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EN 1789:2007+A2:2014

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

Medical vehicles and their equipment - Road ambulances

Superseded date

12-09-2020

Superseded by

EN 1789:2020

Published date

10-09-2014

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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Testing
6 Medical devices
7 Conformity assessment
8 Requirements to be met for a Certificate of Compliance
Annex A (informative) - Test summary
Annex B (informative) - Definition of ambulance body styles
Annex C (informative) - Recognition
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
Bibliography

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.

Committee
CEN/TC 239
DevelopmentNote
2007 Edition Re-issued in September 2014 & incorporates AMD 2 2014. (09/2014)
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Superseded
SupersededBy

DIN EN 1865-1:2015-08 PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 1: GENERAL STRETCHER SYSTEMS AND PATIENT HANDLING EQUIPMENT
BS EN 60601-1-12:2015 Medical electrical equipment 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
BS EN 13976-1:2011 Rescue systems. Transportation of incubators Interface conditions
I.S. EN 1865-5:2012 PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 5: STRETCHER SUPPORT
I.S. EN 1865-2:2010 PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 2: POWER ASSISTED STRETCHER
BS EN 13718-1:2014 Medical vehicles and their equipment. Air ambulances Requirements for medical devices used in air ambulances
EN 13718-2:2015 Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances
BS EN ISO 80601-2-72:2015 Medical electrical equipment Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients
I.S. EN 1865-3:2012 PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 3: HEAVY DUTY STRETCHER
10/30215054 DC : DRAFT JUNE 2010 BS EN 1865-3 - PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 3: HEAVY DUTY STRETCHER
DIN EN ISO 80601-2-72:2016-04 Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (ISO 80601-2-72:2015)
12/30266576 DC : 0 BS EN 13718-2 - MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS OF AIR AMBULANCES
13/30276231 DC : 0 BS EN 13718-1 - MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES
UNE-EN 13976-2:2011 Rescue systems - Transportation of incubators - Part 2: System requirements
EN 13976-1:2011 Rescue systems - Transportation of incubators - Part 1: Interface conditions
I.S. EN 1846-2:2009 FIREFIGHTING AND RESCUE SERVICE VEHICLES - PART 2: COMMON REQUIREMENTS - SAFETY AND PERFORMANCE
I.S. EN 1846-3:2013 FIREFIGHTING AND RESCUE SERVICE VEHICLES - PART 3: PERMANENTLY INSTALLED EQUIPMENT - SAFETY AND PERFORMANCE
I.S. EN 1846-1:2011 FIREFIGHTING AND RESCUE SERVICE VEHICLES - PART 1: NOMENCLATURE AND DESIGNATION
UNI EN 13718-1 : 2014 MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES
DIN EN 1865-2:2015-05 Patient handling equipment used in road ambulances - Part 2: Power assisted stretcher (includes Amendment A1:2015)
UNE-EN 1865-1:2011 Patient handling equipment used in road ambulances - Part 1: General stretcher systems and patient handling equipment
BS EN 1865-5:2012 Patient handling equipment used in road ambulances Stretcher support
09/30205924 DC : 0 BS EN 13976-1 - RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 1: INTERFACE CONDITIONS
08/30176106 DC : DRAFT MAR 2008 BS EN 1865-2 - SPECIFICATION FOR PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 2: POWER ASSISTED STRETCHERS
UNI EN 1865-5 : 2012 PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 5: STRETCHER SUPPORT
CAN/CSA-C22.2 NO. 80601-2-72:17 Medical electrical equipment — Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (Adopted ISO 80601-2-72:2015, first edition, 2015-09-01, with Canadian deviations)
UNI EN 13976-2 : 2011 RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS
BS EN 1865-2 : 2010 PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 2: POWER ASSISTED STRETCHER
I.S. 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
UNE-EN 13976-1:2011 Rescue systems - Transportation of incubators - Part 1: Interface conditions
DIN EN 13718-2:2015-05 MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES
DIN EN 13718-1:2014-12 MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES
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 1846-3:2013 Firefighting and rescue service vehicles - Part 3: Permanently installed equipment - Safety and performance
UNI EN 1846-3 : 2013 FIREFIGHTING AND RESCUE SERVICE VEHICLES - PART 3: PERMANENTLY INSTALLED EQUIPMENT - SAFETY AND PERFORMANCE
UNI EN 1846-1 : 2011 FIREFIGHTING AND RESCUE SERVICE VEHICLES - PART 1: NOMENCLATURE AND DESIGNATION
UNI EN 1846-2 : 2013 FIREFIGHTING AND RESCUE SERVICE VEHICLES - PART 2: COMMON REQUIREMENTS - SAFETY AND PERFORMANCE
PREN 13976-2 : DRAFT 2016 RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS
13/30264413 DC : 0 BS EN ISO 80601-2-72 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-72: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HOME HEALTHCARE ENVIRONMENT VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS
12/30245174 DC : 0 BS EN 60601-1-12 - 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
16/30333925 DC : 0 BS EN 13976-2 - RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS
DIN EN 1865-3:2015-05 PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 3: HEAVY DUTY STRETCHER
I.S. EN ISO 80601-2-72:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-72: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HOME HEALTHCARE ENVIRONMENT VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS (ISO 80601-2-72:2015)
I.S. EN 1865-1:2010 PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 1: GENERAL STRETCHER SYSTEMS AND PATIENT HANDLING EQUIPMENT
CSA C22.2 No. 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
16/30333928 DC : 0 BS EN 13976-1 - RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 1: INTERFACE CONDITIONS
UNI EN 13976-1 : 2011 RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 1: INTERFACE CONDITIONS
I.S. EN 13976-2:2011 RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS
BS EN 1846-3:2013 Firefighting and rescue service vehicles Permanently installed equipment. Safety and performance
UNE-EN 13718-2:2015 Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances
BS EN 13976-2:2011 Rescue systems. Transportation of incubators System requirements
ISO 80601-2-72:2015 Medical electrical equipment — Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients
UNE-EN 1846-1:2011 Firefighting and rescue service vehicles - Part 1: Nomenclature and designation
EN 13718-1:2014 Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances
I.S. EN 13718-1:2014 MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES
BS EN 13718-2:2015 Medical vehicles and their equipment. Air ambulances Operational and technical requirements for air ambulances
UNE-EN 1846-2:2011 Firefighting and rescue service vehicles - Part 2: Common requirements - Safety and performance
I.S. EN 13718-2:2015 MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES
BS EN 1846-2 : 2009 FIREFIGHTING AND RESCUE SERVICE VEHICLES - PART 2: COMMON REQUIREMENTS - SAFETY AND PERFORMANCE
I.S. EN 13718-2:2015+A1:2020 MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES
EN 1865-2:2010+A1:2015 Patient handling equipment used in road ambulances - Part 2: Power assisted stretcher
EN ISO 80601-2-72:2015 Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (ISO 80601-2-72:2015)
EN 1865-5:2012 Patient handling equipment used in road ambulances - Part 5: Stretcher support
EN 1865-3:2012+A1:2015 Patient handling equipment used in road ambulances - Part 3: Heavy duty stretcher
EN 1865-1:2010+A1:2015 Patient handling equipment used in road ambulances - Part 1: General stretcher systems and patient handling equipment
EN 1846-1:2011 Firefighting and rescue service vehicles - Part 1: Nomenclature and designation
EN 1846-2:2009+A1:2013 Firefighting and rescue service vehicles - Part 2: Common requirements - Safety and performance
BS EN 1865-3 : 2012 PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 3: HEAVY DUTY STRETCHER
10/30215048 DC : DRAFT JUNE 2010 BS EN 1865-5 - PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 5: STRETCHER SUPPORT
07/30169858 DC : 0 BS EN 1865-1 - SPECIFICATIONS FOR PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 1: GENERAL STRETCHER SYSTEMS AND PATIENT HANDLING EQUIPMENT
DIN EN 1865-5:2012-09 Patient handling equipment used in road ambulances - Part 5: Stretcher support
BS EN 1865-1 : 2010 PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 1: GENERAL STRETCHER SYSTEMS AND PATIENT HANDLING EQUIPMENT
DIN EN 13976-1:2016-03 (Draft) RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 1: INTERFACE CONDITIONS
UNE-EN 1865-2:2011 Patient handling equipment used in road ambulances - Part 2: Power assisted stretcher
EN 13976-2:2011 Rescue systems - Transportation of incubators - Part 2: System requirements
DIN EN 13976-2:2016-03 (Draft) RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS
I.S. EN 13976-1:2011 RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 1: INTERFACE CONDITIONS
BS EN 1846-1:2011 Firefighting and rescue service vehicles Nomenclature and designation
UNE-EN 1846-3:2015 Firefighting and rescue service vehicles - Part 3: Permanently installed equipment - Safety and performance
DIN EN 1846-2:2013-05 Firefighting and rescue service vehicles - Part 2: Common requirements - Safety and performance (includes Amendment A1:2013)
DIN EN 13976-1:2011-08 RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 1: INTERFACE CONDITIONS
DIN EN 13976-2:2011-08 RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS
DIN EN 1846-1:2011-07 Fire fighting and rescue service vehicles - Part 1: Nomenclature and designation
DIN EN 1846-3:2013-11 FIREFIGHTING AND RESCUE SERVICE VEHICLES - PART 3: PERMANENTLY INSTALLED EQUIPMENT - SAFETY AND PERFORMANCE
UNE-EN 1865-3:2012 Patient handling equipment used in road ambulances - Part 3: Heavy duty stretcher

EN 455-1:2000 Medical gloves for single use - Part 1: Requirements and testing for freedom from holes
EN ISO 11197:2016 Medical supply units (ISO 11197:2016)
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)
EN ISO 407:2004 Small medical gas cylinders - Pin-index yoke-type valve connections (ISO 407:2004)
EN 14052:2012+A1:2012 High performance industrial helmets
EN 1865-1:2010+A1:2015 Patient handling equipment used in road ambulances - Part 1: General stretcher systems and patient handling equipment
EN 13544-1:2007+A1:2009 Respiratory therapy equipment - Part 1: Nebulizing systems and their components
ISO 15002:2008 Flow-metering devices for connection to terminal units of medical gas pipeline systems
EN ISO 15002:2008 Flow-metering devices for connection to terminal units of medical gas pipeline systems (ISO 15002:2008)
EN 1865-4:2012 Patient handling equipment used in road ambulances - Part 4: Foldable patient transfer chair
ISO 19054:2005 Rail systems for supporting medical equipment
EN ISO 10079-2:2014 Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:2014)
EN 60068-2-64:2008 ENVIRONMENTAL TESTING - PART 2-64: TESTS - TEST FH: VIBRATION, BROADBAND RANDOM AND GUIDANCE
EN 1865-2:2010+A1:2015 Patient handling equipment used in road ambulances - Part 2: Power assisted stretcher
EN 794-3:1998+A2:2009 Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators
EN 737-1 : 1998 MEDICAL GAS PIPELINE SYSTEMS - TERMINAL UNITS FOR COMPRESSED MEDICAL GASES AND VACUUM
EN 737-3:1998/A1:1999 MEDICAL GAS PIPELINE SYSTEMS - PIPELINES FOR COMPRESSED MEDICAL GASES AND VACUUM
ISO 7396-2:2007 Medical gas pipeline systems Part 2: Anaesthetic gas scavenging disposal systems
IEC 60068-2-64:2008 Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance
ISO 10079-1:2015 Medical suction equipment Part 1: Electrically powered suction equipment
IEC 60601-2-4:2010 Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
ISO 5359:2014 Anaesthetic and respiratory equipment — Low-pressure hose assemblies for use with medical gases
ISO 5128:1980 Acoustics — Measurement of noise inside motor vehicles
EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
ISO 10524-3:2005 Pressure regulators for use with medical gases Part 3: Pressure regulators integrated with cylinder valves
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
EN 420:2003+A1:2009 Protective gloves - General requirements and test methods
ISO 11197:2016 Medical supply units
EN 12470-1:2000+A1:2009 Clinical thermometers - Part 1: Metallic liquid-in-glass thermometers with maximum device
ISO 10079-2:2014 Medical suction equipment Part 2: Manually powered suction equipment
EN 3-7:2004+A1:2007 Portable fire extinguishers - Part 7: Characteristics, performance requirements and test methods
EN ISO 20345:2011 Personal protective equipment - Safety footwear (ISO 20345:2011)
ISO 20471:2013 High visibility clothing — Test methods and requirements
EN 455-2:2015 Medical gloves for single use - Part 2: Requirements and testing for physical properties
ISO 80601-2-61:2011 Medical electrical equipment Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
ISO 80601-2-55:2011 Medical electrical equipment Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
EN 60068-2-29:1993 Environmental testing - Part 2: Tests - Test Eb and guidance: Bump
ISO 10079-3:2014 Medical suction equipment Part 3: Suction equipment powered from a vacuum or positive pressure gas source
ISO 407:2004 Small medical gas cylinders Pin-index yoke-type valve connections
EN 60068-2-6:2008 Environmental testing - Part 2-6: Tests - Test Fc: Vibration (sinusoidal)
ISO 20345:2011 Personal protective equipment Safety footwear
IEC 60068-2-29:1987 Environmental testing. Part 2: Tests. Test Eb and guidance: Bump
EN ISO 7396-2:2007 Medical gas pipeline systems - Part 2: Anaesthetic gas scavenging disposal systems (ISO 7396-2:2007)
ISO 14971:2007 Medical devices Application of risk management to medical devices
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)
EN 60068-2-32:1993 Basic environmental testing procedures - Part 2: Tests - Test Ed: Free fall
ISO 10524-1:2006 Pressure regulators for use with medical gases Part 1: Pressure regulators and pressure regulators with flow-metering devices
ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
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 1865-5:2012 Patient handling equipment used in road ambulances - Part 5: Stretcher support
EN 60601-2-4:2011 Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators

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