European Committee for Standardization

Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods
 N EN ISO 10328

Annotation

IMPORTANT — This International Standard 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 — This International Standard 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 International Standard 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.

The tests described in this International Standard 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;