Lower-limb prosthetic devices replace the functional or cosmetic function of lower limbs. Given the frequent use and load-bearing activities that involve lower limbs, prosthetic devices must undergo a series of tests. Areas for which lower-limb prosthetic devices are made include the thigh, knee, hip, foot, and ankle. When developing lower-limb prostheses, structural testing to determine the device’s in-vitro behavior is critical to getting your device approved by the FDA and international regulatory bodies.
Several aspects of the structure of a lower-limb prosthetic must be taken into consideration. Given that the device needs to have the long-term ability to function and withstand everyday tasks, structural testing ensures that it is fit for that purpose. It is impossible to know if a device is able to withstand the wide array of activities the recipient might engage in, which is precisely what preliminary testing determines.
In 1977, a series of meetings of the International Society for Prosthetics and Orthotics (ISPO) took place in Philadelphia. After the final meeting, a consensus was reached in determining satisfactory testing methods and required load values for lower-limb prostheses.
Since 1979, the ISO has built upon and expanded these guidelines, which are within the procedures laid out in ISO 10328. All businesses and individuals who want to introduce a new lower-limb replacement device have to ensure they are tested before they are considered for submission to the FDA.
ISO 10328 testing consists primarily of a series of targeted cyclic and static strength tests. The static tests assess the maximum load generated by any activity. Cyclic tests, on the other hand, assess loads that occur from normal walking activities with every single step.
