1、Prosthetics and orthotics Terms relating to the treatment and rehabilitation of persons having a lower limb amputationBS ISO 21065:2017BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06National forewordThis British Standard is the UK implementation of ISO 21065:2017. T
2、he 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 all the necessary provisions of a contract. Use
3、rs are responsible for its correct application. The British Standards Institution 2017 Published by BSI Standards Limited 2017ISBN 978 0 580 93051 5ICS 11.040.40Compliance with a British Standard cannot confer immunity from legal obligations. This British Standard was published under the authority o
4、f the Standards Policy and Strategy Committee on 31 July 2017.Amendments/corrigenda issued since publicationDate Text affected BRITISH STANDARDBS ISO 21065:2017 ISO 2017Prosthetics and orthotics Terms relating to the treatment and rehabilitation of persons having a lower limb amputationProthses et o
5、rthses Termes associs au traitement et la radaptation de personnes amputes du membre infrieurINTERNATIONAL STANDARDISO21065First edition2017-07-15Reference numberISO 21065:2017(E)BS ISO 21065:2017ISO 21065:2017(E)ii ISO 2017 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2017, Published in Swit
6、zerlandAll 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 prior written permission. Permission can be re
7、quested from either ISO at the address below or ISOs member body in the country 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 21065:2017ISO 21065:2017(E)Foreword ivIntroduc
8、tion v1 Scope . 12 Normative references 13 Terms and definitions . 14 Phases of treatment and rehabilitation . 25 Modes of treatment 35.1 General . 35.2 Pre-operative care 35.2.1 Treatments 35.3 Surgery . 35.3.1 Treatments 35.4 Immediate post-operative care . 35.4.1 Treatments 35.4.2 Complications .
9、 35.4.3 Treatment of complications . 45.5 Early rehabilitation . 45.5.1 Treatments 45.5.2 Complications . 55.5.3 Treatment of complications . 55.6 Rehabilitation without a prosthesis . 55.6.1 Treatments 55.6.2 Complications and their treatments . 55.7 Rehabilitation with a prosthesis 55.7.1 Treatmen
10、ts 55.7.2 Complications and their treatments . 65.8 Continuing care. 65.8.1 Treatments 65.8.2 Complications . 65.8.3 Treatment of complications . 6 ISO 2017 All rights reserved iiiContents PageBS ISO 21065:2017ISO 21065:2017(E)ForewordISO (the International Organization for Standardization) is a wor
11、ldwide 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
12、 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 procedures used to develop this d
13、ocument 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 Direc
14、tives, 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 develop
15、ment 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 explanation on the voluntary nature o
16、f 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 - Supplementary informationThis document was prepared by Technic
17、al Committee ISO/TC 168, Prosthetics and orthotics.iv ISO 2017 All rights reservedBS ISO 21065:2017ISO 21065:2017(E)IntroductionCurrently there is no internationally accepted terminology to describe the phases of treatment and rehabilitation of persons having a lower limb amputation and the treatmen
18、ts which are used during these phases.As a consequence the members of the clinic teams in different parts of the world have adopted their own terminology to meet their own needs. This situation makes it difficult to compare the clinical practices adopted in different treatment centres.This document
19、proposes a terminology which is designed to overcome this problem. It is suitable for use in clinical records and will facilitate the analysis of treatment outcomes. ISO 2017 All rights reserved vBS ISO 21065:2017This page deliberately left blankProsthetics and orthotics Terms relating to the treatm
20、ent and rehabilitation of persons having a lower limb amputation1 ScopeThis document specifies a vocabulary for the description of the phases of treatment and rehabilitation of persons having a lower limb amputation and the treatments which are used during these phases.2 Normative referencesThere ar
21、e no normative references in this document.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
22、.org/obp IEC Electropedia: available at http:/www.electropedia.org/ 3.1pre-operative caretreatment provided from the time the decision to amputate is made until surgery is performed3.2surgerytreatment provided when the person is in the operating room3.3stumpresiduumthat part of the limb remaining af
23、ter amputation surgery3.4immediate post-operative caretreatment provided after surgery where the focus is recovery from the procedure, achieving medical stability, preventing complications and initiating mobilityNote 1 to entry: This is normally up to three days.3.5complicationadverse event affectin
24、g the expected progress of treatment3.6debridementsurgical removal of non-viable and necrotic tissues3.7phantom painpain felt as if in the amputated part of the limbINTERNATIONAL STANDARD ISO 21065:2017(E) ISO 2017 All rights reserved 1BS ISO 21065:2017ISO 21065:2017(E)3.8early rehabilitationtreatme
25、nt, provided once the person is medically stable, to achieve optimum conditions for rehabilitation with or without a prosthesis3.9early walking aidsEWAprefabricated assistive devices applied to the stumpNote 1 to entry: They can be used to assess suitability for prosthetic fitting, to promote early
26、mobilization and gait re-education and to control oedema and promote healing. They are intended for use during the early rehabilitation phase.3.10temporary prosthesespreparatory prosthesesindividually manufactured prostheses, to permit early mobilization and gait re-education prior to provision of a
27、 definitive prosthesis3.11definitive prosthesesindividually manufactured prostheses intended for continuing use3.12rehabilitation with a prosthesistreatment provided to the person who is being supplied with a prosthesis3.13rehabilitation without a prosthesistreatment provided to the person who is no
28、t being supplied with a prosthesis3.14continuing careeducation and treatment intended to maintain optimal medical, physical and functional status and quality of life4 Phases of treatment and rehabilitationThe treatment and rehabilitation of a person having a lower limb amputation, from the time the
29、decision is made to amputate, and for the remainder of their lives, may be considered as comprising the following phases: preoperative care; surgery; immediate postoperative care; early rehabilitation; rehabilitation with or without a prosthesis; continuing care.2 ISO 2017 All rights reservedBS ISO
30、21065:2017ISO 21065:2017(E)5 Modes of treatment5.1 GeneralDuring each phase a range of modes of treatment (including education and provision of information) are routinely delivered and a number of complications may occur which will require further treatment, as specified below.5.2 Pre-operative care
31、5.2.1 Treatments Assessment (medical, functional, psychological and social) of suitability for amputation and to determine level of amputation. Counselling of patient, family and/or carer. Obtaining informed consent and marking the site(s) of operation(s). Medical, physical therapy and psychological
32、 treatment as appropriate.5.3 Surgery5.3.1 Treatments Anaesthesia and pain management. Positioning. Amputation. Infection prophylaxis. Thromboembolic prophylaxis. Surgical site dressing (including rigid dressings).5.4 Immediate post-operative care5.4.1 Treatments Routine postoperative medical, physi
33、cal therapy and nursing care. Pain management. Surgical site management. Stump (residuum) management (including oedema control, muscle strengthening and contracture prophylaxis). Psychological support. Physical therapy (including positioning, mobility in bed, general strengthening, standing and bala
34、nce training, falls awareness, and transfers). Care of the contralateral limb (including prevention of pressure ulcers and contractures, and thromboembolic prophylaxis).5.4.2 Complications ISO 2017 All rights reserved 3BS ISO 21065:2017ISO 21065:2017(E) Surgical site infection. Bleeding and haematom
35、a. Wound dehiscence. Excessive oedema. Other infections (e.g. pneumonia, urinary). Excessive wound or unexplained pain. Phantom pain. Pressure ulcers (contralateral limb). Venous thrombosis. Psychological issues.5.4.3 Treatment of complications Antimicrobial therapy. Debridement. Revision amputation
36、. Re-amputation. Intensified compression therapy. Additional pain management (e.g. medication, nerve block). Pressure relieving measures. Anti-coagulation therapy. Wound dressings (e.g. negative pressure).5.5 Early rehabilitation5.5.1 TreatmentsAll the treatments used in the previous phase as approp
37、riate, plus: occupational therapy (e.g. ADL, wheelchair mobility, assessment of living environment); physical therapy (e.g. intensified strength and mobility training, residuum conditioning, hopping and single leg walking training, falls strategy); education and training in stump care and hygiene; t
38、raining using early walking aids and temporary/preparatory prostheses; assessment of suitability for prosthetic fitting; provision of information regarding prosthetic options and supply procedures.4 ISO 2017 All rights reservedBS ISO 21065:2017ISO 21065:2017(E)5.5.2 ComplicationsAll the complication
39、s of the immediate postoperative phase, plus: joint stiffness and/or contracture; phantom pain; cognitive impairment; depression.5.5.3 Treatment of complicationsAll the treatments of complications used in the immediate postoperative phase, plus: psychological therapy (e.g. cognitive behavioural ther
40、apy) and medication; provision of pressure relieving orthoses and/or footwear; mirror therapy, transcutaneous electrical nerve stimulation (TENS) and alternative therapies; manual and mechanical joint stretching, serial casting and orthoses.5.6 Rehabilitation without a prosthesis5.6.1 TreatmentsAll
41、the treatments of the early rehabilitation phase as appropriate, plus: discharge planning (including placement, home adaptation and assistive product provision); wheelchair provision and training; cosmetic-only prosthesis provision if appropriate; appropriate ADL training; specialized rehabilitation
42、 (e.g. recreational, sporting and vocational activities).5.6.2 Complications and their treatmentsAll the complications and their treatments of the early rehabilitation phase.5.7 Rehabilitation with a prosthesis5.7.1 TreatmentsAll the treatments of the early rehabilitation phase as appropriate, plus:
43、 discharge planning (including placement, home adaptation and assistive product provision); prosthetic provision; education and training in the use, care and acceptance of the prosthesis (including handling, putting on and taking off, hygiene and cleaning); gait training and provision of walking aid
44、s; wheelchair provision and training (when appropriate); appropriate ADL training; ISO 2017 All rights reserved 5BS ISO 21065:2017ISO 21065:2017(E) specialized rehabilitation (e.g. recreational, sporting and vocational activities).5.7.2 Complications and their treatmentsAll the complications and the
45、ir treatments of the early rehabilitation phase.5.8 Continuing care5.8.1 TreatmentsAll the treatments of the non-prosthetic and prosthetic phases, as appropriate, plus: social support (including funding sources, information to relatives and carers); medical, surgical and nursing care and therapy as
46、required; prosthetic, wheelchair and assistive products review and maintenance as required; education in the maintenance of physical fitness and a healthy lifestyle; information on disease management and prevention of secondary complications.5.8.2 ComplicationsAll the complications of the earlier re
47、habilitation phases, plus: neuromata; redundant/excessive soft tissue; heterotopic bone formation; excessive bone growth; adherent scar tissue; stump problems related to poor surgical technique.5.8.3 Treatment of complicationsAll the treatments of complications in the earlier rehabilitation phases,
48、plus: management of neuromata by injection or surgery; medication and radiotherapy; revision surgery.6 ISO 2017 All rights reservedBS ISO 21065:2017This page deliberately left blankBSI is the national body responsible for preparing British Standards and other standards-related publications, informat
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