EN 1789:2007/FprA1

Medical vehicles and their equipment - Road ambulances

Rettungsdienstfahrzeuge und deren Ausrüstung - Krankenkraftwagen

Véhicules de transport sanitaire et leurs équipements - Ambulances routières

Medicinska vozila in pripadajoča oprema - Reševalna vozila

General Information

• Status: Not Published
• ICS: 11.160 - First aid
• ICS: 43.160 - Special purpose vehicles
• Technical Committee: CEN/TC 239 - Rescue systems
• Drafting Committee: CEN/TC 239/WG 1 - Medical vehicles and their equipment - Stretchers and other patient handling equipment
• Current Stage: 5060 - Closure of Vote - Formal Approval
• Start Date: 05-Feb-2010
• Due Date: 03-Dec-2010
• Completion Date: 05-Feb-2010
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• 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 1789:2007/kprA1:2010 - Medical vehicles and their equipment - Road ambulances

Relations

• Merged Into: EN 1789:2007+A1:2010 - Medical vehicles and their equipment - Road ambulances
• Effective Date: 18-Jan-2023
• Amends: EN 1789:2007 - Medical vehicles and their equipment - Road ambulances
• Effective Date: 23-May-2009

Overview

EN 1789:2007/FprA1 is a European standard developed by the European Committee for Standardization (CEN) that focuses on medical vehicles and their equipment, specifically road ambulances. Prepared by Technical Committee CEN/TC 239 “Rescue systems,” this standard establishes critical safety and performance requirements for ambulances operating on public roads within European Union member states. It supports compliance with the EU Directive 93/42/EEC on medical devices by defining criteria related to ambulance design, equipment integration, and operational safety.

While ambulances themselves are not classified as medical devices, EN 1789 ensures that they are suitably equipped to safely accommodate medical devices and meet essential regulatory requirements applicable within healthcare transport contexts.

Key Topics

• Scope of Ambulance Standards
  EN 1789 addresses specific design, safety, and equipment requirements for road ambulances to ensure high standards in emergency medical transportation.

• Relationship to EU Directives
  The standard is aligned with the essential requirements of EU Directive 93/42/EEC on Medical Devices. It provides a framework for demonstrating compliance for devices carried and used within ambulances, facilitating regulatory approval and market access throughout Europe.

• Vehicle and Equipment Requirements
  EN 1789 outlines the specifications for ambulance construction, including structural integrity, safety features, and interior design to optimize patient care during transport.

• Modification and Compliance
  Amendments such as FprA1 update the standard to reflect emerging industry needs and regulatory changes. Compliance with the standard’s clauses conveys a presumption of conformity with corresponding essential requirements, particularly concerning medical devices used in ambulances.

• Multilingual Publication and Adoption
  The standard is officially published in English, French, and German, with translations permitted under CEN member responsibility, ensuring wide accessibility and adoption across EU countries.

Applications

• Ambulance Manufacturers
  Producers of emergency medical transport vehicles use EN 1789 as a benchmark for designing ambulances that meet European safety and operational regulations.

• Healthcare Providers and Emergency Services
  Hospitals, ambulance services, and emergency response organizations rely on EN 1789-compliant vehicles to ensure patient safety, effective treatment during transport, and seamless integration of medical equipment.

• Regulatory Authorities
  National standardization bodies and regulatory agencies reference EN 1789 when certifying ambulance compliance with EU regulations, facilitating harmonized medical transport standards across member states.

• Medical Device Integration
  The standard supports compatibility between ambulances and the medical devices they carry, ensuring that life-saving equipment functions reliably within the vehicle environment.

Related Standards

• EU Directive 93/42/EEC on Medical Devices
  EN 1789 supports conformity with this directive, which governs the safety and performance of medical devices across European markets.

• CEN/TC 239 Rescue Systems Standards
  Additional standards developed by the same technical committee cover other types of rescue vehicles and systems, offering a comprehensive safety framework for emergency response.

• National Standards Based on EN 1789
  Various member states implement this European standard as a basis for their own ambulance regulations, adapting it to local legal and operational requirements.

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By adhering to EN 1789:2007/FprA1, stakeholders ensure that road ambulances meet stringent European safety and quality criteria, enhancing emergency medical care and patient outcomes during transportation. This standard plays a vital role in harmonizing medical vehicle regulations within the European Union, thereby supporting reliable, efficient, and safe pre-hospital healthcare delivery.

Standards Content (Sample)

SLOVENSKI STANDARD
01-januar-2010
0HGLFLQVNDYR]LODLQSULSDGDMRþDRSUHPD5HãHYDOQDYR]LOD
Medical vehicles and their equipment - Road ambulances
Rettungsdienstfahrzeuge und deren Ausrüstung - Krankenkraftwagen
Véhicules de transport sanitaire et leurs équipements - Ambulances routières
Ta slovenski standard je istoveten z: EN 1789:2007/FprA1
ICS:
11.160 3UYDSRPRþ First aid
43.160 Vozila za posebne namene Special purpose vehicles
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
FINAL DRAFT
EN 1789:2007
NORME EUROPÉENNE
EUROPÄISCHE NORM
prA1
November 2009
ICS 43.160; 11.160
English Version
Medical vehicles and their equipment - Road ambulances
Véhicules de transport sanitaire et leurs équipements - Rettungsdienstfahrzeuge und deren Ausrüstung -
Ambulances routières Krankenkraftwagen
This draft amendment is submitted to CEN members for unique acceptance procedure. It has been drawn up by the Technical Committee
CEN/TC 239.
This draft amendment A1, if approved, will modify the European Standard EN 1789:2007. 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 Management Centre has the same
status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.

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

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 1789:2007/FprA1:2009: E
worldwide for CEN national Members.

Contents Page
Foreword .3
1 Modification to Annex ZA, Relationship between this European Standard and the
Essential Requirements of EU Directive 93/42/EEC on Medical Devices .4
...