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Prostheses and orthoses - Factors to be considered when specifying a prosthesis for a person who has had a lower limb amputation
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Basic data
| Standard ID | GB/T 30658-2025 (GB/T30658-2025) |
| Description (Translated English) | Prostheses and orthoses - Factors to be considered when specifying a prosthesis for a person who has had a lower limb amputation |
| Sector / Industry | National Standard (Recommended) |
| Classification of Chinese Standard | C45 |
| Classification of International Standard | 11.040.40 |
| Word Count Estimation | 10,170 |
| Date of Issue | 2025-06-30 |
| Date of Implementation | 2025-10-01 |
| Older Standard (superseded by this standard) | GB/T 30658-2014 |
| Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration |
GB/T 30658-2025: Prostheses and orthoses - Factors to be considered when specifying a prosthesis for a person who has had a lower limb amputation
---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/GBT30658-2025
ICS 11.040.40
CCSC45
National Standard of the People's Republic of China
Replaces GB/T 30658-2014
Prosthetics and orthotics
Factors to consider when prescribing lower limb prostheses
(ISO 29782.2022, IDT)
Released on June 30, 2025
Implementation on October 1, 2025
State Administration for Market Regulation
The National Standardization Administration issued
Table of Contents
Preface III
Introduction IV
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Residual limb conditions 1
4.1 Overview 1
4.2 Length and shape 2
4.3 Soft tissue 2
4.4 Skin 2
4.5 Blood Circulation 2
4.6 Pain 2
4.7 Proximal joint 2
5 Constitution 3
6 Clinical symptoms 3
7 Functional status 3
8 Initiatives and Needs 3
9 Expected value 4
9.1 Mobile 4
9.2 Professional Conduct 4
9.3 Sports and recreational activities 4
9.4 Social and cultural activities 4
10 Environmental Conditions 4
11 Local and effective maintenance support 4
12 Social and economic environment 5
Preface
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents".
Drafting is required.
This document replaces GB/T 30658-2014 "Prosthetics and orthotics - Factors to consider when prescribing lower limb prostheses" and is in line with GB/T 30658-2014
In addition to structural adjustments and editorial changes, the main technical changes are as follows.
--- Changed "Length and shape" (see 4.2, 4.2 of the.2014 edition);
--- Added "excessive mobility at the bone/soft tissue interface" (see 4.3);
---Changed "Skin" (see 4.4,.2014 version 4.4);
--- Added "neuralgia" and "phantom limb pain" (see 4.6);
--- Added "gender" and "age" (see Chapter 5);
--- Changed "Move" (see 9.1, 9.1 of the.2014 edition).
This document is equivalent to ISO 29782.2022 “Prosthetics and orthotics — Factors to consider in prescribing lower limb prostheses”.
Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents.
This document is issued by the Ministry of Civil Affairs of the People's Republic of China.
This document is under the jurisdiction of the National Technical Committee for Standardization of Rehabilitation and Special Equipment for Persons with Disabilities (SAC/TC148).
This document was drafted by. National Rehabilitation Assistive Devices Research Center, Beijing Assistive Devices Assembly Department of National Rehabilitation Assistive Devices Research Center, Liaoning Aigemei Medical
Medical Rehabilitation Equipment Development Co., Ltd., the Affiliated Rehabilitation Hospital of the National Rehabilitation Assistive Equipment Research Center, the China Rehabilitation Assistive Equipment Association, Suzhou Aideke
Technology Development Co., Ltd., Shandong Yuhang Medical Co., Ltd.
The main drafters of this document are. Tao Jing, Ma Fengling, Zhang Xiaoxue, Zhao Liwei, Ge Hongjing, Wu Honglei, Zhang Li, Zhang Pengcheng, Jie Yingmin, and Li Xiaotang.
The previous versions of this document and the documents it replaces are as follows.
---First published in.2014 as GB/T 30658-2014;
---This is the first revision.
introduction
The selection of prosthetic components for patients requires consideration of their amputation level, stump and physique, clinical symptoms, functional status, initiative and needs.
The needs, expectations, and socioeconomic environment of the prosthesis also need to be considered, as well as the environment in which the prosthesis is used, local availability, and maintenance.
The other extreme is that the patient wants and can perform strenuous activities and requires a decorative prosthesis.
Some patients need special parts to carry out certain activities. Prosthetic fitting institutions need to use this information to
Components are selected based on their knowledge and clinical experience.
Many factors influence the choice of prosthetic components. The goal of prosthetic treatment is to control damage, reduce limitations, and thus improve daily life.
Participation in all aspects of daily living (ADL).
The final outcome depends on personal factors as well as environmental factors (such as relatives), which are collectively called background factors.
Funding for prostheses, the availability and maintenance of prostheses, and the environmental conditions in which they will be used also influence decisions.
Prosthetics and orthotics
Factors to consider when prescribing lower limb prostheses
1 Scope
This document specifies factors to be considered when prescribing prosthetic limbs for lower limb amputees.
This document applies to the prescription of lower limb prostheses.
2 Normative references
The contents of the following documents constitute the essential clauses of this document through normative references in this document.
For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to
This document.
Note. GB/T 15721.2-2009 Prostheses and orthoses for limb loss Part 2.Description of lower limb amputation stumps (ISO 8548-2.1993,
IDT)
ISO 8548-5 Prosthetics and orthotics for limb loss — Part 5.Description of clinical symptoms in lower limb amputees
anamputation)
Note. GB/T 15721.5-2008 Prosthetics and orthotics for limb loss Part 5.Description of clinical symptoms of amputees (ISO 8548-5.2003, IDT)
3 Terms and Definitions
For the purposes of this document, the terms and definitions defined in ISO 8548-2 and the following apply.
3.1
balance
The ability to maintain body mass above its surface of support.
3.2
coordination
Ability to perform prescribed activities smoothly and precisely.
3.3
Endurance
The ability to maintain muscle strength.
4 Residual limb conditions
4.1 Overview
Methods for describing lower limb amputation stumps are given in ISO 8548-2.
...