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Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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Superseded date
04-08-2020
Superseded by
Published date
03-18-2015
Publisher
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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Superseded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 |
| Standards | Relationship |
| NF EN 13718-2 : 2017 | Identical |
| NBN EN 13718-2 : 2015 | Identical |
| NEN EN 13718-2 : 2015 | Identical |
| NS EN 13718-2 : 2015 | Identical |
| I.S. EN 13718-2:2015 | Identical |
| PN EN 13718-2 : 2015 | Identical |
| SN EN 13718-2 : 2015 | Identical |
| UNI EN 13718-2 : 2008 | Identical |
| UNE-EN 13718-2:2015 | Identical |
| BS EN 13718-2:2015 | Identical |
| DIN EN 13718-2:2015-05 | Identical |
| ONORM EN 13718-2 : 2015 | Identical |
| 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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