EN 12183:2022

Manual wheelchairs - Requirements and test methods

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

Muskelkraftbetriebene Rollstühle - Anforderungen und Prüfverfahren

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

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

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

Invalidski vozički z ročnim upravljanjem - Zahteve in preskusne metode

Ta dokument določa zahteve in preskusne metode za invalidske vozičke z ročnim upravljanjem, ki so namenjeni za eno osebo s težo do 250 kg, vključno z:
–   invalidskimi vozički z ročnim upravljanjem z možnostjo stoječega položaja; ter
–   invalidskimi vozički z ročnim upravljanjem, namenjenimi za tuširanje in/ali toaletno uporabo.
Ta dokument se ne uporablja za invalidske vozičke z ročnim upravljanjem, izdelane po meri, ali invalidske vozičke z ročnim upravljanjem, namenjene za uporabo pri športu.
Ta dokument določa tudi zahteve in preskusne metode za invalidske vozičke z ročnim upravljanjem z električno pomožno opremo.

General Information

• Status: Published
• Publication Date: 06-Sep-2022
• ICS: 11.180.10 - Aids and adaptation for moving
• Technical Committee: CEN/TC 293 - Technical aids for disabled persons
• Drafting Committee: CEN/TC 293/WG 9 - Wheelchairs - Revision of EN 12183 and EN 12184
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 07-Sep-2022
• Due Date: 25-Oct-2021
• Completion Date: 07-Sep-2022
• Directive: 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN 12183:2022 - Manual wheelchairs - Requirements and test methods

Relations

• Replaces: EN 12183:2014 - Manual wheelchairs - Requirements and test methods
• Effective Date: 08-May-2019

Standards Content (Sample)

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 .
...