EN 1865-6:2024
(Main)Patient handling equipment used in ambulances - Part 6: Powered chairs
Patient handling equipment used in ambulances - Part 6: Powered chairs
This document specifies the minimum requirements for the design and performance of power assisted chairs, which are used for the conveyance of patients to and/or from road ambulances. It aims to ensure patient safety and to minimize the physical effort required by staff operating the equipment.
Krankentransportmittel im Krankenkraftwagen - Teil 6: Kraftunterstützte Krankenstühle
Dieses Dokument legt die Mindestanforderungen an die Ausführung und Gebrauchstauglichkeit kraftunterstützter Krankenstühle fest, die zum Transport von Patienten zu und/oder aus Krankenkraftwagen eingesetzt werden. Es ist das Ziel, für die Sicherheit des Patienten zu sorgen und die körperliche Anstrengung des Personals, das dieses Transportmittel bedient, zu minimieren.
Équipements pour le transport de patients dans les ambulances - Part 6 : Chaise motorisée
Le présent document définit les exigences minimales pour la conception et les performances des fauteuils à assistance électrique, qui sont utilisés pour le transport des patients vers et/ou depuis les ambulances routières. Il vise à assurer la sécurité des patients et à minimiser l'effort physique requis par le personnel qui utilise l'équipement.
Oprema za ravnanje s pacienti v reševalnih vozilih - 6. del: Prenosni stol
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN 1865-6:2022
01-oktober-2022
Oprema za ravnanje s pacienti v reševalnih vozilih - 6. del: Prenosni stol
Patient handling equipment used in ambulances - Part 6: Powered chairs
Krankentransportmittel im Krankenkraftwagen - Teil 6: Kraftunterstützte Krankenstühle
Spécifications d'équipements pour le transport de patient dans les ambulances routières
- Partie 6 : Fauteuils à assistance électrique
Ta slovenski standard je istoveten z: prEN 1865-6
ICS:
11.160 Prva pomoč First aid
43.160 Vozila za posebne namene Special purpose vehicles
oSIST prEN 1865-6:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
oSIST prEN 1865-6:2022
oSIST prEN 1865-6:2022
DRAFT
EUROPEAN STANDARD
prEN 1865-6
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2022
ICS 11.160
English Version
Patient handling equipment used in ambulances - Part 6:
Powered chairs
Spécifications d'équipements pour le transport de Krankentransportmittel im Krankenkraftwagen - Teil
patient dans les ambulances routières - Partie 6 : 6: Kraftunterstützte Krankenstühle
Fauteuils à assistance électrique
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, Türkiye 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 1865-6:2022 E
worldwide for CEN national Members.
oSIST prEN 1865-6:2022
prEN 1865-6:2022 (E)
Contents Page
European foreword . 3
1 Scope . 4
2 Normative references . 4
3 Terms and definitions . 5
4 Requirements . 5
4.1 General . 5
4.2 Dimensions . 5
4.3 Mass . 5
4.4 Loading capacity . 6
4.5 Frame . 6
4.6 Power source . 6
4.7 Seat and Backrest . 6
4.8 Restraint system . 6
4.9 Flammability — toxicity burning gases. 6
4.10 Deformation of the frame . 6
4.11 Locking . 6
4.12 Deformation of the backrest lying-sitting area . 6
5 Marking . 7
Annex ZA (informative) Relationship between this European standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered. 8
Bibliography . 12
oSIST prEN 1865-6:2022
prEN 1865-6:2022 (E)
European foreword
This document (prEN 1865-6:2022) 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 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; (forseen for revision)
• 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. (the present document)
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.
oSIST prEN 1865-6:2022
prEN 1865-6:2022 (E)
1 Scope
This document defines the minimum requirements for the design and performance of power assisted
chairs, which are used for the conveyance of patients to and/or from road ambulances. It aims to ensure
patient safety and to 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 1865-1:2010+A1:2015, Patient handling equipment used in road ambulances - Part 1: General stretcher
systems and patient handling equipment
prEN 1865-2:2022, Patient handling equipment used in ambulances — Part 2: Power assisted stretcher
Medical electrical equipment — Part 1-2: General requirements for basic safety and
EN 60601-1-2:2015,
essential performance — Collateral Standard: Electromagnetic disturbances— Requirements and tests
(IEC 60601-1-2:2014 and A1:2020)
EN 62366-1:2015, Medical devices — Part 1: 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)
Document impacted by A1:2021.
Document impacted by AC:2015 and A1:2020.
Document impacted by A11:2021.
oSIST prEN 1865-6:2022
prEN 1865-6:2022 (E)
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 chair
device designed to transfer a patient in a sitting position to the road ambulance, but not to be used to
transport a patient within the road ambulance
4 Requirements
4.1 General
These power assisted chairs shall be fitted with a powered mechanism to assist the descent and/or ascent
of steps in order to minimize the need for manual transportation of the patient and chair.
When power assisted chairs are operated and maintained in accordance with manufacturer instructions,
they should 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 in normal and single fault
condition.
The chair shall ensure that the operators are able to use the chair on stairs whilst maintaining good
ergonomics and posture (e.g. by handles, bars).
All equipment for the handling of patients shall be free of any sharp edges or deformation that could cause
injury to persons or damage to other equipment. The minimum radius should be 0,5 mm.
4.2 Dimensions
The dimensions of the power assisted chair in open position shall be as follows:
— The seat:
— minimum height of 300 mm, measured from the ground;
— maximum height of 550 mm, measured from the ground;
— minimum width of 330 mm;
— minimum depth of 350 mm;
— The backrest: minimum height of 395 mm, measured from the seat;
— minimum width of 300 mm.
4.3 Mass
The total mass (excluding patient restraint) shall be not more than 32 kg.
The mass should be as low as possible.
oSIST prEN 1865-6:2022
prEN 1865-6:2022 (E)
4.4 Loading capacity
The loading capacity shall be a minimum of 200 kg.
4.5 Frame
The frame of the power assisted chair shall be a sturdy, lightweight construction. It shall be furnished
with 2 non-slip lift points on the lower frame, and 2 non-slip lift points on the top frame. It shall also have
a footrest and a minimum of two wheels of a diameter 100 mm minimum at the rear. It shall be possible
to store the power assisted chair in a folded position.
4.6 Power source
a) The chair travel mechanism shall have an integral safety feature to prevent the chair from uncontrolled
ascent / descent. An override system shall be provided to allow the chair to be used manually in the
event of power loss. The override system shall be easily accessible to the operator(s).
b) If a battery is fitted it shall be supplied with a facility to charge from both the vehicle voltage or from
an external AC power supply. The system shall also indicate the battery power condition. In case of
power loss a second battery combined with a charger shall be available.
c) The operating controls shall be clearly and permanently labelled, preferably with graphical symbols,
indicating their positions and settings according to EN 60601-1-2:2015 and EN 62366-1:2015.
4.7 Seat and Backrest
The patient seat and backrest shall be made of a strong material which is bacteria resistant, fungi
resistant, stain resistant, putrid resistant, easy to clean, washable, waterproof and petrol-oil resistant.
4.8 Restraint system
Patient restraint-systems shall secure the patient, but at the same time shall permit treatment of the
patient. Carrying patients down stairs would require a system designed to avoid patient movement side-
to-side and up-and-down, forward from pelvis and forward from shoulders.
All restraint systems shall have a quick-release.
4.9 Flammability — toxicity burning gases
There shall be no progressive smoldering or flaming ignition when tested in accordance with
EN 597-1:2015.
4.10 Deformation of the frame
There shall be no remaining deformation of the frame when tested in accordance with prEN 1865-2:2022,
5.1.
4.11 Locking
The hinges and locks shall not open spontaneously or bend.
4.12 Deformation of the backrest lying-sitting area
There shall be no remaining deformation of the backrest and lying-sitting area when tested in accordance
with EN 1865-1:2010+A1:2015, 5.1.
oSIST prEN 1865-6:2022
prEN 1865-6:2022 (E)
5 Marking
The foldable transfer chair covered by this European Standard shall be labelled in accordance with
EN ISO 15223-1:2021 and EN ISO 20417:2021.
oSIST prEN 1865-6:2022
prEN 1865-6:2022 (E)
Annex ZA
(informative)
Relationship between this European standard and th
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.