EN 13718-1:2014/FprA1

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
• 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: 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 13718-1:2015/oprA1:2018 - Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances

Relations

• Merged Into: EN 13718-1:2014+A1:2020 - Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances
• Effective Date: 09-Jan-2019
• Amends: EN 13718-1:2014 - Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances
• Effective Date: 09-Mar-2016

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
...