BS ISO 21063-2017 Prosthetics and orthotics Soft orthoses Uses functions classification and description《假肢和矫形器 软矫正器 用途、功能、分类和说明》.pdf

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1、Prosthetics and orthotics Soft orthoses Uses, functions, classification and descriptionBS ISO 21063:2017BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06National forewordThis British Standard is the UK implementation of ISO 21063:2017. The UK participation in its prep

2、aration 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 all the necessary provisions of a contract. Users are responsible for its corr

3、ect application. The British Standards Institution 2017 Published by BSI Standards Limited 2017ISBN 978 0 580 93049 2ICS 11.040.40Compliance with a British Standard cannot confer immunity from legal obligations. This British Standard was published under the authority of the Standards Policy and Stra

4、tegy Committee on 31 July 2017.Amendments/corrigenda issued since publicationDate Text affected BRITISH STANDARDBS ISO 21063:2017 ISO 2017Prosthetics and orthotics Soft orthoses Uses, functions, classification and descriptionProthses et orthses Orthses souples Utilisations, fonctions, classification

5、 et descriptionINTERNATIONAL STANDARDISO21063First edition2017-07-15Reference numberISO 21063:2017(E)BS ISO 21063:2017ISO 21063:2017(E)ii ISO 2017 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2017, Published in SwitzerlandAll rights reserved. Unless otherwise specified, no part of this public

6、ation 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 prior written permission. Permission can be requested from either ISO at the address below or ISOs member body in the countr

7、y of the requester.ISO copyright officeCh. de Blandonnet 8 CP 401CH-1214 Vernier, Geneva, SwitzerlandTel. +41 22 749 01 11Fax +41 22 749 09 47copyrightiso.orgwww.iso.orgBS ISO 21063:2017ISO 21063:2017(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Uses 15

8、Functions 26 Classification of devices 27 Description . 27.1 Type of fabrication . 27.2 Types of orthotic component . 37.3 Description of orthotic components 37.3.1 Interface components 37.3.2 Orthotic joints 3 ISO 2017 All rights reserved iiiContents PageBS ISO 21063:2017ISO 21063:2017(E)ForewordIS

9、O (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 out through ISO technical committees. Each member body interested in a subject for which a technical co

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11、technical 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 approval criteria needed for the different types of ISO documents should be noted. This document was draf

12、ted 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 subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rig

13、hts. 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 trade name used in this document is information given for the convenience of users and does not constit

14、ute an endorsement.For an explanation on the voluntary nature of standards, 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 -

15、 Supplementary information.This document was prepared by Technical Committee ISO/TC 168, Prosthetics and orthotics.iv ISO 2017 All rights reservedBS ISO 21063:2017ISO 21063:2017(E)IntroductionNo internationally accepted method is available to describe externally applied devices constructed from flex

16、ible materials which apply pressure to the body segments which they encompass. In some countries these devices are referred to as “bandages”.This situation has created problems for practitioners prescribing these devices, for manufacturers when describing their products and for those reporting on th

17、e devices used in the treatment of their patients and their effects.This document proposes the adoption of the term “soft orthoses” for this group of devices. It specifies their uses and functions, and classifies and describes the devices and their components.Manufacturers trade names and details of

18、 materials and manufacturing processes have been avoided. ISO 2017 All rights reserved vBS ISO 21063:2017This page deliberately left blankProsthetics and orthotics Soft orthoses Uses, functions, classification and description1 ScopeThis document specifies the uses and functions of soft orthoses. It

19、also classifies and describes the devices and their components. It does not describe the materials or manufacturing methods used for their fabrication.2 Normative referencesThe following documents are referred to in the text in such a way that some or all of their content constitutes requirements of

20、 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 8549-1, Prosthetics and orthotics Vocabulary Part 1: General terms for external limb prostheses and external orthosesISO

21、8549-3, Prosthetics and orthotics Vocabulary Part 3: Terms relating to external orthosesISO 8551, Prosthetics and orthotics Functional deficiencies Description of the person to be treated with an orthosis, clinical objectives of treatment, and functional requirements of the orthosisISO 13404, Prosth

22、etics and orthotics Categorization and description of external orthoses and orthotic components3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 85491, ISO 85493, ISO 8551 and ISO 13404 and the following apply.ISO and IEC maintain terminological databas

23、es for use in standardization at the following addresses: ISO Online browsing platform: available at http:/www.iso.org/obp IEC Electropedia: available at http:/www.electropedia.org/ 3.1soft orthosesorthoses whose soft interface materials apply pressure circumferentially and, if required, locally (us

24、ing pads and/or inserts) to the surface of the body segments which they encompassNote 1 to entry: They can incorporate orthotic joints and/or other components intended to control the motion and/or alignment of joints. Taping, stockings and garments used to treat burns are excluded.4 UsesSoft orthose

25、s may be used to achieve the following clinical objectives:a) to stimulate motor-sensory feedback;b) to prevent or reduce swelling;c) to control the motion(s) of a joint(s);INTERNATIONAL STANDARD ISO 21063:2017(E) ISO 2017 All rights reserved 1BS ISO 21063:2017ISO 21063:2017(E)d) to control the alig

26、nment of a joint(s);e) to relieve pain;f) to promote healing;g) to protect tissues.5 FunctionsSoft orthoses can have the following functions:a) to provide continuous circumferential pressure on the underlying tissues;b) to control the motion(s) of a joint(s);c) to control the alignment of a joint(s)

27、;d) to apply pressure on tissue locally.6 Classification of devicesClassify the soft orthosis by reference to the body segment(s) and joint(s) which it encompasses, using the terminology defined in ISO 85493 and shown in Table 1.Table 1 Terminology defined in ISO 85493 Device AbbreviationFoot orthos

28、isAnkle-foot orthosisKnee orthosisHip orthosisFinger orthosisHand orthosisWrist-hand orthosisElbow orthosisShoulder orthosisSacro-iliac orthosisLumbo-sacral orthosisThoraco-lumbo-sacral orthosisFOAFOKOHpOFiOHdOWHOEOSOSIOLSOTLSONOTE Some soft orthoses encompass only the digits while others encompass

29、multiple body segments (e.g. full body suits).7 Description7.1 Type of fabricationSoft orthoses can be eithera) custom fabricated, orb) prefabricated.2 ISO 2017 All rights reservedBS ISO 21063:2017ISO 21063:2017(E)Prefabricated orthoses may require adjustment for the individual user. State whether t

30、he orthosis is custom fabricated or prefabricated.7.2 Types of orthotic componentSoft orthoses comprise the following types of component:a) interface components;b) orthotic joints.7.3 Description of orthotic components7.3.1 Interface componentsInterface components of soft orthoses are those in direc

31、t contact with the user. They are manufactured from soft material which can be:a) non-elastic;b) elastic;c) part elastic/part non-elastic.The direction of action of the elastic part can be: circumferential; longitudinal; both.State if the interface material is elastic or non-elastic; if elastic, des

32、cribe the position of the elastic part and its direction of action.The interface component pressure distribution can be modified by the inclusion of pads, inserts and straps.State, if appropriate, how the interface component is modified.7.3.2 Orthotic jointsOrthotic joints are described by reference

33、 to the anatomical joints whose motions they are intended to control. They include:a) ankle joint;b) knee joint;c) hip joint;d) wrist joint;e) elbow joint;f) shoulder joint.State the type of orthotic joint. ISO 2017 All rights reserved 3BS ISO 21063:2017This page deliberately left blankThis page del

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