BS-EN-ISO-11334-1-1997.pdf

BRITISH STANDARD BS EN ISO 11334-1:1997 Walking aids manipulated by one arm Requirements and test methods Part 1: Elbow crutches The European Standard EN ISO 11334-1:1997 has the status of a British Standard ICS 11.180 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:47:21 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 11334-1:1997 This British Standard, having been prepared under the direction of the Health and Environment Sector Board, was published under the authority of the Standards Board and comes into effect on 15 April 1997 © BSI 12-1998 The following BSI references relate to the work on this standard: Committee reference CH/38 Draft for comment 92/50478 DC ISBN 0 580 27357 1 Committees responsible for this British Standard The preparation of this British Standard was entrusted to Technical Committee CH/38, Walking aids, upon which the following bodies were represented: British Investment Casting Trade Association British Medical Association British Surgical Trades Association Chartered Society of Physiotherapy College of Occupational Therapists Consumer Policy Committee of BSI Department of Health Disabled Living Foundation Disablement Services Authority Institution of Physics and Engineering in Medicine and Biology Royal College of Nursing Amendments issued since publication Amd. No.DateComments Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:47:21 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 11334-1:1997 © BSI 12-1998i Contents Page Committees responsibleInside front cover National forewordii Foreword2 Text of EN ISO 11334-11 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:47:21 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 11334-1:1997 ii © BSI 12-1998 National foreword This Part of BS EN ISO 11334 has been prepared by Technical Committee CH/38, and is the English language version of EN ISO 11334-1:1997 Walking aids manipulated by one arm Requirements and test methods Part 1: Elbow crutches, published by the European Committee for Standardization (CEN). It is identical with ISO 11334-1:1994, published by the International Organization for Standardization (ISO). It supersedes BS 4988:1990 which is withdrawn. A British Standard does not purport to include all the necessary provisions 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 title page, page 2, the ISO title page, pages ii to iv, pages 1 to 8 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. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:47:21 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM EN ISO 11334-1 January 1997 ICS 11.180 Descriptors: See ISO document English version Walking aids manipulated by one arm Requirements and test methods Part 1: Elbow crutches (ISO 11334-1:1994) Aides à la marche manipulées avec un bras Prescriptions et méthodes dessai Partie 1: Cannes à appui antibrachial (ISO 11334-1:1994) Gehhilfen für einarmige Handhabung Anforderungen und Prüfverfahren Teil 1: Unterarmgehstützen (ISO 11334-1:1994) This European Standard was approved by CEN on 1996-05-01. 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 Central Secretariat or to any CEN member. The European Standards exist 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 Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. CEN European Committee for Standardization Comité Européen de Normalisation Europäisches Komitee für Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels © 1997 Copyright reserved to CEN members Ref. No. EN ISO 11334-1:1997 E Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:47:21 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 11334-1:1997 © BSI 12-1998 2 Foreword The text of the International Standard from Technical Committee ISO/TC 173 “Technical systems and aids for disabled or handicapped persons” of the International Organization for Standardization (ISO) has been taken over as an European Standard by 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 of an identical text or by endorsement, at the latest by July 1997, and conflicting national standards shall be withdrawn at the latest by July 1997. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. NOTE 1This European Standard is valid as a level 3-Standard within the 3-level system used in the European standardization for medical devices concerning technical aids for disabled persons. NOTE 2For clarification purpose: last paragraph of 5.3.1: Apply the load via a swivelling joint, e.g. a ball-joint. Endorsement notice The text of the International Standard ISO 11334-1:1994 has been approved by 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 12:47:21 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:47:21 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 11334-1:1997 ii © BSI 12-1998 Contents Page Forewordiii 1Scope1 2Normative reference1 3Definitions1 4Requirements and recommendations2 5Test methods5 6Marking and labelling6 7Test report7 Annex ZA (normative) Normative references to international publications with their relevant European publications8 Figure 1 Example of elbow crutch3 Figure 2 Details of elbow crutch4 Figure 3 Cuff dimensions4 Figure 4 Loading geometry for dynamic and static loading6 Table 17 Descriptors: Medical equipment, disabled persons, crutches, specifications, performance, tests, marking, labelling. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:47:21 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 11334-1:1997 © BSI 12-1998iii Foreword ISO (the International 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 has 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 standardization. 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 least 75 % of the member bodies casting a vote. International Standard ISO 11334-1 was prepared by Technical Committee ISO/TC 173, Technical systems and aids for disabled or handicapped persons. ISO 11334 consists of the following parts, under the general title Walking aids manipulated by one arm Requirements and test methods: Part 1: Elbow crutches; Part 2: Axillary crutches. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:47:21 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iv blank Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:47:21 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 11334-1:1997 © BSI 12-19981 1 Scope This part of ISO 11334 specifies requirements and test methods for elbow crutches fully equipped with handgrip and tip. The methods specify testing of fatigue, separation, static load capacity and resistance to low temperature embrittlement. This part of ISO 11334 also gives the requirements relating to safety, ergonomics, performance, marking and labelling. The tests are based on everyday usage of elbow crutches when performing the through-swing gait. 2 Normative reference The following standard contains provisions which, through reference in this text, constitute provisions of this part of ISO 11334. At the time of publication, the edition indicated was valid. All standards are subject to revision, and parties to agreements based on this part of ISO 11334 are encouraged to investigate the possibility of applying the most recent edition of the standard indicated below. Members of IEC and ISO maintain registers of currently valid International Standards. ISO 9999:1992, Technical aids for disabled persons Classification. 3 Definitions For the purposes of this International Standard, the following definitions apply, with reference to Figure 1, Figure 2 and Figure 3. 3.1 elbow crutch crutch with one leg, a handle and forearm support. Classification No.: 12 03 06 according to ISO 9999 3.2 crutch size size of crutch in accordance with Table 1 3.3 handle; handgrip that part of the crutch which is normally held in the hand when the crutch is in use 3.4 handgrip support line line drawn through the lowest points, if any, at each end of that part of the handle on which the hand rests 3.5 handgrip length distance, h, measured between the two lowest points on the handgrip support line (See Figure 2.) 3.6 handgrip width width of the handle measured horizontally at the thickest point where the hand rests (See Figure 2.) 3.7 datum that point on the upper surface of the handle one-third of the length from the rear end of the handgrip length (See Figure 2.) 3.8 arm section that part of the crutch which is above the inner end of the handgrip length 3.9 leg section that part of the crutch which is below the inner end of the handgrip length 3.10 cuff forearm support as used on an elbow crutch to hold the forearm in the correct position and prevent sideways movement 3.11 cuff support line line drawn from the inner end of the handgrip length and touching the inside rear bottom face of the cuff at maximum extension of the arm section (See Figure 1.) 3.12 cuff internal width maximum internal dimension, y, measured left to right (See Figure 3.) 3.13 cuff internal depth internal dimension, x, measured front to back (See Figure 3.) 3.14 cuff internal height inside measurement, z, of the cuff which is approximately parallel to the cuff support line and which supports the forearm (See Figure 2.) 3.15 tip that part of the crutch which is in contact with the ground 3.16 leg section axis line drawn from the inner end of the handgrip length and through the centre of the tip at maximum extension of the leg section Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:47:21 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 11334-1:1997 2 © BSI 12-1998 3.17 arm section length distance, a, measured between the inner end of the handgrip length and the highest point where the cuff support line touches the inside rear face of the cuff 3.18 leg section length distance, l, measured between the inner end of the handgrip length and the centre of the bottom of the tip 3.19 support angle angle, a, formed by the leg section axis and the cuff support line (See Figure 1.) 3.20 grip angle angle, b, formed by the cuff support line and the handgrip support line (See Figure 1.) 4 Requirements and recommendations 4.1 Cuff 4.1.1 The cuff shall be securely fixed. 4.1.2 The inside dimensions of the cuff should be so designed that the arm, even when covered with clothes, may with comparative ease be inserted into and withdrawn from it. For the arm to escape, the cuff shall have an opening in the front. It shall be possible to increase this opening to 75 mm without permanently deforming the cuff by more than 5 mm. 4.1.3 The cuff inside surface should be approximately parallel to the cuff support line. This is taken care of if the cuff is hinged. 4.1.4 The cuff internal depth against the forearm shall be larger than half of the internal width. 4.1.5 The cuff internal height against the forearm should be at least 40 mm. 4.2 Handle/handgrip 4.2.1 The handle/handgrip may be adjustable but shall be securely fixed when in use. 4.2.2 The shape and/or the material of the handgrip should prevent the hand from sliding when gripped. 4.2.3 The handgrip width shall be not less than 25 mm and not more than 50 mm. This requirement does not apply to anatomic handgrips. 4.2.4 The handgrip should be easy to clean, non-absorbent and should not include known toxic components. 4.3 Leg section and tip 4.3.1 The leg section shall end in a tip of a design which will prevent the leg section from piercing through it when tested in accordance with 5.3. The tip shall be replaceable but shall be secure when fitted. The tip should be pliable, hard-wearing and have a high coefficient of friction against the walking surface. The tip tread against the walking surface should be such that any suction cup effect is avoided. 4.3.2 The part of the tip that is in contact with the walking surface shall have a minimum diameter of 35 mm. 4.4 Adjusting devices 4.4.1 The means of height adjustment shall not work loose when the crutch is in use. 4.4.2 Each of the height adjustments shall be clearly marked with its maximum allowable elongation. 4.4.3 It should be possible to operate the means of adjustment without the use of tools. 4.5 Materials 4.5.1 Structural load-carrying members moulded from plastics materials should be produced from virgin materials. If recycled materials are included, the components shall be of equivalent strength throughout the life of the crutch. 4.6 Finish 4.6.1 All parts of the crutch should be free from burr, sharp edges or projections that could cause damage to clothing or discomfort to the user. 4.6.2 The crutch should not rattle when in use. 4.6.3 The materials should not cause discolouring in normal use. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:47:21 GMT+00: