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现行 ISO 22675:2016
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Prosthetics — Testing of ankle-foot devices and foot units — Requirements and test methods 假肢 - 脚踝装置和脚部测试 - 要求和测试方法
发布日期: 2016-05-26
重要吗?ISO 22675:2016适用于评估踝足假体器械和足部单元是否符合ISO 22523:2006 4.4中规定的强度要求(见注释1)。市场上已通过提交ISO 10328:2006的相关试验证明其符合ISO 22523:2006 4.4中规定的强度要求的假肢踝足装置和足部单元无需按照本国际标准进行重新试验。 警告?ISO 22675:2016不适合作为在个体下肢假肢处方中选择特定踝足装置或足部单元的指南!任何无视这一警告的行为都会给截肢者带来安全风险。 ISO 22675:2016主要规定了脚踝的循环测试程序-外部下肢假肢的足部装置和足部单元,其特征在于能够真实地模拟从脚跟撞击到脚趾离开的行走的完整站立阶段的那些负载条件,这些负载条件与诸如强度、耐用性和使用寿命的性能要求的验证相关。 这种潜力对于评估各种踝足装置和足部单元的最新设计的性能特别重要,这些装置和足部单元具有仅在实际负载条件下才会发展的特定特征。 此外,ISO 22675:2016规定了假肢踝足装置和足部单元的静态测试程序,包括静态验证测试和静态极限强度测试,除其他特征外,其区别在于(见注释2)在与循环测试期间最大脚跟和前脚掌载荷瞬间发生的力一致的作用线上产生脚跟和前脚掌力的潜力。第三段中提到的加载条件的特征在于由垂直和水平(A-P)地面反作用力的合成矢量确定的加载曲线和由胫骨角度确定的运动曲线。 本国际标准中规定的试验载荷条件由这些载荷和运动曲线的标准化格式表征,通过循环和静态试验程序统一应用于提交试验的踝足器械或足部单元的每个样品。
IMPORTANT?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?ISO 22675:2016 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. ISO 22675:2016 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, ISO 22675:2016 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.
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归口单位: ISO/TC 168
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