EN 12184:2022

Electrically powered wheelchairs, scooters and their chargers - Requirements and test methods

This document specifies requirements and test methods for electrically powered wheelchairs, with a maximum speed not exceeding 20 km/h, intended to carry one person of mass not less than 25 kg and not greater than 300 kg, including
- electrically powered scooters with three or more wheels,
- manual wheelchairs with an add-on electrically powered drive system,
- handrim-activated power-assisted wheelchairs,
- electrically powered stand-up wheelchairs,
- wheelchairs with a pivot drive wheel unit, and
- push-assist wheelchairs.
This document does not apply to balancing wheelchairs, custom-made electrically powered wheelchairs or electrically powered wheelchairs intended for use in sports.
This document also specifies requirements and test methods for manual wheelchairs with electrically powered ancillary equipment.

Elektrorollstühle, Scooters und zugehörige Ladegeräte - Anforderungen und Prüfverfahren Elektrorollstühle, Scooter und zugehörige Ladegeräte - Anforderungen und Prüfverfahren

Dieses Dokument legt Anforderungen und Prüfverfahren für Elektrorollstühle mit einer Höchst-geschwindigkeit von 20 km/h fest, die für die Beförderung einer Person mit einem Gewicht von mindestens 25 kg und einem Höchstgewicht von 300 kg bestimmt sind, einschließlich:
   Elektromobile mit drei oder mehr Rädern;
   muskelkraftbetriebene Rollstühle mit elektrischem Zusatzantrieb;
   mit Greifreifen betätigte kraftunterstützte Rollstühle;
   elektrischer Aufrichtrollstuhl;
   Rollstühle mit Achsenantriebseinheit; und
   Rollstühle mit Schiebehilfe.
Dieses Dokument ist nicht anzuwenden für selbstbalancierende Rollstühle, kundenspezifisch angefertigte Elektrorollstühle oder für sportliche Aktivitäten vorgesehene Elektrorollstühle.
Dieses Dokument legt auch Anforderungen an und Prüfverfahren für muskelkraftbetriebene Rollstühle mit elektrischem Zusatzantrieb fest.

Fauteuils roulants électriques, scooters et leurs chargeurs - Exigences et méthodes d'essai

Le présent document spécifie les exigences et les méthodes d’essai relatives aux fauteuils roulants électriques dont la vitesse maximale ne dépasse pas 20 km/h et prévus pour transporter une personne dont la masse n’est pas inférieure à 25 kg et n’excède pas 300 kg, y compris :
   les scooters électriques à trois roues ou plus ;
   les fauteuils roulants à propulsion manuelle équipés d’un système de conduite électrique ;
   les fauteuils roulants à propulsion assistée activée par mains courantes ;
   les fauteuils roulants verticalisateurs électriques ;
   les fauteuils roulants équipés d’un module avec roue motrice pivotante ;
   les fauteuils roulants à pousser équipés d’un système d’aide à la propulsion.
Le présent document ne s’applique pas aux fauteuils roulants gyroscopiques, ni aux fauteuils roulants électriques sur mesure ni aux fauteuils roulants électriques prévus pour la pratique sportive.
Le présent document spécifie également les exigences et méthodes d’essai pour les fauteuils roulants à propulsion manuelle dotés d’un équipement électrique auxiliaire.

Invalidski vozički na električni pogon, skuterji in njihovi polnilniki - Zahteve in preskusne metode

Ta dokument določa zahteve in preskusne metode za invalidske vozičke na električni pogon, katerih največja hitrost ne presega 20 km/h in ki so namenjeni za eno osebo s težo do 300 kg, vključno s/z:
–   skuterji na električni pogon s tremi kolesi ali več;
–   invalidskimi vozički z ročnim upravljanjem z vgrajenim pogonskim sistemom;
–   invalidskimi vozički s pomožnim pogonom na kolesnem obroču;
–   invalidskimi vozički na električni pogon z možnostjo stoječega položaja;
–   invalidskimi vozički s funkcijo uravnoteženja;
–   invalidskimi vozički z vrtljivo pogonsko kolesno enoto; ter
–   invalidskimi vozički, ki jih upravlja pomočnik.
Ta dokument se ne uporablja za invalidske vozičke na električni pogon, izdelane po meri, ali invalidske vozičke na električni pogon, namenjene za uporabo pri športu.
Ta dokument določa tudi zahteve in preskusne metode za invalidske vozičke z ročnim upravljanjem z električno pomožno opremo.

General Information

• Status: Published
• Publication Date: 06-Sep-2022
• ICS: 11.180.10 - Aids and adaptation for moving
• Technical Committee: CEN/TC 293 - Technical aids for disabled persons
• Drafting Committee: CEN/TC 293/WG 9 - Wheelchairs - Revision of EN 12183 and EN 12184
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 07-Sep-2022
• Due Date: 07-Oct-2021
• Completion Date: 07-Sep-2022
• 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: SIST EN 12184:2022 - Electrically powered wheelchairs, scooters and their chargers - Requirements and test methods

Relations

• Replaces: EN 12184:2014 - Electrically powered wheelchairs, scooters and their chargers - Requirements and test methods
• Effective Date: 15-May-2019

Overview

EN 12184:2022 (identical to EN 12184:2022) specifies requirements and test methods for electrically powered wheelchairs, scooters and their chargers. It applies to electrically powered devices with a maximum speed up to 20 km/h intended to carry one person weighing between 25 kg and 300 kg. Covered product types include electrically powered scooters (3+ wheels), manual wheelchairs with add‑on drives, handrim‑activated power‑assisted wheelchairs, stand‑up wheelchairs, pivot‑drive wheelchairs and push‑assist wheelchairs. Exclusions include balancing wheelchairs, custom‑made electrically powered wheelchairs and wheelchairs intended for sports.

Key topics and technical requirements

This standard addresses safety, performance and verification across design, components and electrical systems. Major technical topics include:

• Risk management and intended performance - requirements for identifying hazards and documenting performance claims.
• Test apparatus and test methods - procedures for measuring driving characteristics, static/impact/fatigue strength and climatic performance.
• Component properties - requirements for foot supports, arm supports, tyres, seating and means of posture support.
• Propulsion and braking systems - control, braking functions, freewheel devices and emergency measures.
• Electrical systems and chargers - circuit protection, battery chargers, charging connectors, battery enclosures, emergency stop, lighting and software considerations; includes lithium cell/battery references.
• Operations and controls - occupant and assistant controls, operating forces and occupied seating adjustments.
• Information and labelling - pre‑sale, user and service information, plus labelling requirements and required test reports.
• Normative/ancillary material - annexes with recommended dimensions, lighting/reflector guidance, hazardous substances and changes from the previous edition.

Referenced standards include EN 12183 (manual wheelchairs), EN 60601‑1 and battery safety standards (e.g., EN 62133‑2), among others.

Practical applications - who uses EN 12184:2022

• Manufacturers and designers - to design compliant electrically powered wheelchairs and scooters and select compliant components (batteries, chargers, brakes).
• Testing laboratories and conformity assessors - to carry out standardized performance and safety testing and prepare test reports.
• Procurement teams and clinical purchasers - to specify safety, durability and interoperability requirements for assistive devices.
• Service and maintenance providers - to understand required service information, labelling and safety features (e.g., emergency stop, battery handling).
• Regulators and certification bodies - to evaluate conformity with European safety practice and align with medical device requirements where applicable.

Related standards

• EN 12183:2022 (Manual wheelchairs)
• EN 62133‑2 (lithium battery safety)
• EN 60601 series (medical electrical equipment)
  Use EN 12184:2022 when specifying, testing or certifying electrically powered wheelchairs, scooters and chargers to ensure consistent safety and performance across the supply chain.

Standards Content (Sample)

SLOVENSKI STANDARD
01-november-2022
Nadomešča:
SIST EN 12184:2014
Invalidski vozički na električni pogon, skuterji in njihovi polnilniki - Zahteve in
preskusne metode
Electrically powered wheelchairs, scooters and their chargers - Requirements and test
methods
Elektrorollstühle, Scooters und zugehörige Ladegeräte - Anforderungen und
Prüfverfahren
Fauteuils roulants électriques, scooters et leurs chargeurs - Exigences et méthodes
d'essai
Ta slovenski standard je istoveten z: EN 12184:2022
ICS:
11.180.10 Pripomočki in prilagoditve za Aids and adaptation for
gibanje moving
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN 12184
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2022
EUROPÄISCHE NORM
ICS 11.180.10 Supersedes EN 12184:2014
English Version
Electrically powered wheelchairs, scooters and their
chargers - Requirements and test methods
Fauteuils roulants électriques, scooters et leurs Elektrorollstühle, Scooters und zugehörige Ladegeräte
chargeurs - Exigences et méthodes d'essai - Anforderungen und Prüfverfahren
This European Standard was approved by CEN on 17 July 2022.

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
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 12184:2022 E
worldwide for CEN national Members.

Contents Page
European foreword . 4
Introduction . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 8
4 Test apparatus. 9
5 Type classes . 10
6 General requirements . 11
6.1 Risk management . 11
6.2 Intended performance and technical documentation . 11
6.3 Clinical evaluation and investigation. 11
6.4 Wheelchairs that can be dismantled . 11
6.5 Single-use fasteners . 11
6.6 Biocompatibility and toxicity . 12
6.7 Contaminants and residues . 12
6.8 Infection and microbiological contamination . 12
6.9 Overflow, spillage, leakage, and ingress of liquids . 13
6.10 Safety of moving parts . 14
6.11 Prevention of traps for parts of the human body . 15
6.12 Folding and adjusting mechanisms . 16
6.13 Surfaces, corners, edges and protruding parts . 16
6.14 Ergonomic principles . 17
6.15 General modifications to normative references . 17
6.16 Applicable provisions for specified types of wheelchair . 17
6.17 Recommendations . 17
7 Preparation for testing . 17
7.1 General . 17
7.2 Test dummy . 18
7.3 Human test occupant . 18
8 Wheelchair performance . 18
8.1 Driving characteristics . 18
8.2 Static, impact and fatigue strength . 21
8.3 Wheelchairs for use as seats in motor vehicles . 21
8.4 Climatic performance . 22
9 Component properties . 22
9.1 Foot supports, lower leg support assemblies and arm supports . 22
9.2 Component mass . 24
9.3 Pneumatic tyres . 24
9.4 Means for maintaining a sitting posture . 24
9.5 Resistance to ignition . 24
10 Propulsion and braking systems . 25
10.1 Means for operating brakes . 25
10.2 Braking functions . 26
10.3 Freewheel device . 29
11 Operations . 29
11.1 Operations intended to be carried out by the occupant and/or assistant . 29
11.2 Controls intended for operation by the occupant . 30
11.3 Controls intended for operation by an assistant . 30
11.4 Assistant control unit, push handles and handgrips . 31
11.5 Operating forces . 32
11.6 Occupied seating adjustments . 33
12 Electrical systems . 33
12.1 General requirements . 33
12.2 Circuit protection . 33
12.3 Battery chargers. 34
12.4 Charging connector . 35
12.5 Battery enclosures and containers . 35
12.6 Emergency stop . 35
12.7 Lighting . 36
12.8 Switching off while driving. 36
12.9 Software . 36
12.10 Lithium cells and batteries . 36
12.11 Remote control . 36
13 Information supplied by the manufacturer . 37
13.1 General . 37
13.2 Pre-sale information . 37
13.3 User information . 38
13.4 Service information . 39
13.5 Labelling . 39
14 Test report, tables and figures . 40
Annex A (informative) Recommendations for dimensions and manoeuvring space of
electrically powered wheelchairs. 49
Annex B (informative) Recommended design features . 51
Annex C (informative) Recommendations for lighting and reflectors . 55
Annex D (informative) EN 12184 and rail interoperability . 57
Annex E (informative) Recommendations for safety in freewheel mode . 58
Annex F (informative) Hazardous substances . 60
Annex G (normative) Applicable provisions for particular types of wheelchair . 66
Annex H (informative) Technical changes from the previous edition of EN 12184 . 73
Bibliography . 75

European foreword
This document (EN 12184:2022) has been prepared by Technical Committee CEN/TC 293 “Assistive
products and accessibility”, the secretariat of which is held by SIS.
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 March 2023, and conflicting national standards shall
be withdrawn at the latest by May 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 document supersedes EN 12184:2014.
Annex H provides details of the significant technical changes between this document and
EN 12184:2014.
Requirements and test methods for manual wheelchairs are specified in EN 12183.
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.
Introduction
This is the fifth edition of this European Standard. The previous editions were published in 1999, 2006,
2009 and 2014.
Where this document does not apply to particular wheelchairs, contracting parties should consider
whether appropriate parts of this document can be used. Manufacturers can also consider whether
appropriate parts of this document can be used to assess the performance of their products against the
general safety and performance requirements of Regulation (EU) 2017/745 [21] of 5 April 2017 on
medical devices.
1 Scope
This document specifies requirements and test methods for electrically powered wheelchairs, with a
maximum speed not exceeding 20 km/h, intended to carry one person of mass not less than 25 kg and
not greater than 300 kg, including
— electrically powered scooters with three or more wheels,
— manual wheelchairs with an add-on electrically powered drive system,
— handrim-activated power-assisted wheelchairs,
— electrically powered stand-up wheelchairs,
— wheelchairs with a pivot drive wheel unit, and
— push-assist wheelchairs.
This document does not apply to balancing wheelchairs, custom-made electrically powered wheelchairs
or electrically powered wheelchairs intended for use in sports.
This document also specifies requirements and test methods for manual wheelchairs with electrically
powered ancillary 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 614-1:2006+A1:2009, Safety of machinery - Ergonomic design principles - Part 1: Terminology and
general principles
EN 1021-2:2014, Furniture - Assessment of the ignitability of upholstered furniture - Part 2: Ignition
source match flame equivalent
EN 12183:2022, Manual wheelchairs - Requirements and test methods
EN 15194:2017, Cycles - Electrically power assisted cycles - EPAC Bicycles
EN 60335-2-29:2004, Household and similar electrical appliances - Safety - Part 2-29: Particular
requirements for battery chargers (IEC 60335-2-29:2002)
EN 60601-1:2006, Medical electrical equipment - Part 1: General requirements for basic safety and
essential performance (IEC 60601-1:2005)
Secondary cells and batteries containing alkaline or other non-acid electrolytes -
EN 62133-2:2017,
Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in
portable applications - Part 2: Lithium systems

EN 60335-2-29:2004 is amended by EN 60335-2-29:2004/A2:2010 and EN 60335-2-29:2004/A11:2018.
EN 60601-1:2006 is amended by EN 60601-1:2006/A2:2021, EN 60601-1:2006/A12:2014 and EN 60601-
1:2006/A1:2013; and corrected by EN 60601-1:2006/corrigendum Mar. 2010.
EN 62133-2:2017 is amended by EN 62133-2:2017/A1:2021.
EN 62304:2006, Medical device software - Software life-cycle processes (IEC 62304:2006)
EN ISO 10993-1:2020, Biological evaluation of medical devices - Part 1: Evaluation and testing within a
risk management process (ISO 10993-1:2018, including corrected version 2018-10)
EN ISO 14155:2020, Clinical investigation of medical devices for human subjects - Good clinical practice
(ISO 14155:2020)
EN ISO 14971:2019, Medical devices - Application of risk management to medical devices
(ISO 14971:2019)
EN ISO 20417:2021, Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021,
Corrected version 2021-12)
EN ISO 22442-1:2020, Medical devices utilizing animal tissues and their derivatives - Part 1: Application
of risk management (ISO 22442-1:2020)
ISO 7176-1:2014, Wheelchairs — Part 1: Determination of static stability
ISO 7176-2:2017, Wheelchairs — Part 2: Determination of dynamic stability of electrically powered
wheelchairs
ISO 7176-3:2012, Wheelchairs — Part 3: Determination of effectiveness of brakes
ISO 7176-4:2008, Wheelchairs — Part 4: Energy consumption of electric wheelchairs and scooters for
determination of theoretical distance range
ISO 7176-6:2018, Wheelchairs — Part 6: Determination of maximum speed of electrically powered
wheelchairs
ISO 7176-8:2014, Wheelchairs — Part 8: Requirements and test methods for static, impact and fatigue
strengths
ISO 7176-9:2009, Wheelchairs — Part 9: Climatic tests for electric wheelchairs
ISO 7176-10:2008, Wheelchairs — Part 10: Determination of obstacle-climbing ability of electrically
powered wheelchairs
ISO 7176-11:2012, Wheelchairs — Part 11: Test dummies
ISO 7176-13:1989, Wheelchairs — Part 13: Determination of coefficient of friction of test surfaces
ISO 7176-14:2008, Wheelchairs — Part 14: Power and control systems for electrically powered
wheelchairs and scooters — Requirements and test methods
ISO 7176-19:2008, Wheelchairs — Part 19: Wheeled mobility devices for use as seats in motor vehicles
ISO 7176-21:2009, Wheelchairs — Part 21: Requirements and test methods for electromagnetic
compatibility of electrically powered wheelchairs and scooters, and battery chargers

EN 62304:2006 is amended by EN 62304:2006/A1:2015.
EN ISO 14971:2019 is amended by EN ISO 14971:2019/A11:2021.
ISO 7176-19:2008 is amended by ISO 7176-19:2008/AMD 1:2015.
ISO 7176-22:2014, Wheelchairs — Part 22: Set-up procedures
ISO 7176-25:2013, Wheelchairs — Part 25: Batteries and chargers for powered wheelchairs
ISO 7176-26:2007, Wheelchairs — Part 26: Vocabulary
ISO 8191-2:1988, Furniture — Assessment of ignitability of upholstered furniture — Part 2: Ignition
source: match-flame equivalent
ISO 16840-10:2021, Wheelchair seating — Part 10: Resistance to ignition of postural support devices —
Requirements and test method
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 7176-26:2007,
ISO 7176-14:2008 and the following apply.
NOTE The definitions of wheelchair and electrically powered wheelchair in ISO 7176-26:2007 are replaced
by 3.5 below.
ISO and IEC maintain terminological 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
freewheel device
means for disengaging the parking brake and/or the drive of a wheelchair to allow it to be manoeuvred
manually
3.2
loaded wheelchair
wheelchair loaded with a test dummy or loaded with a human test occupant
Note 1 to entry: Instructions for selecting and fitting a test dummy or a human test occupant are given in Clause 7.
3.3
non-spillable battery
battery from which the electrolyte cannot escape whatever its orientation
3.4
rated slope
maximum slope specified by the manufacturer on which the wheelchair meets the requirements for
dynamic stability, static stability, braking performance and slope climbing, traversing and descending
3.5
wheelchair
electrically powered wheelchair
wheeled mobility device, intended to transport a seated occupant who has impaired mobility, that is
propelled by one or more electric motors controlled by the occupant or by an assistant
Note 1 to entry: An electrically powered wheelchair can have electronic control of speed and electronic or manual
control of direction.
Note 2 to entry: The definition includes scooters.
3.6
pre-sale information
publicly available information provided by the manufacturer about the wheelchair
Note 1 to entry: A specification sheet is part of the pre-sale information.
3.7
push-assist wheelchair
wheelchair intended to be partly propelled, braked, and/or steered by the manual effort of an assistant
EXAMPLE Wheelchair propelled by an electric motor and steered by forces applied to the push handles.
3.8
pivot drive wheel unit
integrated propulsion system comprising a pivot drive wheel, a battery and a controller
3.9
custom-made electrically powered wheelchair
electrically powered wheelchair designed and manufactured for use by a named individual occupant
that is not an adaptation of a mass-produced design
4 Test apparatus
4.1 Horizontal test plane, of sufficient length that the wheelchair can reach its maximum speed and
decelerate to a stop. The horizontal test plane shall be dry, free from ice, and free from loose material
(such as gravel). The horizontal test plane shall include a test area consisting of a continuous, flat, rigid
surface with a coefficient of friction as specified in ISO 7176-13:1989, inclined to the horizontal at less
than 0,5°. The surface of the test area shall lie between two imaginary parallel planes 5 mm apart per
1 000 mm of extension in any direction and 50 mm apart per 6 000 mm of extension in any direction.
The test area shall be of sufficient size to complete the specified manoeuvres, except for acceleration
and deceleration, which may occur outside the test area when they do not affect the test results.
The requirements for the test area do not apply to the parts of the horizontal test plane outside it, but
the properties of all parts of the horizontal test plane, including any transitions at the edges of the test
area, shall be sufficiently similar that the test results are not affected.
4.2 Inclined test plane, of sufficient length that the wheelchair can reach its maximum speed and
decelerate to a stop. The inclined test plane shall be dry, free from ice, and free from loose material
(such as gravel). The inclined test plane shall include a test area consisting of a continuous, flat, rigid
surface with a coefficient of friction as specified in ISO 7176-13:1989, inclined to the horizontal at the
specified angle ±0,5°. The surface of the test area shall lie between two imaginary parallel planes 5 mm
apart per 1 000 mm of extension in any direction and 50 mm apart per 6 000 mm of extension in any
direction. The test area shall be of sufficient size to complete the specified manoeuvres, except for
acceleration and deceleration, which may occur outside the test area when they do not affect the test
results.
The requirements for the test area do not apply to the parts of the inclined test plane outside it, but the
properties and slope of all parts of the inclined test plane, including any transitions at the edges of the
test area, shall be sufficiently similar that the test results are not affected.
See Figure 6.
The inclined test plane may have a fixed or adjustable slope. Where the slope is fixed, it can be
necessary to use more than one inclined test plane.
4.3 Means to apply a force between 25 N and 200 N with an accuracy of ±5 % and with a rate of
application less than 5 N/s.
4.4 Means to measure force in increments of 1 N in the range 0 N to 200 N with an accuracy of ±5 %.
4.5 Means to measure speed between 0 km/h and 25 km/h to an accuracy of ±5 %.
4.6 Means to measure distance in the range 0 m to 5 m with an accuracy of ±1 mm or ±2 %,
whichever is the greater.
4.7 Supplementary weights to add to a human test occupant to achieve the maximum occupant
mass specified by the manufacturer and to achieve a similar mass distribution to the dummy specified
in 4.9.
4.8 Test block capable of supporting the loaded wheelchair under each of its wheels, with length and
width 200 mm ± 10 mm, thickness given in Table 3 'ground unevenness' and corner radii greater than
2,0 mm. For the two large surfaces, the whole of each surface shall lie between two imaginary
horizontal planes 1 mm apart. The coefficient of friction shall be as specified in ISO 7176-13:1989.
4.9 Test dummy, of appropriate mass, as specified in ISO 7176-11:2012.
4.10 Means to measure torque in the range 0,5 Nm to 10 Nm with an accuracy of ±2 %.
4.11 Means to measure angles to an accuracy of ±0,1°.
4.12 Means to move a brake lever smoothly for 60 000 cycles at a frequency of not more than 0,5 Hz.
4.13 Means to measure elapsed time in the range 0 s to 30 s with an accuracy of ±1 s.
5 Type classes
Wheelchairs shall be classified in one or more of the following three classes, depending upon their
intended use:
— Class A: wheelchairs intended for driving on flat horizontal surfaces and gentle slopes;
— Class B: wheelchairs intended for driving on moderately uneven surfaces and on moderate slopes,
in addition to the intended use described for Class A;
— Class C: wheelchairs intended for driving on uneven terrain and on steeper slopes, in addition to
the intended uses described for Classes A and B.
Requirements specific to each class are given in Table 3.
NOTE 1 Scooters are included within the classes above.
NOTE 2 Some requirements and exceptions specific to Class A are given in the text.
6 General requirements
6.1 Risk management
A risk management process shall be performed in accordance with EN ISO 14971:2019 . For conformity
with this document, all elements of the risk management process specified in EN ISO 14971:2019 shall
be applied except:
— the planning for, and execution of, production and post-production monitoring
(EN ISO 14971:2019 , 4.1 fourth indent, 4.4 item g) and Clause 10); and
— periodic reviews of the suitability of the risk management process (EN ISO 14971:2019 , 4.2 third
paragraph).
6.2 Intended performance and technical documentation
a) The wheelchair shall have sufficient strength and durability to sustain all loads expected during
intended use. This shall be confirmed by using, where appropriate, references to relevant clinical
and scientific literature, strength and/or durability calculations, appropriate test standards and
their test results, in addition to the requirements given in this document.
b) The intended performance of the wheelchair, including, where appropriate, strength, durability and
tipping stability, shall be described in technical documentation which sets out its functional
characteristics, its application(s) and conditions of use.
c) The technical documentation shall include, where appropriate, references to relevant clinical and
scientific literature, any strength and/or life calculations, appropriate test standards and their test
results.
6.3 Clinical evaluation and investigation
A clinical evaluation shall be conducted for the wheelchair.
If, as part of the product conformity assessment, the clinical evaluation requires a clinical investigation,
the clinical investigation shall conform to the requirements of EN ISO 14155:2020. A clinical evaluation
shall always be conducted before performing a clinical investigation.
NOTE Guidance for clinical evaluation is given in MEDDEV 2.7/1 [22].
6.4 Wheelchairs that can be dismantled
If it is intended that the wheelchair can be dismantled for storage or transportation, it shall not be
possible to reassemble the wheelchair in a manner that presents a hazard.
6.5 Single-use fasteners
If it is intended that the wheelchair can be dismantled for storage or transportation, the fasteners which
are loosened or removed to allow this dismantling shall not be single-use fasteners.
EXAMPLE Single-use fasteners include wood screws and self-tapping screws.
6.6 Biocompatibility and toxicity
Materials which come into contact with the human body shall be evaluated for biocompatibility in
accordance with EN ISO 10993-1:2020 as part of the risk management process (see 6.1).
The evaluation shall take into account the intended use, including, where appropriate, contact with the
occupant, an assistant, those involved in care of the occupant, and those involved in transportation and
storage of the wheelchair.
Wheelchairs shall be designed and manufactured to minimize the risks posed by substances leaking
from them. Special attention shall be given to substances which are carcinogenic, mutagenic or toxic to
reproduction and other substances of very high concern (SVHCs). The evaluation should follow the
guidance given in Annex F.
NOTE See Annex F for additional guidance.
6.7 Contaminants and residues
6.7.1 General
The requirements given in 6.7.2 apply to substances which are an integral part of the wheelchair or are
necessary for its function, such as oil and grease. The requirements do not apply to body fluids which
the wheelchair is intended to collect (e.g. as a stoma-care product).
6.7.2 Substances which can leak in intended use or in a fault condition
Where a substance can leak from the wheelchair in intended use or in a fault condition:
a) the substance shall be assessed for biocompatibility in accordance with EN ISO 10993-1:2020 as
part of the risk management process, and the assessment shall consider intended use, including,
where appropriate, contact with the occupant, an assistant, those involved in care of the occupant,
and those involved in transportation and storage of the wheelchair; or
b) the wheelchair shall have means of protection that minimizes the possibility of the substance
becoming a biological hazard.
NOTE Substances that can leak include lubricants and hydraulic fluids.
EXAMPLE A method of protection from a hazardous substance is to place batteries in a container made from
acid resistant material.
6.8 Infection and microbiological contamination
6.8.1 Cleaning and disinfection
If any parts of the wheelchair are intended to be cleaned, the method and suitable materials for cleaning
shall be described in the instructions for use.
If any parts of the wheelchair are intended to be disinfected, the method and suitable materials for
disinfection shall be described in the instructions for use.
NOTE For guidance, see B.2.7.
If any parts of the wheelchair are intended to be cleaned by automatic washing systems or hand-held jet
stream or steam washing, the details of the procedure, such as temperature, pressure, flow and pH
value of cleaning/rinsing solution, shall be described in the instructions for use. Where practicable, the
wheelchair shall be labelled with appropriate symbols to represent the method of cleaning.
6.8.2 Animal tissue
Where the wheelchair has been manufactured utilizing tissues of animal origin or their derivatives, the
process specified in EN ISO 22442-1:2020 shall be followed as part of the risk management process (see
6.1).
NOTE For guidance, see B.2.13.
6.9 Overflow, spillage, leakage, and ingress of liquids
6.9.1 Overflow
6.9.1.1 Requirements
If the wheelchair incorporates a reservoir or liquid storage chamber that can be overfilled or can
overflow in intended use, liquid overflowing from the reservoir or chamber shall not wet electrical
insulation or live parts which are liable to be adversely affected by such a liquid, nor shall a hazard be
created. Unless indicated by a marking or by the instructions for use, no hazard shall be created if the
wheelchair is tilted through an angle 15° greater than the maximum inclination that can occur during
intended use.
6.9.1.2 Test method
Fill the reservoir to the maximum level specified by the manufacturer and, if possible, add further liquid
+1
equal to % of the capacity of the reservoir or until the reservoir is full, whichever is the lesser
quantity.
+1
Tilt the wheelchair through an angle of ° to the horizontal in each direction, where a is the
a+ 15
( )
rated slope specified by the manufacturer (see 8.1.1). If necessary, refill the reservoir between tests.
Inspect the wheelchair, including any electrical insulation and any uninsulated live parts, to determine
whether the requirements have been met. For electrical insulation, in case of doubt, subject the
wheelchair to the dielectric strength test specified in EN 60601-1:2006 .
6.9.2 Spillage
6.9.2.1 Requirements
Wheelchairs requiring the handling of liquids in intended use shall be so constructed that spillage does
not wet parts that creates a hazard.
6.9.2.2 Test method
+5
Position the wheelchair on the horizontal test plane. Pour 200 ml water steadily on an arbitrary point
on the seat.
After the test, the wheelchair shall function as specified by the manufacturer.
6.9.3 Leakage
Wheelchairs shall be so constructed that liquid which can escape in single fault condition does not
create a hazard.
6.9.4 Ingress of liquids
6.9.4.1 Requirements
If liquid can enter an enclosure unintentionally, either there shall be a means for the liquid to escape
from the enclosure, or the liquid shall not create a hazard.
NOTE 1 See B.2.14.
NOTE 2 ISO 7176-9:2009 also covers ingress of liquids into enclosures. See 8.4.
6.9.4.2 Test method
Test whether the liquid can escape from an enclosure by adding liquid and then tilting the wheelchair
10° in each direction. If any liquid remains in the enclosure, test the wheelchair to determine whether it
is still functional, and determine whether the liquid can create a hazard.
6.10 Safety of moving parts
6.10.1 Squeezing
Unless the intended purpose of part of the wheelchair is to grip, cut, squeeze or provide a similar
function, or if the intended use cannot be achieved without a risk of squeezing:
a) any moving parts that constitute a hazard shall be provided with guards that cannot be removed
without the use of a tool; or
b) the gap between exposed parts of the wheelchair that move relative to each other shall be
maintained throughout the range of movement at less than the relevant minimum value or more
than the relevant maximum value specified in Table 1; or
c) if cords (ropes), chains or drive belts are used, either they shall be confined so that they cannot run
off or jump out of their guiding devices, or a hazardous situation shall be prevented by other
means; mechanical means used for this purpose shall not be removable without the use of a tool; or
d) the wheelchair shall incorporate a control device which enables the movement when it is operated
and stops the movement when it is released (e.g. a spring-loaded device that returns to the stop
position when released); or
e) the wheelchair shall incorporate means to detect that a person is in danger of being trapped and to
prevent injury automatically (e.g. by stopping the movement).
For moving parts that can cause squeezing, manufacturers shall take into consideration the part or
parts of the body that are at risk. It is necessary to specify the characteristics of the persons involved in
the intended use, so that the appropriate safe distances can be applied.
Table 1 — Safe distances between moving parts
To avoid Safe distances for adults Safe distances for children
Less than 8 mm or Less than 4 mm or
Finger traps
more than 25 mm more than 25 mm
Less than 35 mm or Less than 25 mm or
Foot traps
more than 120 mm more than 120 mm
Less than 120 mm or Less than 60 mm or
Head traps
more than 300 mm more than 300 mm
Less than 8 mm or Less than 8 mm or
Genitalia traps
more than 75 mm more than 75 mm

6.10.2 Mechanical wear
Parts subject to mechanical wear likely to create a hazard shall be accessible for inspection.
6.10.3 Emergency stopping functions
The requirements specified in 12.6 shall apply to moving parts of the body support system if there is a
risk that the occupant can be squeezed or that a single fault can create a hazard.
6.11 Prevention of traps for parts of the human body
6.11.1 Holes and clearances
Holes in, and clearances between stationary parts that are accessible to the occupant and/or assistant
during the intended use of the wheelchair shall be as specified in Table 2.
If the intended purpose of the wheelchair cannot be met without a hazard caused by the size of holes
and the clearance between stationary parts, a warning and instructions on how to control the risk shall
be provided in the instructions for use.
For stationary parts that can cause a trap, manufacturers shall take into consideration the parts of the
body that are at risk. It is necessary to specify the characteristics of the persons involved in the
intended use, so that the appropriate safe distances can be applied.
The design of parts that confine a hole or clearance shall take into consideration the forces that can be
applied in normal use.
NOTE Forces can cause holes or clearances to widen, which can lead to loss of conformity with the
requirements of Table 2.
The lower limits specified in Table 2 do not apply for holes with the shape of a keyhole, or for V-shaped
openings. When inspecting the wheelchair for traps for body parts any flexibility and/or elasticity of
adjacent parts shall be taken into account.
6.11.2 V-shaped openings
The risk of entrapment in V-shaped openings shall be addressed by the risk management process (see
6.1).
NOTE For guidance, see B.2.15.
Table 2 — Safe distances between stationary parts
To avoid Safe distances for adults Safe distances for children
Less than 8 mm or Less than 5 mm or
Finger traps
more than 25 mm more than 12 mm
Less than 35 mm or Less than 25 mm or
Foot traps
more than 100 mm more than 45 mm
Less than 120 mm or Less than 60 mm or
Head traps
more than 250 mm more than 250 mm
Less than 8 mm or Less than 8 mm or
Genitalia traps
more than 75 mm more than 75 mm
6.12 Folding and adjusting mechanisms
6.12.1 General
Folding and adjusting mechanisms can present a hazard if parts of the body can enter a gap between
parts and be trapped when the gap is closed.
If the wheelchair incorporates folding and/or adjusting mechanisms it shall conform to 6.12.2 and
6.12.3.
6.12.2 Locking mechanisms
Folding and adjusting mechanisms shall be capable of being securely locked when the wheelchair is in a
working configuration. They shall also be capable of being securely locked when folded if they
constitute a risk. The wheelchair shall fold in a safe manner.
6.12.3 Guards
Either:
a) the wheelchair shall incorporate means to protect the occupant from trap and/or squeeze hazards;
or
b) the gap between exposed parts of the wheelchair that move relative to each other shall be
maintained throughout the range of movement at less than the applicable minimum value or more
than the applicable maximum value set out in Table 1; or
c) if the intended purpose of the wheelchair cannot be met without a hazard such as squeezing, a
warning and instructions on how to control the risk shall be provided in the instructions for use.
The design of a guard shall take into consideration the forces that can be applied in normal use.
6.13 Surfaces, corners, edges and protruding parts
If not required for intended use, accessible edges, corners and surfaces of the wheelchair shall be
smooth and be free from burrs and sharp edges.
If not required for intended use, wheelchairs shall not have protruding parts. Where practicable,
protruding parts shall have
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