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1、BRITISH STANDARD BS EN ISO 11199-2:1999 Walking aids manipulated by both arms Requirements and test methods Part 2: Rollators The European Standard EN ISO 11199-2:1999 has the status of a British Standard ICS 11.180 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:16:41 GMT+00:00 2006, Unco
2、ntrolled Copy, (c) BSI BS EN ISO 11199-2:1999 This British Standard, having been prepared under the direction of the Health and Environment Sector Committee, was published under the authority of the Standards Committee and comes into effect on 15 November 1999 BSI 04-2000 ISBN 0 580 32976 3 National
3、 foreword This British Standard is the English language version of EN ISO 11199-2:1999. It is identical with ISO 11199-2:1999. The UK participation in its preparation was entrusted to Technical Committee CH/38, Walking aids, which has the responsibility to: aid enquirers to understand the text; pres
4、ent to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. A list of organizations represented on this committee can b
5、e obtained on request to its secretary. Cross-references Attention is drawn to the fact that CEN and CENELEC Standards normally include an annex which lists normative references to international publications with their corresponding European publications. The British Standards which implement these
6、international or European publications may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include all the necessary pr
7、ovisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, pages i and ii, the EN ISO ti
8、tle page, page 2, the ISO title page, pages ii to iv, pages 1 to 12 and a back cover. This standard has been updated (see copyright date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover. Amendments issued since publication Amd. No.Dat
9、eComments Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:16:41 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 11199-2:1999 BSI 04-2000i Contents Page National forewordInside front cover Foreword2 Forewordiii Text of ISO 11199-21 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15
10、 13:16:41 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ii blank Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:16:41 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11199-2 September 1999 ICS 11.180 English version Walking aids manipulated
11、 by both arms Requirements and test methods Part 2: Rollators (ISO 11199-2:1999) Aides la marche manipules avec les deux bras Exigences et mthodes dessai Partie 2: Dambulateurs (ISO 11199-2:1999) Gehhilfen fr beidarmige Handhabung Anforderungen und Prfverfahren Teil 2: Rollatoren (ISO 11199-2:1999)
12、This European Standard was approved by CEN on 21 July 1999. 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 refere
13、nces concerning such national standards may be obtained on application to the Central Secretariat 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 int
14、o its own language and notified to the Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, S
15、pain, Sweden, Switzerland and United Kingdom. CEN European Committee for Standardization Comit Europen de Normalisation Europisches Komitee fr Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1999 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN
16、national Members. Ref. No. EN ISO 11199-2:1999 E Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:16:41 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 11199-2:1999 2 BSI 04-2000 Foreword The text of the International Standard ISO 11199-2:1999 has been prepared by Technical Committee ISO/
17、TC 173 “Technical systems and aids for disabled or handicapped persons” in collaboration with Technical Committee CEN/TC 293 “Technical aids for disabled persons”, the secretariat of which is held by SIS. This European Standard shall be given the status of a national standard, either by publication
18、of an identical text or by endorsement, at the latest by March 2000, and conflicting national standards shall be withdrawn at the latest by March 2000. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this Europ
19、ean Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of the International Standard ISO 11199-2:1999 was approved by
20、 CEN as a European Standard without any modification. NOTENormative references to International Standards are listed in Annex ZA (normative). Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:16:41 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Licensed Copy: sheffieldun sheffieldun, na, Wed Nov
21、 15 13:16:41 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 11199-2:1999 ii BSI 04-2000 Contents Page Forewordiii 1Scope1 2Normative references1 3Terms and definitions1 4Requirements5 5Test methods5 6Marking and labelling10 7Test report10 Annex A (informative) Recommendations11 Annex ZA (normativ
22、e) Normative references to international publications with their relevant European publications12 Figure 1 Example of a rollator2 Figure 2 Details of a handgrip3 Figure 3 Dimensions of a rollator4 Figure 4 Loading geometry for fatigue and static loading tests6 Figure 5 Loading geometry for forward s
23、tability test7 Figure 6 Loading geometry for backwards stability test8 Figure 7 Loading geometry for sideways stability test9 Table A.111 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:16:41 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 11199-2:1999 BSI 04-2000iii Foreword ISO (the In
24、ternational Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee h
25、as been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical
26、 standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by
27、at least 75 % of the member bodies casting a vote. International Standard ISO 11199-2 was prepared by Technical Committee ISO/TC 173, Technical systems and aids for disabled or handicapped persons. ISO 11199 consists of the following parts, under the general title Walking aids manipulated by both ar
28、ms Requirements and test methods: Part 1: Walking frames; Part 2: Rollators. Annex A of this part of ISO 11199 is for information only. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:16:41 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iv blank Licensed Copy: sheffieldun sheffieldun, na, Wed
29、Nov 15 13:16:41 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 11199-2:1999 BSI 04-20001 1 Scope This part of ISO 11199 specifies requirements and methods of testing the fatigue, static load capacity and stability of rollators without accessories, unless specified in the particular test procedure
30、. This part of ISO 11199 also gives the requirements relating to safety, ergonomics, performance, marking and labelling. The requirements and tests are based on everyday usage of rollators as walking aids, manufactured for a user mass of not less than 35 kg. NOTERecommendations further to the requir
31、ements given in this part of ISO 11199 are given in Annex A. 2 Normative references The following normative documents contain provisions which, through reference in this text, constitute provisions of this part of ISO 11199. For dated references, subsequent amendments to, or revisions of, any of the
32、se publications do not apply. However, parties to agreements based on this part of ISO 11199 are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred to
33、 applies. Members of ISO and IEC maintain registers of currently valid International Standards. ISO 9999:1998, Technical aids for disabled persons Classification. ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing. 3 Terms and definitions For the purpose of this par
34、t of ISO 11199, the following terms and definitions apply (see also Figure 1, Figure 2 and Figure 3). 3.1 folded dimensions height, width and length of the rollator measured with the rollator folded together without the use of tools, the height adjustment at its minimum height and handles positioned
35、 as specified in 5.1 3.2 front handgrip reference point that point on the upper surface of the handgrip located 30 mm from the front end of the handgrip length see Figure 2 3.3 handgrip that part of the rollator which is normally held by the hand when the rollator is in use 3.4 handgrip length dimen
36、sion of the handgrip measured longitudinally where the hand rests see Figure 2 NOTEWhere the front end or the rear end of the handgrip is not clear, the full length of the handgrip that can support the weight of the user is defined as the handgrip length. 3.5 handgrip width outside dimension of the
37、handgrip measured horizontally at the thickest point where the hand rests see Figure 2 3.6 handle that part of the rollator to which the handgrip is attached 3.7 maximum length maximum outside dimension of a rollator when the height adjustment is at its maximum, measured parallel to the direction of
38、 movement when the rollator is in normal use see Figure 3 3.8 maximum width maximum outside dimension of a rollator when the height adjustment is at its maximum, measured horizontally at right angles to the direction of movement when the rollator is in normal use see Figure 3 3.9 rear handgrip refer
39、ence point that point on the upper surface of the handgrip located 30 mm from the rear end of the handgrip length see Figure 2 NOTEIf the grip protrudes further than the handle, the measurement is made from the end of the handle. 3.10 rollator walking aid with wheels, to be pushed forward by the han
40、ds NOTEClassification No. 12 06 06 in accordance with ISO 9999:1998. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:16:41 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 11199-2:1999 2 BSI 04-2000 3.11 rollator height vertical distance from the rear handgrip reference point to the groun
41、d see Figure 3 3.12 tips those parts of a two-wheeled rollators rear supporting points which are in contact with the ground NOTETips are also used as pressure brakes on some four-wheeled rollators. 3.13 turning diameter diameter of the largest circle described by a rollator when its height adjustmen
42、t is at maximum and the rollator is turned through 360 about its own central vertical axis see Figure 3 3.14 user weight body mass of the person using the product as a walking aid NOTEStandard user weight is 100 kg for adults and 35 kg for children. Figure 1 Example of a rollator Licensed Copy: shef
43、fieldun sheffieldun, na, Wed Nov 15 13:16:41 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 11199-2:1999 BSI 04-20003 Figure 2 Details of a handgrip Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:16:41 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 11199-2:1999 4 BSI 04-2000 Figure
44、3 Dimensions of a rollator Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:16:41 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 11199-2:1999 BSI 04-20005 4 Requirements 4.1 Mechanical durability When tested according to the fatigue test (5.3), no part of the rollator shall crack or brea
45、k. When tested according to the static loading test (5.4), no part of the rollator shall crack or break. 4.2 Stability When tested according to the forward stability test (5.5), the angle of the plane at the point of rollator tilting shall be not less than 15,0 from the horizontal. When tested accor
46、ding to the backward stability test (5.6), the angle of the plane at the point of rollator tilting shall be not less than 7,0 from the horizontal. When tested according to the sideways stability test (5.7), the angle of the plane at the point of rollator tilting shall be not less than 3,5 from the h
47、orizontal. 4.3 Manoeuvrability The front wheel diameter shall be not less than 75 mm. The front wheel diameter of rollators manufactured for outdoor use shall be not less than 180 mm. The wheel width of rollators manufactured for outdoor use shall be not less than 28 mm. The maximum width of rollato
48、rs manufactured for use in private homes shall be not more than 650 mm. 4.4 Handgrip The handgrip width shall be not less than 20 mm and not more than 50 mm. NOTEThis requirement does not apply to anatomic handgrips. The handgrip shall be replaceable or easy to clean. 4.5 Leg section and tip Where t
49、here is no wheel, the leg section shall end in a tip of a design which will prevent the leg section from piercing through it when used as intended by the manufacturer. See 4.1. Where there is no wheel, the tip shall be replaceable. Where there is no wheel, the tip shall not cause discolouring of the walking surface, as verified by visual inspection. That part of the tip that contacts the walking surface shall have a minimum diameter of 35 mm. Compliance shall be verified by visual inspection. 4.6 Brake