prEN 1865-2

Patient handling equipment used in ambulances - Part 2: Power assisted stretcher

This document defines minimum requirements for the design and performance of power assisted stretchers used in road ambulances for the treatment and transportation of patients. It aims to ensure patient safety and minimize the physical effort required by staff operating the equipment.

Krankentransportmittel im Krankenkraftwagen - Teil 2: Kraftunterstützte Krankentrage

Dieses Dokument legt die Mindestanforderungen an die Ausführung und Gebrauchstauglichkeit von kraftunterstützten Krankentragen fest, die im Krankenkraftwagen für die Behandlung und den Transport von Patienten verwendet werden. Es ist das Ziel, für die Sicherheit des Patienten zu sorgen und die körperliche Anstrengung des Personals, das dieses Transportmittel bedient, zu minimieren.

Spécifications d'équipements pour le transport de patient dans les ambulances - Partie 2 : Brancard motorisé

Le présent document définit les exigences minimales requises en matière de conception et de performances des brancards motorisés utilisés dans les ambulances pour le traitement et le transport des patients afin de réduire les efforts physiques des personnels utilisant ces équipements et d’assurer la sécurité du patient.

Oprema za ravnanje s pacienti v reševalnih vozilih - 2. del: Nosila z zložljivim podvozjem

General Information

• Status: Not Published
• Publication Date: 19-Oct-2023
• ICS: 11.160 - First aid
• 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: 4599 - Dispatch of FV draft to CMC - Finalization for Vote
• Start Date: 24-Jan-2023
• Due Date: 14-Sep-2023
• Completion Date: 24-Jan-2023
• Directive: 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Mandate: M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
• Ref Project: oSIST prEN 1865-2:2022 - Patient handling equipment used in ambulances - Part 2: Power assisted stretcher

Relations

• Revises: EN 1865-2:2010+A1:2015 - Patient handling equipment used in road ambulances - Part 2: Power assisted stretcher
• Effective Date: 19-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
oSIST prEN 1865-2:2022
01-oktober-2022
Oprema za ravnanje s pacienti v reševalnih vozilih - 2. del: Nosila z zložljivim
podvozjem
Patient handling equipment used in ambulances - Part 2: Power assisted stretcher

Krankentransportmittel im Krankenkraftwagen - Teil 2: Kraftunterstützte Krankentrage

Spécifications d'équipements pour le transport de patient dans les ambulances routières

- Partie 2: Brancard motorisé
Ta slovenski standard je istoveten z: prEN 1865-2
ICS:
11.160 Prva pomoč First aid
43.160 Vozila za posebne namene Special purpose vehicles
oSIST prEN 1865-2:2022 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN 1865-2:2022
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oSIST prEN 1865-2:2022
DRAFT
EUROPEAN STANDARD
prEN 1865-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2022
ICS 11.160 Will supersede EN 1865-2:2010+A1:2015
English Version
Patient handling equipment used in ambulances - Part 2:
Power assisted stretcher

Spécifications d'équipements pour le transport de Krankentransportmittel im Krankenkraftwagen - Teil

patient dans les ambulances routières - Partie 2: 2: Kraftunterstützte Krankentrage

Brancard motorisé

This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee

CEN/TC 239.

If this draft becomes a European Standard, 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.

This draft European Standard 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,

Poland, Portugal, Republic of North Macedonia, Romania, Serbia, 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: Rue de la Science 23, B-1040 Brussels

© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 1865-2:2022 E

worldwide for CEN national Members.
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oSIST prEN 1865-2:2022
prEN 1865-2:2022 (E)
Contents Page

European foreword ............................................................................................................................................ 3

Introduction .......................................................................................................................................................... 4

1 Scope .......................................................................................................................................................... 5

2 Normative references .......................................................................................................................... 5

3 Terms and definitions ......................................................................................................................... 5

4 Requirements ......................................................................................................................................... 6

4.1 General...................................................................................................................................................... 6

4.2 Main stretcher ........................................................................................................................................ 6

4.2.1 General...................................................................................................................................................... 6

4.2.2 Dimensions.............................................................................................................................................. 6

4.2.3 Mass ........................................................................................................................................................... 7

4.2.4 Loading capacity .................................................................................................................................... 7

4.2.5 Frame ........................................................................................................................................................ 7

4.2.6 Power source .......................................................................................................................................... 8

4.2.7 Lying part of the stretcher ................................................................................................................. 8

4.2.8 Restraint system ................................................................................................................................... 9

4.2.9 Flammability – Toxicity burning gases ......................................................................................... 9

4.2.10 Deformation of the frame .................................................................................................................. 9

4.2.11 Fixation ..................................................................................................................................................... 9

4.2.12 Deformation of the lying area .......................................................................................................... 9

4.2.13 Resistance to torsion ........................................................................................................................... 9

4.2.14 Splaying of the wheels ......................................................................................................................... 9

5 Test methods ........................................................................................................................................ 10

5.1 Permanent deformation of the frame.......................................................................................... 10

5.1.1 Stretcher frame .................................................................................................................................... 10

5.1.2 Undercarriage frame ......................................................................................................................... 10

5.2 Fixation inside the ambulance ....................................................................................................... 10

5.3 Permanent deformation of the lying area .................................................................................. 11

5.4 Resistance to twisting/torsion ....................................................................................................... 11

5.5 Splaying of the wheels ....................................................................................................................... 12

6 Marking .................................................................................................................................................. 12

Annex ZA (informative) Relationship between this European standard and the General

Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be

covered ................................................................................................................................................... 13

Bibliography ....................................................................................................................................................... 16

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oSIST prEN 1865-2:2022
prEN 1865-2:2022 (E)
European foreword

This document (prEN 1865-2:2022) 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 CEN Enquiry.
This document will supersede EN 1865-2:2010+A1:2015.

This European Standard is a part of EN 1865, Patient handling equipment used in ambulances, which

consists of the following parts:

• Part 1: General stretcher systems and patient handling equipment; (forseen for revision)

• Part 2: Power assisted stretcher (the present document)
• Part 3: Heavy duty stretcher; (forseen for revision)
• Part 4: Foldable patient transfer chair; (forseen for revision)
• Part 5: Stretcher support; (forseen for revision)
• Part 6: Powered chairs. (under new development)

Compared to EN 1865-2:2010+A1:2015 the following main technical changes were made:

a) Title changed from ” Patient handling equipment used in road ambulances” to ” Patient handling

equipment used in ambulances”;
b) Normative reference up-dated;

c) Annex ZA revised to show relationship to Medical Device Regulations (MDR) instead of Medical

Device Directive (MDD);
d) new definition for loading system (3.2) included;

e) requirements for mass (4.2.3), power source (4.2.6) and restraint system (4.2.8) revised;

f) loading capacity (4.2.4) from 150 kg to 200 kg increased;
g) new Clause 5 for testing included.

This document has been prepared under a Standardization Request given to CEN by the European

Commission and the European Free Trade Association, and supports essential requirements of EU

Directive(s) / Regulation(s).

For relationship with EU Directive(s) / Regulation(s), see informative Annex ZA, which is an integral part

of this document.
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oSIST prEN 1865-2:2022
prEN 1865-2:2022(E)
Introduction

In this document, reference is made to EN 1789:2020 which specifies design requirements and test

methods for road ambulances, which are relevant for checking requirements for such handling

equipment.
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oSIST prEN 1865-2:2022
prEN 1865-2:2022 (E)
1 Scope

This document defines minimum requirements for the design and performance of power assisted

stretchers used in road ambulances for the treatment and transportation of patients. It aims to ensure

patient safety and minimize the physical effort required by staff operating the equipment.

2 Normative references

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements of this document. For dated references, only the edition cited applies. For

undated references, the latest edition of the referenced document (including any amendments) applies.

EN 597-1:2015, Furniture - Assessment of the ignitability of mattresses and upholstered bed bases - Part 1:

Ignition source smouldering cigarette

EN ISO 20417:2021, Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021,

Corrected version 2021-12)
EN 1789:2020, Medical vehicles and their equipment - Road ambulances

EN 60601-1-2:2015, Medical electrical equipment — Part 1-2: General requirements for basic safety and

essential performance — Collateral Standard: Electromagnetic disturbances — Requirements and tests

(IEC 60601-1-2:2014 and A1:2020)

EN 62366-1:2015, Medical devices — Application of usability engineering to medical devices

(IEC 62366-1:2015 and COR1:2016 and A1:2020)

EN ISO 14971:2019, Medical devices — Application of risk management to medical devices

(ISO 14971:2019)

EN ISO 15223-1:2021, Medical devices - Symbols to be used with information to be supplied by the

manufacturer - Part 1: General requirements (ISO 15223-1:2021)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
3.1
power assisted stretcher

device designed for the conveyance of sick and/or injured persons or those in labour in transit in a

recumbent position in safety and in comfort whilst facilitating treatment and providing powered

movements in the operation of the stretcher to reduce the physical effort required by operatives

Document impacted by A1:2021.
Document impacted by AC:2015 and A1:2020.
Document impacted by A11:2021.
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oSIST prEN 1865-2:2022
prEN 1865-2:2022(E)
3.2
loading system

system installed on the vehicle and/or on the stretcher to assist loading or unloading the stretcher

4 Requirements
4.1 General

When operated and maintained in accordance with the manufacturer's instructions, power assisted

stretchers shall not present any high level of risk. Any identified risk shall be reduced to an acceptable

level by using risk management principles in accordance with EN ISO 14971:2019.
Power assisted stretchers shall also:

• allow patients to be secured so that any movement during ambulance transport is minimized;

• be free of sharp edges that could cause injury to persons or damage to other equipment on board.

The minimum radius should be 0,5 mm.

For all patients transported in the patient compartment, patient restraint-systems shall be available. All

patient restraint-systems shall have quick release systems.

Patient restraint-systems for all patient handling equipment shall secure the patient, but at the same time

shall permit treatment of the patient.

The lying-sitting part shall be made of a strong material which is bacterial resistant, fungal resistant, stain

resistant, putrid resistant, easy to clean, washable, waterproof and petrol-oil resistant.

4.2 Main stretcher
4.2.1 General

The main stretcher shall consist of a stretcher part that can be used either alone or in combination with

an integrated or detachable undercarriage.

The power assisted stretcher and ambulance loading system shall be compatible. The loading system

shall support the crew, so no manual lifting should be done to load the stretcher under normal daily use.

NOTE To minimize manual loading under normal use.
4.2.2 Dimensions
Dimensions shall be measured from the outermost edges:
+120
length:
−50
(1 950 ) mm;
width: +60
−20
(550 ± ) mm ;

height: maximum 300 mm from loading holding assembly to unloaded lying part. This

height dimension does not apply to stretchers with monoblock undercarriages. If
a monoblock is not available, the stretcher shall be constructed such that it is
detachable from the undercarriage. Where a stretcher support is used the
measurement shall be taken from the top surface of the stretcher support to the
lying part of the stretcher.

— Undercarriage: length and width of the frame of the undercarriage when located in the

ambulance shall not exceed length and width of the stretcher.
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oSIST prEN 1865-2:2022
prEN 1865-2:2022 (E)
4.2.3 Mass

The complete mass of a stretcher with integrated undercarriage system (monoblock), excluding the

mattress and patient restraints, shall not be more than 75 kg.

The complete mass of a detachable stretcher and undercarriage system combined, excluding the mattress

and patient restraints, shall not be more than 81 kg.
• The detachable stretcher part shall not be more than 23 kg.

• The detachable stretcher part may exceed 23 kg, if its main intention is not to be used for manual

lifting or manual carrying purposes.

Where the stretcher is a combined stretcher and loading system, therefore requiring no additional lifting

devices or manual lifting to load it into the ambulance, then the maximum mass of the stretcher excluding

the mattress and patient restraint, may be increased to 95 kg.
In all cases the mass should be as low as possible.
4.2.4 Loading capacity

The loading capacity shall be a minimum of 200 kg. A label on the stretcher should indicate the maximum

loading capacity.
4.2.5 Frame
4.2.5.1 General
The frame shall be in sturdy lightweight non twisting constructio
...