SIST EN 12183:2022

SLOVENSKI STANDARD
SIST EN 12183:2022
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
SIST EN 12183:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 12183:2022

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SIST EN 12183:2022


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.

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SIST EN 12183:2022
EN 12183:2022 (E)
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
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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

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SIST EN 12183:2022
EN 12183:2022 (E)
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.
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EN 12183:2022 (E)
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.
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EN 12183:2022 (E)
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
1
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

1
EN ISO 14971:2019 is amended by EN ISO 14971:2019/A11:2021.
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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
2
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.

2
ISO 7176-19:2008 is amended by ISO 7176-19:2008/AMD 1:2015.
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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
 0
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.
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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
1
A risk management process shall be performed in accordance with EN ISO 14971:2019 . For conformity
1
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
1
(EN ISO 14971:2019 , 4.1 fourth indent, 4.4 item g), and Clause 10); and
1
— 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.
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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.
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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
15
equal to % of the capacity of the reservoir or until the reservoir is full, whichever is the lesser
 0
quantity.
+1
Tilt the wheelchair through an angle of ° to the horizontal in each direction, where a is the
a+ 15
( )
 0
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 T
...