ISO/TS 4549:2023

Orthotics — Method for testing the reliability of microprocessor-controlled ankle moment units of ankle-foot orthoses

Scope

This document specifies a method for testing the reliability of microprocessor-controlled ankle moment units of ankle-foot orthosis, moving in plantar- and dorsiflexion direction.
This document specifies categories of locomotion profiles to be applied together with appropriate loading profiles, to generate plantar- and dorsiflexion ankle moment loads for the microprocessor-controlled ankle moment units. It also defines which measured outcome of the test allows to claim compliance to this document, and how the compliance is documented in the IFU.
This document solely addresses the resistance of microprocessor-controlled ankle moment units in motion. Geometrical constrains like end stops, where motion is stopped instead of sustaining it, can be tested in repetitive quasi static tests instead.
A method to derive test parameters for the reliability test of microprocessor-controlled ankle moment units is described.
This document is applicable to unilateral ankle-foot orthoses and to bilateral jointed orthoses where either both joints are controlled or where one joint is controlled and the other is not controlled.