EN 13718-1:2014+A1:2020

Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances

This European Standard specifies general requirements for medical devices carried in air ambulances and used therein and outside hospitals and clinics in situations where the ambient conditions can differ from normal indoor conditions. 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.

Medizinische Fahrzeuge und ihre Ausrüstung - Luftfahrzeuge zum Patiententransport - Teil 1: Anforderungen an medizinische Geräte, die in Luftfahrzeugen zum Patiententransport verwendet werden

Diese Europäische Norm legt allgemein gültige Leistungsanforderungen an Medizinprodukte (Geräte) fest, die in Luftfahrzeugen zum Patiententransport mitgeführt und in diesen sowie außerhalb von Krankenhäusern und Kliniken in Situationen verwendet werden, in denen die Umgebungsbedingungen von den normalen Bedingungen in Gebäuden abweichen können.
Diese Europäische Norm enthält keine Anforderungen zur Abnahme und Registrierung von den Luftfahrzeugen und an die Ausbildung des Personals, die in der Zuständigkeit der Behörde(n) des Landes liegt, in dem das Luftfahrzeug registriert ist.

Véhicules sanitaires et leurs équipements - Ambulances aériennes - Partie 1 : Exigences pour les dispositifs médicaux utilisés dans les ambulances aériennes

Ambulantna vozila in njihova oprema - Ambulantna zračna vozila - 1. del: Zahteve za medicinsko opremo, ki se uporablja v ambulantnih zračnih vozilih

General Information

• Status: Published
• Publication Date: 24-Mar-2020
• Withdrawal Date: 30-Oct-2020
• ICS: 11.040.01 - Medical equipment in general
• ICS: 11.160 - First aid
• ICS: 49.020 - Aircraft and space vehicles in general
• Technical Committee: CEN/TC 239 - Rescue systems
• Drafting Committee: CEN/TC 239 - Rescue systems
• Current Stage: 9092 - Decision on results of review/2YR ENQ - revise - Review Enquiry
• Start Date: 24-Feb-2025
• Completion Date: 14-Apr-2025
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN 13718-1:2015+A1:2020 - Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances

Relations

• Merged From: EN 13718-1:2014 - Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances
• Effective Date: 18-Jan-2023
• Merged From: EN 13718-1:2014/FprA1 - Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances
• Effective Date: 09-Jan-2019

Overview

EN 13718-1:2014+A1:2020 is a CEN European Standard that sets general requirements for medical devices carried and used in air ambulances. It defines minimum requirements for interfaces, interoperability and device performance where ambient conditions differ from normal clinical environments - for example during flight, vibration, variable atmospheric pressure, temperature and humidity changes. The standard supplements other medical-device standards and supports conformity with the Medical Devices Directive (MDD) through its informative Annex ZA. It does not cover vehicle approval/registration or staff training.

Key topics and requirements

The standard focuses on practical, safety-oriented requirements for equipment used in air ambulances, including:

• Patient and personnel safety - risk management and safety protections consistent with medical device essential requirements.
• User interface and markings - durable markings, colour coding and usable controls under variable conditions.
• Environmental performance - functional temperature ranges, humidity, vibration, shock, free-fall and variable atmospheric pressure considerations for devices used in flight.
• Electrically-powered medical devices - requirements for devices with 12 V DC, 24 V DC and 230 V AC inputs, short-time voltage drops, internal power sources and electromagnetic compatibility.
• Medical gas supply - requirements covering leakage, pressure regulators, flow metering, cylinder valves and low-pressure hose assemblies.
• Mechanical strength and fixation - vibration, bumps, free-fall testing and secure fixation methods for devices inside air ambulances.
• Fire resistance - fire safety expectations for equipment used in aircraft patient compartments.
• Information from manufacturers - documentation, labeling and instructions relevant to air-ambulance use.
• Test methods - defined test conditions and procedures (references include RTCA DO-160G and relevant EN/ISO test standards).

Applications and users

EN 13718-1 is intended for anyone responsible for safe selection, manufacture, procurement or certification of medical equipment used in air ambulance operations:

• Medical device manufacturers designing equipment for pre-hospital and aeromedical use
• Air ambulance operators and clinical teams specifying equipment for rotorcraft and fixed-wing patient transport
• Procurement officers and hospital transport services integrating devices for inter-facility transfer
• Regulators and conformity assessors evaluating device suitability under airborne environmental conditions

Practical benefits include improved interoperability, reduced in-flight device failures, clearer user information and safer patient care during aeromedical transport.

Related standards

• EN 13718-2 (Air ambulance operational and technical requirements)
• EN 60601-1 (medical electrical equipment - basic safety)
• EN ISO 14971 (risk management for medical devices)
• RTCA DO-160G (environmental conditions for airborne equipment)
• EN/ISO standards for medical gas fittings, regulators and hose assemblies

Keywords: EN 13718-1:2014+A1:2020, air ambulances, medical devices, CEN, interoperability, environmental testing, medical gas, electrically-powered devices, fixation, fire resistance.

Standards Content (Sample)

SLOVENSKI STANDARD
01-maj-2020
Nadomešča:
SIST EN 13718-1:2015
Ambulantna vozila in njihova oprema - Ambulantna zračna vozila - 1. del: Zahteve
za medicinsko opremo, ki se uporablja v ambulantnih zračnih vozilih
Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for
medical devices used in air ambulances
Medizinische Fahrzeuge und ihre Ausrüstung - Luftfahrzeuge zum Patiententransport -
Teil 1: Anforderungen an medizinische Geräte, die in Luftfahrzeugen zum
Patiententransport verwendet werden
Véhicules sanitaires et leurs équipements - Ambulances aériennes - Partie 1 : Exigences
pour les dispositifs médicaux utilisés dans les ambulances aériennes
Ta slovenski standard je istoveten z: EN 13718-1:2014+A1:2020
ICS:
11.160 Prva pomoč First aid
49.020 Letala in vesoljska vozila na Aircraft and space vehicles in
splošno general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN 13718-1:2014+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 1: Requirements for medical devices used in air
ambulances
Véhicules sanitaires et leur équipement - Ambulances Medizinische Fahrzeuge und ihre Ausrüstung -
aériennes - Partie 1: Exigences pour les dispositifs Luftfahrzeuge zum Patiententransport - Teil 1:
médicaux utilisés dans les ambulances aériennes Anforderungen an medizinische Geräte, die in
Luftfahrzeugen zum Patiententransport verwendet
werden
This European Standard was approved by CEN on 25 July 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 13718-1:2014+A1:2020 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
Introduction . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 7
4 Requirements for medical devices for air ambulances . 8
4.1 General . 8
4.2 Patient and personnel safety . 8
4.3 User interface . 8
4.4 Environmental conditions and performance of medical devices intended for use in
air ambulances . 9
4.4.1 Functional temperature range . 9
4.4.2 Humidity . 9
4.4.3 Variable atmospheric pressures . 9
4.5 Electrically-powered medical devices . 9
4.5.1 General . 9
4.5.2 Medical devices with 12 V DC power input . 10
4.5.3 Medical devices with 24 V DC power input . 10
4.5.4 Medical devices with 230 V AC power input . 10
4.5.5 Short time voltage drop . 10
4.5.6 Internal electrical power source . 10
4.5.7 Electromagnetic interference of medical devices . 10
4.6 Medical gas supply . 10
4.6.1 General . 10
4.6.2 Gas leakage . 11
4.6.3 Pressure regulators and flow metering devices . 11
4.6.4 Pneumatic power . 11
4.6.5 Cylinder valves . 11
4.6.6 Low pressure hose assemblies . 11
4.7 Mechanical strength . 11
4.7.1 General . 11
4.7.2 Vibration and bump . 11
4.7.3 Free fall . 11
4.8 Fixation of medical devices in air ambulances . 12
4.9 Fire resistance . 12
4.10 Information to be supplied by the manufacturer . 12
5 Test methods . 12
5.1 General . 12
5.2 Ambient conditions . 12
5.3 Test method for durability of markings and colour coding . 13
5.4 Free fall . 13
Annex ZA (informative) !Relationship between this European standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered . 14
Bibliography . 15
European foreword
This document (EN 13718-1:2014+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 October 2020, and conflicting national standards shall
be withdrawn at the latest by October 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 13718-1:2014."
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, see informative Annex ZA, which is an integral part of this
document.
EN 13718-1:2008 has been technically revised. The following points represent the most important
changes in the revision:
a) normative references were updated;
b) the following terms and definitions were deleted: 3.3 "HEMS flight", 3.4 "air ambulance flight", 3.5
"non-dedicated aircraft for patient transportation", 3.6 "HICAMS flight", 3.7 "fixed wing air
ambulance", 3.10 "interchangeability", 3.11 "flight crew", 3.12 "medical crew";
c) a new Subclause 4.5.4 "Medical devices with 230 V AC power input" was introduced;
d) Subclause 4.4.5 "Inverters" was deleted;
e) Subclause 4.5.4 "Pneumatic power supply" (now Subclause 4.6.4) was revised;
f) Subclause 4.8 "Fire resistance" (now Subclause 4.9) was revised;
g) unclear issues were clarified in this part of the standard and between the two parts of the standard
(requirements for patient's compartment illumination, respectively);
h) the standard was 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 ambulances:
— 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.
Introduction
This part of EN 13718 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 from
the Medical Devices Directive (see Bibliography and Annex ZA).
This part of EN 13718 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 that are set are carefully selected to
ensure interoperability and continuous patient care.
The medical devices are being used by the services in air ambulances. Air ambulances carry medical
devices as well as medicinal products and rescue equipment to be used by medical personnel.
The medical devices need to conform to the applicable essential requirements in the Medical Devices
Directive. The essential requirements are listed in Annex I of the Medical Devices Directive (MDD).
Annex ZA lists the essential requirements that are addressed 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.
1 Scope
This European Standard specifies general requirements for medical devices carried in air ambulances
and used therein and outside hospitals and clinics in situations where the ambient conditions can differ
from normal indoor conditions.
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.
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."
!Deleted text"
!EN 13718-2:2015+A1:2020, Medical vehicles and their equipment — Air ambulances — Part 2:
Operational and technical requirements of air ambulances"
EN 60068-2-31:2008, Environmental testing - Part 2-31: Tests - Test Ec: Rough handling shocks, primarily
for equipment-type specimens
!EN 60529:1991/A2:2013, Degrees of protection provided by enclosures (IP Code) (IEC
60529:1989/A2:2013)"
!EN 60601-1:2006+Cor.:2010+A1:2013, Medical electrical equipment — Part 1: General requirements
for basic safety and essential performance (IEC 60601-1:2005+ Cor.:2006 + Cor.:2007 + A1:2012)"
EN ISO 407:2004, Small medical gas cylinders - Pin-index yoke-type valve connections (ISO 407:2004)
!EN ISO 5359:2014+A1:2017, Anaesthetic and respiratory equipment — Low-pressure hose
assemblies for use with medical gases (ISO 5359:2014+Amd 1:2017)"
!EN ISO 10297:2014+A1:2017, Gas cylinders — Cylinder valves — Specification and type testing
(ISO 10297:2014, Corrected Version 2014-11-01 + Amd.1:2017)"
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 10524-3:2006+Amd 1:2013, Pressure regulators for use with medical gases — Part 3:
Pressure regulators integrated with cylinder valves (ISO 10524-3:2005+A1:2013)"
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)
!Deleted text"
!ISO 7000:2014, Graphical symbols for use on equipment — Registered symbols"
1)
RTCA DO-160G:2010, Environmental Conditions and Test Procedures for Airborne Equipment
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
!ISO and IEC maintain terminological databases for use in standardization at the following addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp"
3.1
air ambulance
aircraft designed to be normally staffed by two medical personnel equipped and intended for the
transportation of at least one stretcher patient who will receive medical treatment during transport
3.2
interface
means or place of interaction between one or more of the medical devices, the ambient conditions, the
user, the patient, and when relevant, the various kinds of ambulances
3.3
interoperability
facility to connect various medical devices that are fixed to patients into connections of associated
medical devices including the possibility of connecting powered medical devices to various kinds of
ambulances
3.4
medical device
instrument, apparatus, appliance, material or other article, whether used alone or in combination,
including the software necessary for its proper application, intended by the manufacturer to be used for
human beings for the purpose of diagnosis, prevention, monitoring, treatment or alleviation of disease
and injury
3.5
portable
term referring to transportable equipment that, once installed and placed into service, is intended to be
moved from one location to another while being carried by one or more persons
Note 1 to entry: Equipment can refer to accessories or equipment parts.
Note 2 to entry: See the taxonomy in the rationale for Definition 3.63 in EN 60601-1:2006/A1:2013.

1) This document is a material copyrighted by RTCA, Inc. and used with permission:
RTCA, Inc.
1150 18th Street NW
Suite 910
Washington, DC 20036
[phone]
http://www.rtca.org/
It is available on the RTCA store: http://www.rtca.org/store_product.asp?prodid=770.
[SOURCE: EN 60601-1:2006/A1:2013, 3.85, modified — The wording of Note 2 to entry has been
slightly modified.]
4 Requirements for medical devices for air ambulances
4.1 General
The manufacturers of all medical devices intended to be used in air ambulances shall ensure that the
requirements of this standard are met.
4.2 Patient and personnel safety
Risks associated with medical devices shall be minimized, using risk management process in
accordance with EN ISO 14971:2012, taking account of the intended application of the devices and of
known and foreseeable hazards in both normal and fault conditions. When risk analyses are performed,
they shall reflect storage, installation, operation in normal use and maintenance according to the
instructions of the manufacturer and the ambient conditions of an air ambulance.
4.3 User interface
The user interface of the medical device shall be easy to use in an air ambulance.
NOTE 1 See !EN 62366-1:2015" and EN 60601–1–6:2010 for detailed information on how to design an
easy to use medical device.
A medical device designated as portable shall be:
— able to be carried inside and outside the aircraft;
— able to be carried by one person.
NOTE 2 See Directive 90/269/EEC for information.
The manufacturer of the medical device shall carry out a risk assessment of the manual handling of the
medical device inside and outside of an air ambulance.
NOTE 3 There are several accepted risk assessments methods to use e.g. Key Item Method (KIM), Manual
Handling Assessment Charts and EN 1005–2:2003+A1:2008.
Buttons, switches, indicators, controls etc. shall be accessible and readable under the intended
operational conditions.
NOTE 4 Intended operational conditions are described as requirements in !EN 13718-2:2015+A1:2020."
Medical devices with alarms and signals shall provide a clear visual signal under the intended
operational conditions.
!Deleted text"
Markings shall remain legible following the test in 5.3.
4.4 Environmental conditions and performance of medical devices intended for use i
...