EN 12183:2009

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 12183:2009SIST EN 12183:2010en,fr,de01-januar-2010SIST EN 12183:2010SLOVENSKI
STANDARDSIST EN 12183:20061DGRPHãþD

EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 12183
September 2009 ICS 11.180.10 Supersedes EN 12183:2006English Version
Manual wheelchairs - Requirements and test methods
Fauteuils roulants à propulsion manuelle - Exigences et méthodes d'essai
Rollstühle mit Muskelkraftantrieb - 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
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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 12183:2009: ESIST EN 12183:2010

Recommendations for test dummies of mass greater than 100 kg . 26A.1General . 26A.2Construction . 26SIST EN 12183:2010

Recommendations for dimensions and manoeuvring space . 35B.1 Specific dimensions . 35B.1.1Dimensions when ready for use and when folded and/or dismantled . 35B.1.2Push handle height . 35B.1.3Ground clearance . 35B.2Manoeuvring space . 35B.2.1Turning diameter . 35B.2.2Reversing width . 35Annex C (informative)
Recommended design features . 37C.1Introduction . 37C.2General recommendations . 37C.2.1Fittings and tools . 37C.2.2Tyres . 37C.2.3Means to inflate tyres . 37C.2.4Surface temperature . 37C.2.5Occupant transfer into or out of the wheelchair . 37C.2.6Resistance to contamination from urine incontinence . 38C.2.7Head support . 38C.2.8Accidental release of parking brakes . 38C.2.9Tipping device . 38C.2.10Anti-tip devices . 38Annex D (informative)
Recommended seating design . 39Annex E (informative)
Manoeuvring forces . 40E.1Recommendations . 40E.1.1Push handle force . 40E.1.2Handrim force . 40Annex F (informative)
Technical changes from previous editions of EN 12183. 41F.1Technical changes between the first (1999) and second (2006) editions . 41F.2Technical changes from the second (2006) edition . 42Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices . 43Bibliography . 47 SIST EN 12183:2010

1 Scope This European Standard specifies requirements and test methods for manual wheelchairs intended to carry one person of mass not greater than 100 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;  custom-made wheelchairs;  stand-up wheelchairs; and  add-on power kits for the propulsion of manual wheelchairs. 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 electrically powered wheelchairs are specified in EN 12184. 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 12184, Electrically powered wheelchairs, scooters and their chargers — Requirements and test methods 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 7176-3:2003, 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 7176-11:1992, Wheelchairs — Part 11: Test dummies ISO 7176-13:1989, Wheelchairs — Part 13: Determination of coefficient of friction of test surfaces SIST EN 12183:2010

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 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 25 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°. SIST EN 12183:2010

NOTE Annex A gives guidance on construction of dummies with masses larger than those specified in
ISO 7176-11:1992. 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 to 30 s with an accuracy of ± 1 s. 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 human body;  folding and adjusting mechanisms;  surfaces, corners and edges;  clinical evaulation;  ergonomics. A risk analysis shall also be carried out in accordance with EN ISO 14971:2009. SIST EN 12183:2010

is the force applied to each foot support, expressed in newtons; SIST EN 12183:2010

is the maximum occupant mass specified by the manufacturer, expressed in kilograms; g is the acceleration due to gravity, 9,81 m/s². b) Apply the force for 5 s to 10 s. c) While the force is being applied measure the shortest distance between the foot supports. d) Record whether the foot supports met the requirements. 7.3 Static, impact and fatigue strength 7.3.1 Requirements The wheelchair shall conform to the requirements of ISO 7176-8:1998. Arm supports and back supports shall conform to the static loading requirements of ISO 7176-8:1998 in all intended operating positions with the exception of the upward force on a push handle which shall be 880 N. NOTE The upward force is a correction of the value for upward force on push handles stated in Table 8 of
ISO 7176-8:1998. 7.3.2 Test Test the wheelchair in accordance with ISO 7176-8:1998. 7.4 Braking system 7.4.1 Requirements The braking system shall  be accessible and operable by the occupant or an assistant or both in accordance with the manufacturer's intended use;  have operating forces for engaging and disengaging that do not exceed those stated in Table 1 when tested in accordance with 7.4.2.2; NOTE 1 The brake lever type shown in Figure 1 has a combined hand and arm operation.  not have parts that protrude above the level of the unoccupied seat when the brake is engaged if the wheelchair is fitted with arm supports that can be moved or removed to enable transfer, when tested according to 7.5.3; NOTE 2 Wheelchairs operated by the occupant using a circular handrim attached to the wheels are considered to have provision to stop the wheelchair because the user can slow it down. Wheelchairs intended to be controlled by an assistant might require a running brake to allow an assistant to slow or stop the wheelchair.  include a parking brake that 1) has provision for adjustment to compensate for any wear to any friction surfaces, tyres, etc., that have been worn to the point of replacement, 2) meets the parking brake effectiveness requirement in Table 1 when tested according to 7.4.2.1, 3) has provision for adjustment and/or replacement as specified by the manufacturer, if the parking brake is subject to wear, SIST EN 12183:2010

+)°, or at the maximum safe slope specified by the manufacturer if it is greater. c) Repeat b) with the wheelchair facing downhill. d) Determine whether the parking brakes hold the loaded wheelchair stationary on the slope.
If the wheelchair has adjustable stability or if the manufacturer declares that the wheelchair static stability is less than 7°, apply the minimum force necessary to the wheelchair so that all wheels remain in contact with the test plane during the test procedure. 7.4.2.2 Test for determination of brake lever operating forces a) Adjust the brakes as specified by the manufacturer. b) Select the part of the lever through which the force is to be applied as shown in Figure 4. 1) If the lever is fitted with a generally spherical knob, apply the force through the centre of the knob. 2) If the lever is tapered, apply the force through the point where the largest cross section intersects the centre line of the lever. 3) If the lever is parallel or any shape other than those above, apply the force through a point on the centre line of the lever 15 mm below the top. 4) If the form of the lever is such that the lever is gripped by the whole hand apply the force through the centre line of the lever 15 mm from the end. 5) If the brake is operated by pushing or pulling a bar or pad, apply the force to the centroid of the bar or pad. c) Apply the brakes while measuring the force with the device specified in 4.4 aligned in the direction of travel of the point of application of the force in order to measure the maximum application force required. d) Release the brakes and measure the force with the device as specified in 4.4 aligned in the direction of travel of the point of application of the force in order to measure the maximum releasing force required. e) Perform c) and d) three times in total and record the measurements. SIST EN 12183:2010

Figure 5;  two planes not less than 350 mm apart equidistant from a vertical plane parallel to the forward direction of travel that bisects the wheelchair;  the horizontal test plane. When the wheelchair is fitted with steering and/or manoeuvring handgrips for assistant use, the handgrips shall be at least 75 mm in length and between 20 mm and 50 mm in diameter. SIST EN 12183:2010
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