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
19-Apr-2020
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
02-Apr-2020
Due Date
07-Jun-2020
Completion Date
20-Apr-2020

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SLOVENSKI STANDARD
SIST EN 13718-1:2015+A1:2020
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
SIST EN 13718-1:2015+A1:2020 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN 13718-1:2015+A1:2020
---------------------- Page: 2 ----------------------
SIST EN 13718-1:2015+A1:2020
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.
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SIST EN 13718-1:2015+A1:2020
EN 13718-1:2014+A1:2020 (E)
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

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SIST EN 13718-1:2015+A1:2020
EN 13718-1:2014+A1:2020 (E)
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.
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SIST EN 13718-1:2015+A1:2020
EN 13718-1:2014+A1:2020 (E)

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.
---------------------- Page: 6 ----------------------
SIST EN 13718-1:2015+A1:2020
EN 13718-1:2014+A1:2020 (E)
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.
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SIST EN 13718-1:2015+A1:2020
EN 13718-1:2014+A1:2020 (E)
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"
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SIST EN 13718-1:2015+A1:2020
EN 13718-1:2014+A1:2020 (E)
!ISO 7000:2014, Graphical symbols for use on equipment — Registered symbols"

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
(202) 833-9339
http://www.rtca.org/

It is available on the RTCA store: http://www.rtca.org/store_product.asp?prodid=770.

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SIST EN 13718-1:2015+A1:2020
EN 13718-1:2014+A1:2020 (E)

[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.
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SIST EN 13718-1:2015+A1:2020
EN 13718-1:2014+A1:2020 (E)

4.4 Environmental conditions and performance of medical devices intended for use i

...

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