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: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 25-Mar-2020
• Completion Date: 25-Mar-2020
• 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

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 particula
...