EN 1865-6:2024

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.

Patiententransportmittel im Rettungsdienstfahrzeug - Teil 6: Kraftunterstützte Patiententransportstühle

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 spécifie les exigences minimales pour la conception et les performances des chaises motorisées, 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: Pogonski električni stoli

Ta dokument določa minimalne zahteve glede oblike in zmogljivosti pogonskih električnih stolov, ki se uporabljajo za prevoz pacientov do reševalnega vozila in/ali iz njega. Njegov namen je zagotoviti varnost pacienta in čim bolj zmanjšati fizični napor osebja pri ravnanju s to opremo.

General Information

• Status: Published
• Publication Date: 22-Oct-2024
• 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: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 23-Oct-2024
• Due Date: 14-Mar-2024
• Completion Date: 23-Oct-2024
• 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
• Mandate: M/575 AMD 2 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medicial devices in support of Regulation (EU) 2017746
• Ref Project: SIST EN 1865-6:2024 - Patient handling equipment used in ambulances - Part 6: Powered chairs

Overview

EN 1865-6:2024 is a European standard developed by CEN that specifies the minimum design and performance requirements for powered chairs used in ambulances for patient handling. This standard focuses on power assisted chairs designed to transport patients to and from road ambulances, aiming to enhance patient safety while minimizing the physical effort required from emergency responders.

The powered chair covered by this standard is equipped with mechanisms to assist with descending and ascending steps, ensuring ergonomic operation for staff and secure conveyance of patients. EN 1865-6:2024 is part of the larger EN 1865 series which covers diverse patient handling equipment used in ambulances.

Key Topics

• Scope and Application
  Specifies requirements for power assisted chairs used outside ambulances to transfer patients safely and efficiently.

• Safety and Risk Reduction
  Chairs must present no high-level risks when used according to manufacturer instructions. This includes ergonomic handles and bars to maintain correct posture during operation.

• Dimensions and Weight

  • Seat height: 300mm to 550mm
  • Seat width: minimum 330mm
  • Seat depth: minimum 350mm
  • Backrest height: minimum 395mm
  • Backrest width: minimum 300mm
  • Maximum mass: 32 kg (excluding restraints), with a loading capacity of at least 200 kg.

• Robust Frame Design
  Features include a sturdy yet lightweight frame with non-slip lift points, a footrest, and wheels (minimum 100 mm diameter). The chair must be foldable for storage.

• Power Source and Controls
  Incorporates integral safety features to prevent uncontrolled movements and includes an override for manual use if power is lost. Battery charging from vehicle voltage or external AC supply is required, complemented by battery status indication.

• Patient Comfort and Hygiene
  Seat and backrest materials must resist bacteria, fungi, stains, and liquids, and be easy to clean and waterproof.

• Restraint Systems
  Secure the patient firmly while allowing medical treatment and facilitating safe stair transport. All restraint mechanisms must include quick-release features.

• Fire Safety and Durability
  Compliance with EN 597-1:2015 ensures no progressive smoldering or flaming ignition. The chair must endure load tests simulating patient carriage without permanent deformation or failure.

• Marking and Labelling
  Must meet EN ISO 15223-1:2021 and EN ISO 20417:2021 requirements for manufacturer information and symbols.

• Compliance with EU Regulations
  Aligned with General Safety and Performance Requirements of EU Regulation 2017/745 on medical devices.

Applications

• Emergency Medical Services (EMS)
  Used by ambulance teams to transport patients safely and ergonomically from scenes to vehicles, especially where stairs or uneven surfaces complicate manual transport.

• Patient Transport in Road Ambulances
  Facilitates loading and unloading patients while reducing physical strain on medical personnel.

• Specialized Patient Handling in Confined Spaces
  Designed for use in narrow or difficult environments where powered assistance improves maneuverability and safety.

• Healthcare Facilities with Ambulance Services
  Ensures standardized, reliable equipment for emergency patient handling during hospital transfers.

Related Standards

• EN 1865-1 to EN 1865-7 Series
  Covers other patient handling devices such as stretchers, power assisted stretchers, foldable transfer chairs, stretcher supports, and isolation transport systems.

• EN 597-1:2015
  Specifies fire safety requirements including ignitability tests on mattress and upholstery materials.

• EN 60601-1-2:2015
  Addresses electromagnetic compatibility requirements for medical electrical equipment.

• EN 62366-1:2015
  Focuses on usability engineering applied to medical devices.

• EN ISO 15223-1:2021 & EN ISO 20417:2021
  Define graphical symbols and manufacturer information for medical device labeling.

Practical Benefits

• Enhances patient safety during ambulance transfers by standardizing powered chair features.
• Reduces physical strain and injury risk for ambulance personnel through ergonomic design and powered assistance.
• Ensures compatibility with EU medical device regulations, promoting reliability and quality.
• Facilitates easier maintenance and cleaning with resistant, hygienic materials.
• Supports emergency operations in challenging environments such as stairs or confined spaces.

By adhering to EN 1865-6:2024, manufacturers and EMS providers ensure powered chairs meet stringent safety, durability, and usability standards critical for effective patient handling in ambulance settings.

Standards Content (Sample)

SLOVENSKI STANDARD
01-december-2024
Oprema za ravnanje s pacienti v reševalnih vozilih - 6. del: Pogonski električni stoli
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: EN 1865-6:2024
ICS:
11.160 Prva pomoč 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.

EN 1865-6
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2024
EUROPÄISCHE NORM
ICS 11.160
English Version
Patient handling equipment used in ambulances - Part 6:
Powered chairs
Équipements pour le transport de patients dans les Krankentransportmittel im Krankenkraftwagen - Teil
ambulances - Part 6 : Chaise motorisée 6: Kraftunterstützte Krankenstühle
This European Standard was approved by CEN on 12 August 2024.

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, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 1865-6:2024 E
worldwide for CEN national Members.

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 Permanent deformation of the frame and backrest lying-sitting area . 6
4.11 Locking . 7
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 . 11

European foreword
This document (EN 1865-6:2024) 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 April 2024, and conflicting national standards shall be
withdrawn at the latest by April 2024.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
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; (foreseen for revision)
• Part 2: Power assisted stretcher;
• Part 3: Heavy duty stretcher; (foreseen for revision)
• Part 4: Foldable patient transfer chair; (foreseen for revision)
• Part 5: Stretcher support; (foreseen for revision)
• Part 6: Powered chairs; (this document)
• Part 7: Isolation transport system (preliminary work item under development).
This document has been prepared under a standardization request addressed to CEN by the European
Commission. The Standing Committee of the EFTA States subsequently approves these requests for its
Member States.
For the relationship with EU Legislation, see informative Annex ZA, which is an integral part of this
document.
Any feedback and questions on this document should be directed to the users’ national standards body.
A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organisations 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, Republic of North
Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the United
Kingdom.
1 Scope
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.
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 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 )
EN 62366-1:2015, Medical devices — Part 1: Application of usability engineering to medical devices
(IEC 62366-1:2015 )
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)
EN ISO 20417:2021, Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021,
Corrected version 2021-12)
As impacted by EN 60601-1-2:2015/A1:2021.
As impacted by IEC 60601-1-2:2014/AMD1:2020.
As impacted by EN 60601-1-2:2015/AC:2015, EN 60601-1-2:2015/AC:2016-09 and
EN 60601-1-2:2015/A1:2020.
As impacted by IEC 62366-1:2015/COR1:2016 and IEC 62366-1:2015/AMD1:2020.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
• ISO Online browsing platform: available at https://www.iso.org/obp/
• IEC Electropedia: available at https://www.electropedia.org/
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 as far as possible.
The chair shall ensure that the operators are able to use the chair on stairs whils
...