EN 13718-1:2014/FprA1
(Amendment)Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances
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
Véhicules sanitaires et leur équipement - 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 - Dopolnilo A1
General Information
- Status
- Not Published
- Publication Date
- 16-Feb-2020
- Withdrawal Date
- 16-Aug-2020
- 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
Relations
- Effective Date
- 09-Jan-2019
- Effective Date
- 28-Jan-2026
- Referred By
EN 16602-70-39:2018 - Space product assurance - Welding of metallic materials for flight hardware - Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 09-Mar-2016
Overview
EN 13718-1:2014/FprA1 is a European Standard developed by CEN that specifies general requirements for medical devices used in air ambulances. The standard ensures that these devices are suitable for deployment in challenging environments, including emergency scenarios outside hospitals and clinics where ambient conditions can differ significantly from standard indoor settings. This standard does not address vehicle approval, registration, or crew training, which remain the responsibility of local authorities.
EN 13718-1:2014/FprA1 provides a harmonized approach for the selection and use of medical devices aboard air ambulances, supporting compliance with European directives and enhancing patient safety in airborne medical transport.
Key Topics
- General Requirements for Medical Devices: Outlines standards for the safety, performance, and reliability of medical equipment in air ambulances.
- Environmental Robustness: Ensures that devices function reliably under varying ambient conditions typical of air transport, such as temperature changes and pressure differences.
- Interface with Other Standards: Requires compatibility with other recognized standards, including those for medical electrical equipment and low-pressure hose assemblies.
- Updated Normative References: Aligns references to the latest editions of core standards (e.g., EN 60601-1 for medical electrical equipment and EN ISO 5359 for hose assemblies).
- Presumption of Conformity: Supports compliance with essential requirements of EU Directive 93/42/EEC concerning medical devices.
- Documentation and Marking: Provides guidelines on device labeling, symbols, and instructions, referencing international standards for clarity and consistency.
- Connection and Safety: Addresses the connection of devices to gas installations and other on-board systems to promote operational safety and effectiveness.
Applications
Implementing EN 13718-1:2014/FprA1 delivers practical value across the air ambulance sector:
- Procurement and Specification: Ensures that purchasing decisions for medical devices used in air ambulances are based on compliance with European harmonized standards.
- Design and Engineering: Guides manufacturers in developing medical equipment that meets the physical and operational demands of air ambulance services.
- Maintenance and Operations: Assists operators in selecting suitable devices for use both inside the aircraft and in field settings, optimizing equipment reliability and crew readiness.
- Regulatory Compliance: Facilitates regulatory approval by conferring presumption of conformity with key European medical device directives (such as Directive 93/42/EEC), streamlining the path to market.
- Patient Safety: Enhances safety for patients undergoing aeromedical transport by ensuring robust, dependable medical devices tailored for unique air ambulance environments.
Related Standards
To provide comprehensive coverage of air ambulance requirements, EN 13718-1:2014/FprA1 references and aligns with several related standards:
- EN 13718-2:2015 - Operational and technical requirements for air ambulances
- EN 60529:1991/A2:2013 - Degrees of protection provided by enclosures (IP Code)
- EN 60601-1:2006 - Medical electrical equipment - Basic safety and essential performance
- EN ISO 5359:2014 - Low-pressure hose assemblies for use with medical gases
- EN ISO 10297:2014 - Transportable gas cylinders - Cylinder valves - Specification and type testing
- ISO 7000:2014 - Graphical symbols for use on equipment
- EN 1789:2007+A2:2014 - Medical vehicles and equipment - Road ambulances
By adhering to EN 13718-1:2014/FprA1 and its connected standards, organizations can ensure that their air ambulance operations meet the highest levels of quality, safety, and regulatory compliance within the European context.
Get Certified
Connect with accredited certification bodies for this standard
BSI Group
BSI (British Standards Institution) is the business standards company that helps organizations make excellence a habit.
TÜV Rheinland
TÜV Rheinland is a leading international provider of technical services.
TÜV SÜD
TÜV SÜD is a trusted partner of choice for safety, security and sustainability solutions.
Sponsored listings
Frequently Asked Questions
EN 13718-1:2014/FprA1 is a draft published by the European Committee for Standardization (CEN). Its full title is "Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances". This standard covers: 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.
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.
EN 13718-1:2014/FprA1 is classified under the following ICS (International Classification for Standards) categories: 11.040.01 - Medical equipment in general; 11.160 - First aid; 49.020 - Aircraft and space vehicles in general. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 13718-1:2014/FprA1 has the following relationships with other standards: It is inter standard links to EN 13718-1:2014+A1:2020, EN ISO 15614-1:2017, EN 16602-70-39:2018, EN ISO 15614-13:2021, EN ISO 15792-2:2020, EN ISO 25239-4:2020, EN ISO 25239-5:2020, EN ISO 11970:2016, EN 13718-1:2014. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 13718-1:2014/FprA1 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC; Standardization Mandates: M/023. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
EN 13718-1:2014/FprA1 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
SLOVENSKI STANDARD
01-maj-2018
$PEXODQWQDYR]LODLQQMLKRYDRSUHPD$PEXODQWQD]UDþQDYR]LODGHO =DKWHYH
]DPHGLFLQVNRRSUHPRNLVHXSRUDEOMDYDPEXODQWQLK]UDþQLKYR]LOLK'RSROQLOR
$
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 leur équipement - Ambulances aériennes - Partie 1: Exigences
pour les dispositifs médicaux utilisés dans les ambulances aériennes
Ta slovenski standard je istoveten z: EN 13718-1:2014/prA1
ICS:
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 13718-1:2014
NORME EUROPÉENNE
EUROPÄISCHE NORM
prA1
March 2018
ICS 11.040.01; 11.160; 49.020 Will supersede
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 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 13718-1:2014. 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 13718-1:2014/prA1:2018 E
worldwide for CEN national Members.
EN 13718-1:2014/prA1:2018 (E)
Contents Page
European foreword . 3
1 Modifications to Clause 2, Normative references . 4
2 Modifications to Clause 4, Requirements for medical devices for air ambulances . 5
3 Modification to Annex ZA . 6
4 Modification to Clause Bibliography . 8
EN 13718-1:2014/prA1:2018 (E)
European foreword
This document (EN 13718-1:2014/prA1:2018) has been prepared by Technical Committee CEN/TC 239
“Resuce 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 Directive, see informative Annex ZA, which is an integral part of EN 13718-
1:2014.
EN 13718-1:2014/prA1:2018 (E)
1 Modifications to Clause 2, Normative references
Replace
“EN 13718-2:2008, Medical vehicles and their equipment — Air ambulances — Part 2: Operational and
technical requirements of air ambulances”
With
“EN 13718-2:2015, Medical vehicles and their equipment — Air ambulances — Part 2: Operational and
technical requirements of air ambulances”
Replace
“EN 60529:1991, Degrees of protection provided by enclosures (IP Code) (IEC 60529:1989)”
With
“EN 60529:1991/A2:2013, Degrees of protection provided by enclosures (IP Code)
(IEC 60529:1989/A2:2013)”
Replace
“EN 60601-1 (all parts), Medical electrical equipment (IEC 60601, all parts)”
With
“EN 60601-1:2006, Medical electrical equipment — Part 1: General requirements for basic safety and
essential performance (IEC 60601-1:2005)”
Replace
“EN ISO 5359:2008, Low-pressure hose assemblies for use with medical gases (ISO 5359:2008)”
With
“EN ISO 5359:2014, Low-pressure hose assemblies for use with medical gases (ISO 5359:2014)”
Replace
“EN ISO 10297:2006, Transportable gas cylinders — Cylinder valves — Specification and type testing
(ISO 10297:2006)”
With
“EN ISO 10297:2014, Transportable gas cylinders — Cylinder valves — Specification and type testing
(ISO 10297:2014)”
Replace
“ISO 7000:2012, Graphical symbols for use on equipment — Registered symbols”
With
“ISO 7000:2014, Graphical symbols for use on equipment — Registered symbols”
Delete the following references:
“EN 1041:2008+A1:2013, Information supplied by the manufacturer of medical devices”
“EN ISO 15223-1:2012, Medical devices — Symbols to
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.
Loading comments...