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

Véhicules de transport sanitaire et leurs équipements - Ambulances routières

Medicinska vozila in pripadajoča oprema - Cestna reševalna vozila

General Information

Status
Not Published
Public Enquiry End Date
24-Mar-2019
Technical Committee
Current Stage
5020 - Formal vote (FV) (Adopted Project)
Start Date
29-Jan-2020
Due Date
18-Mar-2020
Completion Date
30-Jan-2020

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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Rettungsdienstfahrzeuge und deren Ausrüstung - KrankenkraftwagenMedical vehicles and their equipment - Road ambulances43.160Vozila za posebne nameneSpecial purpose vehicles11.160First aidICS:Ta slovenski standard je istoveten z:prEN 1789oSIST prEN 1789:2019en,fr,de01-marec-2019oSIST prEN 1789:2019SLOVENSKI

STANDARD
oSIST prEN 1789:2019
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
DRAFT prEN 1789
December
t r s z ICS
Will supersede EN
s y z {ã t r r y ªA tã t r s vEnglish Version
Medical vehicles and their equipment æ Road ambulances

Rettungsdienstfahrzeuge und deren Ausrüstung æ Krankenkraftwagen This draft European Standard is submitted to CEN members for enquiryä It has been drawn up by the Technical Committee

If this draft becomes a European Standardá CEN members are bounwhich stipulate the conditions for giving this European Standard the status of a national standard without any alterationä

This draft European Standard was established by CEN in three ofer language made by translation under the responsibility of a CEN member into its own language and notified to the CENæCENELEC Management Centre has the same status as the official versionsä

CEN members are the national standards bodies of Austriaá Belgiumá Bulgariaá Croatiaá Cyprusá Czech Republicá Denmarká Estoniaá Finlandá Former Yugoslav Republic of Macedoniaá Franceá Germanyá Greeceá Hungaryá Icelandá Irelandá Italyá Latviaá Lithuaniaá Luxembourgá Maltaá Netherlandsá Norwayá Polandá Portugalá Romaniaá Serbiaá Slovakiaá Sloveniaá Spainá Swedená Switzerlandá Turkey and United Kingdomä

Recipients of this draft are invited to submitá with their commentsá notification of any relevant patent rights of which they are aware and to provide supporting documentationä

Warning ã This document is not a European Standardä It is distributed for review and commentsä It is subject to change without notice and shall not be referred to as a European Standardä

EUROPEAN COMMITTEE FOR STANDARDIZATION COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre:
Rue de la Science 23,
B-1040 Brussels

t r s z CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Membersä Refä Noä prEN

s y z {ã t r s z EoSIST prEN 1789:2019

prEN 1789:2018 (E) 2 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 oSIST prEN 1789:2019

prEN 1789:2018 (E) 3 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

oSIST prEN 1789:2019

prEN 1789:2018 (E) 4 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. oSIST prEN 1789:2019

prEN 1789:2018 (E) 5 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). oSIST prEN 1789:2019

prEN 1789:2018 (E) 6 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 oSIST prEN 1789:2019

prEN 1789:2018 (E) 7 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) oSIST prEN 1789:2019

prEN 1789:2018 (E) 8 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 oSIST prEN 1789:2019

prEN 1789:2018 (E) 9 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 A1: suitable for transport of a single patient; — 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 oSIST prEN 1789:2019

prEN 1789:2018 (E) 10 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 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. oSIST prEN 1789:2019

prEN 1789:2018 (E) 11 4.2.2 Electromagnetic compatibility (EMC) Communication equipment (e.g. radio installation) shall comply with national regulations. To minimize any risk of 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 created by the vehicle or its equipment, the complete operational vehicle should consist of components, equipment or sub systems that comply or are certified as conforming to the respective industry EMC regulations. NOTE 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

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