SIST EN 13718-2:2015+A1:2020

SLOVENSKI STANDARD
SIST EN 13718-2:2015+A1:2020
01-maj-2020
Nadomešča:
SIST EN 13718-2:2015
Ambulantna vozila in njihova oprema - Ambulantna zračna vozila - 2. del:
Operativne in tehnične zahteve za ambulantna zračna vozila
Medical vehicles and their equipment - Air ambulances - Part 2: Operational and
technical requirements for air ambulances
Medizinische Fahrzeuge und ihre Ausrüstung - Luftfahrzeuge zum Patiententransport -
Teil 2: Operationelle und technische Anforderungen an Luftfahrzeuge zum
Patiententransport
Véhicules sanitaires et leurs équipements - Ambulances aériennes - Partie 2 : Exigences
opérationnelles et techniques pour les ambulances aérienness
Ta slovenski standard je istoveten z: EN 13718-2:2015+A1:2020
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
11.160 Prva pomoč First aid
49.020 Letala in vesoljska vozila na Aircraft and space vehicles in
splošno general
SIST EN 13718-2:2015+A1:2020 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 13718-2:2015+A1:2020

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SIST EN 13718-2:2015+A1:2020


EN 13718-2:2015+A1
EUROPEAN STANDARD

NORME EUROPÉENNE

March 2020
EUROPÄISCHE NORM
ICS 11.040.01; 11.160; 49.020
English Version

Medical vehicles and their equipment - Air ambulances -
Part 2: Operational and technical requirements for air
ambulances
Véhicules sanitaires et leur équipement - Ambulances Medizinische Fahrzeuge und ihre Ausrüstung -
aériennes - Partie 2 : Exigences opérationnelles et Luftfahrzeuge zum Patiententransport - Teil 2:
techniques pour les ambulances aériennes Operationelle und technische Anforderungen an
Luftfahrzeuge zum Patiententransport
This European Standard was approved by CEN on 26 December 2014 and includes Amendment 1 approved by CEN on 16
December 2019.

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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, 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: Rue de la Science 23, B-1040 Brussels
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 13718-2:2015+A1:2020 E
worldwide for CEN national Members.

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SIST EN 13718-2:2015+A1:2020
EN 13718-2:2015+A1:2020 (E)
Contents Page
European foreword . 4
Introduction . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 10
4 General requirements for air ambulances . 11
4.1 General . 11
4.2 Environmental conditions in the patient compartment . 12
4.2.1 Temperature and humidity . 12
4.2.2 Air conditioning system (ACS) . 12
4.2.3 Variable atmospheric pressure . 12
4.2.4 Interior light. 12
4.2.5 Ventilation . 12
4.2.6 Noise exposure . 13
4.3 Requirements for electrical power supply for medical devices in the patient
compartment . 13
4.4 Electromagnetic interference . 14
4.5 Rail systems . 14
4.6 Mechanical vibration . 14
4.7 Requirements for fixation of medical devices . 14
4.8 Restraint systems in the patient compartment . 14
4.9 Patient compartment . 15
4.9.1 General . 15
4.9.2 Hygienic . 15
4.9.3 Patient loading and unloading . 15
4.9.4 Communication systems . 16
4.9.5 Fire safety requirements . 16
4.9.6 Emergency exit . 16
4.10 Patient treatment area . 16
4.10.1 General . 16
4.10.2 Dimensions . 16
4.11 Lists of equipment. 18
5 Air ambulances, operation and performance requirements . 19
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SIST EN 13718-2:2015+A1:2020
EN 13718-2:2015+A1:2020 (E)
5.1 Personnel . 19
5.1.1 Flight crew . 19
5.1.2 Medical crew . 19
5.2 Specific requirements for helicopters operated in Helicopter Emergency Medical
Service (HEMS) . 19
5.3 Specific requirements for Helicopter Intensive Care Medical Service (HICAMS) . 19
5.4 Specific requirements for Fixed Wing Air Ambulances (FWAA) . 20
6 Gas installations in air ambulances . 20
6.1 System components . 20
6.2 General requirements . 20
6.2.1 Capacity and pressure operating range. 20
6.2.2 Continuity of supply . 21
6.3 Supply systems with gas cylinders . 21
6.4 Supply systems for compressed medical air . 21
6.5 Supply systems with air compressor . 22
6.6 Pipeline distribution system . 22
6.7 Marking and colour coding . 23
6.8 Alarms . 23
6.9 Testing . 23
6.9.1 General . 23
6.9.2 Test for mechanical integrity for compressed medical gas systems . 23
6.9.3 Test for leakage on all pipeline systems and for mechanical integrity of vacuum
pipeline systems . 24
6.9.4 Leakage from the compressed medical gas pipelines . 24
6.9.5 Test for cross connection . 24
6.10 Maintenance . 24
Annex A (normative) Medical devices in air ambulances . 25
A.1 Introduction. 25
A.2 Additional equipment . Error! Bookmark not defined.
Annex B (normative) Medicinal products and equipment additional to medical devices in
air ambulances . 31
B.1 Introduction. 31
Annex C (informative) A–deviations . 34
C.1 Deviation in Germany . 34
C.1.1 Additional specifications for the medical crew . 34
Annex ZA (informative) !Relationship between this European standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered . 35
Bibliography . 37
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SIST EN 13718-2:2015+A1:2020
EN 13718-2:2015+A1:2020 (E)
European foreword
This document (EN 13718-2:2015+A1:2020) 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 September 2020, and conflicting national standards
shall be withdrawn at the latest by September 2020.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document includes Amendment 1 approved by CEN on 2019-12-16.
This document supersedes !EN 13718-2:2015."
The start and finish of text introduced or altered by amendment is indicated in the text by tags !".
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.
EN 13718-2:2008 has been technically revised. The following points represent the most important
changes in the revision:
a) clarified unclear issues in this part of the standard and between the two parts of the standard (for
example requirements for patient's compartment illumination);
b) changed text related to enhancing safety related to the risk from rotors on helicopters;
c) clarified the requirements for the patient compartment;
d) the standard has been modified/integrated to meet the Medical Devices Directive 93/42/EEC
requirements.
EN 13718 consists of the following parts, under the general title: Medical vehicles and their equipment –
Air ambulance:
— Part 1: Requirements for medical devices used in air ambulances;
— Part 2: Operational and technical requirements for air ambulances.
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, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United
Kingdom.
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SIST EN 13718-2:2015+A1:2020
EN 13718-2:2015+A1:2020 (E)
Introduction
This part of EN 13718 provides requirements for air ambulances, and in particular covers requirements
for the ambulance role of the aircraft.
Air ambulances are equipped with medical devices as well as drugs and rescue equipment to be used by
medical personnel. Requirements for medical devices intended for use in air ambulances are provided
in EN 13718-1. This standard is supplementary to several European Standards as well as laws and
regulations providing the requirements for aircraft in order to provide continuous patient care and
monitoring during transport in and between various ambulance types and hospitals. The requirements
cover ambulance flights in general. Several national and regional rules and regulations apply to aircraft
being used as ambulances. This part of EN 13718 gives information on these in the annexes and in notes
throughout the text. Provisions for the safety and care both of the patient as well as of the crew and the
medical personnel are contained in existing national and international laws, regulations and guidelines.
This part of EN 13718 provides some general requirements for the safe operation of aircraft being used
as ambulances. These requirements are not covered by the scope of the Medical Devices Directive or by
international agreements for craft, transportation and traffic. They are provided in order to secure the
safe and secure handling of patients. In order to accommodate continuity of patient care between
different kinds of ambulances, some specific requirements are given. Requirements are set in order to
secure safe use and handling of medical devices.
Aircraft being used as ambulances are equipped with medical devices, medicinal products and rescue
equipment to enable the medical personnel to provide continuous patient care. The minima for the
medical devices are specified in Annex A. The requirements set out in this part of EN 13718 give the
minimum provisions for an ambulance service to provide satisfactory care and medical attention to
emergency patients as well as other patients during transportation. The requirements are based on the
state of the art of today and common practice in Europe.
This European Standard gives minimum requirements for interfaces and compatibility of medical
devices used in air ambulances. The standards work was called for by the EU Commission by a mandate
linked with the Medical Devices Directive (see Annex ZA and Bibliography [1]).
This European Standard is supplementary to several other European Standards and gives requirements
for medical devices when used in situations where the ambient conditions differ from the normal
indoor conditions prevailing within the health care system. Several specific requirements are related to
the conditions prevailing in air ambulances. The requirements set are carefully selected to ensure
interoperability and continuous patient care.
Medical devices need to conform to the applicable essential requirements in the Medical Devices
Directive, 93/42/EEC. The essential requirements are listed in Annex I of the Medical Devices Directive.
Annex ZA in this European Standard lists the essential requirements that are covered by the identified
clauses of this European Standard.
The environmental conditions for medical devices used in air ambulances are different from those
expected in a normal hospital environment. In particular, this implies environmental conditions such as
temperature and humidity, vibration and shock caused by movement of the air ambulances, variable
atmospheric pressures and electromagnetic disturbances between the air ambulances and the medical
device.
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SIST EN 13718-2:2015+A1:2020
EN 13718-2:2015+A1:2020 (E)
1 Scope
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.
NOTE Requirements 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).
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.
EN 3-7:2004+A1:2007, Portable fire extinguishers — Part 7: Characteristics, performance requirements
and test methods
EN 3-8:2006, Portable fire extinguishers — Part 8: Additional requirements to EN 3-7 for the construction,
resistance to pressure and mechanical tests for extinguishers with a maximum allowable pressure equal to
or lower than 30 bar
!EN 3-9:2006+AC:2007, Portable fire extinguishers — Part 9: Additional requirements to EN 3-7 for
pressure resistance of CO2 extinguishers"
EN 3-10:2009, Portable fire extinguishers — Part 10: Provisions for evaluating the conformity of a
portable fire extinguisher to EN 3-7
!EN 143:2000+A1:2017, Respiratory protective devices — Particle filters — Requirements, testing,
marking (Corrigendum AC:2002 and AC:2005 incorporated)"
!EN ISO 374-1:2016+A1:2018, Protective gloves against dangerous chemicals and micro-organisms —
Part 1: Terminology and performance requirements for chemical risks (ISO 374-1:2016+A1:2018)"
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 455-3:2015, Medical gloves for single use — Part 3: Requirements and testing for biological
evaluation"
EN 794-3:1998+A2:2009, Lung ventilators — Part 3: Particular requirements for emergency and
transport ventilators
EN 1618:1997, Catheters other than intravascular catheters — Test methods for common properties
!Deleted tex"t"
!EN 1865-1:2010+A1:2015, Patient handling equipment used in road ambulances — Part 1: General
stretcher systems and patient handling equipment"
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SIST EN 13718-2:2015+A1:2020
EN 13718-2:2015+A1:2020 (E)
!EN 13718-1:2014+A1:2020, Medical vehicles and their equipment — Air ambulances — Part 1:
Requirements for medical devices used in air ambulances"
!EN 13976-1:2018, Rescue systems — Transportation of incubators — Part 1: Interface conditions"
!EN 13976-2:2018, Rescue systems — Transportation of incubators — Part 2: System requirements"
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])
!Deleted text"
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)
!Deleted text"
!EN 60601-2-24:2015, Medical electrical equipment — Part 2-24: Particular requirements for basic
safety and essential performance of infusion pumps and controllers (IEC 60601-2-24:2012)"
!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
(IEC 60601-2-34:2011)"
!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 + Corrigendum Jan. 2010 + A1:2013)"
!EN ISO 5356-1:2015, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones
and sockets (ISO 5356-1:2015)"
!EN ISO 5359:2014+A1:2017, Anaesthetic and respiratory equipment — Low-pressure hose assemblies
for use with medical gases (ISO 5359:2014+Amd1:2017)"
!EN ISO 5361:2016, Anaesthetic and respiratory equipment — Tracheal tubes and connectors
(ISO 5361:2016)"
!EN ISO 5364:2016, Anaesthetic and respiratory equipment — Oropharyngeal airways
(ISO 5364:2016)"
!EN ISO 5366:2016, Anaesthetic and respiratory equipment — Tracheostomy tubes and connectors
(ISO 5366:2016)"
EN ISO 5367:2014, Anaesthetic and respiratory equipment — Breathing sets and connectors
(ISO 5367:2014)
!EN ISO 6009:2016, Hypodermic needles for single use — Colour coding for identification
(ISO 6009:2016)"
EN ISO 7376:2009, Anaesthetic and respiratory equipment — Laryngoscopes for tracheal intubation
(ISO 7376:2009)
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SIST EN 13718-2:2015+A1:2020
EN 13718-2:2015+A1:2020 (E)
!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 7396-2:2007, Medical gas pipeline systems — Part 2: Anaesthetic gas scavenging disposal systems
(ISO 7396-2:2007)
!EN ISO 7864:2016, Sterile hypodermic needles for single use — Requirements and test methods
(ISO 7864:2016)"
!EN ISO 7886-1:2018, Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
(ISO 7886 1:2017)"
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 ISO 8537:2016, Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2016)"
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 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 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)
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 ISO 10524-2:2006, Pressure regulators for use with medical gases — Part 2: Manifold and line
pressure regulators (ISO 10524-2:2005)
!EN ISO 10524-3:2006+A1:2013, Pressure regulators for use with medical gases — Part 3: Pressure
regulators integrated with cylinder valves (ISO 10524-3:2005+Amd1:2013)"
EN ISO 10524-4:2008, Pressure regulators for use with medical gases — Part 4: Low-pressure regulators
(ISO 10524-4:2008)
!EN ISO 10555-1:2013+A1:2017, Intravascular catheters — Sterile and single-use catheters — Part 1:
General requirements (ISO 10555-1:2013+Amd1:2017)"
EN ISO 10555-3:2013, Intravascular catheters — Sterile and single-use catheters — Part 3: Central
venous catheters (ISO 10555-3:2013)
EN ISO 10555-5:2013, Intravascular catheters — Sterile and single-use catheters — Part 5: Over-needle
peripheral catheters (ISO 10555-5:2013)
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SIST EN 13718-2:2015+A1:2020
EN 13718-2:2015+A1:2020 (E)
!EN ISO 11070:2014+A1:2018, Sterile single-use intravascular introducers, dilators and guidewires
(ISO 11070:2014+Amd1:2018)"
EN ISO 13688:2013, Protective clothing — General requirements (ISO 13688:2013)
EN ISO 15002:2008, Flow-metering devices for connection to terminal units of medical gas pipeline
systems (ISO 15002:2008)
EN ISO 18777:2009, Transportable liquid oxygen systems for medical use — Particular requirements
(ISO 18777:2005)
!EN ISO 19054:2006+A1:2016, Rail systems for supporting medical equipment
(ISO 19054:2005+Amd1:2016)"
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 ISO 23328-2:2009, Breathing system filters for anaesthetic and respiratory use — Part 2: Non-
filtration aspects (ISO 23328-2:2002)
!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)"
!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
(IS
...