SIST EN 12184:2022
(Main)Electrically powered wheelchairs, scooters and their chargers - Requirements and test methods
Electrically powered wheelchairs, scooters and their chargers - Requirements and test methods
TThis 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 greater than 300 kg, including:
- electrically powered scooters with three or more wheels,
- manual wheelchairs with an add-on drive system,
- handrim-activated power-assisted wheelchairs,
- electrically powered stand-up wheelchairs,
- balancing wheelchairs,
- wheelchairs with a pivot drive wheel unit, and
- assistant-guided wheelchairs.
This document does not apply to 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
Dieses Dokument legt Anforderungen und Prüfverfahren für Elektrorollstühle mit einer Höchstgeschwindigkeit von 20 km/h fest, die für die Beförderung einer Person mit einem Höchstgewicht von 300 kg bestimmt sind, einschließlich:
- Elektromobile mit drei oder mehr Rädern,
- muskelkraftbetriebene Rollstühle mit Zusatzantrieb,
- mit Greifreifen betätigte kraftunterstützte Rollstühle,
- elektrischer Aufrichtrollstuhl,
- selbstbalancierende Rollstühle,
- Rollstühle mit Drehantrieb, und
- von Hilfspersonen geführte Rollstühle.
Dieses Dokument gilt nicht für 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’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 ;
- les fauteuils roulants à propulsion assistée activée par mains courantes ;
- les fauteuils roulants verticalisateurs électriques ;
- les fauteuils roulants avec système de stabilisation gyroscopique ;
- les fauteuils roulants équipés d’un module avec roue motrice pivotante ;
- les fauteuils roulants avec système d’assistance.
Le présent document ne s’applique pas aux fauteuils roulants électriques personnalisés 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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 12184:2022
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
SIST EN 12184:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN 12184:2022
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SIST EN 12184:2022
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.
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SIST EN 12184:2022
EN 12184:2022 (E)
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
2
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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
3
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EN 12184:2022 (E)
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.
4
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EN 12184:2022 (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 [21] of 5 April 2017 on
medical devices.
5
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EN 12184:2022 (E)
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
1
EN 60335-2-29:2004, Household and similar electrical appliances - Safety - Part 2-29: Particular
requirements for battery chargers (IEC 60335-2-29:2002)
2
EN 60601-1:2006, Medical electrical equipment - Part 1: General requirements for basic safety and
essential performance (IEC 60601-1:2005)
3
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
1
EN 60335-2-29:2004 is amended by EN 60335-2-29:2004/A2:2010 and EN 60335-2-29:2004/A11:2018.
2
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.
3
EN 62133-2:2017 is amended by EN 62133-2:2017/A1:2021.
6
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EN 12184:2022 (E)
4
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)
5
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
6
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
4
EN 62304:2006 is amended by EN 62304:2006/A1:2015.
5
EN ISO 14971:2019 is amended by EN ISO 14971:2019/A11:2021.
6
ISO 7176-19:2008 is amended by ISO 7176-19:2008/AMD 1:2015.
7
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EN 12184:2022 (E)
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
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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
9
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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
...
SLOVENSKI STANDARD
oSIST prEN 12184:2020
01-november-2020
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: prEN 12184
ICS:
11.180.10 Pripomočki in prilagoditve za Aids and adaptation for
gibanje moving
oSIST prEN 12184:2020 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN 12184:2020
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oSIST prEN 12184:2020
DRAFT
EUROPEAN STANDARD
prEN 12184
NORME EUROPÉENNE
EUROPÄISCHE NORM
September 2020
ICS 11.180.10 Will supersede 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 draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee
CEN/TC 293.
If this draft becomes a European Standard, CEN members are bound to comply with the CEN/CENELEC Internal Regulations
which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
This draft European Standard was established by CEN in three official versions (English, French, German). A version in any other
language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC
Management Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are
aware and to provide supporting documentation.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without
notice and shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 12184:2020 E
worldwide for CEN national Members.
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oSIST prEN 12184:2020
prEN 12184:2020 (E)
Contents Page
European foreword . 5
Introduction . 6
1 Scope . 7
2 Normative references . 7
3 Terms and definitions . 9
4 Test apparatus . 10
5 Type classes . 11
6 General requirements . 11
6.1 General. 11
6.2 Risk management . 12
6.3 Speed limitation in normative references . 12
6.4 Applicable provisions . 12
7 Preparation for testing . 12
7.1 General. 12
7.2 Test dummy . 13
7.3 Human test occupant . 13
8 Wheelchair performance . 13
8.1 Driving characteristics . 13
8.1.1 General. 13
8.1.2 Ability to climb rated slope . 13
8.1.3 Ground unevenness . 14
8.1.4 Maximum downhill speed . 14
8.1.5 Dynamic stability . 14
8.1.6 Obstacle climbing and descending . 15
8.1.7 Static stability . 16
8.1.8 Maximum speed . 16
8.1.9 Distance range . 16
8.2 Static, impact and fatigue strength . 17
8.2.1 Requirements . 17
8.2.2 Test method . 17
8.3 Wheelchairs for use as seats in motor vehicles . 17
8.4 Climatic performance . 17
9 Component properties . 17
9.1 Foot supports, lower leg support assemblies and arm supports . 17
9.1.1 Requirements . 17
9.1.2 Test methods . 18
9.2 Component mass . 18
9.3 Pneumatic tyres . 19
9.4 Means for preventing the occupant tipping or sliding . 19
9.5 Resistance to ignition . 19
9.5.1 General. 19
9.5.2 Test methods . 19
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9.5.3 Power and control systems . 19
10 Propulsion and braking systems . 20
10.1 Means for operating brakes . 20
10.1.1 Requirement . 20
10.1.2 Test method for determination of brake operating forces . 20
10.2 Braking functions . 21
10.2.1 Requirements . 21
10.2.2 Test methods . 22
10.3 Freewheel device . 23
11 Operations . 24
11.1 Operations intended to be carried out by the occupant and/or assistant . 24
11.2 Controls intended for operation by the occupant . 24
11.3 Controls intended for operation by an assistant . 25
11.4 Assistant control unit, push handles and handgrips . 25
11.4.1 Requirements . 25
11.4.2 Test method . 26
11.5 Operating forces . 26
11.5.1 Requirements . 26
11.5.2 Test method . 26
11.6 Seating adjustments for tilt and recline systems . 27
11.6.1 Requirements . 27
11.6.2 Test method . 27
12 Electrical systems . 27
12.1 General requirements . 27
12.2 Circuit protection . 27
12.2.1 Requirement . 27
12.2.2 Preparation . 28
12.2.3 Test method . 28
12.3 Battery chargers. 28
12.3.1 General . 28
12.3.2 Operation . 28
12.3.3 Manual adjustment for battery type . 28
12.4 Charging connector . 29
12.5 Battery enclosures and containers . 29
12.6 Emergency stop . 29
12.7 Lighting . 29
12.8 Switching off while driving. 30
12.9 Software . 30
12.10 Lithium cells and batteries . 30
12.11 Remote control . 30
13 Information supplied by the manufacturer . 31
13.1 General . 31
13.2 Pre-sale information . 31
13.3 User information . 32
13.4 Service information . 34
13.5 Labelling . 34
14 Test report . 34
15 Tables . 35
16 Figures . 38
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Annex A (normative) Recommendations for dimensions and manoeuvring space of
electrically powered wheelchairs . 45
Annex B (normative) Recommended design features . 47
Annex C (normative) Recommendations for lighting and reflectors . 50
Annex D (informative) EN 12184 and rail interoperability . 52
Annex E (normative) Recommendations for safety in freewheel mode . 53
Annex F (normative) Postural support devices – static, impact and fatigue strength . 55
Annex G (normative) Applicable provisions for some types of wheelchair . 56
Annex H (informative) Technical changes from the previous edition of EN 12184 . 63
Bibliography . 65
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European foreword
This document (prEN 12184:2020) has been prepared by Technical Committee CEN/TC 293 “Assistive
products and accessibility”, the secretariat of which is held by SIS.
This document is currently submitted to the CEN Enquiry.
This document will supersede EN 12184:2014.
Annex H provides details of significant technical changes between this document and EN 12184:2014.
Requirements and test methods for manual wheelchairs are specified in EN 12183.
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Introduction
This is the fifth edition of EN 12184. 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 might also wish to 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 of 5 April 2017
medical devices.
This document contains requirements for ergonomic design related to the ease of wheelchair operation.
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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 greater than 300 kg,
including:
— electrically powered scooters with three or more wheels,
— manual wheelchairs with an add-on drive system,
— handrim-activated power-assisted wheelchairs,
— electrically powered stand-up wheelchairs,
— balancing wheelchairs,
— wheelchairs with a pivot drive wheel unit, and
— assistant-guided wheelchairs.
This document does not apply to 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 1021-2:2014, Furniture - Assessment of the ignitability of upholstered furniture - Part 2: Ignition
source match flame equivalent
EN 12182:2012, Assistive products for persons with disability - General requirements and test methods
prEN 12183:2020, Manual wheelchairs - Requirements and test methods
EN 15194:2017, Cycles - Electrically power assisted cycles - EPAC Bicycles
EN 60335-2-29, Household and similar electrical appliances - Safety - Part 2-29: Particular requirements
for battery chargers (IEC 60335-2-29)
1
EN 60601-1:2006 , Medical electrical equipment - Part 1: General requirements for basic safety and
essential performance (IEC 60601-1:2005)
EN 62133-2:2017, Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety
requirements for portable sealed secondary cells, and for batteries made from them, for use in portable
applications - Part 2: Lithium systems (IEC 62133-2:2017)
2
EN 62304:2006 , Medical device software - Software life-cycle processes (IEC 62304:2006)
1
A impacted by EN 60601-1:2006/A12:2014.
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EN ISO 14971:2012, Medical devices — Application of risk management to medical devices
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 7176-15:1996, Wheelchairs — Part 15: Requirements for information disclosure, documentation and
labelling
3
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
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 16840-3:2014, Wheelchair seating — Part 3: Determination of static, impact and repetitive load
strengths for postural support devices
2
As impacted by EN 62304:2006/A1:2015.
3
As impacted by ISO 7176 19:2008/A1:2015.
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ISO 16840-10:2014, Wheelchairs — Resistance to ignition of non-integrated seat and back support
cushions — Part 10: Requirements and test methods
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 7176-26:2007,
ISO 7176-14:2008, EN 12182:2012 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at http://www.electropedia.org/
— ISO Online browsing platform: available at http://www.iso.org/obp
NOTE An exception to the terms given in ISO 7176-26:2007 is made for the definition of wheelchair which is
replaced by 3.6 below.
3.1
audible warning device
device for making a warning sound or noise
EXAMPLE A horn.
3.2
freewheel device
means for disengaging the parking brake and/or the drive of a wheelchair to allow it to be manoeuvred
manually
3.3
loaded wheelchair
wheelchair loaded with a test dummy as specified in 4.9 or loaded with a human test occupant
3.4
non-spillable battery
battery from which the electrolyte cannot escape whatever its orientation
3.5
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
3.6
wheelchair
wheeled personal mobility device incorporating a body support system for a disabled occupant, that is
propelled by one or more electric motors controlled by the occupant or by an assistant, and that has
electronic control of speed and electronic or manual control of direction
Note 1 to entry: A disabled occupant is a disabled person or a person not having the full capacity to walk unaided.
Note 2 to entry: The definition includes scooters.
[SOURCE: Global Medical Device Nomenclature (GMDN), modified]
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3.7
pre-sale information
publicly available information provided by the manufacturer about the wheelchair
3.8
stand-up wheelchair
wheelchair which enables the occupant to move between a seated posture and a standing posture and
enables the occupant to maintain a standing posture
3.9
assistant-guided wheelchair
wheelchair partly propelled, braked, and/or steered by the muscular energy of an assistant
3.10
pivot drive wheel unit
integrated propulsion system comprising a pivot drive wheel, a battery and a controller
4 Test apparatus
4.1 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 8.
The inclined test plane may have a fixed or adjustable slope. Where the slope is fixed it might be
necessary to use more than one inclined test plane.
4.2 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. The surface of the test area shall
lie between two im
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