BS ISO 13405-1-2015 Prosthetics and orthotics Classification and description of prosthetic components Classification of prosthetic components《修复术和矫形学 修复部件的分类和描述 修复部件的分类》.pdf

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

2、edes BS ISO 13405-1:1996 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/168, Prosthetics and orthotics.A list of organizations represented on this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 include al

3、l 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 84449 2 ICS 11.040.40 Compliance with a British Standard cannot confer immunity from legal obligations.This Britis

4、h 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 1: Classification o

5、f prosthetic componentsProthses et orthses Classification et description des composants de prothses Partie 1: Classification des composants de prothsesINTERNATIONAL STANDARDISO 13405-1Second edition 2015-01-15Reference number ISO 13405-1:2015(E)BS ISO 13405-1:2015ISO 13405-1:2015(E)ii ISO 2015 All r

6、ights 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 intranet, without pr

7、ior 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.orgPublished in SwitzerlandB

8、S ISO 13405-1:2015ISO 13405-1:2015(E)Contents PageForeword ivIntroduction v1 Scope . 12 Terms and definitions . 13 Classification 23.1 General . 23.2 Interface components . 23.3 Functional components . 23.4 Alignment components 33.5 Structural components (prosthetic construction) . 33.6 Finishing (c

9、osmetic) components 3 ISO 2015 All rights reserved iiiBS ISO 13405-1:2015ISO 13405-1:2015(E)ForewordISO (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 o

10、ut 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 c

11、ollaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.The 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 app

12、roval 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, Part 2 (see www.iso.org/directives).Attention is drawn to the possibility that some of the elements of this document may be the

13、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 of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).Any t

14、rade 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 terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the

15、Technical Barriers to Trade (TBT), see the following URL: Foreword - Supplementary Information. The committee responsible for this document is ISO/TC 168, Prosthetics and orthotics.This second edition cancels and replaces the first edition (ISO 13405-1:1996), which has been technically revised with

16、the following changes:a) liner added to the list of interface components;b) functional components divided into lower and upper limb and listed.ISO 13405 consists of the following parts, under the general title Prosthetics and orthotics Classification and description of prosthetic components: Part 1:

17、 Classification of prosthetic components Part 2: Description of lower limb prosthetic components Part 3: Description of upper limb prosthetic componentsiv ISO 2015 All rights reservedBS ISO 13405-1:2015ISO 13405-1:2015(E)IntroductionThis part of ISO 13405 was the first internationally accepted stand

18、ard method of classifying the components of prostheses. It is designed to permit the users to classify systematically each component which is incorporated in a finished prosthesis. This part of 13405 is envisaged as being suitable for use by both manufacturers producing literature describing their p

19、roducts and practitioners who are reporting on the components used in the treatment of persons requiring prosthesis. ISO 2015 All rights reserved vBS ISO 13405-1:2015BS ISO 13405-1:2015Prosthetics and orthotics Classification and description of prosthetic components Part 1: Classification of prosthe

20、tic components1 ScopeThis part of ISO 13405 specifies a means of classifying the components of limb prostheses and their construction.2 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.2.1axial stabilizationattribute of interface components which rela

21、tes to the transmission of longitudinal (proximally directed) forces from the prosthesis to the body2.2transverse stabilizationattribute of interface components which relates to the transmission of transversely directed forces between the prosthesis and the bodyNote 1 to entry: Three forms of stabil

22、ization are required: anteroposterior, mediolateral, and rotational.2.3suspensionattribute of interface components concerned with the retention of the prosthesis on the body, i.e. the transmission of longitudinal (distally directed) forces from the prosthesis to the body2.4adjustable componentprosth

23、etic component whose features can be changed before use by the manufacturer, prosthetist, or user2.5adaptable componentprosthetic component whose features can be changed by the user to make it suitable for different situations2.6auto-adaptive componentprosthetic component whose features change autom

24、atically in response to varying situations2.7linerremovable lining worn between the stump and the inner surface of the socketNote 1 to entry: It is used to modify the distribution of the forces associated with axial and transverse stabilization and it can additionally form a part of the prosthetic s

25、uspensory system.INTERNATIONAL STANDARD ISO 13405-1:2015(E) ISO 2015 All rights reserved 1BS ISO 13405-1:2015ISO 13405-1:2015(E)3 Classification3.1 GeneralProstheses are externally applied devices used to replace wholly, or in part, an absent or deficient limb segment. They are integrated constructi

26、ons comprising the following classes of components:a) interface components;b) functional components;c) alignment components;d) structural components;e) finishing (cosmetic) components.NOTE Some components can belong to more than one class, e.g. alignment components can also serve as structural compo

27、nents.3.2 Interface componentsInterface components of a prosthesis are in direct contact with the wearer. They are the means of achieving axial stabilization, transverse stabilization, and suspension (see Clause 3). Interface components include:a) the socket;b) suspensory components, which maintain

28、the prosthesis relative to the body;c) the liner.NOTE Interface components can contain elements which contribute to the activation and/or control of functional components.3.3 Functional components3.3.1 Functional components of a prosthesis substitute for some of the dynamic and sensory attributes of

29、 the normal limb.3.3.2 Lower limb prosthetic functional components include:a) ankle-foot units;b) knee units;c) hip units;d) torque reducers;e) load attenuators (shock absorbers);f) turntables;g) external (side) joints.3.3.3 Upper limb prosthetic functional components include:a) terminal devices and

30、 digits;b) wrist units;2 ISO 2015 All rights reservedBS ISO 13405-1:2015ISO 13405-1:2015(E)c) elbow units;d) shoulder units;e) turntables;f) external (side) joints.3.4 Alignment componentsAlignment components of prosthesis permit changes in the position of its components relative to one another.3.5

31、Structural components (prosthetic construction)The structural components of prosthesis connect the interface, functional, and alignment components, and maintain the integrity of the prosthesis. Types of prosthetic construction include:a) endoskeletal: in which the structural components are internal

32、and can be covered by finishing the components,b) exoskeletal: in which the structural components are external and also constitute the shape of the prosthesis.3.6 Finishing (cosmetic) componentsFinishing components of prosthesis can simulate the appearance, and/or texture, and/or consistency of a no

33、rmal limb. They include:a) cosmetic fillers and shells, which provide the desired shape of the prosthesis and can simulate the consistency of soft tissue;b) prosthetic skins, stockings, and gloves, which compose the outermost layer of the prosthesis and can simulate the colour, and/or texture of the

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