This research proposes reliability evaluation for performance of biological transient mechanical stresses scenarios. This is part of a broader research done by the authors for comprehensive analysis of the biological reliability analysis [1]. A literature review is conducted in area of biomechanics phenomenological processes in order to classify the approaches for success criteria determination and reliability metrics calculation based on their merits and limitations. A limited failure mode and effect analysis is performed as a pre-processor for identification of the corresponding figure of merits. Biological environment is complex in correlated occurrence of microscopic and macroscopic phenomena. Therefore the modeling of this complex medium, in context of mechanical stresses, requires numerical solution of conservation equation and inclusion of corresponding constitution models. Determination of success criteria (first phase for reliability calculation in this research) is a challenging object, and requires consideration of several dependent figures of merits (e.g. temperature, mass and etc.).

The developed success criteria matrix is based on the approaches of representation of the figures of merit. A multi-objective criteria is developed according to the phenomena occurrence in the intended study and the selected proper figure(s) of merit. The matrix determines the region of acceptance as well as the rejection area. The reliability index is proposed to estimate the probability of the success based on the calculated system performance in a non-deterministic (stochastic parameters) approach. By augmentation of developed success criteria and the system analysis calculation, a decision is made on the success and rejection of the system performance the methodology is applied to the case of cell cryopreservation phenomenon. The process of freezing in living cells is considerably more complicated than in a solution, primarily due to the presence of cellular structure. The process is considered a transient mechanical stress on the cell structure including the thermal and mass transport. The success criteria is determined based on two figures of merit of temperature and mass and their rate of change. Numerical calculation is completed for study of thermal and mass behavior for the transient of the cell. The uncertain parameters are considered random and Monte Carlo simulation is conducted for inclusion of their variation in the calculation. The situation are specified for the observation of the success criteria and occurrence of the failure.

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