Standards Development

Scope

WARNING — This document 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.

This document 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.

This document specifies Test Ranges (R) by specifying locomotion profiles for the cyclic test in relation to the intended use. According to the concept of the tests of this document, each sample of lower limb prosthetic device / structure submitted for test is, nevertheless, free to develop its individual performance under load.

The tests described in this document comprise

— principal static and cyclic tests for all components;

— a separate static test in torsion for all components;

— separate static and cyclic tests on ankle-foot devices and foot units for all ankle-foot devices as single components including ankle units or ankle attachments and all foot units as single components;

— a separate static ultimate strength test in maximum knee flexion on knee joints and associated parts for all knee units or knee-shin-assemblies and adjacent components that normally provide the flexion stop on a complete prosthesis;

— optional separate tests on knee locks for all mechanisms which lock the knee joint in the extended position of the knee unit or knee-shin-assembly.

The tests described in this document apply to specific types of ankle-disarticulation prostheses (see NOTE 2), to transtibial (below-knee), knee-disarticulation and transfemoral (above-knee) prostheses and to the distal (lower) part of hip-disarticulation and hemi-pelvectomy prostheses (see NOTE 3). The test geometry described in this standard is only intended to be used up to a level of 150 mm above the knee-joint centre.

This document 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). Lower limb prosthetic devices/structures 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 22523:2006, need not be retested to this document.

NOTE 1 The tests can be performed on complete structures, on part structures or on individual components.

NOTE 2 The tests only apply to ankle-disarticulation prostheses which include (foot) components of prosthetic ankle-foot devices taken from the normal production line.

NOTE 3 The distal part comprises the knee unit, the ankle-foot device and all parts between. Tests on hip units are described in ISO 15032.