EN 1789:2007+A1:2010/FprA2

SLOVENSKI STANDARD
01-maj-2014
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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.

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.

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 . 29
13 Modification to Annex ZA . 29

Foreword
This document (EN 1789:2007+A1:2010/FprA2:2014) has been prepared by Technical Committee
CEN/TC 239 “Rescue Systems”, the secretariat of which is held by DIN.
This document is currently submitted to the Unique Acceptance Procedure.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), see informative Annex ZA which is an integral part of this document.
1 Modification to the Foreword
Delete the old Foreword and replace with new Foreword (not tagged).
2 Addition of an Introduction
Add an Introduction with the following text and footnote:
"
Introduction
In the development of the European standard EN during the 90's, Directive 70/156/EEC has been considered.
In October 2009, CEN/TC 239 appointed an ad-hoc group to evaluate the impact of the Directive 2007/46/EC
which replaces Directive 70/156/EEC, on EN 1789:2007 and to assess its application in different member
countries of CEN.
Moreover the definition of ambulance of the COMMISSION REGULATION (EU) No 678/2011 (14 July 2011
replacing Annex II and amending Annexes IV, IX and XI to Directive 2007/46/EC) refers to EN 1789:2007.
The appointed ad-hoc group reported its findings as follows:
 EN 1789:2007 has not been applied consistently by notified bodies since the text for verifying compliance
is open to interpretation and may cause difficulties to Technical Services (TS) as defined in Directive
2007/46/EC, EN 1789:2007 or local authorities.
 these differences can lead to declarations that the same ambulance complies or does not comply with
EN 1789:2007;
 manufacturers of ambulances may have the same problems of interpretation in the design of their
ambulances;
 users of ambulances may have the same problems of interpretation that affects their responsibility.
1)
This second amendment gives an answer to questions concerning the application of EN 1789:2007 and
avoids differences in interpretation between such notified bodies to check compliance of vehicles specially
adapted to medical transportation (Road ambulances).
NOTE Such as the demonstration of compliance to the requirements of 4.5.9 or 4.3.".
3 Modifications to Clause 2, Normative References
Delete the following normative references:
"EN 739, Low-pressure hose assemblies for use with medical gases";
"EN 980, Graphical symbols for use in the labelling of medical devices";
"EN ISO 9919, Medical electrical equipment — Particular requirements for the basic safety and essential
performance of pulse oximeter equipment for medical use (ISO 9919:2005)";
"EN ISO 21647, Medical electrical equipment — Particular requirements for the basic safety and essential
performance of respiratory gas monitors (ISO 21647:2004)";

1)
"The first amendment published in 2010 only updates Table ZA.1 to consider the revision of Directive 93/42/EEC.".
"IEC 60364-7-708, Electrical installations of buildings — Part 7: Requirements for special installations or
1)
locations. Section 708 — Electrical installations in caravan parks and caravans ", delete corresponding
footnote.
ISO 3795, Road vehicles, and tractors and machinery for agriculture and forestry — Determination of burning
behaviour of interior materials"
Replace
"EN 1865, Specifications for stretchers and other patient handling equipment used in road ambulances" with
"EN 1865-1:2010, Patient handling equipment used in road ambulances — Part 1: General stretcher systems
and patient handling equipment";
"EN 60068-2-6, Environmental testing — Part 2: Tests — Tests Fc: Vibration (sinusoidal) (IEC 60068-2-
6:1995 + Corrigendum 1995)" with "EN 60068-2-6, Environmental testing — Part 2-6: Tests — Tests Fc:
Vibration (sinusoidal) (IEC 60068-2-6:2007)";
"EN 60601-2-4, Medical electrical equipment — Part 2-4: Particular requirements for the safety of cardiac
defibrillators (IEC 60601-2-4:2002)" with "EN 60601-2-4:2011, Medical electrical equipment — Part 2-4:
Particular requirements for the basic safety and essential performance of cardiac defibrillators
(IEC 60601-2-4:2010)"
and
"EN 60068-2-64, Environmental testing — Part 2: Test methods — Test Fh: Vibration, broad-band random
(digital control) and guidance (IEC 60068-2-64:1993 + Corrigendum 1993)" with "EN 60068-2-64:2008,
Environmental testing — Part 2-64: Tests — Test Fh: Vibration, broadband random and guidance
(IEC 60068-2-64:2008)";
Add the following normative references:
"EN 1865-2:2010, Patient handling equipment used in road ambulances — Part 2: Power assisted stretcher
EN 1865-4:2012, Patient handling equipment used in road ambulances — Part 4: Foldable patient transfer
chair
EN 1865-5:2012, Patient handling equipment used in road ambulances — Stretcher support";
"EN 13501-1:2009, Fire classification of construction products and building elements — Part 1: Classification
using test data from reaction to fire tests";
"EN ISO 5359:2008, Low-pressure hose assemblies for use with medical gases (ISO 5359:2008)";
"EN ISO 15223-1:2012, Medical devices- Symbols to be used with medical device labels, labelling and
information to be supplied- Part 1: General requirements (ISO 15223-1:2012)";
"EN ISO 80601-2-61:2011, Medical electrical equipment — Part 2-61: Particular requirements for basic safety
and essential performance of pulse oximeter equipment (ISO 80601-2-61:2011)";
"EN ISO 80601-2-55:2011, Medical electrical equipment — Part 2-55: Particular requirements for the basic
safety and essential performance of respiratory gas monitors (ISO 80601-2-55:2011)";
"IEC 60364-7-721:2007, Low-voltage electrical installations — Part 7-721: Requirements for special
installations or locations — Electrical installations in caravans and motor caravans
(IEC 60364-7-721:2007-04)".
Replace
"EN 3-7" with "EN 3-7:2004+A1:2007";
"EN 420" with "EN 420:2003+A1:2009";
"EN 455-1" with "EN 455-1:2000";
"EN 455-2" with "EN 455-2:2009+A2:2013";
"EN 794-3" with "EN 794-3:1998+A1:2009";
"EN 1041" with "EN 1041:2008+A1:2013";
"EN 12470-1" with "EN 12470-1:2000+A1:2009";
"EN 13544-1" with "EN 13544-1:2007+A1:2009";
"EN 60068-2-29" with "EN 60068-2-29:1993";
"prEN ISO 15002" with "EN ISO 15002:2008" and in the title replace "(ISO/DIS 15002:2006)" with
"(ISO 15002:2008)";
"EN ISO 407" with "EN ISO 407:2004";
"EN ISO 10524-1" with "EN ISO 10524-1:2006";
"EN ISO 10524-3" with "EN ISO 10524-3:2006";
"EN ISO 14971" with "EN ISO 14971:2012" and in the title replace "(ISO 14971:2007)" with "(ISO 14971:2007,
Corrected version 2007-10-01)";
"EN ISO 19054" with "EN ISO 19054:2006";
"EN ISO 20345" with "EN ISO 20345:2011" and in the title replace "(ISO 20345:2004)" with
"(ISO 20345:2011)".
4 Modifications to Clause 3, Terms and definitions
In 3.3, footnote 2, replace "Directive 70/156" with "Directive 2007/46/EEC".
In 3.4, delete "unloaded mass" and "vehicle".
Replace 3.5 with the following:
"3.5
ambulance loading capacity
difference between the permissible gross vehicle mass and the mass according to 92/21/EEC modified of the
road ambulance including the driver taken as 75 kg and all fixed installations, mass reserve according to
4.5.10 and all passengers
Note 1 to entry: This represents the mass that may be distributed on the road ambulance such that the permissible
axle loads are not exceeded."
Delete 3.6 loading capacity and update numbering.
Add the following new terms and definitions:
"3.8
Technical Service (TS)
body authorized according to directive 2007/46/EEC to decide the conformity of the ambulance as a road
vehicle
3.9
means of verification (MoV)
deliverables or tests to be performed to allow the technical service to establish the compliance of the
ambulance to EN 1789:2007 in the context of the vehicle type approval
3.10
non equipped ambulance
ambulance without any equipment as listed in Table 9 to Table 19
Note 1 to entry: Stretcher support as defined in EN 1865-5:2012 is included in the non-equipped ambulance.".
5 Modifications to Clause 4, Requirements
In 4.1.1, delete the first paragraph.
In 4.1.1, replace "EN ISO 14971" with "EN ISO 14971:2012".
In 4.1.1, delete the last (third) paragraph.
In 4.2, add "-braking and acceleration" to the heading.
Replace 4.3.1 with the following:
"4.3.1 General
Electrical installations added to the one of the base vehicle shall comply with those clauses of
IEC 60364-7-721:2007 which are applicable to ambulances.".
Replace 4.3.2 with the following:
"4.3.2 Electromagnetic compatibility (EMC) – Communication equipment
Communication equipment (e.g. radio installation) shall comply with national regulations.
For the supply system of the medical equipment the EN 60601-1 and EN 60601-2 series shall apply.
To minimize any risk to the safe operation of the complete ambulance and any of the equipment operated on
or in the vehicle from the effects of electromagnetic influences create
...