prEN ISO 22675

Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods (ISO/DIS 22675:2021)

General information
Base Documents
ISO/DIS 22675; prEN ISO 22675
Directives or regulations
Standard history
This document 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 document 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 document are characterized by standardized formats of these loading and locomotion profiles, to be applied by the cyclic and static test procedures to each sample of ankle-foot device or foot unit submitted for test. This document specifies Test Ranges by specifying locomotion profiles for the cyclic test in relation to the intended use. 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 The lines of action of the heel and forefoot forces generated by the static test procedure for Test Range 4 (R4) 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 referring to ISO 10328:2016, 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 10328:2016
30.00 € incl tax
30.00 € incl tax
Standard monitoring