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GB/T 30658-2025Prostheses and orthoses - Factors to be considered when specifying a prosthesis for a person who has had a lower limb amputation (English PDF)

假肢和矫形器 开具下肢假肢处方考虑的因素

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Issued by

State Administration for Market Regulation, China National Standardization Administration

Level / Type

National · Recommended

Issue date

June 30, 2025

Implementation date

October 1, 2025

Scope

GB/T 30658-2025 is the English-translated version of 假肢和矫形器 开具下肢假肢处方考虑的因素.

GB/T 30658-2025 — 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.

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Document preview — GB/T 30658-2025

National Standard of the People's Republic of China

ICS
11.040.40
Classification
C 45
Replacing
GB/T 30658-2014

Issued by: State Administration for Market Regulation, China National Standardization Administration

Contents

  • Preface
  • Introduction
  • 1 Scope
  • 2 Normative references
  • 3 Terms and Definitions
  • 4 Residual limb conditions
  • 4.1 Overview
  • 4.2 Length and shape
  • 4.3 Soft tissue
  • 4.4 Skin
  • 4.5 Blood Circulation
  • 4.6 Pain
  • 4.7 Proximal joint
  • 5 Constitution
  • 6 Clinical symptoms
  • 7 Functional status
  • 8 Initiatives and Needs
  • 9 Expected value
  • 9.1 Mobile
  • 9.2 Professional Conduct
  • 9.3 Sports and recreational activities
  • 9.4 Social and cultural activities
  • 10 Environmental Conditions
  • 11 Local and effective maintenance support
  • 12 Social and economic environment

Foreword

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".

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.

balance

The ability to maintain body mass above its surface of support.

coordination

Ability to perform prescribed activities smoothly and precisely.

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.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 8 pages — is available in the English PDF.

Referenced standards

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