IMPORTANT - This International Standard is appropriate for assessing the conformity of lower limb prosthetic devices/structures to the strength requirements specified in ISO 22523:2006, 4.4, (see Note 1). Ankle-foot fittings and foot assemblies available on the market that have been demonstrated to conform to the strength requirements specified in ISO 22523:2006, 4.4, by subjecting them to the appropriate tests of ISO 10328:2006 do not require ISO re-testing 22675:2016 to be checked. WARNING - This International Standard is not intended to serve as a guide for the selection of a specific lower limb prosthetic device/structure when prescribing an individual lower limb prosthesis! Any failure to heed this warning may result in a safety hazard for amputees. This International Standard specifies procedures for static and dynamic strength testing of lower limb prostheses (see Note 2), where, typically, compound loads are generated by the application of a single test force. The compound loads in the test specimen are related to the peak values of the load components that normally occur at different times during the stance phase of running. The tests described in this International Standard include main static and dynamic tests for all components; an additional static test against torsion for all components; static and dynamic additional tests on ankle-foot components and foot units for all ankle-foot components as individual components including ankle units or ankle attachments and all foot units as individual components; an additional test of the static limit strength at maximum knee flexion of knee joints and associated parts for all knee units or knee-tibia assemblies and adjacent components that usually provide flexion limitation in a complete prosthesis; static and dynamic additional tests on knee joint locks for all mechanisms that lock the knee joint in the extended position of the knee unit or the knee-shin assembly. The tests described in this International Standard apply to certain types of ankle disarticulation prostheses (see Note 2), transtibial (lower leg), knee disarticulation and transfemoral (thigh) prostheses, as well as to the distal (lower) part of hip (joint) disarticulations - and hemipelvectomy prostheses (see note 3). NOTE 1 The tests can be carried out on complete structures, partial structures or individual components. NOTE 2 The tests apply only to ankle disarticulation prostheses that contain (foot) components of prosthetic ankle-foot fittings taken from the normal production line. NOTE 3 The distal part includes the knee assembly, the ankle-foot device and all parts in between. Tests on hip units are described in ISO 15032. 6
EN ISO 10328:2016 Referenced Document
ISO 15032:2000 Prostheses - Structural testing of hip units
ISO 22523:2006 External limb prostheses and external orthoses - Requirements and test methods
ISO 22675:2016 Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods
ISO 8549-1:1989 Prosthetics and orthotics; vocabulary; part 1: general terms for external limb protheses and external orthoses
ISO/TR 16142:1999 Medical devices - Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
EN ISO 10328:2016 history
2016EN ISO 10328:2016 Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods
2006EN ISO 10328:2006 Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods