EN 1789:2007+A1:2010/FprA2

Medical vehicles and their equipment - Road ambulances

2012-11-21 EMA: Tolerance of 9 months before UAP requested through Decision 226 taken on 2012-10-23.

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: 13-Jun-2014
• Completion Date: 13-Jun-2014
• 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+A1:2010/kFprA2:2014 - Medical vehicles and their equipment - Road ambulances

Relations

• Merged Into: EN 1789:2007+A2:2014 - Medical vehicles and their equipment - Road ambulances
• Effective Date: 19-Jan-2023
• Amends: EN 1789:2007+A1:2010 - Medical vehicles and their equipment - Road ambulances
• Effective Date: 21-Dec-2011

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 1789:2007+A1:2010/kFprA2:2014
01-maj-2014
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+A1:2010/FprA2
ICS:
11.160 3UYDSRPRþ First aid
43.160 Vozila za posebne namene Special purpose vehicles
SIST EN en,fr,de
1789:2007+A1:2010/kFprA2:2014
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 1789:2007+A1:2010/kFprA2:2014

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SIST EN 1789:2007+A1:2010/kFprA2:2014

EUROPEAN STANDARD
FINAL DRAFT
EN 1789:2007+A1:2010
NORME EUROPÉENNE

EUROPÄISCHE NORM
FprA2
March 2014
ICS 11.160; 43.160
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 A2, if approved, will modify the European Standard EN 1789:2007+A1:2010. 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, 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: Avenue Marnix 17, B-1000 Brussels
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 1789:2007+A1:2010/FprA2:2014 E
worldwide for CEN national Members.

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SIST EN 1789:2007+A1:2010/kFprA2:2014
EN 1789:2007+A1:2010/FprA2:2014 (E)
Contents
Page
Foreword .3
1 Modification to the Foreword .4
2 Addition of an Introduction .4
3 Modifications to Clause 2, Normative References .4
4 Modifications to Clause 3, Terms and definitions .6
5 Modifications to Clause 4, Requirements .7
6 Modification to Clause 5, Testing . 11
7 Modification to Clause 6, Medical devices . 24
8 Addition of a new Clause 7, Conformity assessment . 25
9 Addition of a new Clause 8, Requirements to be met for a Certificate of Compliance . 26
10 Modification to Annex A . 26
11 Modification to Annex B . 28
12 Modification to Annex C .
...