ISO 10328 Prostheses - Structural Testing of Lower Limb Prostheses - Requirements and Test Methods

The standard "ISO 10328 Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods" developed by the International Organization for Standardization (ISO) describes procedures for static and cyclic strength tests on lower-limb prostheses, which typically produce combined loads by the application of a single test force. The combined loads on the test specimen relate to the peak values ​​of the loading components that normally occur at different moments during the stance phase of walking.

The main tests described in this standard include:

• Basic static and cyclic tests for all components
• Separate static test in torsion for all components
• Separate static and cyclic testing on ankle-foot devices and foot units, including ankle units or ankle inserts for all ankle-foot devices and entire foot units as single components
• A separate static ultimate strength test at maximum knee flexion on the knee joints and associated components for entire knee units or knee-tibia assemblies and adjacent components that normally provide flexion stop in a complete prosthesis.
• Separate static and cyclic tests on knee locks for all mechanisms that lock the knee joint in the extended position of the knee unit or knee-tibia assembly.

The tests described in this international standard apply to certain types of ankle articulation prostheses, transtibial, knee articulation and above-knee (transfemoral) prostheses and the distal (lower) portion of hip articulation and hemi-pelvectomy prostheses. The tests may be performed on complete structures, partial structures or individual components. The tests apply only to ankle articulation prostheses that include components of prosthetic ankle-foot devices (foot) from the normal production line. The distal portion includes the knee unit, the ankle-foot device and all components in between. Tests on hip units are described in ISO 15032 Prostheses - Structural testing of hip units.

This international standard is suitable for assessing the conformity of lower limb prosthetic devices/structures to the strength requirements specified in the standard “ISO 22523 External limb prostheses and external orthoses - Requirements and test methods”.

This standard is not intended to serve as a guide for the selection of a specific lower limb prosthetic device/construct in an individual lower limb prosthesis prescription. Any disregard for this warning may pose a safety risk to amputees.

For the purposes of this standard,

For the purposes of this standard, the following definitions apply, along with the terms and definitions in ISO 8549-1:

• Evidence strength refers to the static load representing an occasional violent event that can be supported by the prosthetic device/structure and still allow it to function as intended.
• Ultimate strength refers to the static load representing a gross single event that can be supported by the prosthetic device/structure but may subsequently render it unusable.
• Fatigue strength refers to the cyclic load that can be supported by the prosthetic device/structure for a specified number of cycles.
• Batch refers to a set of test samples of a prosthetic device/structure sent together to a testing laboratory to demonstrate compliance with the requirements of one or more international standards.

In this standard, two test configurations are specified for ease of interpretation and presentation, one for right-sided application and the other for mirror-image left-sided application. This precaution enables the application of uniform sign conventions for the relevant components of the loading occurring in the load-bearing structures of right and left prostheses or in asymmetrically designed prosthetic components. Each test configuration shall be defined in a three-dimensional rectangular coordinate system with origin 0 and containing a geometric system of planes, lines and points.

Among the numerous tests, measurements, analyses and evaluation studies that our organization has carried out for businesses in various sectors, it also provides testing services defined in the “ISO 10328 Prostheses - Structural testing of lower extremity prostheses - Requirements and test methods” standard with its trained and expert staff and advanced technological equipment.