BS EN 1985-1999 Walking aids - General requirements and test methods《助步器 一般要求和试验方法》.pdf

1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 1985:1999 The Europ

2、ean Standard EN 1985:1998 has the status of a British Standard ICS 11.180 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Walking aids General requirements and test methodsBS EN 1985:1999 This British Standard, having been prepared under the direction of the Health and Environ

3、ment Sector Committee, was published under the authority of the Standards Committee and comes into effect on 15 March 1999 BSI 03-1999 ISBN 0 580 32183 5 Amendments issued since publication Amd. No. Date Text affected National foreword This British Standard is the English language version of EN 1985

4、:1998. It partially supersedes BS 4997:1991 Specification for wooden axilla crutches, BS 5181:1975 Specification for wooden walking sticks and BS 5205:1990 Specification for adjustable metal walking sticks. The UK participation in its preparation was entrusted to Technical Committee CH/38, Walking a

5、ids, which has the responsibility to: aid enquirers to understand the text; present to the responsible 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 t

6、he UK. A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled

7、“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 Standards are responsible for their correct application. Compliance w

8、ith 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, the EN title page, pages 2 to 7 and a back cover.CEN European Committee for Standardization Comite Europe en de Normalisation Europa isches

9、 Komitee fu r Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1998 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 1985:1998 E EUROPEAN STANDARD EN 1985 NORME EUROPE ENNE EUROPA ISCHE NORM November 1998 ICS 11.180

10、Descriptors: medical equipment, disabled persons aids, disabled persons, elbow crutches, walking rehabilitation carriages, design, equipment specifications, safety, accident prevention, hazards, protection against mechanical hazards, thermal protection, tests, information English version Walking aid

11、s General requirements and test methods Aides a la marche Prescriptions ge ne rales et me thodes dessai Gehhilfen Allgemeine Anforderungen und Pru fmethoden This European Standard was approved by CEN on 8 November 1998. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which

12、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. This European Standa

13、rd 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 Central Secretariat has the same status as the official versions. CEN members are the national standa

14、rds bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.Page 2 EN 1985:1998 BSI 03-1999 Foreword This European Standard has been prepared by Technical

15、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 May 1999, and conflicting national standards sha

16、ll be withdrawn at the latest by May 1999. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland,

17、Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. This European Standard 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(s). For r

18、elationship with EU Directive(s), see informative annex Z, which is an integral part of this standard. This standard provides a means to demonstrate that walking aids, which are also medical devices, conform to the essential requirements outlined in general terms in annex 1 of the EU Directive 93/42

19、 EEC. It is not intended to provide a means to show conformity with the requirements of any other directive. There are three levels of European Standards dealing with technical aids for disabled persons. These are as follows, with level 1 being the highest: level 1: general requirements for technica

20、l aids; level 2: particular requirements for families of technical aids; level 3: specific requirements for types of technical aids. Where standards for particular aids or groups of aids exist (level 2 or 3), the requirements of lower level standards take presedence over higher level standards. Ther

21、efore, to address all requirements for a particular aid, it is necessary to start with standards of the lowest available standard. This is a level 2 standard for walking aids, as specified in the scope. Lower level standards may specify the requirements of the higher level standards or may modify th

22、em. Where standards for particular types of walking aids exist (level 3 standards), this standard should not be used alone. The level 1 standard may be applicable. All European Standards produced or currently being developed by CEN/TC 293 and which concern the family of walking aids are listed in an

23、nex A. Contents Page Foreword 2 1 Scope 3 2 Normative references 3 3 Definitions 3 4 Risk analysis 3 5 Requirements regarding design and construction 3 6 Requirements regarding construction and environmental properties 3 7 Protection against mechanical and thermal risks 4 8 Information supplied by t

24、he manufacturer 4 Annex A (informative) European Standards concerning walking aids, produced or currently being developed by CEN/TC 293 5 Annex B (informative) Walking aids Recommendations 5 Annex Z (informative) Clauses of this European Standard addressing essential requirements or other provisions

25、 of EU Directives 6Page 3 EN 1985:1998 BSI 03-1999 1 Scope This standard specifies requirements and test methods for walking aids manipulated by one arm (walking aids used singly or in pairs, each manipulated by one of the arms, possibly in combination with the upper body) and walking aids manipulat

26、ed by both arms (walking aids used singly, manipulated by both arms, possibly in combination with the upper body), as covered by the subclasses 1203 and 1206 in EN ISO 9999:1998. This standard does not apply to walking aids specially designed or with adaptations for specific disabled persons. NOTE A

27、ppropriate parts of this standard may be applied to the above products and other walking aids outside this scope. 2 Normative references This European Standard incorporates by dated or undated references, provisions from other publications. These normative references are cited at the appropriate pla

28、ces in the text and the publications are listed hereafter. For dated references subsequent amendments to or revisions of any of these publications apply to this European Standard only when incorporated in it by amendment or revision. For undated references the latest edition of the publication refer

29、red to applies. EN 1441, Medical devices Risk analysis. EN ISO 9999:1998, Technical aids for disabled persons Classification. prEN 12182:1997, Technical aids for disabled persons General requirements and test methods. 3 Definitions For the purpose of this standard the following definitions apply. 3.

30、1 walking aid device which, together with one or both legs, is designed to give support to the user for walking 3.2 user weight body mass of the person the walking aid is designed to accommodate 4 Risk analysis EN 1441 applies. 5 Requirements regarding design and construction 5.1 A walking aid shall

31、 conform to prEN 12182:1997, clauses 11 and 12 in respect of safety of moving parts and prevention of traps for the human body. 5.2 Materials used in the manufacture of a walking aid shall conform to prEN 12182:1997, 5.2. 5.3 The materials used in a walking aid shall not mark, scratch or discolour t

32、he surroundings or the walking surface. 5.4 All parts of a walking aid and its auxiliary parts shall be designed so as to be accessible for cleaning. Any cavities in which liquid could accumulate shall be self-draining. Compliance shall be verified by inspection. 5.5 For ergonomical principles, prEN

33、 12182:1997, clause 22 shall apply. 6 Requirements regarding construction and environmental properties 6.1 Ancillaries supplied by the manufacturer or supplier for use in combination with a walking aid and the possible mechanisms for fixing them to a walking aid, shall be according to the same safet

34、y requirements and quality as for the walking aid. 6.2 Unless a specific part of the function of a walking aid, all accessible edges, corners and surfaces shall conform to prEN 12182:1997, clause 17. 6.3 A walking aid shall be designed so as to be manoeuvrable for indoor or outdoor use or a combinat

35、ion of the two. Where applicable, the following requirements apply: Indoor use on a level surface the front wheel diameter shall be greater or equal to 75 mm (to aid manoeuvrability on carpets); a walking aid shall be equipped with parking brakes operating on two wheels (rubber tips are deemed to be

36、 such parking brakes); the maximum width of a walking aid shall be smaller or equal to 650 mm for use in private homes; Outdoor use the front wheel diameter shall be greater or equal to 180 mm; the wheel width shall be greater or equal to 28 mm; a walking aid shall be equipped with brakes operating

37、on two wheels. The user shall be able to manipulate the brakes when walking. Rubber tips are deemed to be such brakes; a walking aid shall be equipped with parking brakes operating on two wheels. Rubber tips are deemed to be such parking brakes.Page 4 EN 1985:1998 BSI 03-1999 7 Protection against me

38、chanical and thermal risks 7.1 A walking aid shall function as intended by the manufacturer and there shall be no material failure of any part of the walking aid subjected to the static loading, fatigue, stability and temperature tests either as specified in the relevant level 3 standard, or to comp

39、arable performance criteria for those walking aids where no level 3 standard has been specified. The manufacturer shall provide evidence validating such performance criteria. NOTE Recommendations are given in B.5.1. Values for some of the loadings specified in the specific level 3 standards are rela

40、ted to a user weight of 100 kg, and will be adjusted according to the user weight specified by the manufacturer for each individual walking aid. 7.2 A walking aid shall be clearly and indelibly marked with the maximum limits of its adjustment ranges. Compliance shall be verified by inspection. 7.3 F

41、olding and adjusting mechanisms shall be securely locked when a walking aid is in the working position. Compliance shall be verified by inspection. 8 Information supplied by the manufacturer 8.1 The requirements given in prEN 12182:1997, clause 23 apply together with 8.2 to 8.5 below. 8.2 Informatio

42、n on whether or not the walking aid is designed for indoor or outdoor use, according to 6.3. 8.3 Information regarding assembly, adjustment of all kinds, folding and unfolding of a walking aid shall accompany each product or be clearly marked on it. 8.4 A walking aid shall be clearly and indelibly m

43、arked with the maximum permissible user weight. 8.5 A walking aid shall be clearly and indelibly marked with the maximum limits of its adjustment ranges (see 7.2).Page 5 EN 1985:1998 BSI 03-1999 Table B.1 Recommended values for testing walking aids where no specific standard exists Classification ac

44、cording to EN ISO 9999:1998 Type of aid Fatigue test: Force (N)/ number of cycles Static test force (N) Forwards stability test angle Backward stability test angle Sideways stability test angle Temperature test 120303 Walking stick 250 58 58 2258C 825 000 120309 Forearm support crutches 550 1 000 22

45、58C 1 000 000 120312 Axillary crutches 550 1 000 2258C 1 000 000 120609 Walking chairs 800 + 108 48 3,58 200 000 120612 Walking tables 800 + 108 48 3,58 200 000 Annex A (informative) European Standards concerning walking aids, produced or currently being developed by CEN/TC 293 Level 1: prEN 12182,

46、Technical aids for disabled persons General requirements and test methods. Level 2: EN 1985, Walking aids General requirements and test methods (this document). Level 3: EN ISO 11334-1:1997, Elbow crutches Requirements and test methods. prEN ISO 11199-1, Walking frames Requirements and test methods.

47、 prEN ISO 11199-2, Rollators Requirements and test methods. prEN ISO 11334-4, Walking sticks with three or more legs Requirements and test methods. NOTE The above listed level 3 documents are International Standards as well. The use or the status as International Standards is not affected by the Eur

48、opean 3 level system. Annex B (informative) Walking aids Recommendations B.1 Scope This annex gives supplementary information and guidance on details which also should be taken into account when a walking aid is designed, manufactured and tested. B.2 General B.2.1 A walking aid should be of an aesth

49、etic design. B.2.2 Light-reflecting material should be mounted as close as possible to the vertical, as close as possible to right angles to the line of travel and as low as possible on a walking aid, not higher than 800 mm above the walking surface. B.2.3 The operating force for operating devices to activate, hold, move and release by arm (and hand) should not exceed 60 N. B.2.4 The operating force for operating devices to activate, hold, move and release by hand or fingers should not exce