BS EN ISO 11199-1-1999 Walking aids manipulated by both arms - Requirements and test methods - Walking frames《双臂操作的助步器 要求和试验方法 步行支架》.pdf

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1、BRITISH STANDARD BS EN ISO 11199-1:1999 Walking aids manipulated by both arms Requirements and test methods Part 1: Walking frames The European Standard EN ISO 11199-1:1999 has the status of a BritishStandard ICS 11.180BSEN ISO 11199-1:1999 This British Standard, having been prepared under the direc

2、tionof the Health and Environment Sector Committee, was published under the authorityof the Standards Committee and comes into effect on 15 November 1999 BSI 03-2000 ISBN 0 580 32975 5 National foreword This British Standard is the English language version of EN ISO11199-1:1999. It is identical with

3、 ISO 11199-1:1999. It supersedes BS4986:1990 and BS5104:1990 which are withdrawn. 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; present to the responsible international/European

4、 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 be obtained on request to its secretary. Cross

5、-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 international or European publications may be

6、 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 provisions of a contract. Users of British Stan

7、dards 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, theEN ISO title page, page 2, the ISO title page, pages ii

8、 to iv, pages 1 to 14, an inside back cover 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. Date CommentsBSEN ISO 1119

9、9-1:1999 BSI 03-2000 i Contents Page National foreword Inside front cover Foreword 2 Foreword iii Text of ISO 11199-1 1ii blankEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11199-1 August 1999 ICS 11.180 English version Walking aids manipulated by both arms Requirements and test methods P

10、art 1: Walking frames (ISO 11199-1:1999) Aides la marche manipules avec les deux bras Exigences et mthodes dessai Partie1: Cadres de marche (ISO 11199-1:1999) Gehhilfen fr beidarmige Handhabung Anforderungen und Prfverfahren Teil 1: Gehbcke (ISO 11199-1:1999) This European Standard was approved by C

11、EN 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 references concerning such national standards

12、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 into its own language and notified to the C

13、entral Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, CzechRepublic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United King

14、dom. 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 national Members. Ref. No. EN ISO 11199-1

15、:1999 EEN ISO 11199-1:1999 BSI 03-2000 2 Foreword The text of the International Standard ISO 11199-1:1999 has been prepared by Technical Committee ISO/TC 173 “Technical systems and aids for disabled or handicapped persons” in collaboration with Technical Committee CEN/TC 293 “Technical aids for disa

16、bled persons”, 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 February 2000, and conflicting national standards shall be withdrawn at the latest by Februa

17、ry 2000. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, CzechRepublic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Nor

18、way, Portugal, Spain, Sweden, Switzerland and the UnitedKingdom. Endorsement notice The text of the International Standard ISO11199-1:1999 was approved by CEN as a European Standard without any modification. NOTENormative references to International Standards are listed in Annex ZA (normative).EN IS

19、O 11199-1:1999 ii BSI 03-2000 Contents Page Foreword iii 1 Scope 1 2 Normative references 1 3 Terms and definitions 1 4 Requirements 4 5 Test methods 6 6 Marking and labelling 11 7 Test report 12 Annex A (informative) Recommendations 13 Annex ZA (normative) Normative references to international publ

20、ications with relevant European publications Inside back cover Figure 1 Example of a walking frame 3 Figure 2 Details of a handgrip 4 Figure 3 Dimensions of a walking frame 5 Figure 4 Loading geometry for fatigue and static loading tests 7 Figure 5 Loading geometry for static strength tests 8 Figure

21、 6 Loading geometry for forwards stability 9 Figure 7 Loading geometry for backward stability 10 Figure 8 Loading geometry for sideways stability 11 Table A.1 14EN ISO 11199-1:1999 BSI 03-2000 iii Foreword ISO (the International Organization for Standardization) is a worldwide federation of national

22、 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 has been established has the right to be represented on that committee. Internationa

23、l 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 standardization. International Standards are drafted in accordance with the rules

24、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 at least75% of the member bodies casting a vote. International Standard ISO 11199-1

25、 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 arms Requirements and test methods: Part 1: Walking frames; Part 2: Rollators. Annex A

26、of this part of ISO 11199 is for information only.iv blankEN ISO 11199-1:1999 BSI 03-2000 1 1 Scope This part of ISO 11199 specifies requirements and methods of testing fatigue, static load capacity and stability of walking frames without accessories, unless specified in the particular test procedur

27、e. This part of ISO11199 also gives the requirements relating to safety, ergonomics, performance, marking and labelling. The requirements and tests are based on everyday usage of walking frames manufactured for a user mass of not less than35kg. NOTERecommendations further to the requirements given i

28、n this part of ISO11199 are given inAnnex A. 2 Normative references The following normative documents contain provisions which, through reference in this text, constitute provisions of this part of ISO11199. For dated references, subsequent amendments to, or revisions of, any of these publications d

29、o not apply. However, parties to agreements based on this part of ISO11199 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 applies. Members

30、of ISO and IEC maintain registers of currently valid International Standards. ISO 9999:1998, Technical aids for disabled persons Classification. ISO 10933-1, Biological evaluation of medical devices Part 1: Evaluation and testing. 3 Terms and definitions For the purposes of this part of ISO11199, th

31、e following terms and definitions apply (see also Figure 1, Figure 2 and Figure 3). 3.1 folded dimensions height, width and length of the walking frame measured with the frame folded together without the use of tools, the height adjustment at its minimum height and the handles positioned as in 5.1.

32、3.2 frame height vertical distance from the rear handgrip reference point to the ground see Figure 3 3.3 front handgrip reference point that point on the upper surface of the handgrip located30mm from the front end of the handgrip length see Figure 2 3.4 handgrip that part of the walking frame which

33、 is normally held by the hand when the frame is in use 3.5 handgrip length dimension 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

34、 is defined as the handgrip length. 3.6 handgrip width outside dimension of the handgrip measured horizontally at the thickest point where the hand rests see Figure 2 3.7 handle that part of the walking frame to which the handgrip is attachedEN ISO 11199-1:1999 2 BSI 03-2000 3.8 maximum length maxim

35、um outside dimension of a walking frame when the height adjustment is at its maximum, measured parallel to the direction of movement when the frame is in normal use see Figure 3 3.9 maximum width maximum outside dimension of a walking frame when the height adjustment is at its maximum, measured hori

36、zontally at right angles to the direction of movement when the frame is in normal use see Figure 3 3.10 rear handgrip reference point that point on the upper surface of the handgrip located30mm from the rear end of the handgrip length see Figure 2 NOTEIf the grip protrudes further than the handle, t

37、he measurement is made from the end of the handle. 3.11 tip that part of a walking frame which is in contact with the ground 3.12 turning diameter diameter of the largest circle described by a walking frame when the height adjustment is at its maximum and the walking frame is turned through360 about

38、 its own central vertical axis see Figure 3 3.13 user weight body mass of the person using the product as a technical aid NOTEStandard user weight is100kg for adults and35kg for children. 3.14 walking frame walking aid without wheels and with no support devices other than handles NOTEClassification

39、No. 12 06 03 in accordance with ISO9999:1998.EN ISO 11199-1:1999 BSI 03-2000 3 Figure 1 Example of a walking frameEN ISO 11199-1:1999 4 BSI 03-2000 4 Requirements 4.1 Mechanical durability When tested according to the fatigue test (5.3), no part of the walking frame shall crack or break. When tested

40、 according to the static loading test (5.4), no part of the frame shall crack or break. When tested according to the static leg-strength test (5.5), none of the legs shall crack, break or show any permanent set of more than15mm, measured at the end of the leg. 4.2 Stability When tested according to

41、the forward stability test (5.6), the angle of the plane at the point of walking frame tilting shall be not less than10,0 . When tested according to the backward stability test (5.7), the angle of the plane at the point of walking frame tilting shall be not less than7,0 . When tested according to th

42、e sideways stability test (5.8), the angle of the plane at the point of walking frame tilting shall be not less than3,5 . It is acknowledged that a reciprocal walking frame cannot meet this sideways stability requirement. Therefore, an analysis of the risks related to the instability shall be assess

43、ed by the manufacturer, and appropriate guidance and warnings on limitations for use shall be given. Figure 2 Details of a handgripEN ISO 11199-1:1999 BSI 03-2000 5 4.3 Manoeuvrability Maximum width of a walking frame manufactured for use in private homes shall be not larger than650mm. The width of

44、reciprocating walking frames, when reciprocated, shall be not less than90% of maximum width. 4.4 Handgrip The handgrip width shall be not less than20mm and not more than50mm. NOTEThis requirement does not apply to anatomic handgrips. The handgrip shall be replaceable or easy to clean. Figure 3 Dimen

45、sions of a walking frameEN ISO 11199-1:1999 6 BSI 03-2000 4.5 Leg section and tip 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 also 4.1. The tip shall be replaceable. The tip shall not cause

46、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 of35mm. Compliance shall be verified by visual inspection. 4.6 Adjusting devices Each of the height adjustments shall be clearly marked with its

47、 maximum allowable elongation. After the fatigue test (5.3), the adjustment/folding mechanisms shall operate as intended by the manufacturer. Folding walking frames shall lock into working position when unfolded. 4.7 Materials and finish Taking into account the intended use and contact by those invo

48、lved in user care or transportation and storage of the product, walking frame materials which come into contact with the human body shall be assessed for biocompatibility using the guidance given in ISO 10993-1. The walking frame materials shall not cause discolouring of skin or clothing when the fr

49、ame is in normal use. All parts of the walking frame shall be free from burrs, sharp edges or projections that could cause damage to clothing or discomfort to the user. 5 Test methods 5.1 General Walking frames are grouped into six sizes, as given in Table A.1. All tests, if not otherwise specified, shall be performed at an ambient temperature of21 C 5 C. If not otherwise specified, all tests shall be performed with the height adjustments at their maximum. The handles shall be positioned at the