oSIST prEN 12183:2020

Manual wheelchairs - Requirements and test methods

This document specifies requirements and test methods for manual wheelchairs intended to carry one person of mass not greater than 250 kg, including:
—   stand-up manual wheelchairs, and
—   manual wheelchairs for showering and/or toileting.
This document does not apply to custom-made manual wheelchairs or manual wheelchairs intended for use in sports.
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 an und Prüfverfahren für muskelkraftbetriebene Rollstühle fest, die für die Beförderung einer Person mit einem Höchstgewicht von 250 kg bestimmt sind, einschließlich:
—   Aufsteh-Rollstühle und
—   muskelkraftbetriebene Rollstühle für das Duschen und/oder den Toilettengang.
Dieses Dokument gilt nicht für kundenspezifisch angefertigte muskelkraftbetriebene Rollstühle oder für sportliche Aktivitäten vorgesehene muskelkraftbetriebene Rollstühle.
Dieses Dokument legt auch Anforderungen an 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’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.
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

General Information

• Status: Not Published
• Public Enquiry End Date: 19-Oct-2020
• ICS: 11.180.10 - Aids and adaptation for moving
• Technical Committee: VAZ - Healthcare
• Current Stage: 4020 - Public enquire (PE) (Adopted Project)
• Start Date: 24-Aug-2020
• Due Date: 11-Jan-2021
• Completion Date: 20-Oct-2020
• 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: prEN 12183 - Manual wheelchairs - Requirements and test methods

RELATIONS

• Revised: SIST EN 12183:2014 - Manual wheelchairs - Requirements and test methods
• Effective Date: 01-Oct-2020

Standards Content (sample)

SLOVENSKI STANDARD
oSIST prEN 12183:2020
01-oktober-2020
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: prEN 12183
ICS:
11.180.10 Pripomočki in prilagoditve za Aids and adaptation for
gibanje moving
oSIST prEN 12183:2020 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN 12183:2020
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oSIST prEN 12183:2020
DRAFT
EUROPEAN STANDARD
prEN 12183
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2020
ICS 11.180.10 Will supersede 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 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 12183:2020 E

worldwide for CEN national Members.
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Contents Page

European foreword ...................................................................................................................................................... 5

Introduction .................................................................................................................................................................... 6

1 Scope .................................................................................................................................................................... 7

2 Normative references .................................................................................................................................... 7

3 Terms and definitions ................................................................................................................................... 8

4 Test apparatus ................................................................................................................................................. 8

5 General requirements ................................................................................................................................... 9

5.1 General................................................................................................................................................................ 9

5.2 Risk management ......................................................................................................................................... 10

5.3 Applicable provisions .................................................................................................................................. 10

6 Preparation for testing ............................................................................................................................... 10

6.1 General.............................................................................................................................................................. 10

6.2 Test dummy .................................................................................................................................................... 10

7 Wheelchair performance ........................................................................................................................... 11

7.1 Static stability ................................................................................................................................................. 11

7.1.1 Requirements ................................................................................................................................................. 11

7.1.2 Test method .................................................................................................................................................... 11

7.2 Static, impact and fatigue strength ......................................................................................................... 11

7.2.1 Requirements ................................................................................................................................................. 11

7.2.2 Test method .................................................................................................................................................... 11

7.3 Tilting fatigue strength ............................................................................................................................... 11

7.3.1 General.............................................................................................................................................................. 11

7.3.2 Requirement ................................................................................................................................................... 11

7.3.3 Test method .................................................................................................................................................... 12

7.4 Wheelchairs for use as seats in motor vehicles ................................................................................. 12

7.5 Surface temperature .................................................................................................................................... 12

8 Component properties ................................................................................................................................ 13

8.1 Foot supports, lower leg support assemblies and arm supports ................................................ 13

8.1.1 Requirements ................................................................................................................................................. 13

8.1.2 Test methods .................................................................................................................................................. 13

8.2 Component mass ........................................................................................................................................... 14

8.3 Pneumatic tyres ............................................................................................................................................. 14

8.4 Means for preventing the occupant tipping or sliding .................................................................... 14

8.5 Resistance to ignition .................................................................................................................................. 14

8.5.1 General.............................................................................................................................................................. 14

8.5.2 Test methods .................................................................................................................................................. 14

9 Propulsion and braking systems ............................................................................................................. 15

9.1 Means for operating brakes ...................................................................................................................... 15

9.1.1 Requirement ................................................................................................................................................... 15

9.1.2 Test method for determination of brake operating forces ............................................................ 15

9.2 Braking functions.......................................................................................................................................... 16

9.2.1 Requirements ................................................................................................................................................. 16

9.2.2 Test methods .................................................................................................................................................. 17

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9.3 Pushing force .................................................................................................................................................. 17

9.3.1 Requirements ................................................................................................................................................. 17

9.3.2 Test method .................................................................................................................................................... 18

10 Operations ....................................................................................................................................................... 18

10.1 Operations intended to be carried out by the occupant and/or assistant ............................... 18

10.2 Controls intended for operation by the occupant ............................................................................. 19

10.3 Controls intended for operation by an assistant ............................................................................... 19

10.4 Push handles and handgrips .................................................................................................................... 20

10.4.1 Requirements ................................................................................................................................................. 20

10.4.2 Test method .................................................................................................................................................... 20

10.5 Operating forces ............................................................................................................................................ 20

10.5.1 Requirements ................................................................................................................................................. 20

10.5.2 Test method .................................................................................................................................................... 21

10.6 Seating adjustments for tilting and reclining ..................................................................................... 21

10.6.1 Requirements ................................................................................................................................................. 21

10.6.2 Test method .................................................................................................................................................... 21

11 Electrical systems — Electrically powered ancillary equipment ................................................ 21

12 Information supplied by the manufacturer ........................................................................................ 22

12.1 General ............................................................................................................................................................. 22

12.2 Pre-sale information ................................................................................................................................... 22

12.3 User information ........................................................................................................................................... 23

12.4 Service information ..................................................................................................................................... 24

12.5 Labelling .......................................................................................................................................................... 24

13 Test report ...................................................................................................................................................... 24

14 Tables ................................................................................................................................................................ 25

15 Figures .............................................................................................................................................................. 26

Annex A (normative) Recommendations for dimensions and manoeuvring space of manual

wheelchairs ..................................................................................................................................................... 32

A.1 Specific dimensions ..................................................................................................................................... 32

A.1.1 Dimensions when ready for use and when folded and/or dismantled ..................................... 32

A.1.2 Push handle height ....................................................................................................................................... 32

A.1.3 Ground clearance .......................................................................................................................................... 32

A.2 Manoeuvring space ...................................................................................................................................... 32

A.2.1 Turning diameter ......................................................................................................................................... 32

A.2.2 Pivot width ...................................................................................................................................................... 32

Annex B (normative) Recommended design features .................................................................................. 34

B.1 Introduction ................................................................................................................................................... 34

B.2 General recommendations ........................................................................................................................ 34

B.2.1 Fittings and tools .......................................................................................................................................... 34

B.2.2 Tyres .................................................................................................................................................................. 34

B.2.3 Means for inflating tyres ............................................................................................................................ 34

B.2.4 Surface temperature.................................................................................................................................... 34

B.2.5 Occupant transfer into or out of the wheelchair ............................................................................... 34

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B.2.6 Resistance to contamination from urine incontinence ................................................................... 35

B.2.7 Head support .................................................................................................................................................. 35

B.2.8 Tipping device ................................................................................................................................................ 35

B.2.9 Anti-tip devices .............................................................................................................................................. 35

B.2.10 Accidental release of parking brakes .................................................................................................... 35

B.2.11 Continuous operating forces ..................................................................................................................... 35

Annex C (informative) EN 12183 and rail interoperability ........................................................................ 36

C.1 Background ..................................................................................................................................................... 36

C.2 Related provisions in this document ..................................................................................................... 36

Annex D (normative) Recommendations for caster stem angle ............................................................... 37

D.1 Recommendations ........................................................................................................................................ 37

D.2 Test method .................................................................................................................................................... 37

Annex E (normative) Postural support devices – static, impact and fatigue strength ...................... 38

E.1 General.............................................................................................................................................................. 38

E.2 Test method .................................................................................................................................................... 38

Annex F (normative) Applicable requirements for particular types of manual wheelchair .......... 39

F.1 General.............................................................................................................................................................. 39

F.2 Manual wheelchairs for showering or toileting................................................................................. 39

F.3 Stand-up wheelchairs .................................................................................................................................. 39

F.3.1 General.............................................................................................................................................................. 39

F.3.2 Applicable provisions for standing configuration ............................................................................ 39

Annex G (informative) Technical changes from the previous edition of EN 12183 ........................... 41

Bibliography ................................................................................................................................................................. 42

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European foreword

This document (prEN 12183:2020) 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 12183:2014.

Annex G provides details of the significant technical changes between this document and the previous

edition of 2014.

Requirements and test methods for electrically powered wheelchairs are specified in EN 12184.

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Introduction

This is the fifth edition of EN 12183. 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

on 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 manual wheelchairs intended to carry one

person of mass not greater than 250 kg, including:
— stand-up manual wheelchairs, and
— manual wheelchairs for showering and/or toileting.

This document does not apply to custom-made manual wheelchairs or manual 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 12182:2012, Assistive products for persons with disability - General requirements and test methods

prEN 12184:2020, Electrically powered wheelchairs, scooters and their chargers - Requirements and test

methods

EN ISO 14971:2012, Medical devices — Application of risk management to medical devices

(ISO 14971:2007)
ISO 7176-1:2014, Wheelchairs — Part 1: Determination of static stability
ISO 7176-3:2012, Wheelchairs — Part 3: Determination of effectiveness of brakes

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 7176-15:1996, Wheelchairs — Part 15: Requirements for information disclosure, documentation and

labelling

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 16840-3:2014, Wheelchair seating — Part 3: Determination of static, impact and repetitive load

strengths for postural support devices
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

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,

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 Exceptionally, the definition of wheelchair in ISO 7176-26:2007 is replaced by 3.2 below.

3.1
loaded wheelchair
wheelchair loaded with a test dummy as specified in 4.8
3.2
wheelchair

wheeled personal mobility device incorporating a body support system for a disabled occupant that is

manually propelled by the occupant and/or an assistant whilst the occupant is seated

Note 1 to entry: A disabled occupant is a disabled person or a person not having the full capacity to walk unaided.

[SOURCE: Global Medical Device Nomenclature (GMDN), modified]
3.3
pre-sale information
publicly available information provided by the manufacturer about the wheelchair
3.4
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
4 Test apparatus

4.1 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.

The inclined test plane may have a fixed or adjustable slope. Where the slope is fixed it could be

necessary to use more than one inclined test plane.

4.2 Horizontal test plane, a continuous, flat, rigid surface with a coefficient of friction as specified in

ISO 7176-13:1989. The surface shall lie between two imaginary parallel planes 5 mm apart per 1

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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.

4.3 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 1 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

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 2 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 General

The wheelchair shall conform to the requirements specified in EN 12182:2012 for the following:

— intended performance and technical documentation;
— aids that can be dismantled;
— single use fasteners;
— biocompatibility and toxicity;
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— contaminants and residues;
— infection and microbiological contamination;
— overflow, spillage, leakage and ingress of liquids;
— safety of moving parts;
— prevention of traps for parts of the human body;
— folding and adjusting mechanisms;
— surfaces, corners and edges;
— clinical evaluation;
— ergonomics.
5.2 Risk management

A risk management process shall be performed in accordance with EN ISO 14971:2012. For conformity

with this document, all elements of the risk management process specified in EN ISO 14971:2012 shall

be applied except:
— the planning for, and execution of, production and post-production monitoring
(EN ISO 14971:2012, 3.1 fourth indent, 3.4 item f), and Clause 9), and

— periodic reviews of the suitability of the risk management process (EN ISO 14971:2012, 3.2 fourth

indent).
5.3 Applicable provisions

Annex F specifies the provisions in this document that apply to some types of wheelchair. See F.1.

6 Preparation for testing
...