This work presents a procedure to simulate the static and cyclic strength tests implemented to ensure the structural integrity of a four-bar linkage prosthetic knee. The test protocols used in this work follow a standard defined by the International Organization for Standardization (ISO). This standard is titled ‘Prosthetics—Structural Testing of Lower-Limb Prostheses—Requirements and Test Methods’ or shortly called ISO 10328:2006. The purpose of this standard is to guarantee that a prosthesis is able to survive a random severe load and has a sufficient fatigue life. Finite element method, which is a numerical technique used to model a physical system, is employed as a primary computational tool to simulate the prosthesis under the tests. The method of explicit nonlinear transient stress analysis is applied to determine the strength of prosthesis. Consequently, the finite element model reveals the stress distributions induced on the prosthesis and predicts its fatigue life. Besides, to examine the accuracy of the model, the simulation results, particularly structural strains, are validated with those obtained from experiments. In each testing condition, five repetitions are performed to ensure the result consistency. The validation results confirm the fidelity of the proposed finite element model. The average of absolute percentage errors between the simulation and experimental results in all testing scenarios is estimated to be 22%. Keywords: prosthetic knee; artificial limb; ISO 10328:2006; finite element analysis; static strength test; cyclic strength test (Published: 24 February 2014) Citation: Journal of Assistive, Rehabilitative & Therapeutic Technologies 2014, 2 : 23211 - http://dx.doi.org/10.3402/jartt.v2.23211