BS ISO 13405-2-2015 Prosthetics and orthotics Classification and description of prosthetic components Description of lower limb prosthetic components《修复术和矫形学 修复部件的分类和描述 下肢修复部件的描述》.pdf

1、BSI Standards PublicationBS ISO 13405-2:2015Prosthetics and orthotics Classification and descriptionof prosthetic componentsPart 2: Description of lower limb prostheticcomponentsBS ISO 13405-2:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of ISO 13405-2:2015. I

2、t supersedes BS ISO 13405-2:1996 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/168, Prosthetics and orthotics.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to in

3、clude all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2015.Published by BSI Standards Limited 2015ISBN 978 0 580 84450 8 ICS 11.040.40 Compliance with a British Standard cannot confer immunity from legal obligations.Thi

4、s British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 January 2015.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e d ISO 2015Prosthetics and orthotics Classification and description of prosthetic components Part 2: Descript

5、ion of lower limb prosthetic componentsProthses et orthses Classification et description des composants de prothses Partie 2: Description des composants de prothses des membres infrieursINTERNATIONAL STANDARDISO 13405-2Second edition 2015-01-15Reference number ISO 13405-2:2015(E)BS ISO 13405-2:2015I

6、SO 13405-2:2015(E)ii ISO 2015 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2015All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the

7、internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below or ISOs member body in the country of the requester.ISO copyright officeCase postale 56 CH-1211 Geneva 20Tel. + 41 22 749 01 11Fax + 41 22 749 09 47E-mail copyrightiso.orgWeb w

8、ww.iso.orgPublished in SwitzerlandBS ISO 13405-2:2015ISO 13405-2:2015(E)Contents PageForeword vIntroduction vi1 Scope . 12 Normative references 13 Terms and definitions . 14 Classification and description 15 Interface components . 25.1 Sockets . 25.1.1 Level of amputation . 25.1.2 Force-transmission

9、 properties 35.1.3 Stiffness 45.2 Suspensory components (other than sockets and liners) . 45.2.1 General 45.2.2 Type . 45.2.3 Suspension site 46 Functional components . 56.1 General . 56.2 Ankle-foot units 56.2.1 General 56.2.2 Motions 66.2.3 Activation and control . 66.2.4 Special features . 76.3 K

10、nee units 76.3.1 General 76.3.2 Motions 76.3.3 Axis of rotation 76.3.4 Activation and controls 76.3.5 Transition between swing and stance . 96.4 Hip units . 96.4.1 General 96.4.2 Motions 96.4.3 Axis of rotation 96.4.4 Activation and control 106.5 External (side) joints 106.5.1 General. 106.5.2 Motio

11、ns . 116.5.3 Axis of rotation .116.5.4 Activation and control 116.6 Axial rotators (Torque reducers) . 116.6.1 General. 116.6.2 Motion 116.6.3 Activation and control 116.7 Load attenuators (Shock absorbers) 126.7.1 General. 126.7.2 Motion 126.7.3 Activation and control 126.8 Turntables 127 Alignment

12、 components .127.1 Type . 127.2 Ranges of adjustment . 128 Structural components .12 ISO 2015 All rights reserved iiiBS ISO 13405-2:2015ISO 13405-2:2015(E)9 Finishing (cosmetic) components .13iv ISO 2015 All rights reservedBS ISO 13405-2:2015ISO 13405-2:2015(E)ForewordISO (the International Organiza

13、tion 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

14、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.The

15、 procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the ed

16、itorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives). 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 rights. Details of any patent r

17、ights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents). Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.For an e

18、xplanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT), see the following URL: Foreword - Supplementary informationThe committee responsible for this

19、document is ISO/TC 168, Prostheses and orthotics.This second edition cancels and replaces the first edition (ISO 13405-2:1996), which has been technically revised.The major technical changes are the following:a) classification tree for lower limb prosthetic components added in Clause 5;b) levels of

20、amputation extended to include all partial foot levels;c) methods of socket suspension extended;d) classification tree for functional components added in Clause 6;e) range of types of ankle foot units, knee units, hip units, and external (side) joints extended;f) load attenuators and turntables adde

21、d to Clause 6.ISO 13405 consists of the following parts, under the general title Prosthetics and orthotics Classification and description of prosthetic components: Part 1: Classification of prosthetic components Part 2: Description of lower limb prosthetic components Part 3: Description of upper lim

22、b prosthetic components ISO 2015 All rights reserved vBS ISO 13405-2:2015ISO 13405-2:2015(E)IntroductionThis part of ISO 13405 was the first internationally accepted standard method to describe the components of lower limb prostheses. It is designed to permit users to describe systematically each co

23、mponent which is incorporated in a finished prosthesis in a manner which clearly explains its principal characteristics. It is envisaged as being suitable for use by both manufacturers producing literature describing their products and practitioners who are reporting on the components used in the tr

24、eatment of persons requiring prosthesis.Prosthetic technology has made considerable advances since the publication of this part of ISO 13405. This first revision is designed to include the new types of components which have come into use during this period.Manufacturers trade names and details of th

25、e materials and manufacturing methods employed have been avoided.vi ISO 2015 All rights reservedBS ISO 13405-2:2015Prosthetics and orthotics Classification and description of prosthetic components Part 2: Description of lower limb prosthetic components1 ScopeThis part of ISO 13405 specifies a method

26、 for describing lower limb prosthetic components.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition

27、 of the referenced document (including any amendments) applies.ISO 8549-1, Prosthetics and orthotics Vocabulary Part 1: General terms for external limb prostheses and external orthosesISO 8549-2, Prosthetics and orthotics Vocabulary Part 2: Terms relating to external limb prostheses and wearers of t

28、hese prosthesesISO 8549-4:2014, Prosthetics and orthotics Vocabulary Part 4: Terms relating to limb amputationISO 13405-1:2014, Prosthetics and orthotics Classification and description of prosthetic components Part 1: Classification of prosthetic components3 Terms and definitionsFor the purposes of

29、this document, the terms and definitions given in ISO 8549-1, ISO 8549-2, and the following apply.3.1jointed ankle-foot unitankle-foot unit where motion(s) is (are) obtained by rotation at a joint(s) within the unit3.2unjointed ankle-foot unitankle-foot unit where motion(s) is (are) obtained by defo

30、rmation of a part(s) of the unit4 Classification and descriptionThe components of lower limb prostheses include five classes identified in ISO 13405-1:2014, 3.1 shown in Figures 1 and 2 and described in Clauses 5 to 9.INTERNATIONAL STANDARD ISO 13405-2:2015(E) ISO 2015 All rights reserved 1BS ISO 13

31、405-2:2015ISO 13405-2:2015(E)5Interfacecomponents6Functionalcomponents7Alignmentcomponents8Structuralcomponents9Finishing(cosmetic)components5.1Sockets5.1.2Force-transmissionproperties5.2Suspensorycomponents5.1.1Level ofamputation5.1.3Stiffness5.2.2Type5.2.3Suspensionsite7.2Ranges ofadjustment7.1Typ

32、e5.1.2.4Suspension5.1.2.2AxialStabilization5.1.2.3TransverseStabilizationFigure 1 Lower limb prosthetic components Classification tree5 Interface components5.1 Sockets5.1.1 Level of amputationState the level of amputation for which the prosthesis, and hence the socket, is intended by reference to th

33、e list of levels defined in ISO 8549-4:2014, 3.1.4, that is, as one of the following:a) partial foot amputations; these include;1) phalangeal,2) metatarso-phalangeal disarticulation,3) metatarsal,4) tarso-metatarsal disarticulation, and5) tarsal;b) ankle disarticulation;c) trans-tibial amputation;d)

34、 knee disarticulation;e) trans-femoral amputation;f) hip disarticulation;g) trans-pelvic amputation.2 ISO 2015 All rights reservedBS ISO 13405-2:2015ISO 13405-2:2015(E)5.1.2 Force-transmission properties5.1.2.1 GeneralThe force-transmission properties of a socket relate to the features of the socket

35、 which are concerned with the transfer of the forces necessary for axial stabilization, transverse stabilization, and suspension. In some instances the socket is designed to be used with a liner.Various terms (e.g. total contact and total surface bearing) have been proposed to describe the way these

36、 forces are transferred between the stump and the socket. The biomechanical principles, upon which these terms are based, are ill-defined. Thus, the use of these terms is discouraged.5.1.2.2 Axial stabilizationAxial stabilization is necessary to minimize axial movement between the stump and the sock

37、et during weight bearing (e.g. during stance phase).State the principal intended method(s) of axial stabilization as one or more of the following:a) proximal stabilization, in which the principal stabilizing forces are generated by the shaping of the proximal region of the socket;b) distal stabiliza

38、tion, in which the principal stabilizing forces are generated by the shaping of the end of the socket; orc) total socket stabilization, in which the stabilizing forces are generated by the shaping of the whole surface of the socket.State whether the axial stabilization forces of the socket are modif

39、ied by the use of a liner.5.1.2.3 Transverse stabilizationTransverse stabilization is necessary to minimize angular movement between the stump and the socket during prosthetic use. Three forms of stabilization are required: anteroposterior, mediolateral, and rotational.State when appropriate, any pa

40、rticular features of the socket shape associated with transverse stabilization.State whether the transverse stabilization forces of the socket are modified by the use of a liner.5.1.2.4 SuspensionSuspension is necessary to minimize axial movement between the stump and the socket when the prosthesis

41、is unloaded (e.g. during swing phase).The socket can be suspended either by:a) anatomical suspension, in which the suspensory properties are obtained by shaping the socket to the underlying bony anatomy. This might require the socket to be opened using removable sections, splits, or other means to a

42、llow donning and doffing; orb) pressure-differential (suction) suspension, in which the suspensory properties are obtained using a socket with an air-tight fit which resists removal by virtue of the pressure differential resulting from such action. It might be necessary to use an external sleeve to

43、achieve the air tight fit; orc) using a liner.Suspension between the stump and the liner is obtained by pressure differential while suspension between the liner and the socket may be obtained either by1) mechanical coupling to the socket, ISO 2015 All rights reserved 3BS ISO 13405-2:2015ISO 13405-2:

44、2015(E)2) pressure differential, or3) both.The pressure differential effect in methods b) and c) may be enhanced using a vacuum pump.In any of these methods, adhesion between stump and liner and/or socket can contribute to the suspensory properties.State when appropriate, the type of suspension prov

45、ided by the socket and any means of opening the socket.5.1.3 StiffnessThe stiffness of the socket refers to its elastic deformability in normal usage.State whether the socket isa) rigid (when the socket is designed not to deform),b) flexible (when the socket is designed to deform), orc) partly flexi

46、ble (when specific areas of the socket are designed to deform).Flexible and partly flexible sockets might be supported and/or constrained by a rigid frame/container.5.2 Suspensory components (other than sockets and liners)5.2.1 GeneralSuspensory components provide a mechanical link between the socke

47、t and a suitable proximal anatomical site.External (side) joints which might be part of the suspension system are classified as functional components because their principle function is to constrain unwanted joint motion (see 6.4).5.2.2 TypeTypes of suspensory components include straps, sleeves, cuf

48、fs, thigh corsets or shells, and belts.State the type of suspensory component(s).5.2.3 Suspension siteAnatomical suspension sites include:a) shoulder;b) pelvis;c) thigh;d) femoral condyles;e) malleoli.State the anatomical site(s) used for suspension.4 ISO 2015 All rights reservedBS ISO 13405-2:2015I

49、SO 13405-2:2015(E)6 Functional components6.1 GeneralThe motions of the functional components of prostheses are described with respect to the standard reference planes of the body, which area) the sagittal plane,b) the frontal plane, andc) the transverse plane,with the component in its intended position of use and the body in the anatomical position (see 6.2 to 6.8).6Functionalcomponents6.2.3.3Swing phasecontrol6.2.3.2Stance phasecontrol6.2.4Special features6.2.2Motions6.2.3Activation andcontrol6.2Ankle-footunits6.