SIST EN 1789:2007+A1:2010/kFprA2:2014
(Amendment)Medical vehicles and their equipment - Road ambulances
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
Relations
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 . 29
13 Modification to Annex ZA . 29
2
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SIST EN 1789:2007+A1:2010/kFprA2:2014
EN 1789:2007+A1:2010/FprA2:2014 (E)
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.
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SIST EN 1789:2007+A1:2010/kFprA2:2014
EN 1789:2007+A1:2010/FprA2:2014 (E)
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.".
4
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"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)".
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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:
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EN 1789:2007+A1:2010/FprA2:2014 (E)
"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 created by the vehicle or its equipment, the
complete operational vehicle should consists of components, equipment or sub systems that complies or are
certified as conforming to the respective industry EMC regulations.
NOTE An ambulance as supplied and certified may not be fully equipped and therefore some responsibility for added
equipment after conversion rests with the customer/user.".
In 4.3.3, note 2 after Table 1, replace "prioritisation" with "prioritization".
In 4.3.4.1, third paragraph, delete "220/240 V".
In 4.3.4.3, replace the third paragraph
"The system shall have enough circuits and be so constructed that when/if a circuit fails all illumination and
medical technical equipment can be switched to an alternative power source."
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with the following:
"The system shall have enough circuits and be so constructed that when/if a circuit fails some illumination and
some power supply sources for medical technical equipment still work.".
Add the following new subclause:
"4.3.5 Visual and audible warning system
The vehicle shall be fitted with a visual warning and audible warning system to assist emergency passage.
These systems shall comply with national regulations where they exist.
NOTE The visual and audible warning system is optional for type A ambulances according to national regulations.".
In 4.4.1, replace the first sentence with the following:
"The interior materials shall conform to the specification of EN 13501-1:2009.".
In 4.4.2, first sentence, delete "vehicles".
In 4.4.3, after Table 3, add the following text:
"If needed, a notice shall be displayed in the drivers' compartment stating the maximum number of seated,
wheelchair and stretcher patients and cab occupants that can be carried.
EXAMPLE 1
DRIVER COMPARTMENT: driver and no cab passenger with the following patient's compartment occupants
PATIENT COMPARTMENT:
3 seated persons and 1 stretcher person;
or 4 seated persons and no stretcher;
or 2 seated persons and 2 wheelchair occupants.
EXAMPLE 2
DRIVER COMPARTMENT: driver and one cab passenger with the following patient's compartment occupants
PATIENT COMPARTMENT:
2 seated persons and 1 stretcher person;
or 2 seated persons and 1 wheelchair.
The notice shall be supplied by the ambulance builder taking account of the maximum weight capacity of the
vehicle.".
In 4.4.4, second paragraph, delete the following:
"made of material complying with the requirements of Directive 92/22/EEC modified.".
In 4.4.5.1, in the title to Table 4, replace "patient" with "patient's"; change this throughout the whole document.
In 4.4.5.1, add the following note at the end of this subclause:
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"NOTE The side and/or rear doors can be used as emergency exit.".
st
In 4.4.5.2, 1 sentence, delete "of" and add the following after "door":
"allowing direct access to".
In 4.4.5.2, add the following footnote 7 to b):
"7) The key can be a mechanical or non-mechanical device.".
In 4.4.5.2, last paragraph, replace "door" with the following:
"external door including those not allowing direct access to the patient's compartment,".
In 4.4.5.3, second paragraph, replace "screened" with "designed".
In 4.4.5.3, second paragraph, delete the following:
"Windows shall be made of material complying with the requirements of Directive 92/22/EEC modified.".
In 4.4.6, Table 5, delete the column "H minimum" and "maximum" add "H minimum" after "open" in the
2 2
brackets and add "α" after "loading angle" and "maximum" after "(stretcher)"to read as follows:
"Table 5 — Loading area dimensions
Type of road ambulance
A A B C
1 2
Tailgate height (in the open H minimum position) 1 800 1 800 1 900 1 900
2
a mm mm mm mm
(see Figure 1)
Loading angle α (stretcher) maximum b b b b
16° 16° 16° 16°
Loading height (stretcher) When the patient is manually loaded or unloaded on the stretcher, the
centre of the stretcher handles shall be no more than 825 mm above
ground level. The maximum height of either the floor or the loading
holding assembly above ground level shall not exceed 750 mm at net
vehicle mass plus loose equipment.
A
From ground to lowest point of fully opened tailgate at gross vehicle mass.
B
The loading angle shall be kept as low as possible.
".
In 4.4.6, second paragraph (after Table 5), replace "a anti-slip" with "an anti-slip" and delete "constant".
In 4.4.6, Figure 1, add the following key:
Key
H tailgate height
2
α loading angle
In 4.5.1, seventh paragraph (beginning with “Drawers”), replace twice “should” with “shall”.
In 4.5.1, tenth paragraph (beginning with “If the.”), replace “EN 1865” with “EN 1865-4:2012”.
In 4.5.2.2, add the following note at the end of the subclause and before the figures:
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“NOTE Full line equals interior wall and ceiling of the patient's compartment.”.
In 4.5.2.3, replace the third paragraph with the following:
“h = A working height of the stretcher surface (excluding mattress and included a support platform where
fitted) between 400 mm (minimum) and 650 mm (maximum) shall be ensured.”.
In 4.5.2.3, add the following note before Figure 5:
"NOTE Full line represents the ergonomic space."
In 4.5.3, Table 6, row 6, add "the" before "stretcher" to read as follows:
"Table 6 — Number of patient and attendant seats
Type of road ambulance
A A B C
1 2
Minimum number 1 2 2 2
Position(s) on one side of the
1 1 – –
stretcher
on one side of the
stretcher upper
– – 1 1
2
/ end
3
Position(s) at head or side of the – a 1 1
1
stretcher
a
Only when fewer than four seats.
".
In 4.5.3, after Table 7, delete the following sentence:
"Head restraints shall be fitted in accordance with Directive 78/932/EEC.".
In 4.5.3, replace the following sentence:
"Seats for patients and attendants shall not be permanently fixed in a side-facing position."
with
"All seats shall be equipped with head rests.".
In 4.5.5.1 and 4.5.5.2, replace "mid point" with "mid-point".
In 4.5.7, first paragraph, replace reference "5.1" with "5.2".
In 4.5.8, replace "minimise" with "minimize".
In 4.5.9, delete the second paragraph:
"Head restrain shall be fitted in accordance with Directive 78/932/EEC.".
In 4.5.9, add the following note after c):
"NOTE Requirement c) is considered to be fulfilled if it is possible to open at least one external access door or an
emergency exit of the patient's compartment after testing according to 6.4.1.".
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Add the following new subclause:
"4.5.10 Mass reserve
The minimum mass reserve required for the listed sanitary, medical and technical devices in Tables 9 to 19
shall be as follows:
road ambulance type A1: 100 kg;
road ambulance type A2: 115 kg;
road ambulance type B: 225 kg;
road ambulance type C: 260 kg.".
6 Modification to Clause 5, Testing
Add the following new subclause:
"5.1 General
For vehicles designed to carry stretcher(s) all shall be in place during testing according to 5.2 and 5.3. Each
stretcher shall be loaded according to this standard and be tested in the normal position for use.
The general tolerances used are those for the automotive regulation.
NOTE Surrogate stretcher(s) can be used. ".
Renumber the whole clause.
In new 5.2, add the following title before the first paragraph:
"5.2.1 Specific measurement conditions".
In new 5.2.1, add the following note after the first indent:
"NOTE 1 Permanent equipment(s) means stretcher(s), their mattresses and accessories that cannot be removed
without using tools delivered with the ambulance.".
In new 5.2.1, add the following note after the last indent:
"NOTE 2 Values are Leq (average).".
Add the following new subclauses:
"5.2.2 Measurements
The noise level of the vehicle at the speed according to 4.5.7 is determined by estimating the interior noise
level for five speeds, one at each end and three evenly distributed between the end points.
For each speed, two measurements are carried out.
For a given speed, the test result is the average of these two measurements.
EXAMPLE An example of measurements according to ISO 5128:1980 is given in Figure 6.
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Key
X different speeds in km/h
Y noise level in dB (A)
measurement
test result (average of 2 measurements)
Figure 6 — Example of measurement
5.2.3 Establishment of compliance
The regression line is drawn from the five test results.
Each point of this regression line is the interior noise level for the considered speed.
The interior noise level shall not exceed the line resulting coordinates 70 dB(A) at 60 km/h or 40 % of the
maximum speed, taking the lowest speed, and 78 dB(A) at 120 km/h or 60 % of the maximum speed, taking
the lowest speed.
Test results shall not differ by more than +3 dB(A) of this limit line.
EXAMPLE An example is given in Figure 7.
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Key
X different speeds in km/h
Y noise level in dB (A)
limit for the interior noise level
interior noise level (regression line of the test results)
limit for the measured pressure level
measured pressure level (test results)
Figure 7 — Example of result".
In new 5.4, replace the whole subclause with the following:
"5.4.1 General
To verify the requirements of 4.5.9 (strength of mounting system in the patient compartment) on a new
vehicle, a dynamic test under 5 axis, ± x'x, ± y'y and for + z'z axis shall be performed (see Figure 8).
It is permissible to perform the test on each direction on a fresh sample at the request of the manufacturer.
Each direction in the test is an independent test. Use of fresh sample body is therefore allowed.
NOTE 1 Test configuration is defined on the principle of the worst case criteria to limit the number of tests.
NOTE 2 Bodies in white or chassis cab in white plus box bodies can be used for test purposes.
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Figure 8 — Test directions for dynamic test
The maximum test mass for which the devices are qualified, shall be indicated by a label.
The method used to secure the vehicle during the test shall not be such as to strengthen the body or the
arrangement of the patient compartment or to lessen the normal deformation of the structure.
Securing of the vehicle or body shell:
The only reinforcements allowed are a sub frame under the original van shell or chassis longitudinal box
sections or chassis rails to fix the body/shell to the test facility. For a box body, a sub frame representing the
chassis can be used in conjunction with the original attachment points under the box designated for fixing to
the vehicle chassis.
Figure 9 — Supporting point for Z’Z axis
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NOTE 3 A supporting point (not a fixation) for Z’Z axis can be used as shown on Figure 9.
In the case of a fully independent box body, it is possible to test it alone.
Types of ambulance vehicles are defined in Annex C.
To check 4.5.9 on a new vehicle, a dynamic test in the 5 directions shall be carried out.
Dynamic test is the reference method.
Manufacturer should present to TS documentation of the fixation and mounting manufacture approach prior to
tests.
For a modification on a previously dynamically tested and approved ambulance body/shell, a dynamic test or
static test of the modified components or computer simulation can be presented depending on the nature of
the change. The appropriate method shall be agreed with the approval authority.
NOTE 4 Documentation of all modifications will be added to the original tests documentation.
To verify the requirement of 4.5.9 c), the TS will verify that at least one patient's compartment door or an
emergency exit can be used after the test without using tools.
For racks, rails and non-dedicated storage devices or storage, the TS shall state in the test report the
maximum approved load. It is the responsibility of the ambulance builder to fix labels to these storage items
declaring the maximum permitted load in production vehicles. The TS shall verify that labels are provided in
the nomenclature in accordance with validated results.
Acceptance criteria for 4.5.9: the test mass shall remain fixed to the attachment point. Cracks and tears of
metal sheet are acceptable.
The displacement shall be checked during the test to verify criteria 4.5.9 b).
5.4.2 Testing of the stretcher fixations on the vehicle floor
For all types, the test shall be performed with a stretcher support or floor mounted locks and an equivalent
mass simulating the stretcher and the dummy whose characteristics are:
stretcher and dummy test mass: 126 kg according to EN 1865-5:2012;
table stretcher support as defined by the ambulance manufacturer, with maximum weight and height of
the centre of gravity defined by the ambulance manufacturer.
Manufacture shall present to the TS documentation of the fixation and mounting manufacture approach prior
to tests.
In addition, the stretcher support fixed in the ambulance shall comply to EN 1865-5:2012 of the interface
(stretcher support).
The stretcher fixing device on the interface or on the floor should be validated by an appropriate test.
5.4.3 Testing of the medical devices fixations
For the medical equipment fastened in the vehicle, the manufacturer of the ambulance defines the type of
fixation to use, the admissible mass and the location of the fixing points. The manufacturer provides
recommendations to the users.
Fixing points are tested with a test mass corresponding to the permissible load declared by the manufacturer
of the ambulance for each point.
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EN 1789:2007+A1:2010/FprA2:2014 (E)
5.4.4 Testing of furniture
For the same vehicle type or a specific box body, the patient's compartment furniture shall be validated
utilising the worst case condition agreed with the TS.
The test is carried out according to 5.4.5.
5.4.5 Test procedure
For test purposes a surrogate stretcher c
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