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.
Testing standards for in-vitro wear lower-limb have been issued by the International Organization for Standardization (ISO), which is a worldwide federation that establishes uniform standards. ISO 10328 lays out structural testing requirements of lower limb prostheses that ensure that the device is safe for use.
ISO 10328: Structural Testing of Lower-Limb Prostheses
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.
Through the application of a test force, compound loading is produced that simulates typical loading that occurs at various stages while walking. The prosthesis will be subjected to a series of load actions during various time periods to ensure all movements are tested and represented by subsequent test results. A separate static test in torsion is conducted in addition to principal static and cyclic tests of the single components of lower-limb prostheses.
Other tests included within ISO 10328 are separate static and cyclic tests of ankle-foot devices, and foot units, separate static and cyclic tests on knee locks, and a separate static ultimate strength test when in maximum knee flexion on knee joints and associated components. Following these tests, the results will inform whether or not your prosthetic device is safe for in-vitro use and is ready for FDA submission.
Working with Empirical Technologies Corp.
Any time someone wants to market or sell a product, it must be approved by the FDA and approved by ASTM Standards. Here at Empirical Technologies, we work with an exceptional and talented team that is dedicated to ensuring safety, quality, and accuracy. For over 20 years, Empirical Technology has worked closely with businesses and individuals to prepare their product for FDA submission successfully, including lower-limb prostheses.
Empirical Technologies can help you on your way to bringing a new device to the medical community. We are an industry leader in mechanical testing, and we provide the full series of ISO 10328 tests necessary for consideration from regulatory bodies—an essential component if you’re seeking to enter U.S. and/or international markets.
Contact us today to request a quote for ISO 10328 testing for your lower-limb prostheses.
Please refer to the ISO website for the most up to date information on ISO 10328 or visit our Quality Standards page to see additional accredited test standards performed at our certified testing laboratory.