SIST EN 12183:2014

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.HWRGHRollstühle mit Muskelkraftantrieb - Anforderungen und PrüfverfahrenFauteuils roulants à propulsion manuelle - Exigences et méthodes d'essaiManual wheelchairs - Requirements and test methods11.180.10JLEDQMHAids and adaptation for movingICS:Ta slovenski standard je istoveten z:EN 12183:2014SIST EN 12183:2014en,de01-maj-2014SIST EN 12183:2014SLOVENSKI
STANDARDSIST EN 12183:20101DGRPHãþD



SIST EN 12183:2014



EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 12183
March 2014 ICS 11.180.10 Supersedes EN 12183:2009English Version
Manual wheelchairs - Requirements and test methods
Fauteuils roulants à propulsion manuelle - Exigences et méthodes d'essai
Muskelkraftbetriebene Rollstühle - Anforderungen und Prüfverfahren This European Standard was approved by CEN on 27 December 2013.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2014 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 12183:2014 ESIST EN 12183:2014



EN 12183:2014 (E) 2 Contents
Page Foreword .5 Introduction .6 1 Scope .7 2 Normative references .7 3 Terms and definitions .8 4 Test apparatus .8 5 General requirements .9 6 Preparation for testing . 10 6.1 General . 10 6.2 Test dummy . 10 7 Wheelchair performance . 10 7.1 Static stability . 10 7.1.1 Requirements . 10 7.1.2 Test method . 10 7.2 Static, impact and fatigue strength . 10 7.2.1 Requirements . 10 7.2.2 Test . 10 7.3 Tilting fatigue strength . 11 7.3.1 General . 11 7.3.2 Requirement . 11 7.3.3 Test method . 11 7.4 Wheelchairs for use as seats in motor vehicles . 11 7.5 Surface temperature . 12 8 Component properties . 12 8.1 Foot supports, lower leg support assemblies and arm supports . 12 8.1.1 Requirements . 12 8.1.2 Test methods . 13 8.2 Component mass . 13 8.3 Pneumatic tyres . 13 8.4 Anterior pelvic support . 14 8.5 Resistance to ignition . 14 8.5.1 Upholstered composite parts . 14 8.5.2 Foam materials . 14 8.5.3 Other parts . 14 9 Propulsion and braking systems . 14 9.1 Means for operating brakes . 14 9.1.1 Requirement . 14 9.1.2 Test method for determination of brake operating forces . 15 9.2 Braking functions . 15 9.2.1 Requirements . 16 9.2.2 Test methods . 16 9.3 Pushing force . 17 9.3.1 Requirements . 17 9.3.2 Test . 17 SIST EN 12183:2014



EN 12183:2014 (E) 3 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 . 18 10.3 Controls intended for operation by an assistant . 19 10.4 Push handles and handgrips . 19 10.4.1 Requirements . 19 10.4.2 Test method . 19 10.5 Operating forces . 20 10.5.1 Requirements . 20 10.5.2 Test . 20 10.6 Seating adjustments for tilt and recline systems . 20 10.6.1 Requirements . 20 10.6.2 Test method . 21 11 Electrical systems — Electrically powered ancillary equipment . 21 12 Information supplied by the manufacturer . 21 12.1 General . 21 12.2 Pre-sale information . 21 12.3 User information . 22 12.4 Service information . 23 12.5 Labelling . 23 13 Test report . 24 14 Tables . 25 15 Figures . 27 Annex A (informative)
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 (informative)
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 to inflate tyres . 34 B.2.4 Surface temperature . 34 B.2.5 Occupant transfer into or out of the wheelchair . 34 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 SIST EN 12183:2014



EN 12183:2014 (E) 4 C.2 Related provisions in this document . 36 Annex D (informative)
Recommendations for castor stem angle . 37 D.1 Recommendations . 37 D.2 Test method . 37 Annex E (informative)
Technical changes from previous editions of EN 12183 . 38 E.1 Technical changes between the first (1999) and second (2006) editions . 38 E.2 Technical changes between the second (2006) and third (2009) editions . 39 E.3 Technical changes from the third (2009) edition . 40 Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of Council Directive 93/42/EEC . 41 Bibliography . 45
SIST EN 12183:2014



EN 12183:2014 (E) 5 Foreword This document (EN 12183:2014) 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 by September 2014 and conflicting national standards shall be withdrawn at the latest by March 2017. 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 12183:2009, which is to be withdrawn (dow) three years after the date of availability of this edition. See CEN/TC 293 resolution 492. 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 EU Directive 93/42/EEC of 14 June 1993 concerning medical devices. For relationship with the applicable EU Directive(s), see informative Annex ZA, which is an integral part of this document. Informative Annex E provides details of significant technical changes between this European Standard and the previous editions of 1999, 2006 and 2009. 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, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. SIST EN 12183:2014



EN 12183:2014 (E) 6 Introduction This is the fourth edition of this European Standard. The first edition was published in 1999, the second in 2006 (withdrawn in 2007) and the third in 2009. 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 93/42/EEC of 14 June 1993 concerning medical devices. This European Standard contains requirements for ergonomic design related to the ease of wheelchair operation. SIST EN 12183:2014



EN 12183:2014 (E) 7 1 Scope This European Standard specifies requirements and test methods for manual wheelchairs intended to carry one person of mass not greater than 250 kg. It also specifies requirements and test methods for manual wheelchairs with electrically powered ancillary equipment. This European Standard does not apply in total to: — wheelchairs intended for special purposes, such as sports, showering or toileting, — manual wheelchairs with handrim-activated power-assisted propulsion, — custom-made wheelchairs, — stand-up wheelchairs, and — manual wheelchairs with add-on power kits used for propulsion. NOTE Requirements for electrically powered wheelchairs are specified in EN 12184. 2 Normative references The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. EN 1021-2:2006, 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 EN 12184, 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, Corrected version 2007-10-01) ISO 7176-1:1999, Wheelchairs — Part 1: Determination of static stability ISO 7176-3:2012, Wheelchairs — Part 3: Determination of effectiveness of brakes ISO 7176-8:1998, 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 SIST EN 12183:2014



EN 12183:2014 (E) 8 ISO 7176-22:2000, Wheelchairs — Part 22: Set-up procedures ISO 7176-26:2007, Wheelchairs — Part 26: Vocabulary ISO 8191-2:1988, Furniture — Assessment of ignitability of upholstered furniture — Part 2: Ignition source: match-flame equivalent 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 3.2 below), EN 12182:2012 and the following apply. 3.1 loaded wheelchair wheelchair loaded with a 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 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. 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 9.2, 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 50 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 defined in ISO 7176-13:1989, of sufficient size to accommodate the wheelchair under test, and such that the whole surface lies between two imaginary horizontal 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. 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 with an accuracy of ± 5 % in increments of 1 N in the range of 0 N to 200 N. 4.5 Means to measure distance in the range of 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 with an accuracy of ± 2 % in the range of 0,5 Nm to 10 Nm. 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. SIST EN 12183:2014



EN 12183:2014 (E) 9 4.11 Means to measure elapsed time in the range 0 s to 30 s with an accuracy of ± 1 s. 4.12 Means to restrain the rear wheels of a wheelchair so that the wheelchair can be tipped backwards about the axles of the rear wheels without the wheels moving. EXAMPLE Chocks attached to the horizontal test plane. 4.13 Means to tip a wheelchair backwards smoothly about the axles of the rear wheels and return it to the upright position for 20 000 cycles, at a rate of 1020+ 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 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, for example straps or bicycle inner tubes. NOTE ISO 7176-8:1998, 10.3, provides guidance on restraining a test dummy. 5 General requirements The wheelchair shall conform to the requirements specified in EN 12182 for the following: — intended performance and technical documentation; — aids that can be dismantled; — single use fasteners; — biocompatibility and toxicity; — 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. A risk analysis shall also be carried out in accordance with EN ISO 14971:2012. SIST EN 12183:2014



EN 12183:2014 (E) 10 6 Preparation for testing 6.1 General Unless otherwise specified in Clauses 7, 8, 9, 10 and 11, the wheelchair shall be prepared for testing as specified in ISO 7176-22:2000 with the following modification. If a test procedure requires the use of a test dummy, it shall be selected and fitted as specified in 6.2. NOTE This instruction supersedes instructions for loading the wheelchair in the referenced standards. 6.2 Test dummy Select a test dummy, as specified in ISO 7176-11:2012, of mass equal to the maximum occupant mass specified by the wheelchair manufacturer, with a tolerance of 0 kg to +5 kg. Fit the test dummy in the wheelchair as specified in ISO 7176-22:2000. 7 Wheelchair performance 7.1 Static stability 7.1.1 Requirements The wheelchair shall have provision for anti-tip devices if the static stability is less than 10°. 7.1.2 Test method Test the loaded wheelchair as specified in ISO 7176-1:1999. Use the angles recorded in Table 4 of ISO 7176-1:1999 to establish whether provision for anti-tip devices is required, and, if so, determine whether the wheelchair has such provision. 7.2 Static, impact and fatigue strength 7.2.1 Requirements The wheelchair shall conform to the requirements of ISO 7176-8:1998. Arm supports shall conform to the static loading requirements of ISO 7176-8:1998 in all intended operating positions. Where the manufacturer specifies a maximum occupant mass greater than 100 kg the forces specified in Table 2 shall apply. 7.2.2 Test Test the wheelchair in accordance with ISO 7176-8:1998 with modifications as stated in 7.2.1. SIST EN 12183:2014



EN 12183:2014 (E) 11 7.3 Tilting fatigue strength 7.3.1 General Occupied wheelchairs can often be tipped backwards by assistants when manoeuvring them. The tipping action can put considerable stress on the back support and related components. It is important that a manual wheelchair that can be tipped in this way is able to withstand repeated tipping without damage. 7.3.2 Requirement This requirement applies only to wheelchairs where the maximum occupant mass is not greater than 150 kg and where the intended use includes tipping the occupied wheelchair backwards about the rear wheel axles by use of the push handles. After the wheelchair has been subjected to the test specified in 7.3.3, no part of the back support shall have moved from the pre-set position and no component or assembly of parts shall show visible signs of cracks, breakages, gross deformations, free play, loss of adjustment or any other damage that adversely affects the function of the wheelchair. 7.3.3 Test method a) If the position of the rear wheels is adjustable, set them to the most rearward position in accordance with the manufacturer's instructions for use. If the position of the front wheels is adjustable, set them to the most forward position in accordance with the manufacturer's instructions. b) If the position of the back support and/or push handles is adjustable, set them to the maximum height in accordance with the manufacturer's instructions. c) Ensure that the rear wheels are free to rotate, for example by disengaging parking brakes. d) Restrain the rear wheels using appropriate means (4.12) so that the wheelchair can be tipped about the axles of the rear wheels wi
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