SIST EN 13718-1:2015/oprA1:2018
(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
- Public Enquiry End Date
- 24-May-2018
- Technical Committee
- VAZ - Healthcare
- Current Stage
- 98 - Abandoned project (Adopted Project)
- Start Date
- 14-Apr-2020
- Due Date
- 19-Apr-2020
- Completion Date
- 14-Apr-2020
Relations
- Effective Date
- 01-May-2020
- Effective Date
- 01-May-2018
Overview
The SIST EN 13718-1:2015/oprA1:2018 standard, developed by CEN (European Committee for Standardization), specifies essential requirements for medical devices used in air ambulances. It focuses on ensuring that medical equipment carried in air ambulances functions safely and effectively under varying ambient conditions encountered during air transport. This standard addresses crucial aspects such as device performance, safety, and compatibility within the unique operational environment of air ambulances, distinct from typical hospital settings.
Importantly, SIST EN 13718-1:2015/oprA1:2018 does not cover vehicle approval, registration, or staff training-which remain under national authority jurisdiction-but concentrates solely on medical devices used in airborne emergency medical services.
Key Topics
General Requirements for Medical Devices in Air Ambulances
The standard outlines comprehensive criteria for devices to withstand changing temperatures, pressures, and vibration levels in air transport conditions, maintaining essential performance and safety standards.Updated Normative References
Latest references include EN 13718-2:2015 for operational requirements, EN 60529:1991/A2:2013 (IP Code for enclosure protection), EN 60601-1:2006 for medical electrical equipment safety, and updated ISO standards on medical gas hose assemblies and cylinder valves, ensuring compatibility with current technologies.Marking and Labeling
The standard refines marking requirements, focusing on clear, standardized graphical symbols and instructions to support safe use and maintenance under airborne conditions, aligned with harmonized European directives.Gas Connections and Medical Gas Supply Safety
Enhanced specifications on connections to medical gas installations ensure reliability and prevent errors in critical care scenarios.Risk Management Compliance
The document reinforces adherence to EU Directive 93/42/EEC (Medical Devices Directive), emphasizing manufacturers’ risk management to minimize hazards ‘to the lowest possible level’ consistent with essential requirements.Maintenance and Usability
Guidelines address device maintenance procedures and usability considerations specific to mobile and airborne emergency healthcare settings.
Applications
Air Ambulance Medical Equipment Selection
Enables procurement specialists and technical managers to identify and verify medical devices fit for use in air ambulance environments, ensuring compliance with European safety and performance norms.Device Design and Certification
Manufacturers use this standard to design, test, and certify medical devices tailored to withstand the physical and operational challenges experienced in air medical transport.Compliance with European Medical Device Regulations
Helps medical device producers demonstrate conformity to the Medical Devices Directive (93/42/EEC), aiding market access and regulatory approval across Europe.Operational Safety Enhancements
Assists healthcare providers and aircraft operators in maintaining a high level of safety for critically ill patients during air transport via proper device selection, installation, and upkeep.
Related Standards
- EN 13718-2:2015 – Operational and technical requirements of air ambulances, complementary to part 1 on medical devices.
- EN 1789:2007+A2:2014 – Standards for road ambulances and their equipment, relevant for ground-air ambulance coordination.
- EN 60601-1:2006 – General safety and performance requirements for medical electrical equipment.
- EN ISO 5359:2014 – Standards for low-pressure hose assemblies used with medical gases.
- EN ISO 10297:2014 – Specifications and testing for transportable gas cylinder valves.
- EN 60529:1991/A2:2013 – Protection ratings (IP Code) for device enclosures, critical for protecting equipment onboard aircraft.
Keywords: SIST EN 13718-1:2015/oprA1:2018, medical devices, air ambulances, air medical transport, European standard, medical equipment, air ambulance equipment, CEN standards, Medical Devices Directive 93/42/EEC compliance, medical device safety, medical gas supply, operational requirements air ambulance.
Frequently Asked Questions
SIST EN 13718-1:2015/oprA1:2018 is a draft published by the Slovenian Institute for Standardization (SIST). 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.
SIST EN 13718-1:2015/oprA1:2018 is classified under the following ICS (International Classification for Standards) categories: 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.
SIST EN 13718-1:2015/oprA1:2018 has the following relationships with other standards: It is inter standard links to SIST EN 13718-1:2015+A1:2020, SIST EN 13718-1:2015. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
SIST EN 13718-1:2015/oprA1:2018 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.
You can purchase SIST EN 13718-1:2015/oprA1:2018 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of SIST standards.
Standards Content (Sample)
SLOVENSKI STANDARD
01-maj-2018
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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
...
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