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GB/T 43350-2023Prosthetics - Quantification of physical parameters of ankle foot devices and foot units (English PDF)

假肢踝足装置和足部组件物理参数的量化

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Issued by

State Administration for Market Regulation, China National Standardization Administration

Level / Type

National · Recommended

Issue date

November 27, 2023

Implementation date

March 1, 2024

Scope

GB/T 43350-2023 is the English-translated version of 假肢踝足装置和足部组件物理参数的量化.

GB/T 43350-2023 is the Chinese national standard for the quantification of physical parameters of prosthetic ankle-foot devices and foot units, adopted from ISO/TS 16955:2016 as a national standard.

It describes a quantitative method for measuring or evaluating key performance indicators of these devices, with set-up and test settings for each method and parameters derived or calculated from the recorded data.

Its clauses cover symbols and abbreviations, requirements, test configuration and quantification of heel, midfoot and toe characteristics, rolling, torsional and frontal plane characteristics.

Further parts deal with the procedure and results, and appendices include a quick reference and the three-dimensional trajectory of the plantar force contact point.

Issued on 27 November 2023 and applicable from 1 March 2024, it replaces no earlier edition.

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Document preview — GB/T 43350-2023

National Standard of the People's Republic of China

ICS: 11.040.40
Classification: C 35

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

PrefaceI
1 Scope
2 Normative references
3 Terms and Definitions
4 Symbols and abbreviations
5 Requirements
6 Test configuration
7 Quantification
7.1 Heel, midfoot and toe characteristics
7.2 Scrolling characteristics
7.3 Torsional characteristics
7.4 Frontal plane characteristics
8 Annex
8.1 General
8.2 Procedure
8.3 Results
Appendix A (Informative) Quick Reference
Appendix B (informative) Three-dimensional trajectory of plantar force contact point
Reference

Foreword

This document complies with the regulations of GB/T 1.1-2020 "Standardization Work Guidelines Part 1: Structure and Drafting Rules of Standardization Documents" Custom drafting.

This document is equivalent to ISO /T S16955.2016 "Quantification of physical parameters of prosthetic ankle and foot devices and foot components". The file type is. ISO technical specifications are adjusted to my country's national standards.

1 Scope

This document describes a quantitative method for measuring or evaluating key performance indicators of prosthetic ankle and foot devices.

Setup and test settings are specified for each method and include various parameters derived or calculated from the recorded data.

2 Normative reference documents

The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, the dated quotations For undated referenced documents, only the version corresponding to that date applies to this document; for undated referenced documents, the latest version (including all amendments) applies to this document.

GB/T 30659-2014 Prosthetics and orthotics requirements and test methods (ISO 22523:2006, IDT)

ISO 10328 Structural testing requirements and testing methods for prosthetic lower limb prostheses (Prosthetics-Structural testing of ISO 22675:2016 Prosthetic ankle and foot devices and foot components Requirements and test methods (Prosthetics-Testingofan- Note: GB/T 31181-2014 Prosthetic ankle and foot devices and foot components requirements and test methods (ISO 22675:2006, IDT)

3 Terms and definitions

The following terms and definitions apply to this document.

3.1 Physical parameters used to describe

the response of the ankle-foot device after heel strike, mid-stance, and before toe-off under the load-bearing state of the ankle-foot device.

3.2 Rol-overcharacteristics

Used to describe the physical parameters of the patient's ankle-foot device in the sagittal plane during stance.

3.3 Full contact motion

A physical parameter used to describe the angular range of motion of the tibia when the heel and toe strike the ground simultaneously.

3.4 Used to describe

the physical parameters of the ankle-foot device in the horizontal plane load-bearing and torsion state.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 18 pages — is available in the English PDF.

Referenced standards

Normative references

GB/T 30659-2014External limb prostheses and external orthoses -- Requirements and test methods

ISO 10328

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