은 환자의 운송, 모니터링, 치료 및 간호에 사용되는 도로 구급차의 디자인, 시험, 성능 및 장비에 대한 요구 사항을 명시합니다. 이는 작업 환경, 적절한 디자인 및 승무원 및 환자의 안전에 관한 요구 사항을 포함합니다. 이 유럽 표준은 구급차의 등록 국가에서 교육 책임이 있는 당국 / 당국에 의한 스태프 교육을 다루지 않습니다. 이 유럽 표준은 적어도 한 명의 환자를 놓을 수 있는 도로 구급차에 적용되며, 병원 침상의 운송은 제외됩니다. 이 표준은 수송 산태속기 시스템을 갖춘 구급차에 대한 요구 사항도 규정합니다. 유럽 표준은 환자 상태에 따라 지정된 각 유형의 도로 구급차에 대한 특정 요구 사항을 다룹니다. 예를 들어, 환자 운송 도로 구급차 유형 A1, A2, B 및 C와 같습니다. 이 유럽 표준은 도로 구급차에 탑재되고 그 안에서 사용되는 의료 기기에 대한 일반 요구 사항도 제공하며, 실내 조건과 다른 환경에서 사용되는 병원 및 클리닉 외부에서 사용되는 상황을 다룹니다.
記事タイトル:SIST EN 1789:2020 - 医療車両及びそれらの装置 - 道路救急車 記事内容:このヨーロッパ規格は、患者の輸送、監視、治療、介護に使用される道路救急車の設計、試験、性能、および装備に関する要件を明示しています。クルーと患者の安全性、作業環境、人間工学的デザインに関する要件が含まれています。このヨーロッパ規格では、救急車の登録される国の当局/当局によるスタッフの訓練を対象としていません。 このヨーロッパ規格は、ストレッチャーで少なくとも1人の患者を輸送できる道路救急車に適用されますが、病院用ベッドの輸送は除外されます。 この規格は、輸送保育器システムを搭載した救急車にも要件を定めています。 ヨーロッパ規格は、患者の状態に応じて指定される各タイプの道路救急車に特定の要件をカバーしています。例えば、患者輸送の道路救急車タイプA1、A2、B、およびCです。 このヨーロッパ規格は、道路救急車に搭載され、病院やクリニックの通常の室内環境と異なる環境で使用される医療機器の一般的要件も示しています。
The article discusses the European Standard EN 1789:2020, which outlines the requirements for road ambulances and their equipment. The standard covers the design, testing, performance, and equipping of ambulances used for transporting, monitoring, treating, and caring for patients. It focuses on the patient's compartment, ensuring a safe and ergonomic working environment for both the crew and patients. However, the standard does not cover staff training, as this is the responsibility of the relevant authority in each country. The standard applies to ambulances capable of transporting at least one person on a stretcher but excludes the transportation of hospital beds. It also includes specific requirements for ambulances equipped with transport incubator systems. Additionally, the standard addresses the general requirements for medical devices carried in ambulances and used in different ambient conditions, both inside and outside hospitals and clinics.








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