SIST EN 12183:2022

Manual wheelchairs - Requirements and test methods

This document specifies requirements and test methods for manual wheelchairs intended to carry one person of mass not less than 25 kg and not greater than 250 kg, including
- stand-up manual wheelchairs, and
- manual wheelchairs whose intended use includes showering and/or toileting.
This document does not apply to custom-made manual wheelchairs, manual wheelchairs intended for use in sports, or manual wheelchairs intended only for showering and/or toileting.
This document also specifies requirements and test methods for manual wheelchairs with electrically powered ancillary equipment.

Muskelkraftbetriebene Rollstühle - Anforderungen und Prüfverfahren

Dieses Dokument legt Anforderungen und Prüfverfahren für muskelkraftbetriebene Rollstühle fest, die für die Beförderung einer Person mit einem Gewicht von mindestens 25 kg und höchstens 250 kg bestimmt sind, einschließlich:
—   Aufsteh-Rollstühle, und
—   muskelkraftbetriebene Rollstühle, die die Zweckbestimmung für Duschen und/oder Toilettengang einschließen.
Dieses Dokument gilt nicht für kundenspezifisch angefertigte muskelkraftbetriebene Rollstühle, für sportliche Aktivitäten vorgesehene muskelkraftbetriebene Rollstühle oder für muskelkraftbetriebene Rollstühle, die ausschließlich für das Duschen und/oder den Toilettengang vorgesehen sind.
Dieses Dokument legt auch Anforderungen und Prüfverfahren für muskelkraftbetriebene Rollstühle mit elektrischem Zusatzantrieb fest.

Fauteuils roulants à propulsion manuelle - Exigences et méthodes d'essai

Le présent document spécifie des exigences et des méthodes d'essai relatives aux fauteuils roulants à propulsion manuelle conçus pour accueillir une personne dont la masse n'est pas inférieure à 25 kg et n'excède pas 250 kg, notamment
   les fauteuils roulants verticalisateurs à propulsion manuelle ; et
   les fauteuils roulants à propulsion manuelle prévus pour la douche et/ou la toilette.
Le présent document ne s'applique ni aux fauteuils roulants à propulsion manuelle fabriqués sur mesure ni aux fauteuils roulants à propulsion manuelle conçus pour le sport, ni aux fauteuils roulants à propulsion manuelle uniquement conçus pour la douche et/ou la toilette.
Le présent document spécifie également des exigences et des méthodes d'essai pour les fauteuils roulants à propulsion manuelle munis d'un équipement électrique auxiliaire.

Invalidski vozički z ročnim upravljanjem - Zahteve in preskusne metode

Ta dokument določa zahteve in preskusne metode za invalidske vozičke z ročnim upravljanjem, ki so namenjeni za eno osebo s težo do 250 kg, vključno z:
–   invalidskimi vozički z ročnim upravljanjem z možnostjo stoječega položaja; ter
–   invalidskimi vozički z ročnim upravljanjem, namenjenimi za tuširanje in/ali toaletno uporabo.
Ta dokument se ne uporablja za invalidske vozičke z ročnim upravljanjem, izdelane po meri, ali invalidske vozičke z ročnim upravljanjem, 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
• Public Enquiry End Date: 19-Oct-2020
• Publication Date: 09-Oct-2022
• ICS: 11.180.10 - Aids and adaptation for moving
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 04-Oct-2022
• Due Date: 09-Dec-2022
• Completion Date: 10-Oct-2022
• 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
• 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 12183:2022 - Manual wheelchairs - Requirements and test methods

Relations

• Replaces: SIST EN 12183:2014 - Manual wheelchairs - Requirements and test methods
• Effective Date: 01-Nov-2022

Overview

EN 12183:2022 - Manual wheelchairs: Requirements and test methods is a CEN European standard that defines safety, performance and testing requirements for mass‑produced manual wheelchairs intended to carry a single occupant with mass between 25 kg and 250 kg. The scope includes stand‑up wheelchairs and models whose intended use may include showering and/or toileting, and it also covers manual wheelchairs fitted with electrically powered ancillary equipment. It does not apply to custom‑made, sports, or showering‑only wheelchairs.

Key topics

This standard organizes practical requirements and test methods across product lifecycle and components. Major areas covered include:

• Risk management and intended performance (documentation, clinical evaluation, technical files)
• Preparation for testing, including selection and use of test dummies
• Stability and structural tests: static stability, static/impact/fatigue strength, tipping fatigue
• Braking and propulsion systems: brake effectiveness, braking functions, pushing force
• Component requirements: foot/arm supports, tyres, seating posture systems, resistance to ignition
• Operational safety: moving parts, folding/adjusting mechanisms, prevention of entrapment, ergonomic controls for occupant and assistant
• Hygiene and materials: biocompatibility, contaminants, infection control, liquid ingress and surface temperature
• Electrical ancillary equipment: requirements and test methods for electrically powered accessories
• Manufacturer information and labelling: pre‑sale specifications, user instructions, service/maintenance data, and test reporting

Applications and who uses it

EN 12183:2022 is essential for:

• Wheelchair manufacturers and product designers - for product development, type testing and conformity demonstration
• Test laboratories and certification bodies - to perform standardised performance and safety tests
• Procurement and specification writers - to define acceptance criteria for suppliers and tenders
• Clinical engineers, rehabilitation professionals and safety assessors - to understand capability, safe use limits and compatibility with assistive environments
• Regulatory and compliance teams - for alignment with EU medical device requirements and harmonized standards

Adopting EN 12183 helps ensure wheelchair safety, reliable performance, and consistent test evidence for market access in CEN member countries.

Related standards

Key normative references and complementary documents include:

• EN 12184:2022 (electrically powered wheelchairs and chargers)
• ISO/EN standards in the ISO 7176 series (stability, strength, test dummies, friction, vehicle seating)
• EN ISO 14971 (risk management) and EN ISO 10993‑1 (biological evaluation)

To obtain the full text and normative test procedures, consult your national standards body or the CEN/CENELEC Management Centre.

Standards Content (Sample)

SLOVENSKI STANDARD
01-november-2022
Nadomešča:
SIST EN 12183:2014
Invalidski vozički z ročnim upravljanjem - Zahteve in preskusne metode
Manual wheelchairs - Requirements and test methods
Muskelkraftbetriebene Rollstühle - Anforderungen und Prüfverfahren
Fauteuils roulants à propulsion manuelle - Exigences et méthodes d'essai
Ta slovenski standard je istoveten z: EN 12183:2022
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 12183
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2022
EUROPÄISCHE NORM
ICS 11.180.10 Supersedes EN 12183:2014
English Version
Manual wheelchairs - Requirements and test methods
Fauteuils roulants à propulsion manuelle - Exigences et Muskelkraftbetriebene Rollstühle - Anforderungen und
méthodes d'essai 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 12183:2022 E
worldwide for CEN national Members.

Contents Page
European foreword . 4
Introduction . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 7
4 Test apparatus . 8
5 General requirements . 9
5.1 Risk management . 9
5.2 Intended performance and technical documentation . 9
5.3 Clinical evaluation and investigation . 9
5.4 Wheelchairs that can be dismantled . 9
5.5 Single-use fasteners . 9
5.6 Biocompatibility and toxicity . 10
5.7 Contaminants and residues . 10
5.8 Infection and microbiological contamination . 10
5.9 Overflow, spillage, leakage, and ingress of liquids . 11
5.10 Safety of moving parts . 12
5.11 Prevention of traps for parts of the human body . 13
5.12 Folding and adjusting mechanisms . 13
5.13 Surfaces, corners, edges and protruding parts . 14
5.14 Ergonomic principles . 14
5.15 Applicable provisions for specified types of wheelchair . 15
5.16 Recommendations . 15
6 Preparation for testing . 15
6.1 General. 15
6.2 Test dummy . 15
7 Wheelchair performance . 15
7.1 Static stability . 15
7.2 Static, impact and fatigue strength . 16
7.3 Tipping fatigue strength . 16
7.4 Wheelchairs for use as seats in motor vehicles . 17
7.5 Surface temperature . 18
8 Component properties . 19
8.1 Foot supports, lower leg support assemblies and arm supports . 19
8.2 Component mass . 20
8.3 Pneumatic tyres . 20
8.4 Means for maintaining a sitting posture . 20
8.5 Resistance to ignition . 21
9 Propulsion and braking systems . 21
9.1 Means for operating brakes . 21
9.2 Braking functions. 23
9.3 Pushing force . 25
10 Operations . 26
10.1 Operations intended to be carried out by the occupant and/or assistant . 26
10.2 Controls intended for operation by the occupant . 26
10.3 Controls intended for operation by an assistant . 26
10.4 Push handles and handgrips . 27
10.5 Operating forces . 27
10.6 Seating adjustments for tilting and reclining . 28
11 Electrical systems — Electrically powered ancillary equipment . 29
12 Information supplied by the manufacturer . 29
12.1 General . 29
12.2 Pre-sale information . 29
12.3 User information . 29
12.4 Service information . 30
12.5 Labelling . 31
13 Test report and figures . 31
Annex A (informative) Recommendations for dimensions and manoeuvring space of
manual wheelchairs. 37
Annex B (informative) Recommended design features . 39
Annex C (informative) EN 12183 and rail interoperability . 42
Annex D (informative) Recommendations for caster stem angle . 43
Annex E (informative) Hazardous substances . 44
Annex F (normative) Applicable requirements for particular types of manual wheelchair . 49
Annex G (informative) Technical changes from the previous edition of EN 12183. 51
Bibliography . 52

European foreword
This document (EN 12183:2022) 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 12183:2014.
Annex G provides details of the significant technical changes between this document and
EN 12183:2014.
Requirements and test methods for electrically powered wheelchairs are specified in EN 12184.
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 [18] of 5 April 2017 on
medical devices.
1 Scope
This document specifies requirements and test methods for manual wheelchairs intended to carry one
person of mass not less than 25 kg and not greater than 250 kg, including
— stand-up manual wheelchairs, and
— manual wheelchairs whose intended use includes showering and/or toileting.
This document does not apply to custom-made manual wheelchairs, manual wheelchairs intended for
use in sports, or manual wheelchairs intended only for showering and/or toileting.
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 12184:2022, Electrically powered wheelchairs, scooters and their chargers - Requirements and test
methods
EN ISO 14971:2019 , Medical devices - Application of risk management to medical devices
(ISO 14971:2019)
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 13732-1:2008, Ergonomics of the thermal environment - Methods for the assessment of human
responses to contact with surfaces - Part 1: Hot surfaces (ISO 13732-1:2006)
EN ISO 14155:2020, Clinical investigation of medical devices for human subjects - Good clinical practice
(ISO 14155:2020)
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 7176-3:2012, Wheelchairs — Part 3: Determination of effectiveness of brakes

EN ISO 14971:2019 is amended by EN ISO 14971:2019/A11:2021.
ISO 7176-8:2014, Wheelchairs — Part 8: Requirements and test methods for static, impact and fatigue
strengths
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 7176-19:2008 , Wheelchairs — Part 19: Wheeled mobility devices for use as seats in motor vehicles
ISO 7176-22:2014, Wheelchairs — Part 22: Set-up procedures
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
ISO 17966:2016, Assistive products for personal hygiene that support users — Requirements and test
methods
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 7176-26:2007 and the
following apply.
NOTE The definitions of wheelchair and manual wheelchair in ISO 7176-26:2007 are replaced by 3.2 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
loaded wheelchair
wheelchair loaded with a test dummy
Note 1 to entry: Instructions for selecting and fitting a test dummy are given in Clause 6.
3.2
wheelchair
manual wheelchair
wheeled mobility device, intended to transport a seated occupant who has impaired mobility, that is
manually propelled by the occupant and/or an assistant
3.3
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.

ISO 7176-19:2008 is amended by ISO 7176-19:2008/AMD 1:2015.
3.4
custom-made manual wheelchair
manual 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, 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 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 horizontal test plane shall be dry, free from ice, free from
loose material (such as gravel), and shall be of sufficient size to accommodate the wheelchair under test.
4.2 Inclined test plane, 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 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 inclined test plane shall be dry, free from ice, free from
loose material (such as gravel), and shall be of sufficient size to accommodate the wheelchair during the
tests specified in 9.2.2.
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 distance in the range 0 m to 5 m with an accuracy of ±1 mm or ±2%
whichever is the greater.
4.6 Means to measure angles to an accuracy of ±0,1°.
4.7 Means to measure torque in the range 0,5 Nm to 10 Nm with an accuracy of ±2 %.
4.8 Test dummy, of appropriate mass, as specified in ISO 7176-11:2012.
4.9 Means to measure speed in the range 0,5 m/s to 1,5 m/s with an accuracy of ±0,05 m/s.
4.10 Means to move a brake lever smoothly for 60 000 cycles at a frequency of not more than 0,5 Hz.
4.11 Means to measure elapsed time in the range 0 s to 30 s with an accuracy of ±1 s.
4.12 Means to restrain the rear wheels of a wheelchair so that the wheelchair can be tipped
backwards about the axles of the rear wheels without the wheels moving.
EXAMPLE Chocks attached to the horizontal test plane.
4.13 Means to tip a wheelchair backwards smoothly about the axles of the rear wheels and return it
+2
to the upright position for 20 000 cycles, at a rate of 10 cycles per minute, that can be attached to the
push handles of the wheelchair in a manner that does not cause any lateral forces to be applied to them.
EXAMPLE Pneumatic cylinder at an angle of 45° to the horizontal when the wheelchair is upright, attached
by a sliding bearing to a bar connecting the push handles.
4.14 Means to restrain the test dummy in a wheelchair, as specified in ISO 7176-22:2014.
5 General requirements
5.1 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).
5.2 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.
5.3 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 [19].
5.4 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.
5.5 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.
5.6 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 5.1).
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 E.
NOTE See Annex E for additional guidance.
5.7 Contaminants and residues
5.7.1 General
The requirements given in 5.7.2 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).
5.7.2 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.
5.8 Infection and microbiological contamination
5.8.1 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.2.5.
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.
5.8.2 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
5.1).
NOTE For guidance, see B.2.11.
5.9 Overflow, spillage, leakage, and ingress of liquids
5.9.1 Overflow
5.9.1.1 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.
5.9.1.2 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
( )
maximum slope for use of parking brakes. If necessary, refill the reservoir between tests.
5.9.2 Spillage
5.9.2.1 Requirements
Wheelchairs requiring the handling of liquids in intended use shall be so constructed that spillage does
not wet parts that creates a hazard.
5.9.2.2 Test method
+5
Position the wheelchair on the horizontal test plane. Pour  200 ml of water steadily on an arbitrary
point on the seat.
After the test, the wheelchair shall function as specified by the manufacturer.
5.9.3 Leakage
Wheelchairs shall be so constructed that liquid which can escape in single fault condition does not
create a hazard.
5.9.4 Ingress of liquids
5.9.4.1 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.
Hazards that can be caused by the ingress of liquids shall be addressed in the risk management process
(see 5.1).
NOTE See B.2.12.
5.9.4.2 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.
5.10 Safety of moving parts
5.10.1 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).
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
Finger traps Less than 8 mm or Less than 4 mm or
more than 25 mm more than 25 mm
Foot traps Less than 35 mm or Less than 25 mm or
more than 120 mm more than 120 mm
Head traps Less than 120 mm or Less than 60 mm or
more than 300 mm more than 300 mm
Genitalia traps Less than 8 mm or Less than 8 mm or
more than 75 mm more than 75 mm
5.10.2 Mechanical wear
Parts subject to mechanical wear likely to create a hazard shall be accessible for inspection.
5.11 Prevention of traps for parts of the human body
5.11.1 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.
Table 2 — Safe distances between stationary parts
To avoid Safe distances for adults Safe distances for children
Finger traps Less than 8 mm or Less than 5 mm or
more than 25 mm more than 12 mm
Foot traps Less than 35 mm or Less than 25 mm or
more than 100 mm more than 45 mm
Head traps Less than 120 mm or Less than 60 mm or
more than 250 mm more than 250 mm
Genitalia traps Less than 8 mm or Less than 8 mm or
more than 75 mm more than 75 mm
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.
5.11.2 V-shaped openings
The risk of entrapment in V-shaped openings shall be addressed by the risk management process (see
5.1).
NOTE For guidance, see B.2.13.
5.12 Folding and adjusting mechanisms
5.12.1 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 5.12.2 and
5.12.3.
5.12.2 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.
5.12.3 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.
5.13 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 protection to prevent injury and/or damage.
NOTE For guidance, see B.2.14.
5.14 Ergonomic principles
Wheelchairs shall be designed in accordance with the ergonomic principles set out in
EN 614-1:2006+A1:2009, taking into account the specific needs of the intended occupant. The
ergonomic principles set out in EN 614-1:2006+A1:2009 also apply to an assistant, those involved in
care of the wheelchair occupant, and those involved in transportation and storage of the wheelchair.
Grips, handles and foot supports shall suit the functional anatomy of the occupant and/or assistant, in
accordance with the intended use, and meet the following requirements:
a) the distance between any handle (part intended to be gripped) requiring an operating force of
more than 10 N and any other part of the wheelchair shall not be less than 35 mm;
b) the vertical distance between the upper surface of a foot support or pedal in its operating position
and any other part of the wheelchair shall not be less than 75 mm;
c) the diameter of any operating handle or knob requiring an operating force of more than 10 N shall
be between 19 mm and 43 mm;
d) the upper surface of any pedal intended for operation by an assistant shall not be more than
300 mm above the ground.
NOTE For guidance on operating forces, see B.2.15.
5.15 Applicable provisions for specified types of wheelchair
Annex F specifies the provisions in this document that apply to some specified types of wheelchair.
Wheelchairs of types listed in F.1 shall meet the applicable requirements of Annex F.
5.16 Recommendations
The following annexes provide recommendations:
— Annex A for dimensions and manoeuvring space;
— Annex B for design features;
— Annex D for castor stem angles.
6 Preparation for testing
6.1 General
Unless otherwise specified in Clauses 7, 8, 9, 10 and 11, the wheelchair shall be prepared for testing as
specified in ISO 7176-22:2014 with the following modification.
If a test procedure requires the use of a test dummy, it shall be selected and fitted as specified in 6.2.
This instruction supersedes instructions for loading the wheelchair in the referenced standards.
6.2 Test dummy
Unless otherwise specified in this document, select a test dummy, as specified in ISO 7176-11:2012, of
mass equal to the maximum occupant mass specified by the wheelchair manufacturer, with a tolerance
of 0 kg to +5 kg.
Fit the test dummy in the wheelchair as specified in ISO 7176-22:2014.
7 Wheelchair performance
7.1 Static stability
7.1.1 Requirements
If the static stability of the wheelchair in the rearward direction is less than 10°, the wheelchair shall
have provision for anti-tip devices that increase the static stability in the rearward direction to at least
10°.
7.1.2 Test method
Test the loaded wheelchair as specified in ISO 7176-1:2014. Where the maximum occupant mass is
greater than 100 kg, repeat the rearward static stability test with a 100 kg dummy fitted to the
wheelchair.
If the wheelchair is equipped with anti-tip devices which can be removed without the use of a tool, or if
the manufacturer does not state that it is necessary to use anti-tip devices, use the results of tests
without anti-tip devices recorded in ISO 7176-1:2014, Table 4, to establish whether provision for anti-
tip devices is required, and, if so, determine whether the wheelchair has such provision and whether
the anti-tip devices provide the required static stability.
7.2 Static, impact and fatigue strength
7.2.1 Requirements
The wheelchair shall conform to the requirements of ISO 7176-8:2014.
Arm supports shall conform to the static loading requirements of ISO 7176-8:2014 in the least
favourable intended operating position.
NOTE ISO 16840-3 provides related test methods for postural support devices.
7.2.2 Test method
Test the wheelchair in accordance with ISO 7176-8:2014. If the maximum occupant mass is greater than
100 kg, make the following modifications to the preparation for the fatigue test.
a) Fit a 100 kg test dummy to the wheelchair as specified in ISO 7176-8:2014. Note the location of the
centre of mass of the thigh segment relative to the seat reference point (see Figure 1).
b) Measure the load on the front wheels relative to the load on the rear wheels.
c) Remove the 100 kg test dummy and fit a test dummy with mass equal to the maximum occupant
mass as specified in ISO 7176-8:2014.
d) Without changing the overall mass of the thigh segment and without moving the overall centre of
mass of the thigh segment closer to the seat reference point than the location noted in step a),
adjust the distribution of mass in the thigh segment to approach as closely as practicable the
relative loading on the front and rear wheels measured in step b).
e) If the relative load distribution measured in step b) has not been achieved, and the positions of the
rear wheels are adjustable, adjust the positions of the rear wheels to approach as closely as
practicable the relative loading on the front and rear wheels measured in step b).
7.3 Tipping fatigue strength
7.3.1 General
Occupied wheelchairs can often be tipped backwards by assistants when manoeuvring them. The
tipping action can put considerable stress on the back support and related components. It is important
that a manual wheelchair that can be tipped in this way is able to withstand repeated tipping without
damage.
7.3.2 Requirement
This requirement applies only to wheelchairs where the intended use includes tipping the occupied
wheelchair backwards about the rear wheel axles by use of the push handles.
After the wheelchair has been subjected to the test specified in 7.3.3, no part of the back support shall
have moved from the pre-set position and no component or assembly of parts shall show visible signs of
cracks, breakages, gross deformations, free play, loss of adjustment or any other damage that adversely
affects the function of the wheelchair.
7.3.3 Test method
a) If the position of the rear wheels is adjustable, set them to the most rearward position in
accordance with the manufacturer's instructions for use. If the position of the front wheels is
adjustable, set them to the most forward position in accordance with the manufacturer's
instructions.
b) If the position of the back support and/or push handles is adjustable, set them to the maximum
height in accordance with the manufacturer's instructions.
c) Ensure that the rear wheels are free to rotate, for example by disengaging parking brakes.
d) Restrain the rear wheels using appropriate means (4.12) so that the wheelchair can be tipped
about the axles of the rear wheels without the wheels moving.
e) Attach the means to tip the wheelchair (4.13) to the push handles so that it will apply forces in a
vertical plane parallel to the forward direction of travel that bisects the wheelchair. Make sure the
means of attachment cannot apply any lateral forces to the push handles.
f) Select a test dummy in accordance with 6.2, except that the mass shall be the maximum occupant
mass or 150 kg, whichever is the lower. Secure the dummy in the wheelchair using appropriate
means (4.14) so that it will remain in position as the wheelchair is tipped and returned to the
upright position.
g) Using the means to tip the wheelchair (4.13), smoothly tip the loaded wheelchair backwards to the
point of balance (where the centre of mass of the loaded wheelchair is directly above the rear
+10
axles), ±1°, to the angle where the front wheels are lifted to a height of 120 mm above the test
surface, or to the point where the wheelchair cannot be tipped further (e.g. due to an anti-tip
device), whichever occurs first. Then smoothly return the loaded wheelchair to the upright
position. Ensure the push handles are not pushed
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