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EN 13718-2:2015

EN 13718-2:2015

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by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 - Air ambulances - Part 2: Operational and technical requirements for air ambulances

Superseded date

08-04-2020

Superseded by

EN 13718-2:2015+A1:2020

Published date

18-03-2015

Publisher

Comite Europeen de Normalisation

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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements for air ambulances
5 Air ambulances, operation and performance requirements
6 Gas installations in air ambulances
Annex A (normative) - Medical devices in air ambulances
Annex B (normative) - Medicinal products and equipment
        additional to medical devices in air ambulances
Annex C (informative) - A-deviations
Annex ZA (informative) - Relationship between this European
         Standard and the Essential Requirements
         of EU Directive 93/42/EEC
Bibliography

This part of EN 13718 specifies the requirements for performance and equipping for air ambulances, including requirements for interfaces to medical devices used for the transport and treatment of sick or injured persons. This part of EN 13718 is applicable to air ambulances capable of transporting at least one person on a stretcher.NOTERequirements are specified for categories of air ambulances based on the different intended use. These are the helicopter emergency medical service (HEMS) the helicopter intensive care medical service (HICAMS) and the fixed wing air ambulance (FWAA).

Committee
CEN/TC 239
DevelopmentNote
Supersedes PREN 13718-2. (03/2015)
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Superseded
SupersededBy

BS EN 13718-1:2014 Medical vehicles and their equipment. Air ambulances Requirements for medical devices used in air ambulances
BS EN 13976-1:2011 Rescue systems. Transportation of incubators Interface conditions
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
UNI EN 13718-1 : 2014 MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES
09/30205924 DC : 0 BS EN 13976-1 - RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 1: INTERFACE CONDITIONS
UNE-EN 13976-1:2011 Rescue systems - Transportation of incubators - Part 1: Interface conditions
DIN EN 13718-1:2014-12 MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES
PREN 13976-2 : DRAFT 2016 RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS
16/30333925 DC : 0 BS EN 13976-2 - RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS
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 13976-2:2011 Rescue systems. Transportation of incubators System requirements
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
UNI EN 13976-2 : 2011 RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS
DIN EN 13976-1:2016-03 (Draft) RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 1: INTERFACE CONDITIONS
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
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

ISO 11070:2014 Sterile single-use intravascular introducers, dilators and guidewires
EN ISO 5367:2014 Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2014)
EN 60601-2-34:2014 Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment
EN 374-1:2003 Protective gloves against chemicals and micro-organisms - Part 1: Terminology and performance requirements
EN 455-1:2000 Medical gloves for single use - Part 1: Requirements and testing for freedom from holes
ISO 5364:2016 Anaesthetic and respiratory equipment — Oropharyngeal airways
EN 60601-2-31:2008/A1:2011 MEDICAL ELECTRICAL EQUIPMENT - PART 2-31: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF EXTERNAL CARDIAC PACEMAKERS WITH INTERNAL POWER SOURCE
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 18777:2009 Transportable liquid oxygen systems for medical use - Particular requirements (ISO 18777:2005)
EN ISO 407:2004 Small medical gas cylinders - Pin-index yoke-type valve connections (ISO 407:2004)
ISO 7376:2009 Anaesthetic and respiratory equipment Laryngoscopes for tracheal intubation
EN 60601-2-24:2015 Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers
EN ISO 7886-2:1997 Sterile hypodermic syringes for single use - Part 2: Syringes for use with power-driven syringe pumps (ISO 7886-2:1996)
EN 1618:1997 Catheters other than intravascular catheters - Test methods for common properties
EN 1865-1:2010+A1:2015 Patient handling equipment used in road ambulances - Part 1: General stretcher systems and patient handling equipment
ISO 15002:2008 Flow-metering devices for connection to terminal units of medical gas pipeline systems
ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin
EN 13718-1:2014 Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances
MIL-DTL-26482 Revision H:2007 Connectors, Electrical, Circular, Miniature, Quick Disconnect, Environment Resisting, Receptacles and Plugs, General Specification for
EN ISO 81060-1:2012 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type (ISO 81060-1:2007)
EN ISO 5356-1:2015 Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets (ISO 5356-1:2015)
ISO 13688:2013 Protective clothing — General requirements
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
EN ISO 15002:2008 Flow-metering devices for connection to terminal units of medical gas pipeline systems (ISO 15002:2008)
ISO 10524-4:2008 Pressure regulators for use with medical gases — Part 4: Low-pressure regulators
EN ISO 7376:2009 Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation (ISO 7376:2009)
ISO 80601-2-56:2017 Medical electrical equipment — Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
ISO 81060-1:2007 Non-invasive sphygmomanometers — Part 1: Requirements and test methods for non-automated measurement type
ISO 5356-1:2015 Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
EN 1865-4:2012 Patient handling equipment used in road ambulances - Part 4: Foldable patient transfer chair
ISO 9170-2:2008 Terminal units for medical gas pipeline systems — Part 2: Terminal units for anaesthetic gas scavenging systems
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 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 ISO 10524-4:2008 Pressure regulators for use with medical gases - Part 4: Low-pressure regulators (ISO 10524-4:2008)
EN 455-3:2015 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
ISO 7886-2:1996 Sterile hypodermic syringes for single use Part 2: Syringes for use with power-driven syringe pumps
ISO 18777:2005 Transportable liquid oxygen systems for medical use — Particular requirements
EN ISO 10555-3:2013 Intravascular catheters - Sterile and single-use catheters - Part 3: Central venous catheters (ISO 10555-3:2013)
ISO 7396-2:2007 Medical gas pipeline systems Part 2: Anaesthetic gas scavenging disposal systems
EN ISO 6009:2016 Hypodermic needles for single use - Colour coding for identification (ISO 6009:2016)
ISO 5356-2:2012 Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors
ISO 10079-1:2015 Medical suction equipment Part 1: Electrically powered suction equipment
IEC 60601-2-34:2011 Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment
EN 3-10:2009 Portable fire extinguishers - Part 10: Provisions for evaluating the conformity of a portable fire extinguisher to EN 3-7
EN ISO 23328-2:2009 Breathing system filters for anaesthetic and respiratory use - Part 2: Non-filtration aspects (ISO 23328-2:2002)
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 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016)
ISO 3795:1989 Road vehicles, and tractors and machinery for agriculture and forestry — Determination of burning behaviour of interior materials
IEC 60601-2-31:2008+AMD1:2011 CSV Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
IEC 60601-2-4:2010 Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
ISO 5367:2014 Anaesthetic and respiratory equipment — Breathing sets and connectors
ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
ISO 5359:2014 Anaesthetic and respiratory equipment — Low-pressure hose assemblies for use with medical gases
ISO 10524-3:2005 Pressure regulators for use with medical gases Part 3: Pressure regulators integrated with cylinder valves
ISO 23328-2:2002 Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration aspects
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 80601-2-30:2010/A1:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-30: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATED NON-INVASIVE SPHYGMOMANOMETERS (IEC 80601-2-30:2009/A1:2013)
EN ISO 10555-5:2013 Intravascular catheters - Sterile and single-use catheters - Part 5: Over-needle peripheral catheters (ISO 10555-5:2013)
EN 13976-2:2011 Rescue systems - Transportation of incubators - Part 2: System requirements
EN ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2016)
EN ISO 5364:2016 Anaesthetic and respiratory equipment - Oropharyngeal airways (ISO 5364:2016)
ISO 81060-2:2013 Non-invasive sphygmomanometers Part 2: Clinical investigation of automated measurement type
ISO 5366-1:2000 Anaesthetic and respiratory equipment Tracheostomy tubes Part 1: Tubes and connectors for use in adults
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 81060-2:2014 Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type (ISO 81060-2:2013)
ISO 7864:2016 Sterile hypodermic needles for single use — Requirements and test methods
IEC 80601-2-30:2009+AMD1:2013 CSV Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
EN ISO 5356-2:2012 Anaesthetic and respiratory equipment - Conical connectors - Part 2: Screw-threaded weight-bearing connectors (ISO 5356-2:2012)
EN ISO 5366-1:2009 Anaesthetic and respiratory equipment - Tracheostomy tubes - Part 1: Tubes and connectors for use in adults (ISO 5366-1:2000)
IEC 60601-2-27:2011 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
ISO 10555-3:2013 Intravascular catheters — Sterile and single-use catheters — Part 3: Central venous catheters
EN ISO 9360-1:2009 Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 1: HMEs for use with minimum tidal volumes of 250 ml (ISO 9360-1:2000)
EN 1865-3:2012+A1:2015 Patient handling equipment used in road ambulances - Part 3: Heavy duty stretcher
ISO 10555-1:2013 Intravascular catheters — Sterile and single-use catheters — Part 1: General 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
ISO 2631-1:1997 Mechanical vibration and shock — Evaluation of human exposure to whole-body vibration — Part 1: General requirements
EN ISO 5361:2016 Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2016)
ISO 10079-3:2014 Medical suction equipment Part 3: Suction equipment powered from a vacuum or positive pressure gas source
EN ISO 13688:2013 Protective clothing - General requirements (ISO 13688:2013)
IEC 60601-2-24:2012 Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers
ISO 407:2004 Small medical gas cylinders Pin-index yoke-type valve connections
ISO 23328-1:2003 Breathing system filters for anaesthetic and respiratory use — Part 1: Salt test method to assess filtration performance
ISO 7137:1995 Aircraft — Environmental conditions and test procedures for airborne equipment
EN ISO 9170-2:2008 Terminal units for medical gas pipeline systems - Part 2: Terminal units for anaesthetic gas scavenging systems (ISO 9170-2:2008)
ISO 9360-1:2000 Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for humidifying respired gases in humans — Part 1: HMEs for use with minimum tidal volumes of 250 ml
EN 1789:2007+A2:2014 Medical vehicles and their equipment - Road ambulances
EN 14605:2005+A1:2009 Protective clothing against liquid chemicals - performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only (Types PB [3] and PB [4])
ISO 5361:2016 Anaesthetic and respiratory equipment — Tracheal tubes and connectors
ISO 9170-1:2017 Terminal units for medical gas pipeline systems — Part 1: Terminal units for use with compressed medical gases and vacuum
EN ISO 9170-1:2008 Terminal units for medical gas pipeline systems - Part 1: Terminal units for use with compressed medical gases and vacuum (ISO 9170-1:2008)
EN ISO 7396-2:2007 Medical gas pipeline systems - Part 2: Anaesthetic gas scavenging disposal systems (ISO 7396-2:2007)
EN 60601-2-12:2006 Medical electrical equipment - Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators
EN ISO 80601-2-56:2017 Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (ISO 80601-2-56:2017)
EN ISO 10524-2:2006 Pressure regulators for use with medical gases - Part 2: Manifold and line pressure regulators (ISO 10524-2:2005)
EN 13976-1:2011 Rescue systems - Transportation of incubators - Part 1: Interface conditions
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)
ISO 10524-1:2006 Pressure regulators for use with medical gases Part 1: Pressure regulators and pressure regulators with flow-metering devices
IEC 60601-2-12:2001 Medical electrical equipment - Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators
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)
96/98/EC : 1996 COR 3 2015 COUNCIL DIRECTIVE 96/98/EC OF 20 DECEMBER 1996 ON MARINE EQUIPMENT
ISO 6009:2016 Hypodermic needles for single use Colour coding for identification
EN 1707:1996 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Lock fittings
ISO 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements
ISO 10555-5:2013 Intravascular catheters — Sterile and single-use catheters — Part 5: Over-needle peripheral catheters
EN ISO 23328-1:2008 Breathing system filters for anaesthetic and respiratory use - Part 1: Salt test method to assess filtration performance (ISO 23328-1:2003)
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
ISO 10524-2:2005 Pressure regulators for use with medical gases Part 2: Manifold and line pressure regulators
ISO 7396-1:2016 Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum

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