SIST EN 1789:2007+A2:2015
(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 and care of patients. It contains requirements for the patient’s compartment.
This European Standard does not cover the requirements for approval and registration of the vehicle and the training of the staff which is the responsibility of the authority/authorities in the country where the ambulance is to be registered.
This European Standard is applicable to road ambulances capable of transporting at least one person on a stretcher.
Requirements are specified for categories of road ambulances based in increasing order of the level of treatment that can be carried out. These are the patient transport ambulance (types A1 A2), the emergency ambulance (type B) and the mobile intensive care unit (type C).
This European Standard gives general requirements for medical devices carried in road ambulances and used therein and outside hospitals and clinics in situations where the ambient conditions can differ from normal indoor conditions.
Rettungsdienstfahrzeuge und deren Ausrüstung - Krankenkraftwagen
Diese Europäische Norm legt Anforderungen, Prüfung und Ausrüstung für den Transport und die Sicherheit von Patienten in Krankenkraftwagen fest. Sie enthält Anforderungen an den Krankenraum.
Diese Europäische Norm enthält keine Anforderungen für die Zulassung und Registrierung von Fahrzeugen und die Ausbildung des Personals. Dafür ist die Behörde des Landes zuständig, in der der Krankenkraftwagen registriert ist.
Die Europäische Norm gilt für Krankenkraftwagen, in denen mindestens eine Person liegend auf einer Krankentrage transportiert werden kann.
Die Anforderungen werden für drei Kategorien von Krankenkraftwagen festgelegt, die sich in aufsteigender Ordnung auf den Umfang der Behandlung im Fahrzeug beziehen. Es sind dies Krankentransportwagen (Typen A1, A2), Notfallkrankenwagen (Typ B) und Rettungswagen (Typ C).
Diese Europäische Norm enthält allgemeine Anforderungen an Medizinprodukte (Geräte), die in Krankenkraftwagen befördert und in ihnen sowie außerhalb von Krankenhäusern und Kliniken verwendet werden, wo die Umweltbedingungen sich von üblichen Innenraumbedingungen unterscheiden können.
Véhicules de transport sanitaire et leurs équipements - Ambulances routières
La présente Norme européenne définit les exigences concernant la conception, les méthodes d'essai,
les performances et l'armement des ambulances routières utilisées pour le transport et le traitement des patients.
Elle comporte des exigences relatives à la cellule sanitaire.
La présente Norme européenne ne couvre pas les exigences pour l’approbation et l’immatriculation du véhicule
ni la formation du personnel dont la responsabilité incombe à l’autorité/aux autorités du pays dans lequel l’ambulance
doit être immatriculée.
La présente Norme européenne s'applique aux ambulances routières capables de transporter au moins un patient
sur un brancard.
Des exigences sont définies pour des catégories d'ambulances routières basées sur l'ordre croissant du niveau
de soins pouvant être prodigués à bord. Ce sont l'ambulance pour le transport des patients (types A1 et A2),
l'ambulance de soins d'urgence (type B) et l'unité mobile de soins intensifs (type C).
La présente Norme européenne énonce des exigences générales pour les dispositifs médicaux transportés et utilisés
dans les ambulances routières et en dehors des hôpitaux et des cliniques dans des situations où les conditions
ambiantes peuvent différer de celles normales en intérieur.
Medicinska vozila in pripadajoča oprema - Cestna reševalna vozila
Ta evropski standard določa zahteve za načrtovanje, preskušanje, zmogljivost in opremljanje cestnih reševalnih vozil, ki se uporabljajo za prevoz in oskrbo pacientov. Vsebuje zahteve za oddelek za pacienta.
Ta evropski standard ne obravnava zahtev za odobritev in registracijo vozila ter usposabljanje osebja, za kar je odgovoren organ oz. organi v državi, v kateri bo ambulantno vozilo registrirano.
Ta evropski standard se uporablja za cestna reševalna vozila, ki lahko prevažajo najmanj eno osebo na nosilih.
Zahteve so opredeljene za kategorije cestnih reševalnih vozil po naraščajočem vrstnem redu ravni oskrbe, ki jo je mogoče nuditi. To so reševalna vozila za prevoz pacientov (tipa A1, A2), urgentna reševalna vozila (tip B) in mobilna enota za intenzivno nego (tip C).
Ta evropski standard določa splošne zahteve za medicinsko opremo, ki se prevaža v cestnih reševalnih vozilih in uporablja v teh vozilih ter zunaj bolnišnic in klinik v primerih, v katerih obstaja možnost, da se okoljski pogoji razlikujejo od običajnih notranjih pogojev.
General Information
Relations
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Rettungsdienstfahrzeuge und deren Ausrüstung - KrankenkraftwagenVéhicules de transport sanitaire et leurs équipements - Ambulances routièresMedical vehicles and their equipment - Road ambulances43.160Vozila za posebne nameneSpecial purpose vehicles11.160First aidICS:Ta slovenski standard je istoveten z:EN 1789:2007+A2:2014SIST EN 1789:2007+A2:2015en,fr,de01-januar-2015SIST EN 1789:2007+A2:2015SLOVENSKI
STANDARD
SIST EN 1789:2007+A2:2015
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 1789:2007+A2
September 2014 ICS 11.160; 43.160 Supersedes EN 1789:2007+A1:2010
English Version
Medical vehicles and their equipment - Road ambulances
Véhicules de transport sanitaire et leurs équipements - Ambulances routières
Rettungsdienstfahrzeuge und deren Ausrüstung - Krankenkraftwagen This European Standard was approved by CEN on 24 February 2007 and includes Amendment 1 approved by CEN on 6 March 2010 and Amendment 2 approved by CEN on 14 July 2014.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2014 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 1789:2007+A2:2014 E SIST EN 1789:2007+A2:2015
EN 1789:2007+A2:2014 (E) 2 Contents Page Foreword .5 #Introduction$ .6 1 Scope .7 2 Normative references .7 3 Terms and definitions .9 4 Requirements . 11 4.1 General requirements . 11 4.1.1 General . 11 4.1.2 Maximum overall dimensions . 11 4.1.3 Wheel arch clearance . 11 4.2 #Performance-braking and acceleration$ . 11 4.2.1 Acceleration . 11 4.2.2 Braking . 12 4.2.3 Safety system . 12 4.3 Electrical requirements . 12 4.3.1 General . 12 4.3.2 Electromagnetic compatibility (EMC) – Communication equipment . 12 4.3.3 Battery and alternator . 12 4.3.4 Electrical installation . 13 4.3.5 Visual and audible warning system . 14 4.4 Vehicle body . 14 4.4.1 Fire safety . 14 4.4.2 Driver's seat configuration . 14 4.4.3 Minimum loading capacity . 14 4.4.4 Bulkhead . 15 4.4.5 Openings (doors, windows, emergency exits) . 16 4.4.6 Loading area . 17 4.5 Patient’s compartment . 18 4.5.1 General . 18 4.5.2 Patient’s compartment dimensions . 19 4.5.3 Patient and attendant seating . 23 4.5.4 Ventilation and anaesthetic gas scavenging systems. 24 4.5.5 Temperature system . 25 4.5.6 Interior lighting . 25 4.5.7 Interior noise level . 26 4.5.8 Holding system for infusion . 26 4.5.9 Mounting systems . 26 4.5.10 Mass reserve . 27 5 Testing . 27 5.1 General . 27 5.2 Testing of the interior noise level . 27 5.2.1 #Specific measurement conditions$ . 27 5.2.2 Measurements . 28 5.2.3 Establishment of compliance . 29 5.3 Testing of the acceleration . 30 5.4 Testing of maintain systems and fixations of the equipment in the patient’s compartment . 30 5.4.1 General . 30 SIST EN 1789:2007+A2:2015
EN 1789:2007+A2:2014 (E) 3 5.4.2 Testing of the stretcher fixations on the vehicle floor . 32 5.4.3 Testing of the medical devices fixations . 33 5.4.4 Testing of furniture . 33 5.4.5 Test procedure . 33 5.5 #Testing of rounded edges and radius inside the patient's compartment$ . 34 5.5.1 #Testing of rounded edges$ . 34 5.5.2 Testing of rounded edges and radius inside the patient's compartment . 35 5.6 Procedure to verify the patient's compartment specifications . 35 5.7 Procedure to verify the loading area specifications . 36 5.7.1 General . 36 5.7.2 Procedure to verify the loading angle of 16° . 36 5.8 Procedure to verify the dimensions of the patient's compartment . 37 5.8.1 Type A and B road ambulances . 37 5.8.2 Type C road ambulances . 37 5.9 Procedure to verify the seats dimensions of the patient's compartment . 38 5.10 Testing of the ventilation system . 39 5.11 Testing of the heating system . 39 5.12 Testing of the cooling system . 40 5.12.1 Test procedure . 40 5.12.2 Testing of independent air conditioning system . 40 5.13 Testing of interior lighting . 41 5.14 Testing of infusion holding system . 41 6 Medical devices . 41 6.1 Provision of medical devices . 41 6.2 Medical devices storage . 41 6.3 Requirements for medical devices . 42 6.3.1 General . 42 6.3.2 Temperature . 42 6.3.3 Humidity and ingress of liquids . 42 6.3.4 Mechanical strength . 42 6.3.5 Fixation of devices . 43 6.3.6 Electrical safety . 43 6.3.7 User interface . 43 6.3.8 Gas installation . 43 6.3.9 Marking and instructions . 45 6.3.10 Maintenance . 45 6.4 Mechanical strength – Test methods for medical devices for use in road ambulances . 45 6.4.1 Vibration and bump test . 45 6.4.2 Free fall . 46 6.5 List of equipment . 46 7 Conformity assessment . 53 8 Requirements to be met for a Certificate of Compliance . 53 Annex A (informative)
#Test summary$ . 55 Annex B (informative)
#Definition of ambulance body styles$ . 56 B.1 General . 56 B.2 Van based Ambulance . 56 B.3 Fully independent box body . 57 Annex C (informative)
#Recognition$ . 58 C.1 Recognition and visibility of ambulances. 58 C.2 Recognition of personnel . 58 SIST EN 1789:2007+A2:2015
EN 1789:2007+A2:2014 (E) 4 Annex ZA (informative)
!#Relationship between this European Standard and the Essential Requirements of EC Directive 93/42/EEC on Medical Devices and Directive 2007/46/EC of the European Parliament and of the Council of 5 September 2007 establishing a framework for the approval of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles$ . 59 Bibliography . 60
SIST EN 1789:2007+A2:2015
EN 1789:2007+A2:2014 (E) 5 Foreword This document (EN 1789:2007+A2:2014) has been prepared by Technical Committee CEN/TC 239 “Rescue systems”, the secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by March 2015, and conflicting national standards shall be withdrawn at the latest by March 2015. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights. This document includes Amendment 1, approved by CEN on 2010-03-06 and Amendment 2, approved by CEN on 2014-07-14. This document supersedes #EN 1789:2007+A1:2010$. The start and finish of text introduced or altered by amendment is indicated in the text by tags ! " and #$. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. SIST EN 1789:2007+A2:2015
EN 1789:2007+A2:2014 (E) 6 #Introduction In the development of the European standard EN during the 90's, Directive 70/156/EEC has been considered. In October 2009, CEN/TC 239 appointed an ad-hoc group to evaluate the impact of the Directive 2007/46/EC which replaces Directive 70/156/EEC, on EN 1789:2007 and to assess its application in different member countries of CEN. Moreover the definition of ambulance of the COMMISSION REGULATION (EU) No 678/2011 (14 July 2011 replacing Annex II and amending Annexes IV, IX and XI to Directive 2007/46/EC) refers to EN 1789:2007. The appointed ad-hoc group reported its findings as follows: — EN 1789:2007 has not been applied consistently by notified bodies since the text for verifying compliance is open to interpretation and may cause difficulties to Technical Services (TS) as defined in Directive 2007/46/EC, EN 1789:2007 or local authorities; — these differences can lead to declarations that the same ambulance complies or does not comply with EN 1789:2007; — manufacturers of ambulances may have the same problems of interpretation in the design of their ambulances; — users of ambulances may have the same problems of interpretation that affects their responsibility. This second amendment1) gives an answer to questions concerning the application of EN 1789:2007 and avoids differences in interpretation between such notified bodies to check compliance of vehicles specially adapted to medical transportation (Road ambulances). NOTE Such as the demonstration of compliance to the requirements of 4.5.9 or 4.3.$
1) #The first amendment published in 2010 only updates Table ZA.1 to consider the revision of Directive 93/42/EEC.$ SIST EN 1789:2007+A2:2015
EN 1789:2007+A2:2014 (E) 7 1 Scope This European Standard specifies requirements for the design, testing, performance and equipping of road ambulances used for the transport and care of patients. It contains requirements for the patient’s compartment. This European Standard does not cover the requirements for approval and registration of the vehicle and the training of the staff which is the responsibility of the authority/authorities in the country where the ambulance is to be registered. This European Standard is applicable to road ambulances capable of transporting at least one person on a stretcher. Requirements are specified for categories of road ambulances based in increasing order of the level of treatment that can be carried out. These are the patient transport ambulance (types A1 A2), the emergency ambulance (type B) and the mobile intensive care unit (type C). This European Standard gives general requirements for medical devices carried in road ambulances and used therein and outside hospitals and clinics in situations where the ambient conditions can differ from normal indoor conditions. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. #EN 3-7:2004+A1:2007$, Portable fire extinguishers — Part 7: Characteristics, performance requirements and test methods #EN 420:2003+A1:2009$, Protective gloves — General requirements and test methods #EN 455-1:2000$, Medical gloves for single use — Part 1: Requirements and testing for freedom from holes #EN 455-2:2009+A2:2013$, Medical gloves for single use — Part 2: Requirements and testing for physical properties #deleted text$ EN 737-1:1998, Medical gas pipeline systems — Part 1: Terminal units for compressed medical gases and vacuum EN 737-3:1998, Medical gas pipeline systems — Part 3: Pipelines for compressed medical gases and vacuum #deleted text$ #EN 794-3:1998+A2:2009$, Lung ventilators — Part 3: Particular requirements for emergency and transport ventilators #deleted text$ #EN 1041:2008+A1:2013, Information supplied by the manufacturer of medical devices$ SIST EN 1789:2007+A2:2015
EN 1789:2007+A2:2014 (E) 8 #EN 1865-1:2010, Patient handling equipment used in road ambulances — Part 1: General stretcher systems and patient handling equipment$ #EN 1865-2:2010, 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$, Clinical thermometers — Part 1: Metallic liquid-in-glass thermometers with maximum device #EN 13501-1:2007+A1:2009, Fire classification of construction products and building elements — Part 1: Classification using test data from reaction to fire tests$ #EN 13544-1:2007+A1:2009$, Respiratory therapy equipment — Part 1: Nebulizing systems and their components #EN 14052:2012+A1:2012$, High performance industrial helmets #EN 60068-2-6:2008, Environmental testing — Part 2-6: Tests — Tests Fc: Vibration (sinusoidal) (IEC 60068-2-6:2007)$ #EN 60068-2-29:1993$, Basic environmental testing procedures — Part 2: Tests; test Eb and guidance: bump (IEC 60068-2-29:1987) EN 60068-2-32, Basic environmental testing procedures — Part 2: Tests; test Ed: free fall (IEC 60068-2-32:1975 + A1:1982 + A2:1990) #EN 60068-2-64:2008, Environmental testing — Part 2-64: Tests — Test Fh: Vibration, broadband random and guidance (IEC 60068-2-64:2008)$ EN 60601-1, Medical electrical equipment EN 60601-2, Medical electrical equipment #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 ISO 407:2004$, Small medical gas cylinders - Pin-index yoke-type valve connections (ISO 407:2004) #deleted text$ #EN ISO 5359:2008, Low-pressure hose assemblies for use with medical gases (ISO 5359:2008)$ EN ISO 10079-1:1999, Medical suction equipment — Part 1: Electrically powered suction equipment — Safety requirements (ISO 10079-1:1999) EN ISO 10079-2:1999, Medical suction equipment — Part 2: Manually powered suction equipment (ISO 10079-2:1999) EN ISO 10079-3:1999, Medical suction equipment — Part 3: Suction equipment powered from a vacuum or pressure source (ISO 10079-3:1999) #EN ISO 10524-1:2006$, Pressure regulators for use with medical gases — Part 1: Pressure regulators and pressure regulators with flow-metering devices (ISO 10524-1:2006) SIST EN 1789:2007+A2:2015
EN 1789:2007+A2:2014 (E) 9 #EN ISO 10524-3:2006$, Pressure regulators for use with medical gases — Part 3: Pressure regulators integrated with cylinder valves (ISO 10524-3:2005) EN ISO 11197:2004, Medical supply units (ISO 11197:2004) #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 15223-1:2012, Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements #(ISO 15223-1:2012)$ #EN ISO 19054:2006$, Rail systems for supporting medical equipment (ISO 19054:2005) #EN ISO 20345:2011$, Personal protective equipment — Safety footwear (ISO 20345:2011)$ #EN ISO 20471:2013, High visibility clothing — Test methods and requirements (ISO 20471:2013, Corrected version 2013-06-01)$ #deleted text$ #EN ISO 80601-2-55:2011, Medical electrical equipment — Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 80601-2-55:2011) EN ISO 80601-2-61:2011, Medical electrical equipment — Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (ISO 80601-2-61:2011)$ #IEC 60364-7-721:2007, Low-voltage electrical installations — Part 7-721: Requirements for special installations or locations — Electrical installations in caravans and motor caravans (IEC 60364-7-721:2007-04)$ #deleted text$ ISO 5128:1980, Acoustics — Measurement of noise inside motor vehicles 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 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 SIST EN 1789:2007+A2:2015
EN 1789:2007+A2:2014 (E) 10 3.2 ambulance vehicle or craft intended to be crewed by a minimum of two appropriately trained staff for the provision of care and transport of at least one stretchered patient 3.3 types of road ambulances2) 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. 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/or chair(s)) 3.3.2 type B: emergency ambulance road ambulance designed and equipped for the transport, basic treatment and monitoring of patients 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 #deleted text$ #deleted text$ mass according to 92/21/EEC modified of the road ambulance including the driver taken as 75 kg and all fixed installations NOTE Loose portable patient handling, sanitary, medical and technical equipment are not included in net vehicle mass. #3.5 ambulance loading capacity difference between the permissible gross vehicle mass and the mass according to 92/21/EEC modified of the road ambulance including the driver taken as 75 kg and all fixed installations, mass reserve according to 4.5.10 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.$ #deleted text$ #3.6$ fixation system system or device to ensure the permanent fixation of medical devices or other equipment into the ambulance #3.7$ maintain system bracket or other interface device used to secure a mobile or transportable item of equipment or medical device of the vehicle without the use of tools
2) Road ambulances are road vehicles which comply with type approval for special use vehicles according to
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