EN 13718-2:2015+A1:2020

Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances

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).

Medizinische Fahrzeuge und ihre Ausrüstung - Luftfahrzeuge zum Patiententransport - Teil 2: Operationelle und technische Anforderungen an Luftfahrzeuge zum Patiententransport

Dieser Teil von EN 13718 legt die Anforderungen an die Leistung und Ausrüstung von Luftfahrzeugen zum Patiententransport fest, die für den Transport und die Behandlung kranker oder verletzter Personen eingesetzt werden; dies schließt Anforderungen an die Schnittstellen mit den Medizinprodukten (Geräten) ein. Dieser Teil von EN 13718 ist für Luftfahrzeuge zum Patiententransport anwendbar, die in der Lage sind, mindestens eine Person auf einer Krankentrage zu transportieren.
ANMERKUNG Die Anforderungen für Kategorien von Luftfahrzeugen zum Patiententransport werden auf der Grundlage der verschiedenen vorgesehenen Verwendungszwecke festgelegt. Bei diesen Kategorien handelt es sich um Rettungstransporthubschrauber (RTH) (en: helicopter emergency medical service (HEMS)), intensivmedizinische Hubschrauber (ITH) (en: helicopter intensive care medical service (HICAMS)) und Flächenflugzeuge zum Patiententransport (en: fixed wing air ambulance (FWAA)).

Véhicules sanitaires et leurs équipements - Ambulances aériennes - Partie 2 : Exigences opérationnelles et techniques pour les ambulances aérienness

N/A

Ambulantna vozila in njihova oprema - Ambulantna zračna vozila - 2. del: Operativne in tehnične zahteve za ambulantna zračna vozila

General Information

• Status: Published
• Publication Date: 24-Mar-2020
• Withdrawal Date: 29-Sep-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: 9060 - Closure of 2 Year Review Enquiry - Review Enquiry
• Start Date: 02-Dec-2021
• Completion Date: 02-Dec-2021
• 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 13718-2:2015+A1:2020 - Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances

Relations

• Merged From: EN 13718-2:2015/FprA1 - Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances
• Effective Date: 19-Jan-2023
• Merged From: EN 13718-2:2015 - Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances
• Effective Date: 09-Jan-2019

Standards Content (Sample)

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

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.

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
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
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 th
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