ISO/TS 4549:2023 矫形器 踝足矫形器的微处理器控制踝力矩单元的可靠性测试方法

标准编号：ISO/TS 4549:2023

中文名称：矫形器 踝足矫形器的微处理器控制踝力矩单元的可靠性测试方法

英文名称：Orthotics — Method for testing the reliability of microprocessor-controlled ankle moment units of ankle-foot orthoses

发布日期：2023-07

标准范围

本文件规定了一种测试踝足矫形器的微处理器控制的踝力矩单元的可靠性的方法，该装置在跖屈和背屈方向上移动。本文件规定了与适当载荷曲线一起应用的运动曲线类别，以为微处理器控制的踝关节力矩单元生成跖屈和背屈踝关节力矩载荷。它还定义了允许声明符合本文件的试验测量结果，以及如何在IFU中记录符合性。本文件仅涉及微处理器控制的踝关节力矩装置在运动中的阻力。像末端停止这样的几何约束，运动停止而不是维持运动，可以在重复的准静态测试中进行测试。描述了一种用于微处理器控制的踝关节力矩单元可靠性试验的试验参数推导方法。本文件适用于单侧踝足矫形器和双侧关节矫形器，其中两个关节都受到控制，或者一个关节受到控制而另一个关节不受控制。

This document specifies a method for testing the reliability of microprocessor-controlled ankle moment units of ankle-foot orthosis, moving in plantar- and dorsiflexion direction.

This document specifies categories of locomotion profiles to be applied together with appropriate loading profiles, to generate plantar- and dorsiflexion ankle moment loads for the microprocessor-controlled ankle moment units. It also defines which measured outcome of the test allows to claim compliance to this document, and how the compliance is documented in the IFU.

This document solely addresses the resistance of microprocessor-controlled ankle moment units in motion. Geometrical constrains like end stops, where motion is stopped instead of sustaining it, can be tested in repetitive quasi static tests instead.

A method to derive test parameters for the reliability test of microprocessor-controlled ankle moment units is described.

This document is applicable to unilateral ankle-foot orthoses and to bilateral jointed orthoses where either both joints are controlled or where one joint is controlled and the other is not controlled.

标准预览图