SIST EN 1865-5:2012

Patient handling equipment used in road ambulances - Part 5: Stretcher support

This European Standard specifies the minimum requirements for the design and performance of stretcher supports that are installed in road ambulances to hold the main stretcher or incubator systems in accordance with EN 1865-1, EN 1865-2 and EN 13976-2 to ensure patient and operators safety and to minimise the physical effort required by staff operating the equipment.
In this European Standard reference is made to EN 1789.

Krankentransportmittel in Krankenkraftwagen - Teil 5: Festlegungen zur Krankentragenaufnahme

Diese Europäische Norm legt die Mindestanforderungen an die Ausführung und Gebrauchstauglichkeit von
Krankentragenaufnahmen fest, die in Krankenkraftwagen eingebaut sind, um die Hauptkrankentragen oder
das Inkubatorsystem entsprechend EN 1865-1, EN 1865-2 und EN 13976-2 in ihrer Stellung zu halten. Die
Zielsetzung ist, für die Sicherheit des Patienten zu sorgen und die körperliche Anstrengung des Personals, die
dieses Transportmittel bedient, so gering wie möglich zu halten.
In dieser Europäischen Norm wird auf EN 1789 Bezug genommen.

Spécifications d'équipements pour le transport de patient dans les ambulances routières - Partie 5: Table support brancard

La présente partie norme européenne définit les exigences minimales requises pour la conception et les performances des tables supports brancards installées dans les ambulances routières pour maintenir le brancard principal conforme à l’EN 1865-1, l’EN1865-2 et à l’EN 13976-2 pour assurer la sécurité du patient et des opérateurs et réduire les efforts physiques des personnels faisant fonctionner l'équipement.
Dans cette norme l'EN 1789 est citée en référence.

Oprema za ravnanje s pacienti v reševalnih vozilih - 5. del: Podpora za snemanje bolniških nosil

Ta evropski standard določa minimalne zahteve za konstruiranje in zmogljivost nosilcev za snemanje bolniških nosil, ki so nameščeni v reševalnih vozilih za pritrditev glavnega nosila ali sistemov inkubatorjev, v skladu s standardi EN 1865-1, EN 1865-2 in EN 13976-2, da bi se zagotovila varnost pacientov in osebja ter čim bolj zmanjšal fizični napor osebja pri ravnanju s to opremo. Ta evropski standard se sklicuje na standard EN 1789.

General Information

• Status: Published
• Public Enquiry End Date: 14-Jul-2010
• Publication Date: 26-Sep-2012
• ICS: 11.160 - First aid
• ICS: 43.160 - Special purpose vehicles
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 07-Aug-2012
• Due Date: 12-Oct-2012
• Completion Date: 27-Sep-2012
• 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: EN 1865-5:2012 - Patient handling equipment used in road ambulances - Part 5: Stretcher support

Relations

• Replaces: SIST EN 1865:2000 - Specifications for stretchers and other patient handling equipment used in road ambulances
• Effective Date: 01-Oct-2012

Overview

EN 1865-5:2012 - published by CEN - is the European standard that defines minimum design and performance requirements for stretcher supports installed in road ambulances. It ensures patient and operator safety, reduces manual handling effort, and sets test methods (including dynamic tests) for supports that hold main stretchers or incubators in accordance with EN 1865-1 / EN 1865-2 and EN 13976-2. The standard references EN 1789 and includes requirements for manual, powered and shock-absorbing stretcher supports.

Key topics and technical requirements

• Loading capacity
  • Must perform all functions with a minimum mass of 220 kg.
  • Must allow loading/unloading with a load up to 300 kg. Manufacturer-declared higher capacities require additional testing (Annex B).
• Fixation & interface
  • Manufacturers must supply mass, dimensions, centre of gravity position, fixing point locations and mechanical characteristics for correct floor/wall reinforcement and installation.
  • Fixation tested per EN 1789 with residual deflection limits: X+/X- and Y+/Y- ≤ 125 mm, Z ≤ 200 mm. The unit must retain integrity after testing.
• Dynamic testing
  • Verification via dynamic tests with a 126 kg test mass and sensor/filtering requirements: CFC 60 per ISO 6487.
  • Impact/acceleration impulses run in longitudinal, transverse and vertical directions at 30–32 km/h in line with EN 1789.
• Powered systems
  • Must allow manual operation in the event of power failure and provide an accessible emergency stop for fully automated systems.
• Shock-absorbing supports
  • Require automatic self-adjusting/self-levelling suspension based on load with readjustment time ≤ 20 s.
  • Must allow locking to a rigid, horizontal position for CPR and safe discharge behavior during power loss.
• Safety & EMC
  • No exposed sharp edges; electrical/electronic items must conform to EN 60601-1 and EMC requirements.

Applications and users

• Intended for ambulance manufacturers, vehicle converters, medical equipment designers, stretcher and incubator manufacturers, installers and fitters, procurement specialists and notified test bodies.
• Used to specify, design, install and verify stretcher supports to meet safety, regulatory and procurement requirements for road ambulances and special-purpose medical vehicles.

Related standards (normative references)

• EN 1789:2007+A1:2010 - Medical vehicles and their equipment - Road ambulances
• EN 1865 series - Parts 1–4 (general stretcher systems, power assisted stretcher, heavy duty stretcher, transfer chair)
• EN 60601-1 (IEC 60601-1) - Medical electrical equipment - General requirements
• ISO 6487 - Road vehicles - Measurement techniques in impact tests

Keywords: EN 1865-5:2012, stretcher support, patient handling equipment, road ambulances, CEN, EN 1789, loading capacity, dynamic testing, shock-absorbing, powered stretcher support, fixation, EMC.

Standards Content (Sample)

SLOVENSKI STANDARD
01-oktober-2012
1DGRPHãþD
SIST EN 1865:2000
Oprema za ravnanje s pacienti v reševalnih vozilih - 5. del: Podpora za snemanje
bolniških nosil
Patient handling equipment used in road ambulances - Part 5: Stretcher support
Krankentransportmittel in Krankenkraftwagen - Teil 5: Festlegungen zur
Krankentragenaufnahme
Spécifications d'équipements pour le transport de patient dans les ambulances routières
- Partie 5: Table support brancard
Ta slovenski standard je istoveten z: EN 1865-5:2012
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
EN 1865-5
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2012
ICS 11.160 Supersedes EN 1865:1999
English Version
Patient handling equipment used in road ambulances - Part 5:
Stretcher support
Spécifications d'équipements pour le transport de patient Krankentransportmittel in Krankenkraftwagen - Teil 5:
dans les ambulances routières - Partie 5: Table support Festlegungen zur Krankentragenaufnahme
brancard
This European Standard was approved by CEN on 10 May 2012.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.

This European Standard exists 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, 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.

EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 1865-5:2012: E
worldwide for CEN national Members.

Contents Page
Foreword .3
1 Scope .4
2 Normative references .4
3 Terms and definitions .4
4 Requirements .5
4.1 Edges .5
4.2 Loading capacity.5
4.3 Interface on ambulance floor or/and sidewall and stretcher support tray .5
4.4 Fixation on ambulance floor or/and sidewall and stretcher support tray.5
4.5 Powered stretcher support .6
4.6 Shock-absorbing stretcher support.6
4.7 EMC .6
4.8 Test method for fixation on ambulance floor or/and sidewall and stretcher support tray .6
4.8.1 General .6
4.8.2 Dynamic testing .7
Annex A (informative) Test summary . 10
Annex B (informative) Optional requirements . 11
B.1 Sliding test . 11
B.2 Sideways movement . 11
B.3 Sliding tray (backwards and forward movement) . 11
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical Devices . 12
Bibliography . 14

Foreword
This document (EN 1865-5:2012) has been prepared by Technical Committee CEN/TC 239 “Rescue systems”,
the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by December 2012, and conflicting national standards shall be withdrawn
at the latest by December 2012.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document together with the EN 1865-1:2010, EN 1865-2:2010, EN 1865-3:2012 and EN 1865-4:2012
supersedes EN 1865:1999.
With respect to EN 1865:1999 the following changes were made:
a) the stretcher support was introduced as a new item;

b) the standard has been modified/integrated to meet the Medical Device Directive requirements;

c) the standard has been modified t/integrated to comply with the Machinery Directive 2006/42/EC and
its Essential Health and Safety Requirements (EHSRs).
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.
For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document.
This European Standard is a part of EN 1865, Patient handling equipment used in road ambulances, which
consists of the following parts:
 Part 1: General stretcher systems and patient handling equipment
 Part 2: Power assisted stretcher
 Part 3: Heavy duty stretcher
 Part 4: Foldable patient transfer chair
 Part 5: Stretcher support
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, 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, Turkey and the United Kingdom.

1 Scope
This European Standard specifies the minimum requirements for the design and performance of stretcher
supports that are installed in road ambulances to hold the main stretcher or incubator systems in accordance
with EN 1865-1, EN 1865-2 and EN 13976-2 to ensure patient and operators safety and to minimise the
physical effort required by staff operating the equipment.
In this European Standard reference is made to EN 1789.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
EN 1789:2007+A1:2010, Medical vehicles and their equipment — Road ambulances
EN 60601-1 (all subparts), Medical electrical equipment — Part 1: General requirements for basic safety and
essential performance (IEC 60601-1)
ISO 6487, Road vehicles — Measurement techniques in impact tests — Instrumentation
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
stretcher support
device that is fitted to the floor and/or sidewall of an ambulance, on which a stretcher or incubator is located
Note 1 to entry: Stretcher supports may be manually/power operated and may include a shock absorbing system.
Note 2 to entry: The stretcher support may be equipped with special devices to reduce the effect of acceleration forces
of the vehicle to the stretcher or incubator during transportation.
Note 3 to entry: The stretcher support may be equipped with devices such as a tilting and extendable top tray, a fixed
or folding ramp.
3.2
stretcher support with manual operation
support that can only be moved by using manual force of the operator
3.3
powered stretcher support
support that is completely or partially power-operated by means of actuators (electrical, hydraulic, pneumatic,
etc.)
3.4
shock absorbing stretcher support
support with pneumatic, hydraulic, hydro-pneumatic or mechanical suspension(s)
Note 1 to entry: It is designed to cushion the effect of road surfaces, thus providing better comfort for the patient.
3.5
residual deflection
sum expressed in millimetres of permanent deformation and sliding displacement in test direction
4 Requirements
4.1 Edges
In order to reduce risk of injury to patients, staff and equipment, there shall be no exposed sharp edges.
4.2 Loading capacity
Stretcher supports shall be able to perform all their functions when loaded with a minimum mass of 220 kg.
This load corresponds to the sum of the maximum weight allowed for the stretcher, undercarriage, minimum
stretcher loading capacity (see EN 1865-1:2010, 4.2.3 and 4.2.4) and the fixation brackets.
Over this weight the stretcher support might not perform all functions, however, it shall be possible to load/
unload the stretcher with a load of 300 kg.
NOTE If the manufacturer declares a higher loading capacity, then tests described in Annex B should be performed
using the manufacturer's advised maximum admissible loading.
4.3 Interface on ambulance floor or/and sidewall and stretcher support tray
The stretcher support manufacturer shall supply the installer with the following data:
a) mass and dimensions of the stretcher support;
b) position of the centre of gravity with regard to ambulance floor or/and sidewall and the top tray, at the
maximum available height;
c) position of the fixing points with regard to the centre of gravity, including number of fixing points, type and
mechanical characteristics of the connection devices to be used in order to allow the correct positioning of
the floor/wall plate reinforcement;
d) to with
...