Prosthetics — Structural testing of lower-limb prostheses — Requirements and test methods
假肢 - 下肢假体的结构测试 - 要求和测试方法
发布日期:
2016-05-26
重要的ISO 10328:2016适用于评估下肢假肢装置/结构是否符合ISO 22523:2006第4.4条规定的强度要求(见注1)。市场上通过提交ISO 10328:2006的相关试验证明其符合ISO 22523:2006第4.4条规定的强度要求的人工踝足装置和足部装置,无需按照ISO 22675:2016进行重新试验。
警告ISO 10328:2016不适合作为选择单个下肢假肢处方中特定下肢假肢装置/结构的指南!忽视这一警告可能会给截肢者带来安全风险。
ISO 10328:2016规定了下肢假肢静态和循环强度试验的程序(见注2),其通常通过施加单一试验力产生复合载荷。试样中的复合载荷与载荷分量的峰值有关,这些峰值通常出现在行走的站立阶段的不同时刻。
IMPORTANT - ISO 10328:2016 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 - ISO 10328:2016 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.
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.