ISO 22675-2006 修复术.足-踝器械和足部组件的试验.要求和试验方法

标准号：ISO 22675-2006
中文标准名称：修复术.足-踝器械和足部组件的试验.要求和试验方法
英文标准名称：Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods
标准类型：C45
发布日期：1999/12/31 12:00:00
实施日期：1999/12/31 12:00:00
中国标准分类号：C45
国际标准分类号：11.180.10
适用范围：IMPORTANT — This International Standard is suitable for the assessment of the conformity ofprosthetic ankle-foot devices and foot units with the strength requirements specified in 4.4 ofISO 22523:2006 (see NOTE 1). Prosthetic ankle-foot devices and foot units on the market, which havedemonstrated their compliance with the strength requirements specified in 4.4 of EN 12523:1999through submission to the relevant tests of ISO 10328:1996, need not be retested to this International Standard.This International Standard primarily specifies a cyclic test procedure for ankle-foot devices and foot units ofexternal lower limb prostheses, distinguished by the potential to realistically simulate those loading conditionsof the complete stance phase of walking from heel strike to toe-off that are relevant to the verification ofperformance 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 designsof ankle-foot devices and foot units with specific characteristics that will only develop under realistic conditionsof loading.In addition, this International Standard specifies a static test procedure for prosthetic ankle-foot devices andfoot units, consisting of a static proof test and a static ultimate strength test, distinguished, besides otherfeatures, (see NOTE 2) by the potential to generate heel and forefoot forces at lines of action conforming tothose 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 bythe resultant vector of the vertical and horizontal (A-P) ground reaction forces and by a locomotion profiledetermined by the tibia angle.The test loading conditions specified in this International Standard are characterized by standardized formatsof these loading and locomotion profiles, to be uniformly applied by the cyclic and static test procedures toeach 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 footunit submitted for test is, nevertheless, free to develop its individual performance under load.NOTE 1 ISO 22523 (formerly EN 12523) addresses those of the Essential Requirements listed in Annex I of theEuropean Medical Device Directive 93/42/EEC that are applicable to external limb prostheses and external orthoses.NOTE 2 The lines of action of the heel and forefoot forces generated by the static test procedure specified in thisInternational Standard approach those determining the sagittal plane loading of the test loading conditions I and II for theprincipal structural tests specified in ISO 10328, without changing the values of the angles of the heel and forefootplatform(s) for the structural tests on ankle-foot devices and foot units specified in ISO 10328.