EN 13718-2:2015/FprA1

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

Véhicules sanitaires et leur équipement - Ambulances aériennes - Partie 2 : Exigences opérationnelles et techniques pour les ambulances aériennes

N/A

Ambulantna vozila in njihova oprema - Ambulantna zračna vozila - 2. del: Operativne in tehnične zahteve za ambulantna zračna vozila - Dopolnilo A1

General Information

• Status: Not Published
• Publication Date: 16-Feb-2020
• Withdrawal Date: 16-Aug-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/WG 5 - Air, water and difficult terrain ambulances
• Current Stage: 6055 - CEN Ratification completed (DOR) - Publishing
• Start Date: 15-Dec-2019
• Completion Date: 15-Dec-2019
• Directive: Not Harmonized93/42/EEC - 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/oprA1:2018 - Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances

Relations

• Merged Into: EN 13718-2:2015+A1:2020 - Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances
• Effective Date: 19-Jan-2023
• Amends: EN 13718-2:2015 - Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances
• Effective Date: 06-Apr-2016

Overview

EN 13718-2:2015/FprA1 is a European standard developed by CEN that defines operational and technical requirements for air ambulances and their equipment. This standard is specifically applicable to air ambulances capable of transporting at least one patient on a stretcher, and it addresses performance, equipment, and interfaces with medical devices essential for safe patient transport and care during air transfers. The requirements are tailored for different categories of air ambulances, including helicopter emergency medical services (HEMS), helicopter intensive care medical services (HICAMS), and fixed-wing air ambulances (FWAA).

Adhering to EN 13718-2 ensures that air ambulances are equipped and operated to the highest safety and medical care standards, supporting compliance with EU medical device directives and enhancing patient outcomes in critical care situations.

Key Topics

• Operational Requirements: Clear criteria for air ambulance operations, including crew responsibilities, protocols, and compliance with safety standards and critical medical care procedures.
• Technical Requirements: Specifications for essential features such as electrical outlets, patient handling systems, and interfaces with medical devices. Includes requirements for integrating systems like incubators and ensuring essential power and gas supply.
• Medical Device Compatibility: Guidelines for interfaces and interconnectivity with stretchers, ventilators, incubators, and medical monitoring equipment to facilitate seamless use of certified devices between road and air transport.
• Safety and Risk Management: Measures to reduce risks associated with air ambulance environments, such as fire, explosion, environmental hazards, and physical injury.
• Harmonization with Directives: Alignment with EU Directive 93/42/EEC concerning medical devices, providing a framework for presumption of conformity and regulatory compliance.
• Best Practices for Equipping: Up-to-date references to related equipment standards, ensuring safety, identification, and maintenance of firefighting equipment, medical gloves, and patient handling systems.

Applications

EN 13718-2:2015/FprA1 finds practical application in multiple areas associated with air ambulance operations:

• Helicopter Emergency Medical Service (HEMS): Emergency responses and rapid patient transport from remote or hard-to-reach locations to specialized care centers.
• Helicopter Intensive Care Medical Service (HICAMS): Transport of critically ill patients requiring advanced medical interventions and intensive monitoring en route.
• Fixed-Wing Air Ambulance (FWAA): Long-distance or international patient transfers where travel by road is not feasible.
• Medical Device Manufacturers: Ensuring that manufactured devices and equipment interfaces conform to recognized standards for compatibility and safety within air ambulances.
• Regulatory and Compliance Departments: Supporting medical and aviation organizations in demonstrating conformity with European health and safety directives.
• Emergency Response Planning: Facilitating coordinated integration between ground and air ambulance services for seamless patient transfer and continuity of care.

Related Standards

• EN 1865-1:2010+A1:2015: Patient handling equipment used in road ambulances, particularly general stretcher systems and associated patient transfer equipment.
• EN ISO 5361:2016, EN ISO 5364:2016, EN ISO 5366:2016: Standards for anaesthetic and respiratory equipment used during intensive care and patient transport.
• EN ISO 5356-1:2015, EN ISO 5356-2:2015: Conical connectors for respiratory and anaesthetic equipment.
• EN 3-9:2006/AC:2007: Requirements for fire extinguishers used in air ambulances.
• EN 13976-1:2017: Requirements for transport incubator systems used in neonatal and infant care during air transfers.
• EN ISO 374-1:2016: Standard for protective gloves to safeguard crew and patients against chemicals and microorganisms.
• EN ISO 7864:2016, EN ISO 6009:2016, EN ISO 8537:2016: Requirements for hypodermic needles, syringes, and identification systems used in emergency medical care.

Meeting EN 13718-2:2015/FprA1 requirements helps air ambulance services ensure regulatory compliance, operational readiness, and optimal patient care during high-risk medical transport.

Standards Content (Sample)

SLOVENSKI STANDARD
01-maj-2018
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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 leur équipement - Ambulances aériennes - Partie 2 : Exigences
opérationnelles et techniques pour les ambulances aériennes
Ta slovenski standard je istoveten z: EN 13718-2:2015/prA1
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
11.160 3UYDSRPRþ 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.

DRAFT
EUROPEAN STANDARD
EN 13718-2:2015
NORME EUROPÉENNE
EUROPÄISCHE NORM
prA1
March 2018
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 draft amendment is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee CEN/TC 239.

This draft amendment A1, if approved, will modify the European Standard EN 13718-2:2015. If this draft becomes an
amendment, CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for
inclusion of this amendment into the relevant national standard without any alteration.

This draft amendment was established by CEN 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are
aware and to provide supporting documentation.

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without
notice and shall not be referred to as a European Standard.

EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 13718-2:2015/prA1:2018 E
worldwide for CEN national Members.

EN 13718-2:2015/prA1:2018 (E)
Contents Page
European foreword . 3
1 Modifications to Clause 2, Normative references . 4
2 Modifications to Clause 4, General requirements for air ambulances. 6
3 Modification to Annex A, Medical devices in air ambulances . 6
4 Modification to Annex B, Medicinal products and equipment additional to medical
devices in air ambulances . 7
5 Modification to Annex ZA . 8
6 Modification to Bibliography . 9

EN 13718-2:2015/prA1:2018 (E)
European foreword
This document (EN 13718-2:2015/prA1:2018) has been prepared by Technical Committee CEN/TC 239
“Rescue systems”, the secretariat of which is held by DIN.
This document is currently submitted to the CEN Enquiry.
This document has been prepared under a standardization request given to CEN by the European
Commission and the European Free Trade Association, and supports essential requirements of
EU Directive 93/42/EEC.
For relationship with EU Directives, see informative Annex ZA, which is an integral part of EN 13718-
2:2015.
EN 13718-2:2015/prA1:2018 (E)
1 Modifications to Clause 2, Normative references
Replace
“EN 3-9:2006, Portable fire extinguishers — Part 9: Additional requirements to EN 3-7 for pressure
resistance of CO2 extinguishers”
With
“EN 3-9:2006/AC:2007, Portable fire extinguishers — Part 9: Additional requirements to EN 3-7 for
pressure resistance of CO2 extinguishers”
Replace
“EN 143:2000, Respiratory protective devices — Particle filters — Requirements, testing, marking”
With
“EN 143:2000, Respiratory protective devices — Particle filters — Requirements, testing, marking
(Corrigendum AC:2002 and AC:2005 incorporated)”
Replace
“EN 374-1:2003, Protective gloves against chemicals and micro-organisms — Part 1: Terminology and
performance requirements”
With
“EN ISO 374-1:2016 Protective gloves against dangerous chemicals and micro-organisms - Part 1:
Terminology and performance requirements for chemical risks (ISO 374-1:2016)”
Replace
“EN 1865-1:2010, Patient handling equipment used in road ambulances — Part 1: General stretcher
systems and patient handling equipment”
With
“EN 1865-1:2010+A1:2015, Patient handling equipment used in road ambulances — Part 1: General
stretcher systems and patient handling equipment”
Replace
“EN 20594-1:1993, Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical
equipment — Part 1: General requirements (ISO 594-1:1986)”
With
“EN 20594-1:1993/A1:1997, Conical fittings with a 6% (Luer) taper for syringes, needles and certain
other medical equipment — Part 1: General requirements (ISO 594-1:1986)”
Replace
“EN ISO 5356-1:2004, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and
sockets (ISO 5356-1:2004)”
With
“EN ISO 5356-1:2015, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and
sockets (ISO 5356-1:2015)”
EN 13718-2:2015/prA1:2018 (E)
Replace
“EN ISO 5361:2012, Anaesthetic and respiratory equipment — Tracheal tubes and connectors
(ISO 5361:2012)”
With
“EN ISO 5361:2016, Anaesthetic and respiratory equipment - Tracheal tubes and connectors
(ISO 5361:2016)”
Replace
“EN ISO 5364:2011, Anaesthetic and respiratory equipment — Oropharyngeal airways (ISO 5364:2008)”
With
“EN ISO 5364:2016, Anaestheti
...