ISO 10328:2016Published

Prosthetics — Structural testing of lower-limb prostheses — Requirements and test methods

Prothèses — Essais portant sur la structure des prothèses de membres inférieurs — Exigences et méthodes d'essai

A new edition is under development: ISO 10328.

Abstract / scope

IMPORTANT - ISO 10328:2016 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 - ISO 10328:2016 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.

ISO 10328:2016 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.

Life cycle

Replaces

ISO 10328:2006WithdrawnProsthetics — Structural testing of lower-limb prostheses — Requirements and test methodsInternational Standard · Published 14 Sep 2006 · ISO/TC 168

Replaced by

ISO 10328Under developmentProsthetics — Structural testing of lower-limb prostheses — Requirements and test methodsInternational Standard · ISO/TC 168ISO/CD 10328Deleted (project abandoned)Prosthetics — Structural testing of lower-limb prostheses — Requirements and test methodsInternational Standard · ISO/TC 168