1、June 2014 Translation by DIN-Sprachendienst.English price group 18No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 1
2、1.180.10!%2:;“2152324www.din.deDDIN EN 12183Manual wheelchairs Requirements and test methods;English version EN 12183:2014,English translation of DIN EN 12183:2014-06Muskelkraftbetriebene Rollsthle Anforderungen und Prfverfahren;Englische Fassung EN 12183:2014,Englische bersetzung von DIN EN 12183:2
3、014-06Fauteuils roulants propulsion manuelle Exigences et mthodes dessai;Version anglaise EN 12183:2014,Traduction anglaise de DIN EN 12183:2014-06SupersedesDIN EN 12183:2009-12See start of applicationwww.beuth.deIn case of doubt, the German-language original shall be considered authoritative.Docume
4、nt comprises 49 pages 05.14 DIN EN 12183:2014-06 2A comma is used as the decimal marker. Start of application The start of application of this standard is 2014-06-01. DIN EN 12183:2009-12 may be used in parallel until 2017-03-31. National foreword This document (EN 12183:2014) has been prepared by T
5、echnical Committee CEN/TC 293 “Assistive products for persons with disability” (Secretariat: SIS, Sweden). The responsible German body involved in its preparation was the Normenausschuss Rettungsdienst und Krankenhaus (Rescue Services and Hospital Standards Committee), Working Committee NA 053-01-06
6、 AA Rollsthle. Amendments This standard differs from DIN EN 12183:2009-12 as follows: a) the upper limit for maximum occupant mass covered by the scope has been extended to 250 kg; b) the standard deals more clearly with wheelchairs, which come partially into its scope; c) the list of normative refe
7、rences has been brought up to date, most notably including the latest editions of ISO 7176-11 and ISO 7176-19; d) wheelchairs are tested at the specified maximum user mass; e) the document has been extensively restructured to group related requirements and test methods together; f) the tilting fatig
8、ue strength requirement and test method have been added; g) some sections of text in ISO 7176-19:2008 have been replaced, and the reference to ISO 10542-5 has been removed; h) the requirements for handgrip width have been revised; i) static loading force limits for occupant mass above 100 kg have be
9、en provided in Table 2; j) the term “maximum safe slope” is no longer used, since only parking brake performance is relevant; k) the criteria for footrest gaps have been improved; l) either ISO 8191-2 or EN 1021-2 may be used for assessment of ignitability. ISO 8191-1 and EN 1021-1 are no longer use
10、d; DIN EN 12183:2014-06 3 m) a separate test rig can be used for the parking brake fatigue test; n) pushing force limits for user mass above 100 kg have been added; o) the occupant reach space has been extended beneath the front part of the seat; p) requirements for brakes have been clarified; q) re
11、commended dummy designs have been removed; r) guidance has been added concerning the PRM-TSI (see Annex C); s) castor stem angle requirements have been changed to recommendations; t) Annexes concerning recommended seating design and manoeuvring forces have been removed; u) Annex ZA (informative) has
12、 been updated; v) CEN/TC 293 agreed a three-year transition period between the third and fourth editions. Previous editions DIN 13241-3: 1988-11, 1992-09 DIN EN 12183: 1999-11, 2009-12 DIN EN 12183:2014-06 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 12183
13、March 2014 ICS 11.180.10 Supersedes EN 12183:2009English Version Manual wheelchairs - Requirements and test methods Fauteuils roulants propulsion manuelle - Exigences et mthodes dessai Muskelkraftbetriebene Rollsthle - Anforderungen und Prfverfahren This European Standard was approved by CEN on 27 D
14、ecember 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
15、 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 t
16、he 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, Ir
17、eland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management C
18、entre: 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 EEN 12183:2014 (E) 2 Contents Page Foreword 5 Introduction .6 1 Scope 7 2 Normative references 7 3 Terms and definitions .8 4
19、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 Tilti
20、ng 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 12 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 Tes
21、t methods . 13 8.2 Component mass 13 8.3 Pneumatic tyres 14 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.
22、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 . 16 9.3 Pushing force 17 9.3.1 Requirements 17 9.3.2 Test . 17 DINEN 12183:2014-06EN 12183:2014 (E) 3 10 Operations 18 10.1 Operations intended to be carried out by t
23、he 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
24、 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
25、 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 P
26、ush 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 infla
27、te 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 Continuou
28、s operating forces . 35 Annex C (informative) EN 12183 and rail interoperability . 36 C.1 Background 36 DIN EN 12183:2014-06 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 Ann
29、ex 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 (
30、informative) Relationship between this European Standard and the Essential Requirements of Council Directive 93/42/EEC 41 Bibliography . 45 DIN EN 12183:2014-06 EN 12183:2014 (E)5 Foreword This document (EN 12183:2014) has been prepared by Technical Committee CEN/TC 293 “Assistive products for perso
31、ns 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
32、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) thr
33、ee 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 conce
34、rning 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. Ac
35、cording 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, Germa
36、ny, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. DINEN 12183:2014-06EN 12183:2014 (E)6 Introduction This is the fourth edition of this Eur
37、opean 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. Manufactu
38、rers 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
39、for ergonomic design related to the ease of wheelchair operation. DIN EN 12183:2014-06 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 tes
40、t 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 wheel
41、chairs, 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
42、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
43、 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 medic
44、al 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 fat
45、igue 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, Wheelchair
46、s Part 19: Wheeled mobility devices for use as seats in motor vehicles DIN EN 12183:2014-06 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 Par
47、t 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 wheelchai
48、r 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 p
