SIST EN 12184:2010
(Main)Electrically powered wheelchairs, scooters and their chargers - Requirements and test methods
Electrically powered wheelchairs, scooters and their chargers - Requirements and test methods
This European Standard specifies requirements and test methods for electrically powered wheelchairs with a maximum speed not exceeding 15 km/h intended to carry one person of mass not greater than 100 kg, which includes:
manual wheelchairs with add-on power kits used for propulsion,
electrically powered wheelchairs, and
electrically powered scooters with three or more wheels.
It also specifies requirements and test methods for battery chargers for wheelchairs and scooters.
This European Standard does not apply in total to:
- wheelchairs intended for special purposes, such as sports,
- custom made wheelchairs,
- handrim activated power assisted wheelchairs and
- powered office chairs.
NOTE 1 The application of this standard is limited to wheelchairs with a maximum occupant mass of 100 kg because the maximum mass of dummy specified in ISO 7176-11:1992 is 100 kg. Annex A (informative) provides guidance for construction of dummies of mass 125 kg and 150 kg. At the time of publication, a new edition of ISO 7176-11 was under development, including test dummies with masses above 100 kg.
NOTE 2 Requirements for manually propelled wheelchairs are specified in EN 12183.
Elektrorollstühle und -mobile und zugehörige Ladegeräte - Anforderungen und Prüfverfahren
Diese Europäische Norm legt Anforderungen und Prüfverfahren für Elektrorollstühle mit einer Höchst-geschwindigkeit von 15 km/h fest, die für die Beförderung einer Person mit einem Höchstgewicht von 100 kg bestimmt sind, einschließlich:
Rollstühlen mit Muskelkraftantrieb und zusätzlich angebauten Antriebseinheiten;
Elektrorollstühlen; und
Elektromobilen mit drei oder mehr Rädern.
Sie legt auch Anforderungen und Prüfverfahren für Batterieladegeräte für Rollstühle und Elektromobile fest.
Die vorliegende Europäische Norm gilt nicht vollständig für:
Rollstühle für besondere Zwecke, wie für die Verwendung beim Sport;
kundenspezifisch angefertigte Rollstühle;
mit Greifreifen betätigte Rollstühle mit elektrischer Zusatzeinrichtung; und
Bürostühle mit Motorantrieb.
ANMERKUNG 1 Die Anwendung dieser Norm ist auf Rollstühle für Personen mit einem Höchstgewicht von 100 kg begrenzt, da das Höchstgewicht der Prüfpuppe nach ISO 7176-11:1992 100 kg beträgt. Anhang A (informativ) enthält Leit¬linien für die Konstruktion von Prüfpuppen mit Massen von 125 kg bzw. 150 kg. Zum Zeitpunkt der Veröffentlichung befand sich eine neue Ausgabe der ISO 7176-11 in Arbeit, die Prüfpuppen mit einem Gewicht über 100 kg einschließt.
ANMERKUNG 2 Die Anforderungen an Rollstühle mit Muskelkraftantrieb sind in EN 12183 festgelegt.
Fauteuils roulants électriques, scooters et leurs chargeurs - Exigences et méthodes d'essai
La présente Norme européenne spécifie les exigences et les méthodes d'essai relatives aux fauteuils roulants électriques dont la vitesse maximale ne dépasse pas 15 km/h et prévus pour accueillir une personne dont le poids n'excède pas 100 kg, à savoir :
les fauteuils roulants à propulsion manuelle équipés de kits de motorisation utilisés pour la propulsion ;
les fauteuils roulants électriques ; et
les scooters électriques à trois roues ou plus.
Elle spécifie également les exigences et méthodes d'essais pour les chargeurs de batterie pour les fauteuils roulants et les scooters.
La présente Norme européenne ne s'applique pas en totalité aux :
fauteuils roulants prévus pour des usages spéciaux, tels que le sport ;
fauteuils sur mesure ;
fauteuils roulants à propulsion manuelle munis d’un équipement électrique auxiliaire ; et
fauteuils de bureau motorisés.
NOTE 1 L'application de la présente Norme européenne se limite aux fauteuils roulants dont le poids maximal de l'utilisateur est de 100 kg car le poids maximal du mannequin spécifié dans l'ISO 7176-11:1992 est de 100 kg. L'Annexe A (informative) donne des indications pour la construction de mannequins ayant un poids de 125 kg et 150 kg. Au moment de la publication de la présente Norme européenne, une nouvelle édition de l'ISO 7176-11 incluant des mannequins d'essai pesant plus de 100 kg était en préparation.
NOTE 2 Les exigences pour les fauteuils roulants à propulsion manuelle sont spécifiées dans l'EN 12183.
Invalidski vozički na električni pogon, skuterji in njihovi polnilniki - Zahteve in preskusne metode
Ta evropski standard določa zahteve in preskusne metode za invalidske vozičke na električni pogon z največjo hitrostjo, ki ne presega 15 km/h, namenjene prevažanju osebe s težo, ki ne presega 100 kg, in vključuje: - invalidske vozičke z ročnim upravljanjem z dodatnimi pogonskimi kompleti za pogon, - invalidske vozičke na električni pogon in – skuterje na električni pogon s tremi kolesi ali več. Določa tudi zahteve in preskusne metode za polnilnike baterij za invalidske vozičke in skuterje. Ta evropski standard ne velja v celoti za: - invalidske vozičke za posebne namene, kot je športni voziček; - po meri narejene invalidske vozičke; - invalidske vozičke s pogonom na pogonski obroč in pomožno silo in – gnane pisarniške stole.
General Information
Relations
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Elektrorollstühle und -mobile und zugehörige Ladegeräte - Anforderungen und PrüfverfahrenFauteuils roulants électriques, scooters et leurs chargeurs - Exigences et méthodes d'essaiElectrically powered wheelchairs, scooters and their chargers - Requirements and test methods11.180.10JLEDQMHAids and adaptation for movingICS:Ta slovenski standard je istoveten z:EN 12184:2009SIST EN 12184:2010en,fr,de01-januar-2010SIST EN 12184:2010SLOVENSKI
STANDARDSIST EN 12184:20061DGRPHãþD
SIST EN 12184:2010
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 12184
September 2009 ICS 11.180.10 Supersedes EN 12184:2006English Version
Electrically powered wheelchairs, scooters and their chargers - Requirements and test methods
Fauteuils roulants électriques, scooters et leurs chargeurs -Exigences et méthodes d'essai
Elektrorollstühle und -mobile und zugehörige Ladegeräte - Anforderungen und Prüfverfahren This European Standard was approved by CEN on 27 August 2009.
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 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 Management Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 12184:2009: ESIST EN 12184:2010
EN 12184:2009 (E) 2 Contents Page Foreword .5Introduction .61Scope .72Normative references .73Terms and definitions .94Test apparatus .95Type classes . 106General requirements . 107Design requirements . 117.1Foot supports, lower leg supports and arm supports . 117.2Pneumatic tyres . 117.3Fitting an anterior pelvic support . 117.4Wheelchairs for use as seats in motor vehicles . 117.5Braking systems . 127.6Freewheel device . 127.7Component mass . 127.8Battery enclosures and containers . 127.9Operations intended to be carried out by the occupant and/or assistant . 137.10Controls intended for operation by the occupant . 137.11Assistant control unit, push handles and handgrips . 147.12Charging connector . 148Performance requirements . 148.1General . 148.2Foot supports, lower leg support assemblies and arm supports . 148.2.1Requirements . 148.2.2Tests . 158.3Static, impact and fatigue strength . 158.3.1Requirements . 158.3.2Test . 158.4Braking system . 168.4.1General requirements . 168.4.2Tests . 178.5Operating forces . 188.5.1Requirements . 188.5.2Test . 198.6Assistant control unit, push handles and handgrips . 198.6.1Requirements . 198.6.2Test . 208.7Charging connector . 208.7.1Requirements . 208.7.2Test . 208.8Performance of driving characteristics . 208.8.1General . 208.8.2Ability to climb maximum safe slope . 208.8.3Ground unevenness . 218.8.4Maximum downhill speed . 218.8.5Dynamic stability . 22SIST EN 12184:2010
EN 12184:2009 (E) 3 8.8.6Obstacle climbing . 228.8.7Static stability . 238.8.8Maximum speed . 238.8.9Distance range . 238.9Surface temperature . 238.10Resistance to ignition . 248.10.1Upholstered composite parts . 248.10.2Foam materials . 248.10.3Other parts . 248.11Climatic test . 248.12Seating adjustments for tilt and recline systems . 248.12.1Requirements . 248.12.2Test method . 249Electrical requirements . 259.1General requirements . 259.2Requirement for controller on/off switch . 259.3Requirement for power indicator . 259.4Requirements for circuit protection . 259.5Requirements for battery chargers . 259.6Charge level indicator . 2610Requirements for information supplied by the manufacturer . 2610.1General . 2610.2Pre-sale information . 2610.3User information . 2710.4Service information . 2810.5Labels . 2811Test report . 2812Tables . 3013Figures . 32Annex A (informative)
Recommendations for test dummies of mass greater than 100 kg . 36A.1General . 36A.2Construction . 36A.3Accelerometer mounting . 36A.4Design aims . 37Annex B (informative)
Recommendations for dimensions and manoeuvring space of electrically powered wheelchairs . 45B.1Specific dimensions . 45B.1.1Dimensions when ready for use . 45B.1.2Push handle height . 45B.1.3Ground clearance . 45B.2Manoeuvring space . 45B.2.1Turning diameter . 45B.2.2Reversing width . 45B.3Speed settings . 45Annex C (informative)
Recommended design features . 47C.1Introduction . 47C.2General recommendations . 47C.2.1Anti-tip devices . 47C.2.2Component mass . 47C.2.3Fittings and tools . 47C.2.4Tyres . 47SIST EN 12184:2010
EN 12184:2009 (E) 4 C.2.5Means to inflate tyres . 47C.2.6Surface temperature . 47C.2.7Occupant transfer into or out of the wheelchair . 48C.2.8Resistance to contamination from urine incontinence . 48C.2.9Indication for maximum safe slope. 48C.2.10Mirrors . 48C.2.11Head support . 48C.2.12Accidental release of parking brakes and freewheel devices . 48C.3Recommendations for performance characteristics . 49C.3.1Indication of electrical faults . 49C.3.2Batteries and their containers . 49C.3.3Lighting . 49C.3.4Control mechanism feedback . 49C.3.5Freewheel alarm . 49C.3.6Maximum speed . 49Annex D (informative)
Recommended seating design . 50Annex E (informative)
Manoeuvring forces . 51E.1Recommendations . 51E.1.1Push handle force . 51E.1.2Handrim force . 51E.2Manoeuvring test for handrim-activated power-assisted wheelchairs . 51Annex F (informative)
Technical changes from previous editions of EN 12184 . 52F.1Technical changes between the first (1999) and second (2006) editions . 52F.2Technical changes from the second (2006) edition . 53Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices . 55Bibliography . 59 SIST EN 12184:2010
EN 12184:2009 (E) 5 Foreword This document (EN 12184:2009) has been prepared by Technical Committee CEN/TC 293 “Assistive products for persons with disability”, 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 March 2010, and conflicting national standards shall be withdrawn at the latest by March 2010. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights. This document supersedes EN 12184:2006. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, as amended by Directive 2007/47/EC. For relationship(s) with the applicable EU Directive(s), see informative Annex ZA, which is an integral part of this document. Informative Annex F provides details of significant technical changes between this European Standard and the previous editions of 1999 and 2006. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom.
SIST EN 12184:2010
EN 12184:2009 (E) 6 Introduction This is the third edition of this European Standard which was originally issued in 1999. The second edition was published in 2006 but was withdrawn in 2007. Where this European Standard does not apply to particular wheelchairs, contracting parties should consider whether appropriate parts of this European Standard can be used. Manufacturers might also wish to consider whether appropriate parts of this European Standard can be used to assess the performance of their products against the Essential Requirements of the Council Directive concerning medical devices 93/42/EEC of 14 June 1993, as amended by Directive 2007/47/EC. This European Standard contains requirements for ergonomic design related to the ease of wheelchair operation. They are intended to be applicable to at least 80 % of adult occupants and are based upon: the body size of occupants within the range 5th percentile adult female to 95th percentile adult male, the abilities and restrictions of a 65-year-old 50th percentile female, and the wheelchair being equipped with operating devices which are not custom-made for individual occupants.
SIST EN 12184:2010
EN 12184:2009 (E) 7
1 Scope This European Standard specifies requirements and test methods for electrically powered wheelchairs with a maximum speed not exceeding 15 km/h intended to carry one person of mass not greater than 100 kg, which includes: manual wheelchairs with add-on power kits used for propulsion, electrically powered wheelchairs, and electrically powered scooters with three or more wheels. It also specifies requirements and test methods for battery chargers for wheelchairs and scooters. This European Standard does not apply in total to: wheelchairs intended for special purposes, such as sports, custom-made wheelchairs, handrim activated power assisted wheelchairs and powered office chairs. NOTE 1 The application of this standard is limited to wheelchairs with a maximum occupant mass of 100 kg because the maximum mass of dummy specified in ISO 7176-11:1992 is 100 kg. Annex A (informative) provides guidance for construction of dummies of mass 125 kg and 150 kg. At the time of publication, a new edition of ISO 7176-11 was under development, including test dummies with masses above 100 kg. NOTE 2 Requirements for manually propelled wheelchairs are specified in EN 12183. 2 Normative references The following referenced documents are indispensable for the application 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 1021-1:2006, Furniture — Assessment of the ignitability of upholstered furniture — Part 1: Ignition source smouldering cigarette EN 1021-2:2006, Furniture — Assessment of the ignitability of upholstered furniture — Part 2: Ignition source match flame equivalent EN 12182, Technical aids for disabled persons — General requirements and test methods EN 50272-3:2002, Safety requirements for secondary batteries and battery installations — Part 3: Traction batteries EN 60335-1:2002, Household and similar electrical appliances — Safety — Part 1: General requirements (IEC 60335-1:2001, modified) EN 60529:1991, Degrees of protection provided by enclosures (IP code) (IEC 60529:1989) SIST EN 12184:2010
EN 12184:2009 (E) 8 EN 60601-1:2006, Medical electrical equipment — Part 1: General requirements for basic safety and essential performance (IEC 60601- 1:2005) EN 61000-3-2:2006, Electromagnetic compatibility (EMC) — Part 3-2: Limits — Limits for harmonic current emissions (equipment input current ≤ 16 A per phase) (IEC 61000-3-2:2005) EN ISO 14971:2009, Medical devices — Application of risk management to medical devices
(ISO 14971:2007, Corrected version 2007-10-01) ISO 7176-1:1999, Wheelchairs — Part 1: Determination of static stability ISO 7176-2:2001, Wheelchairs — Part 2: Determination of dynamic stability of electric wheelchairs ISO 7176-3:2003, 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 7176-6:2001, Wheelchairs — Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs ISO 7176-8:1998, Wheelchairs — Part 8: Requirements and test methods for static, impact and fatigue strengths ISO 7176-9:2001, Wheelchairs — Part 9: Climatic test for electric wheelchairs ISO 7176-10:2008, Wheelchairs — Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs ISO 7176-11:1992, Wheelchairs — Part 11: Test dummies ISO 7176-13:1989, Wheelchairs — Part 13: Determination of coefficient of friction of test surfaces ISO 7176-14:1997, Wheelchairs — Part 14: Power and control systems for electric wheelchairs — Requirements and test methods NOTE ISO 7176-14:1997 is used only for requirements and test methods for battery chargers. 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 ISO 7176-19:2001, Wheelchairs — Part 19: Wheeled mobility devices for use in motor vehicles ISO 7176-21:2003, Wheelchairs — Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and motorized scooters ISO 7176-22:2000, Wheelchairs — Part 22: Set-up procedures ISO 7176-26:2007, Wheelchairs — Part 26: Vocabulary ISO 10542-5:2004, Technical systems and aids for disabled or handicapped persons — Wheelchair tiedown and occupant-restraint systems — Part 5: Systems for specific wheelchairs SIST EN 12184:2010
EN 12184:2009 (E) 9 3 Terms and definitions For the purposes of this document the terms and definitions given in ISO 7176-26:2007 (with the exception of the definition of wheelchair which is replaced by 3.7 below), ISO 7176-14:2008, EN 12182 and the following apply. 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 dummy as specified in 4.9 or loaded with a human test occupant 3.4 maximum safe slope maximum slope specified by the manufacturer on which the wheelchair meets all the requirements of dynamic stability, static stability, braking performance and slope climbing, traversing and descending 3.5 non-spillable battery battery from which the electrolyte can not escape whatever its orientation 3.6 spillable battery battery from which the electrolyte can escape in some orientations 3.7 wheelchair wheeled personal mobility device incorporating a seating 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 Definition is adapted from the definition given in the Global Medical Devices Nomenclature (GMDN). NOTE 2 A disabled occupant is a disabled person or a pers
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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Elektrorollstühle und -mobile und zugehörige Ladegeräte - Anforderungen und PrüfverfahrenFauteuils roulants électriques, scooters et leurs chargeurs - Exigences et méthodes d'essaiElectrically powered wheelchairs, scooters and their chargers - Requirements and test methods11.180.10JLEDQMHAids and adaptation for movingICS:Ta slovenski standard je istoveten z:prEN 12184kSIST prEN 12184:2009en,fr,de01-maj-2009kSIST prEN 12184:2009SLOVENSKI
STANDARD
kSIST prEN 12184:2009
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMFINAL DRAFTprEN 12184February 2009ICS 11.180.10Will supersede EN 12184:2006
English VersionElectrically powered wheelchairs, scooters and their chargers -Requirements and test methodsFauteuils roulants électriques, scooters et leurs chargeurs -Exigences et méthodes d'essaiElektrorollstühle und -mobile und zugehörige Ladegeräte -Anforderungen und PrüfverfahrenThis draft European Standard is submitted to CEN members for unique acceptance procedure. It has been drawn up by the TechnicalCommittee CEN/TC 293.If this draft becomes a European Standard, CEN members are bound to comply with the CEN/CENELEC Internal Regulations whichstipulate 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 languagemade by translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has thesame status as the official versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice andshall not be referred to as a European Standard.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre:
Avenue Marnix 17,
B-1000 Brussels© 2009 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. prEN 12184:2009: EkSIST prEN 12184:2009
prEN 12184:2009 (E) 2 Contents Page Foreword .5Introduction .61Scope .72Normative references .73Terms and definitions .94Test apparatus .95Type classes . 106General requirements . 107Design requirements . 117.1Foot supports, lower leg supports and arm supports . 117.2Pneumatic tyres . 117.3Fitting an anterior pelvic support . 117.4Wheelchairs for use as seats in motor vehicles . 117.5Braking systems . 127.6Freewheel device . 127.7Component mass . 127.8Battery enclosures and containers . 127.9Operations intended to be carried out by the occupant and/or assistant . 137.10Controls intended for operation by the occupant . 137.11Assistant control unit, push handles and handgrips . 147.12Charging connector . 148Performance requirements . 148.1General . 148.2Foot supports, lower leg support assemblies and arm supports . 148.2.1Requirements . 148.2.2Tests . 158.3Static, impact and fatigue strength . 158.3.1Requirements . 158.3.2Test . 158.4Braking system . 168.4.1General requirements . 168.4.2Tests . 178.5Operating forces . 188.5.1Requirements . 188.5.2Test . 198.6Assistant control unit, push handles and handgrips . 198.6.1Requirements . 198.6.2Test . 208.7Charging connector . 208.7.1Requirements . 208.7.2Test . 208.8Performance of driving characteristics . 208.8.1General . 208.8.2Ability to climb maximum safe slope . 208.8.3Ground unevenness . 218.8.4Maximum downhill speed . 218.8.5Dynamic stability . 22kSIST prEN 12184:2009
prEN 12184:2009 (E) 3 8.8.6Obstacle climbing . 228.8.7Static stability . 238.8.8Maximum speed . 238.8.9Distance range . 238.9Surface temperature . 238.10Resistance to ignition . 248.10.1Upholstered composite parts . 248.10.2Foam materials . 248.10.3Other parts . 248.11Climatic test . 248.12Seating adjustments for tilt and recline systems . 248.12.1Requirements . 248.12.2Test method . 249Electrical requirements . 259.1General requirements . 259.2Requirement for controller on/off switch . 259.3Requirement for power indicator . 259.4Requirements for circuit protection . 259.5Requirements for battery chargers . 259.6Charge level indicator . 2610Requirements for information supplied by the manufacturer . 2610.1General . 2610.2Pre-sale information . 2610.3User information . 2710.4Service information . 2810.5Labels . 2811Test report . 2812Tables . 3013Figures . 32Annex A (informative)
Recommendations for test dummies of mass greater than 100 kg . 36A.1General . 36A.2Construction . 36A.3Accelerometer mounting . 36A.4Design aims . 37Annex B (informative)
Recommendations for dimensions and manoeuvring space of electrically powered wheelchairs . 45B.1Specific dimensions . 45B.1.1Dimensions when ready for use . 45B.1.2Push handle height . 45B.1.3Ground clearance . 45B.2Manoeuvring space . 45B.2.1Turning diameter . 45B.2.2Reversing width . 45B.3Speed settings . 45Annex C (informative)
Recommended design features . 47C.1Introduction . 47C.2General recommendations . 47C.2.1Anti-tip devices . 47C.2.2Component mass . 47C.2.3Fittings and tools . 47C.2.4Tyres . 47kSIST prEN 12184:2009
prEN 12184:2009 (E) 4 C.2.5Means to inflate tyres . 47C.2.6Surface temperature . 47C.2.7Occupant transfer into or out of the wheelchair . 48C.2.8Resistance to contamination from urine incontinence . 48C.2.9Indication for maximum safe slope. 48C.2.10Mirrors . 48C.2.11Head support . 48C.2.12Accidental release of parking brakes and freewheel devices . 48C.3Recommendations for performance characteristics . 49C.3.1Indication of electrical faults . 49C.3.2Batteries and their containers . 49C.3.3Lighting . 49C.3.4Control mechanism feedback . 49C.3.5Freewheel alarm . 49C.3.6Maximum speed . 49Annex D (informative)
Recommended seating design . 50Annex E (informative)
Manoeuvring forces . 51E.1Recommendations . 51E.1.1Push handle force . 51E.1.2Handrim force . 51E.2Manoeuvring test for handrim-activated power-assisted wheelchairs . 51Annex F (informative)
Technical changes from previous editions of EN 12184 . 52F.1Technical changes between the first (1999) and second (2006) editions . 52F.2Technical changes from the second (2006) edition . 53Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices . 55Bibliography . 59 kSIST prEN 12184:2009
prEN 12184:2009 (E) 5 Foreword This document (prEN 12184:2009) has been prepared by Technical Committee CEN/TC 293 “Assistive products for persons with disability”, the secretariat of which is held by SIS. This document is currently submitted to the Unique Acceptance Procedure. This document will supersede EN 12184:2006. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, as amended by Directive 2007/47/EC. For relationship(s) with the applicable EU Directive(s), see informative Annex ZA, which is an integral part of this document. Informative Annex F provides details of significant technical changes between this European Standard and the previous editions of 1999 and 2006. kSIST prEN 12184:2009
prEN 12184:2009 (E) 6 Introduction This is the third edition of this European Standard which was originally issued in 1999. The second edition was published in 2006 but was withdrawn in 2007. Where this European Standard does not apply to particular wheelchairs, contracting parties should consider whether appropriate parts of this European Standard can be used. Manufacturers might also wish to consider whether appropriate parts of this European Standard can be used to assess the performance of their products against the Essential Requirements of the Council Directive concerning medical devices 93/42/EEC of 14 June 1993, as amended by Directive 2007/47/EC. This European Standard contains requirements for ergonomic design related to the ease of wheelchair operation. They are intended to be applicable to at least 80 % of adult occupants and are based upon: the body size of occupants within the range 5th percentile adult female to 95th percentile adult male, the abilities and restrictions of a 65-year-old 50th percentile female, and the wheelchair being equipped with operating devices which are not custom-made for individual occupants.
kSIST prEN 12184:2009
prEN 12184:2009 (E) 7
1 Scope This European Standard specifies requirements and test methods for electrically powered wheelchairs with a maximum speed not exceeding 15 km/h intended to carry one person of mass not greater than 100 kg, which includes: manual wheelchairs with add-on power kits used for propulsion, electrically powered wheelchairs, and electrically powered scooters with three or more wheels. It also specifies requirements and test methods for battery chargers for wheelchairs and scooters. This European Standard does not apply in total to: wheelchairs intended for special purposes, such as sports, custom-made wheelchairs, handrim activated power assisted wheelchairs and powered office chairs. NOTE 1 The application of this standard is limited to wheelchairs with a maximum occupant mass of 100 kg because the maximum mass of dummy specified in ISO 7176-11:1992 is 100 kg. Annex A (informative) provides guidance for construction of dummies of mass 125 kg and 150 kg. At the time of publication, a new edition of ISO 7176-11 was under development, including test dummies with masses above 100 kg. NOTE 2 Requirements for manually propelled wheelchairs are specified in EN 12183. 2 Normative references The following referenced documents are indispensable for the application 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 1021-1:2006, Furniture — Assessment of the ignitability of upholstered furniture — Part 1: Ignition source smouldering cigarette EN 1021-2:2006, Furniture — Assessment of the ignitability of upholstered furniture — Part 2: Ignition source match flame equivalent EN 12182, Technical aids for disabled persons — General requirements and test methods EN 50272-3:2002, Safety requirements for secondary batteries and battery installations — Part 3: Traction batteries EN 60335-1:2002, Household and similar electrical appliances — Safety — Part 1: General requirements (IEC 60335-1:2001, modified) EN 60529:1991, Degrees of protection provided by enclosures (IP code) (IEC 60529:1989) kSIST prEN 12184:2009
prEN 12184:2009 (E) 8 EN 60601-1:2006, Medical electrical equipment — Part 1: General requirements for basic safety and essential performance (IEC 60601- 1:2005) EN 61000-3-2:2006, Electromagnetic compatibility (EMC) — Part 3-2: Limits — Limits for harmonic current emissions (equipment input current ≤ 16 A per phase) (IEC 61000-3-2:2005) EN ISO 14971:2007, Medical devices — Application of risk management to medical devices
(ISO 14971:2007) ISO 7176-1:1999, Wheelchairs — Part 1: Determination of static stability ISO 7176-2:2001, Wheelchairs — Part 2: Determination of dynamic stability of electric wheelchairs ISO 7176-3:2003, 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 7176-6:2001, Wheelchairs — Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs ISO 7176-8:1998, Wheelchairs — Part 8: Requirements and test methods for static, impact and fatigue strengths ISO 7176-9:2001, Wheelchairs — Part 9: Climatic test for electric wheelchairs ISO 7176-10:2008, Wheelchairs — Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs ISO 7176-11:1992, Wheelchairs — Part 11: Test dummies ISO 7176-13:1989, Wheelchairs — Part 13: Determination of coefficient of friction of test surfaces ISO 7176-14:1997, Wheelchairs — Part 14: Power and control systems for electric wheelchairs — Requirements and test methods NOTE ISO 7176-14:1997 is used only for requirements and test methods for battery chargers. 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 ISO 7176-19:2001, Wheelchairs — Part 19: Wheeled mobility devices for use in motor vehicles ISO 7176-21:2003, Wheelchairs — Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and motorized scooters ISO 7176-22:2000, Wheelchairs — Part 22: Set-up procedures ISO 7176-26:2007, Wheelchairs — Part 26: Vocabulary ISO 10542-5:2004, Technical systems and aids for disabled or handicapped persons — Wheelchair tiedown and occupant-restraint systems — Part 5: Systems for specific wheelchairs kSIST prEN 12184:2009
prEN 12184:2009 (E) 9 3 Terms and definitions For the purposes of this document the terms and definitions given in ISO 7176-26:2007 (with the exception of the definition of wheelchair which is replaced by 3.7 below), ISO 7176-14:2008, EN 12182 and the following apply. 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 dummy as specified in 4.9 or loaded with a human test occupant 3.4 maximum safe slope maximum slope specified by the manufacturer on which the wheelchair meets all the requirements of dynamic stability, static stability, braking performance and slope climbing, traversing and descending 3.5 non-spillable battery battery from which the electrolyte can not escape whatever its orientation 3.6 spillable battery battery from which the electrolyte can escape in some orientations 3.7 wheelchair wheeled personal mobility device incorporating a seating 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 Definition is adapted from the definition given in the Global Medical Devices Nomenclature (GMDN). NOTE 2 A disabled occupant is a disabled person or a person not having the full capacity to walk unaided. NOTE 3 The definition includes scooters. 4 Test apparatus 4.1 Adjustable test plane, a flat, rigid plane having an adjustable slope, with a coefficient of friction as specified in ISO 7176-13:1989, of sufficient size to accommodate the wheelchair during the tests specified in 8.4 and 8.8, and such that the whole surface lies between two imaginary parallel planes 5 mm apart per
1 000 mm of extension in any direction and 25 mm apart per 6 000 mm of extension in any direction. 4.2 Horizontal test plane, a flat, rigid plane with a coefficient of friction as specified in ISO 7176-13:1989, of sufficient size to accommodate the wheelchair
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