重要事项——本国际标准适用于合格评定 具有4.4中规定强度要求的下肢假肢装置/结构 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 根据ISO 22675:2016重新测试。警告——本国际标准不适合作为选择产品的指南 特定的下肢假肢装置/结构，适用于单个下肢 假肢！忽视这一警告可能会给截肢者带来安全风险。BS EN ISO 10328:2016规定了下肢静态和循环强度试验程序 假体（见注2），通常通过一次试验产生复合载荷 武力试样中的复合载荷与载荷分量的峰值有关 这通常发生在行走的站立阶段的不同时刻。本国际标准中描述的试验包括所有部件的主要静态和循环试验；对所有部件进行单独的静态扭转试验；对踝足装置和所有踝足装置的足部单元进行单独的静态和循环试验 组件包括脚踝单元或脚踝附件，以及作为单个组件的所有足部单元；一项单独的静态极限强度试验，用于膝关节最大屈曲和相关 所有膝关节装置或膝胫组件以及通常提供 完整假体上的屈曲止点；对锁定膝关节的所有机构的膝锁进行单独的静态和循环测试 膝盖单元或膝盖的伸展位置- 胫骨组件。本国际标准中描述的测试适用于特定类型的踝关节离断 经胫骨（膝下）、膝关节离断和经股关节（膝上）的假体（见注2） 假体和髋关节离断和半骨盆切除假体的远端（下部） （见注3）。注1:试验可在完整结构、零件结构或单个组件上进行。注2:本试验仅适用于踝关节离断假肢，包括从正常生产线取出的假肢踝足装置的（脚）部件。注3:远侧部分包括膝关节单元、踝足装置以及两者之间的所有部分。ISO 15032中描述了hip装置的测试。交叉引用:ISO 8549-1:1989ISO/TR 16142:1999ISO 22523:2006ISO 22675:2016ISO 15032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 - This International Standard is suitable for the assessment of the conformity of lower limb prosthetic devices/structures 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 ISO 22675:2016.WARNING - This International Standard is not suitable to serve as a guide for the selection of a specific lower limb prosthetic device/structure in the prescription of an individual lower limb prosthesis! Any disregard of this warning can result in a safety risk for amputees.BS EN ISO 10328:2016 specifies procedures for static and cyclic strength tests on lower-limb prostheses (see NOTE 2) which typically produce compound loadings by the application of a single test force. The compound loads in the test sample relate to the peak values of the components of loading which normally occur at different instants during the stance phase of walking.The tests described in this International Standard compriseprincipal static and cyclic tests for all components;a separate static test in torsion for all components;separate static and cyclic tests on ankle-foot devices and foot units for all ankle-foot devices as single components including ankle units or ankle attachments and all foot units as single components;a separate static ultimate strength test in maximum knee flexion on knee joints and associated parts for all knee units or knee-shin-assemblies and adjacent components that normally provide the flexion stop on a complete prosthesis;separate static and cyclic tests on knee locks for all mechanisms which lock the knee joint in the extended position of the knee unit or knee-shin-assembly.The tests described in this International Standard apply to specific types of ankle-disarticulation prostheses (see NOTE 2), to transtibial (below-knee), knee-disarticulation and transfemoral (aboveknee) prostheses and to the distal (lower) part of hip-disarticulation and hemi-pelvectomy prostheses (see NOTE 3).NOTE 1 The tests can be performed on complete structures, on part structures or on individual components.NOTE 2 The tests only apply to ankle-disarticulation prostheses which include (foot) components of prosthetic ankle-foot devices taken from the normal production line.NOTE 3 The distal part comprises the knee unit, the ankle-foot device and all parts between. Tests on hip units are described in ISO 15032.Cross References:ISO 8549-1:1989ISO/TR 16142:1999ISO 22523:2006ISO 22675:2016ISO 15032All current amendments available at time of purchase are included with the purchase of this document.