BS ISO 21064-2017 Prosthetics and orthotics Foot orthotics Uses functions classification and description《假肢和矫形器 足部矫形器 用途、功能分类和说明》.pdf

1、Prosthetics and orthotics Foot orthotics Uses, functions classification and descriptionBS ISO 21064:2017BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06National forewordThis British Standard is the UK implementation of ISO 21064:2017. 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 93050 8ICS 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 21064:2017 ISO 2017Prosthetics and orthotics Foot orthotics Uses, functions classification and descriptionProthses et orthses Orthses de pied Utilisations, fonctions, classification

5、 et descriptionINTERNATIONAL STANDARDISO21064First edition2017-07-15Reference numberISO 21064:2017(E)BS ISO 21064:2017ISO 21064:2017(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 21064:2017ISO 21064:2017(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Uses 25

8、Functions 26 Classification and description of devices 26.1 Classification . 26.2 Description of foot orthoses (used in conjunction with footwear) . 36.3 Description of orthotic footwear . 36.3.1 Type of fabrication . 36.3.2 Prefabricated orthotic footwear . 36.3.3 Custom fabricated orthotic footwea

9、r . 46.4 Description of adaptations (modifications) to footwear 4Bibliography 5 ISO 2017 All rights reserved iiiContents PageBS ISO 21064:2017ISO 21064:2017(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies).

10、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 committee. International organizations, governmental and non-g

11、overnmental, 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 document and those intended for its further maintenance are described

12、 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, Part 2 (see www.iso.org/directives).Attention is drawn to the

13、 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 of the document will be in the Introduction and/or on the ISO l

14、ist 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 voluntary nature of standards, the meaning of ISO specific terms and expressions relat

15、ed 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 informationThis document was prepared by Technical Committee ISO/TC 168, Prosthetics and orthotics.iv ISO 2017 All r

16、ights reservedBS ISO 21064:2017ISO 21064:2017(E)IntroductionNo internationally accepted method is available to describe devices applied to the foot to address neuromusculoskeletal impairments.This situation has created problems for practitioners prescribing these devices, for manufacturers when desc

17、ribing their products and for those reporting on the devices used in the treatment of their patients and their effects.This document proposes the adoption of the term “foot orthotics” for this field of orthotic practice. It also specifies the clinical objectives for the use of these devices and desc

18、ribes their functions and constituent components.Manufacturers trade names and details of materials and manufacturing processes have been avoided. ISO 2017 All rights reserved vBS ISO 21064:2017This page deliberately left blankProsthetics and orthotics Foot orthotics Uses, functions classification a

19、nd description1 ScopeThis document establishes a method of classifying and describing the devices that are used in the field of foot orthotics. It does not describe the materials or manufacturing methods used for their fabrication.2 Normative referencesThere are no normative references in this docum

20、ent.3 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.ISO and IEC maintain terminological databases for use in standardization at the following addresses: ISO Online browsing platform: available at http:/www.iso.org/obp IEC Electropedia: available at

21、 http:/www.electropedia.org/ 3.1foot orthosesorthoses that encompass the whole or part of the foot intended to address the effect of a neuromusculoskeletal impairment(s)Note 1 to entry: They can be custom fabricated or prefabricated.Note 2 to entry: This definition supersedes the definition of “foot

22、 orthoses” in ISO 85493.3.2orthotic footwearfootwear intended to address the effect of a neuromusculoskeletal impairment(s)Note 1 to entry: These can encompass the ankle joint. These devices are sometimes referred to as “orthopaedic footwear”. They can be custom fabricated or prefabricated.3.2.1cust

23、om fabricated orthotic footwearorthotic footwear designed and manufactured to meet the clinical needs of the individual user based on information such as moulds, lasts and measurementsNote 1 to entry: They can include a custom fabricated foot orthosis.3.2.2prefabricated orthotic footwearorthotic foo

24、twear designed and manufactured to meet the clinical needs of a particular group of users and which may be available in a range of sizes, styles and materialsNote 1 to entry: They can require adjustments and can include a foot orthosis in order to meet the clinical needs of the individual user.INTER

25、NATIONAL STANDARD ISO 21064:2017(E) ISO 2017 All rights reserved 1BS ISO 21064:2017ISO 21064:2017(E)3.3adaptations (modifications) to footwearadaptations (modifications) to either standard footwear or prefabricated orthotic footwear intended to meet the clinical needs of the individual user4 UsesFoo

26、t orthotic devices may be used to achieve the following clinical objectives:a) to relieve pain;b) to promote balanced standing and walking;c) to manage deformities which are:1) reducible (flexible) (e.g. pes planus);2) irreducible (fixed) (e.g. fixed equinus);d) to control joint instability (e.g. an

27、kle ligament insufficiency);e) to compensate for abnormal limb length and/or foot length or shape;f) to protect tissues (e.g. diabetic neuropathy and inflammatory arthropathy);g) to promote healing (e.g. foot ulcer);h) to stimulate motor-sensory feedback.5 FunctionsThe function of the device may be:

28、a) for deformities:1) to reduce or correct a deformity (i.e. to move a reducible (flexible) deformity into an improved alignment and hold the correction obtained);2) to hold a deformity (i.e. to prevent a fixed deformity from increasing);b) to control the alignment of a joint;c) to control the motio

29、n of a joint;d) to compensate for abnormal limb length and/or foot shape and size;e) to reduce or redistribute the load on the foot;f) to apply increased pressure on a specific area(s) of the foot surface.6 Classification and description of devices6.1 ClassificationThree classes of device are recogn

30、ised:a) foot orthoses;b) orthotic footwear;c) adaptations (modifications) to footwear.2 ISO 2017 All rights reservedBS ISO 21064:2017ISO 21064:2017(E)6.2 Description of foot orthoses (used in conjunction with footwear)Types of foot orthoses include:a) heel raises;b) heel cups/shells (which may be ex

31、tended);c) foot orthoses with:1) flares;2) supramalleolar extensions;3) medial/longitudinal arch supports;4) metatarsal supports;5) stiffening;6) cushioning;7) toe supports, spacers and protectors;8) medial and lateral wedges;9) local pressure relief;10) increased local pressure shaping;11) toe exte

32、nsion shaping.6.3 Description of orthotic footwear6.3.1 Type of fabricationOrthotic footwear can be:a) prefabricated orthotic footwear;b) custom fabricated orthotic footwear.6.3.2 Prefabricated orthotic footwearTypes include footwear with:a) extra width and/or depth;b) protective toe caps (excluding

33、 industrial footwear);c) stiffened soles;d) rocker soles;e) extended openings;f) easy closures;and footwear tog) partially unload the foot;h) accommodate vulnerable (at risk) feet; ISO 2017 All rights reserved 3BS ISO 21064:2017ISO 21064:2017(E)i) stabilise/immobilize the foot and ankle;and footwear

34、 forj) forefoot correction;k) temporary/healing/treatment (to accommodate wound dressings or casts).Some types of prefabricated footwear incorporate several of these features.6.3.3 Custom fabricated orthotic footwearTypes include footwear to:a) accommodate foot deformity(ies);b) accommodate extreme

35、foot shape and size;c) compensate for severe limb discrepancy;d) compensate for foot deficiencies;e) accommodate vulnerable (at risk) feet.Some types of custom fabricated footwear incorporate several of these features.6.4 Description of adaptations (modifications) to footwearTypes of footwear adapta

36、tion include:a) raises (heel or heel and sole);b) medial/lateral heel wedges;c) medial/lateral sole wedges;d) medial/lateral heel flares;e) medial/lateral sole flares;f) cushion heels;g) foot, heel, midfoot/forefoot and toe rockers;h) stiffened soles;i) stiffened shoe heel cups;j) localised stretche

37、d shoe uppers;k) modified closures;l) modified sole surface (nonslip and/or hardwearing and/or localised pressure relief).Several types of adaptation can be applied to the same shoe.4 ISO 2017 All rights reservedBS ISO 21064:2017ISO 21064:2017(E)Bibliography1 ISO 8549-3, Prosthetics and orthotics Vo

38、cabulary Part 3: Terms relating to external orthoses ISO 2017 All rights reserved 5BS ISO 21064:2017This page deliberately left blankThis page deliberately left blankBSI is the national body responsible for preparing British Standards and other standards-related publications, information and service

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