BS ISO 13405-3-2015 Prosthetics and orthotics Classification and description of prosthetic components Description of upper limb prosthetic components《修复术和矫形学 修复部件的分类和描述 上肢修复部件的描述》.pdf

1、BSI Standards PublicationBS ISO 13405-3:2015Prosthetics and orthotics Classification and descriptionof prosthetic componentsPart 3: Description of upper limb prostheticcomponentsBS ISO 13405-3:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of ISO 13405-3:2015.It

2、 supersedes BS ISO 13405-3:1996 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/168, Prosthetics and orthotics.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to inclu

3、de all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2015. Published by BSI StandardsLimited 2015ISBN 978 0 580 84451 5ICS 11.040.40Compliance with a British Standard cannot confer immunity fromlegal obligations.This Britis

4、h Standard was published under the authority of theStandards Policy and Strategy Committee on 31 January 2015.Amendments issued since publicationDate Text affectedBS ISO 13405-3:2015 ISO 2015Prosthetics and orthotics Classification and description of prosthetic components Part 3: Description of uppe

5、r limb prosthetic componentsProthses et orthses Classification et description des composants de prothses Partie 3: Description des composants de prothses des membres suprieursINTERNATIONAL STANDARDISO13405-3Second edition2015-01-15Reference numberISO 13405-3:2015(E)BS ISO 13405-3:2015ISO 13405-3:201

6、5(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 internet or an

7、 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 www.iso.orgPubl

8、ished in SwitzerlandBS ISO 13405-3:2015ISO 13405-3:2015(E)Contents PageForeword vIntroduction vi1 Scope . 12 Normative references 13 Terms and definitions . 14 Classification 15 Interface components . 25.1 Sockets . 25.1.1 General 25.1.2 Level of amputation . 25.1.3 Force-transmission properties 35.

9、1.4 Area of contact . 35.1.5 Stiffness 45.1.6 Activation and control . 45.2 Suspensory components (other than sockets and liners) . 45.2.1 General 45.2.2 Type . 45.2.3 Suspension sites . 46 Functional components . 56.1 General . 56.2 Description of permissible motions . 56.3 Terminal devices 56.3.1

10、General 56.3.2 Types 66.3.3 Activation . 66.3.4 Control 76.3.5 Special features . 76.4 Wrist units 76.4.1 General 76.4.2 Motions 86.4.3 Activation . 86.4.4 Control 96.5 Elbow unit . 96.5.1 General 96.5.2 Motions . 106.5.3 Activation 106.5.4 Control . 106.6 Shoulder unit . 116.6.1 General. 116.6.2 Mo

11、tions . 116.6.3 Activation 116.6.4 Control . 116.7 External (side) joints 126.7.1 General. 126.7.2 Motion 126.7.3 Axis of rotation .126.7.4 Activation and control 136.8 Humeral rotation units . 136.8.1 General. 136.8.2 Motion 136.8.3 Activation and control 136.9 Additional flexion unit . 13 ISO 2015

12、 All rights reserved iiiBS ISO 13405-3:2015ISO 13405-3:2015(E)7 Alignment components .148 Structural components .149 Finishing (cosmetic) components .14iv ISO 2015 All rights reservedBS ISO 13405-3:2015ISO 13405-3:2015(E)ForewordISO (the International Organization for Standardization) is a worldwide

13、 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

14、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 procedures used to develop this documen

15、t 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 editorial rules of the ISO/IEC Directives,

16、 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 rights identified during the development o

17、f 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 explanation on the meaning of ISO specific

18、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 Information. The committee responsible for this document is ISO/TC 168, Prosthetics and

19、orthotics.This second edition cancels and replaces the first edition (ISO 13405-3:1996), which has been technically revised with the following changes:a) classification tree of upper limb prosthetic components added to Clause 4;b) levels of amputation extended to include all partial hand levels;c) m

20、ethods of socket suspension extended;d) classification tree for functional components added in Clause 5;e) range of the types of terminal devices, wrist units, elbow units, and shoulder units extended;f) range of adjustment of alignment components deleted.ISO 13405 consists of the following parts, u

21、nder 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 limb prosthetic components ISO 2015 All rights reserved vBS I

22、SO 13405-3:2015ISO 13405-3:2015(E)IntroductionThis part of ISO 13405 was the first internationally accepted standard method to describe the components of upper limb prostheses. It is designed to permit the users to describe systematically each component which is incorporated in a finished prosthesis

23、 in a manner which clearly explains its principal characteristics. This part of ISO 13405 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 treatment of persons requiring prost

24、hesis.Prosthetic technology has made considerable advances since the publication of the first edition 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 the materials a

25、nd manufacturing methods employed have been avoided.vi ISO 2015 All rights reservedBS ISO 13405-3:2015Prosthetics and orthotics Classification and description of prosthetic components Part 3: Description of upper limb prosthetic components1 ScopeThis part of ISO 13405 specifies a method for describi

26、ng upper 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 of the refer

27、enced document (including any amendments) applies.ISO 8549-4, 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 d

28、efinitionsFor the purposes of this document, the following terms and definitions apply.3.1grip configurationposition of function of a prosthetic hand4 ClassificationThe components of upper limb prostheses include the five classes identified in ISO 13405-1:2014, 3.1, as shown in Figure 1 and Figure 2

29、, and as described in Clauses 5 to 9.INTERNATIONAL STANDARD ISO 13405-3:2015(E) ISO 2015 All rights reserved 1BS ISO 13405-3:2015ISO 13405-3:2015(E)5Interfacecomponents6Functionalcomponents7Alignmentcomponents8Structuralcomponents9Finishing(cosmetic)components5.1Sockets5.1.3Force-transmissionpropert

30、ies5.2Suspensorycomponents5.1.2Level ofamputation5.1.4Area of contact5.2.2Type5.2.3Suspensionsite5.1.3.4Suspension5.1.3.2Axial stabilization5.1.3.3Transversestabilization5.1.5Stiffness5.1.6Activation andcontrolFigure 1 Upper limb prosthetic components Classification tree5 Interface components5.1 Soc

31、kets5.1.1 GeneralDescribe the socket by including the following information.5.1.2 Level of amputationState the level of amputation for which the socket, and hence, the prosthesis, is intended by referring to the list of levels defined in ISO 8549-4:2014, 3.1.3, that is, as one of the following:a) pa

32、rtial hand amputations; these include: thumb; phalangeal; metacarpo-phalangeal disarticulation; metacarpal; carpo-metacarpal disarticulation; carpal;b) wrist disarticulation;c) trans-radial amputation;d) elbow disarticulation;e) trans-humeral amputation;f) shoulder disarticulation;g) scapulo-thoraci

33、c disarticulation amputation (forequarter).2 ISO 2015 All rights reservedBS ISO 13405-3:2015ISO 13405-3:2015(E)5.1.3 Force-transmission properties5.1.3.1 GeneralThe force-transmission properties of a socket relate to that aspect of the shaping of the socket which is concerned with axial stabilizatio

34、n, transverse stabilization, and suspension.5.1.3.2 Axial stabilizationState the principal intended method of axial stabilization as one of the following:a) proximal stabilization, in which the principal stabilization forces are generated by the shaping of the proximal region of the socket;b) distal

35、 stabilization, in which the principal stabilization forces are generated by the shaping of the end of the socket;c) total socket stabilization, in which the stabilization forces are generated by the shaping of the whole surface of the socket.5.1.3.3 Transverse stabilizationTransverse stabilization

36、is necessary to minimize the 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 particular features of the socket shaping associated with transverse stabilizatio

37、n.State whether the socket stabilization forces are modified by the use of a liner.5.1.3.4 SuspensionSuspension is necessary to minimize axial movement between the stump and the socket when the external longitudinal forces are distally directed.The socket may be suspended either bya) anatomical susp

38、ension, in which the suspensory properties are obtained by shaping the socket to the underlying anatomy (this might require the socket to be opened using removable sections, splits, or other means to allow donning and doffing),b) pressure-differential (suction) suspension, in which the suspensory pr

39、operties are obtained using a socket with an air-tight fit, which resists removal by virtue of the pressure differential resulting from such action, orc) using a liner, which creates a pressure differential by virtue of its intimate contact with the stump and which is mechanically coupled to the soc

40、ket distally.In any of these methods, adhesion between the stump, liner, and/or the socket, can contribute to the suspensory properties.State the types of suspension provided and any means of opening the socket.5.1.4 Area of contactState the area of contact of the socket with the stump as eithera) t

41、otal, orb) partial. ISO 2015 All rights reserved 3BS ISO 13405-3:2015ISO 13405-3:2015(E)5.1.5 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 desig

42、ned to deform), orc) partly flexible (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 or container.5.1.6 Activation and controlPart(s) of the socket can contribute to the activation and/or control o

43、f functional components. This can include movement of any part of the socket or the generation of forces between the stump and the socket.State which part(s) of the socket contribute(s) and their mode of action, when appropriate.5.2 Suspensory components (other than sockets and liners)5.2.1 GeneralS

44、uspensory components provide a mechanical link between the socket and a suitable proximal anatomical site.External (side) joints, which can be part of the suspension system, are classified as functional components because their principle function is to constrain unwanted joint motion (see 6.7).5.2.2

45、 TypeTypes of suspensory components include straps, sleeves, and cuffs.State the type of suspensory components.5.2.3 Suspension sitesState the anatomical location of the principal suspension site(s) as thea) trunk,b) shoulder(s),c) upper arm,d) humeral epicondyles,e) radial/ulnar styloids,f) carpals

46、/metacarpals, org) phalanges.4 ISO 2015 All rights reservedBS ISO 13405-3:2015ISO 13405-3:2015(E)6 Functional components6.1 GeneralFunctional components of a prosthesis substitute for some of the dynamic and sensory attributes of the normal limb. They can be passive or active. Active components can

47、be body powered or externally powered. This part of ISO 13405 does not include a description of the power source (e.g. battery/batteries) required by externally powered components.6Functionalcomponents6.2Description ofpermissiblemotions6.4.2Motions6.4.3Activation6.4Wrist units6.4.4Control6.6Shoulder

48、 unit6.8Humeral rotationunits6.3Terminaldevices6.3.3Activation6.3.2Types6.3.4Control6.3.5Special features6.5.4Control6.5Elbow unit6.5.3Activation6.5.2Motions6.7External (side)joints6.7.2Motion6.7.3Axis of rotation6.6.4Control6.6.3Activation6.6.2Motions6.7.4Activation andcontrol6.8.2Motion6.8.3Activa

49、tion andcontrol6.9Additional g976lexion unitFigure 2 Functional components Classification tree6.2 Description of permissible motionsThe permissible motions of the functional components of prostheses are described with respect to the standard reference planes of the body that 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 6.3 to 6.9).6.3 Terminal devices6.3.1 GeneralTerminal devices are desig