BS EN ISO 11334-1-2007 Assistive products for walking manipulated by one arm - Requirements and test methods - Elbow crutches《由单臂操作行走的辅助产品 要求和试验方法 肘拐杖》.pdf

1、 g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58Requirements and test methods Part 1: Elbow crutchesThe European Standard EN ISO 11334-1:2007 has t

2、he status of a British StandardICS 11.180.10Assistive products for walking manipulated by one arm BRITISH STANDARDBS EN ISO 11334-1:2007BS EN ISO 11334-1:2007This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 March 2007 BSI 2007ISBN 978 0 580

3、 50342 9Amendments issued since publicationAmd. No. Date CommentsThis publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunity from legal obligations. National forew

4、ordThis British Standard was published by BSI. It is the UK implementation of EN ISO 11334-1:2007. It supersedes BS EN ISO 11334-1:1997 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/173, Assistive products for persons with disability.A list of org

5、anizations represented on CH/173 can be obtained on request to its secretary.EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 11334-1February 2007ICS 11.180.10 Supersedes EN ISO 11334-1:1997 English VersionAssistive products for walking manipulated by one arm -Requirements and test methods - Pa

6、rt 1: Elbow crutches (ISO11334-1:2007)Produits dassistance la marche manipuls avec un bras -Exigences et mthodes dessai - Partie 1: Cannes appuiantibrachial (ISO 11334-1:2007)Gehhilfen fr einarmige Handhabung - Anforderungen undPrfverfahren - Teil 1: Unterarmgehsttzen (ISO 11334-1:2007)This European

7、 Standard was approved by CEN on 20 January 2007.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concern

8、ing such nationalstandards 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 translationunder the responsibility of a CEN member into its own lan

9、guage and notified to the CEN Management Centre has the same status as theofficial 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, Lux

10、embourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: rue de Stassart, 36 B-1050 Brussels 2007 CEN All right

11、s of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 11334-1:2007: EForeword This document (EN ISO 11334-1:2007) has been prepared by Technical Committee ISO/TC 173 “Technical systems and aids for disabled or handicapped persons“ in collaboration

12、with Technical Committee CEN/TC 293 “Assistive products for persons 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 August 2007, and conf

13、licting national standards shall be withdrawn at the latest by August 2007. This document supersedes EN ISO 11334-1:1997. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium

14、, 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. Endorsement notice The te

15、xt of ISO 11334-1:2007 has been approved by CEN as EN ISO 11334-1:2007 without any modifications. EN ISO 11334-1:2007Reference numberISO 11334-1:2007(E)INTERNATIONAL STANDARD ISO11334-1Second edition2007-02-01Assistive products for walking manipulated by one arm Requirements and test methods Part 1:

16、 Elbow crutches Produits dassistance la marche manipuls avec un bras Exigences et mthodes dessai Partie 1: Cannes appui antibrachial EN ISO 11334-1:2007ii iiiContents Page Foreword iv 1 Scope . 1 2 Normative references . 1 3 Terms and definitions. 1 4 Requirements 6 4.1 Cuff. 6 4.2 Handgrip 6 4.3 Le

17、g section and tip . 6 4.4 Adjusting devices . 6 4.5 Materials 6 4.6 Mechanical durability . 7 5 Test methods. 7 5.1 General. 7 5.2 Testing environment. 7 5.3 Sampling 7 5.4 Forearm withdrawal test 7 5.5 Separation tests 8 5.6 Static loading test. 10 5.7 Fatigue test 12 5.8 Low temperature falling te

18、st 12 5.9 Final inspection. 12 6 Information supplied by the manufacturer 12 6.1 General. 12 6.2 Information marked on the product 13 6.3 Documentation 13 7 Test report . 14 Annex A (informative) Recommendations. 15 Bibliography . 17 EN ISO 11334-1:2007iv Foreword ISO (the International Organization

19、 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

20、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. Intern

21、ational Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publicati

22、on as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent right

23、s. ISO 11334-1 was prepared by Technical Committee ISO/TC 173, Assistive products for persons with disability. This second edition cancels and replaces the first edition (ISO 11334-1:1994), which has been technically revised. ISO 11334 consists of the following parts, under the general title Assisti

24、ve products for walking manipulated by one arm Requirements and test methods: Part 1: Elbow crutches Part 4: Walking sticks with three or more legs EN ISO 11334-1:20071Assistive products for walking manipulated by one arm Requirements and test methods Part 1: Elbow crutches 1 Scope This part of ISO

25、11334 specifies requirements and test methods for elbow crutches fully equipped with handgrip and tip. The methods specify testing of separation, static load capacity, fatigue and resistance to low temperature embrittlement. This part of ISO 11334 also gives the requirements relating to safety, ergo

26、nomics, performance, and information to be supplied by the manufacturer, including marking and labelling. The requirements and tests are based on every-day usage of elbow crutches when performing the through-swing gait, for a maximum user mass as specified by the manufacturer. This part of ISO 11334

27、 is applicable to elbow crutches specified for a user mass of not less than 35 kg. Requirements and test methods for friction of rubber tips against the walking surface are dealt with separately. NOTE The recommendations given in Annex A supplement the requirements given in this part of ISO 11334. 2

28、 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. ISO 9999, Assistive product

29、s for persons with disabilities Classification and terminology EN 1041, Information supplied by the manufacturer with medical devices 3 Terms and definitions For the purpose of this document, the following terms and definitions apply. 3.1 elbow crutch assistive product for walking with one leg, a ha

30、ndle and a non-horizontal forearm support See Figure 1. NOTE Classification no. 12 03 06, according to ISO 9999. EN ISO 11334-1:20072 3.2 handle part of the crutch to which the handgrip is attached 3.3 handgrip part of the crutch which is intended by the manufacturer to be held by the hand when the

31、crutch is in use See Figure 1, item 5. 3.4 handgrip length h dimension of the handgrip measured longitudinally where the hand rests, starting at the lowest point as near as possible to the front stop of the handgrip, and ending at the point as near as possible to the rear stop and at the shortest po

32、ssible distance from the tip See Figures 1 and 2. NOTE If there is no rear stop, the maximum handgrip length is 110 mm. 3.5 front handgrip reference point lowest point next to the front stop where the handgrip length starts See Figure 1, item 7 and Figure 2, item 6. 3.6 rear handgrip reference point

33、 point next to the rear stop where the handgrip length stops See Figure 1, item 8 and Figure 2, item 7. 3.7 handgrip support line line drawn through the front and the rear handgrip reference points See Figure 1, item 6 and Figure 2, item 4. 3.8 handgrip width width of the handle measured horizontall

34、y at the thickest part of the handgrip where the hand rests See Figure 2, item 5. 3.9 datum point on the upper surface of the handgrip measuring one-third of the length from the rear handgrip reference point See Figure 2, item 3. 3.10 arm section part of the crutch which is above the rear handgrip r

35、eference point 3.11 leg section part of the crutch which is below the rear handgrip reference point EN ISO 11334-1:200733.12 cuff forearm support as used on an elbow crutch to hold the forearm in the correct position and prevent sideways movement See Figure 1, item 2. 3.13 cuff support line line dra

36、wn from the rear handgrip reference point and touching the inside rear bottom face of the cuff at maximum extension of the arm section See Figure 1, item 1 and Figure 2, item 1. 3.14 cuff internal width y maximum internal dimension of the cuff measured left to right See Figure 3. 3.15 cuff internal

37、depth x internal dimension of the cuff measured front to back See Figure 3. 3.16 cuff internal height z inside measurement of the cuff which is approximately parallel to the cuff support line and which supports the forearm See Figure 2. 3.17 tip part of the crutch which is in contact with the ground

38、 See Figure 1, item 3. 3.18 leg section axis line drawn from the rear handgrip reference point and through the centre of the tip at maximum extension of the leg section See Figure 1, item 4. 3.19 arm section length a distance measured between the rear handgrip reference point and the highest point w

39、here the cuff support line touches the inside rear face of the cuff See Figure 1. EN ISO 11334-1:20074 3.20 leg section length l distance measured between the rear handgrip reference point and the centre of the bottom of the tip See Figure 1. Key 1 cuff support line 2 cuff 3 tip 4 leg section axis 5

40、 handgrip 6 handgrip support line 7 front handgrip reference point 8 rear handgrip reference point a arm section length h handgrip length l leg section length support angle grip angle Figure 1 Example of an elbow crutch EN ISO 11334-1:20075Key 1 cuff support line 2 wrist hinge point 3 datum 4 handgr

41、ip support line 5 handgrip width 6 front handgrip reference point 7 rear handgrip reference point h handgrip length z cuff internal height aParallel. Figure 2 Details of an elbow crutch Key x cuff internal depth y cuff internal width Figure 3 Cuff dimensions EN ISO 11334-1:20076 3.21 support angle a

42、ngle formed by the leg section axis and the cuff support line See Figure 1. 3.22 grip angle angle formed by the cuff support line and the handgrip support line See Figure 1. 4 Requirements 4.1 Cuff The cuff internal depth against the forearm shall be larger than half of the internal width. This is v

43、erified by measurement, as indicated in 5.3.2 and Figure 3. For the arm not to be trapped in accidentally, the cuff shall have an opening in the front side. When tested in accordance with 5.4, it shall be possible to increase this opening to 75 mm by applying a pulling force of maximum 120 N. The pe

44、rmanent deformation of the cuff opening shall not be more than 5 mm. The cuff shall be securely fixed when tested in accordance with 5.5. 4.2 Handgrip The handgrip may be adjustable, but shall be securely fixed when tested in accordance with 5.5. The handgrip width shall be not less than 25 mm and n

45、ot more than 50 mm. This requirement does not apply to anatomic handgrips. This is verified by measurement, as indicated in 5.3.2 and Figure 2, item 5. 4.3 Leg section and tip The leg section shall end in a tip of a design that will prevent the leg section from piercing through the tip when tested i

46、n accordance with 5.6 and 5.7. This is verified by inspection. The tip shall be replaceable, but shall be secure when fitted. This is verified by inspection. The part of the tip that is in contact with the walking surface shall have a minimum diameter of 35 mm. This is verified by measurement, as in

47、dicated in 5.3.2. 4.4 Adjusting devices The means of height adjustment shall not become loose. This is verified by inspection after the crutch has been subjected to the tests described in 5.6 and 5.7. Each of the height adjustments shall be clearly marked with its maximum allowable elongation. This

48、is verified by measurement, as indicated in 5.3.2. 4.5 Materials If structural load carrying components moulded from recycled plastic materials are included, the components shall be of a strength equivalent to virgin materials throughout the life of the crutch. EN ISO 11334-1:200774.6 Mechanical dur

49、ability When tested in accordance with the separation tests (see 5.5), none of the joints where parts of the crutch are joined together shall come apart. When tested in accordance with the static loading test (see 5.6), the crutch shall stand the load and no part of the crutch shall crack or break. When tested in accordance with the fatigue test (see 5.7), no part of the crutch shall crack or break. When tested in accordance with the low temperature falling test (see 5.8), no part of the