Prosthetics. Testing of ankle-foot devices and foot units. Requirements and test methods
假肢 踝足装置和足部装置的测试 要求和试验方法
发布日期:
2016-07-31
重要信息——BS EN ISO 22675:2016适用于评估产品的符合性
4.4中规定强度要求的人工踝足装置和足部装置
ISO 22523:2006标准(见注1)。市场上的人工踝足装置和足部装置,
已证明其符合4.4中规定的强度要求
通过提交ISO 10328:2006的相关测试,无需
按照本国际标准重新测试。警告——本国际标准不适合作为选择产品的指南
个人下肢假肢处方中的特定踝足装置或足部装置!
忽视这一警告可能会给截肢者带来安全风险。本国际标准主要规定了踝足装置和足部的循环试验程序
外部下肢假肢的单位,其特点是能够真实地模拟这些假肢
从脚跟撞击到脚趾离开的完整站立阶段的相关负载条件
用于验证强度、耐久性和使用寿命等性能要求。这一潜力对于评估各种近期项目的绩效尤其重要
踝足装置和足部装置的设计,具有特定的特点,只有在
装载的实际条件。此外,本国际标准规定了人工踝足的静态试验程序
由静态验证试验和静态极限强度试验组成的装置和脚踏装置,
除其他功能外,(见注2),还可能在鞋跟线处产生脚跟和前掌力
符合以下情况的动作:在运动过程中,脚跟和前脚承受最大载荷的瞬间
循环试验。第三段中所述的荷载条件以荷载剖面为特征
由垂直和水平(A-P)地面反作用力的合力矢量和
运动轮廓由胫骨角度决定。本国际标准中规定的试验荷载条件具有标准化的特点
这些载荷和运动曲线的格式,将由循环和静态试验统一应用
提交用于测试的踝足装置或足部装置的每个样品的程序。根据本国际标准试验的概念,踝足器械或
然而,提交测试的脚单元可以自由开发其在负载下的单独性能。注1:中规定的静态试验程序产生的脚跟和前掌力的作用线
本国际标准适用于确定试验荷载条件下矢状面荷载的方法
I和II用于ISO 10328:2016中规定的主要结构试验,且不改变角度值
对脚踝-足部装置和足部装置进行结构试验的脚跟和前脚平台的尺寸,如
ISO 10328:2016。交叉引用:ISO 8549-1:1989ISO 10328:2016ISO 22523:2006ISO/TR 22676:2006ISO/TR 16142:1999购买本文件时提供的所有当前修订版均包含在购买本文件中。
IMPORTANT - BS EN ISO 22675:2016 is suitable for the assessment of the conformity of
prosthetic ankle-foot devices and foot units with the strength requirements specified in 4.4
of ISO 22523:2006 (see NOTE 1). Prosthetic ankle-foot devices and foot units on the market,
which have demonstrated their compliance with the strength requirements specified in 4.4
of ISO 22523:2006 through submission to the relevant tests of ISO 10328:2006, need not be
retested to this International Standard.WARNING - This International Standard is not suitable to serve as a guide for the selection of a
specific ankle-foot device or foot unit in the prescription of an individual lower limb prosthesis!
Any disregard of this warning can result in a safety risk for amputees.This International Standard primarily specifies a cyclic test procedure for ankle-foot devices and foot
units of external lower limb prostheses, distinguished by the potential to realistically simulate those
loading conditions of the complete stance phase of walking from heel strike to toe-off that are relevant
to the verification of performance requirements such as strength, durability and service life.This potential is of particular importance for the assessment of the performance of a variety of recent
designs of ankle-foot devices and foot units with specific characteristics that will only develop under
realistic conditions of loading.In addition, this International Standard specifies a static test procedure for prosthetic ankle-foot
devices and foot units, consisting of a static proof test and a static ultimate strength test, distinguished,
besides other features, (see NOTE 2) by the potential to generate heel and forefoot forces at lines of
action conforming to those occurring at the instants of maximum heel and forefoot loading during the
cyclic test.The loading conditions addressed in the third paragraph are characterized by a loading profile
determined by the resultant vector of the vertical and horizontal (A-P) ground reaction forces and by a
locomotion profile determined by the tibia angle.The test loading conditions specified in this International Standard are characterized by standardized
formats of these loading and locomotion profiles, to be uniformly applied by the cyclic and static test
procedures to each sample of ankle-foot device or foot unit submitted for test.According to the concept of the tests of this International Standard, each sample of ankle-foot device or
foot unit submitted for test is, nevertheless, free to develop its individual performance under load.NOTE 1 The lines of action of the heel and forefoot forces generated by the static test procedure specified in
this International Standard approach those determining the sagittal plane loading of the test loading conditions
I and II for the principal structural tests specified in ISO 10328:2016, without changing the values of the angles
of the heel and forefoot platform(s) for the structural tests on ankle-foot devices and foot units specified in
ISO 10328:2016.Cross References:ISO 8549-1:1989ISO 10328:2016ISO 22523:2006ISO/TR 22676:2006ISO/TR 16142:1999All current amendments available at time of purchase are included with the purchase of this document.