标准号：ISO 22675-2006
实施状态：作废
中文名称：修复术.足-踝器械和足部组件的试验.要求和试验方法
英文名称：Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods
发布日期：2006-10
被替代标准：ISO 22675-2016
代替标准：ISO/FDIS 22675-2006
采用标准：DIN EN ISO 22675-2007,IDT;BS EN ISO 22675-2006,IDT;EN ISO 22675-2006,IDT;NF S96-801-2006,IDT;SN EN ISO 22675-2007,IDT;OENORM EN ISO 22675-2007,IDT;PN-EN ISO 22675-2007,IDT;UNE-EN ISO 22675-2007,IDT
起草单位：ISO/TC 168
标准简介：IMPORTANT — This International Standard 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 EN 12523:1999
through 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 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 ISO 22523 (formerly EN 12523) addresses those of the Essential Requirements listed in Annex I of the
European 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 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, 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.
文件格式：PDF
文件大小：2.75MB
文件页数：102
（以上信息更新时间为：2019-11-22）
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.pdf
(2.75 MB)
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