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This study briefly introduces the basic theory of sterilization, the characteristics of ethylene oxide sterilization for medical devices and the key factors about sterilization effectiveness, analyzes and compares three methods used in the product release of medical devices sterilized by ethylene oxide: test for sterility, traditional release and parametric release, and focuses on the theoretical basis, feasibility, validation requirements, advantages and disadvantages of parametric release.

Objective: Quantitative technique based on In-line phase-contrast computed tomography with single scanning attracts more attention in application due to the flexibility of the implementation. However, the quantitative results usually suffer from artifacts and noise, since the phase retrieval and reconstruction are independent ("two-steps") without feedback from the original data. Our goal is to develop a method for material quantitative imaging based on a priori information specifically for the single-scanning data. Method: An iterative method that directly reconstructs the refractive index decrement delta and imaginary beta of the object from observed data ("one-step") within single object-to-detector distance (ODD) scanning. Simultaneously, high-quality quantitative reconstruction results are obtained by using a linear approximation that achieves material decomposition in the iterative process. Results: By comparing the equivalent atomic number of the material decomposition results in experiments, the accuracy of the proposed method is greater than 97.2%. Conclusion: The quantitative reconstruction and decomposition results are effectively improved, and there are feedback and corrections during the iteration, which effectively reduce the impact of noise and errors. Significance: This algorithm has the potential for quantitative imaging research, especially for imaging live samples and human breast preclinical studies.

In this work, a general theoretical framework is presented to explain the formation of the phase signal in an X-ray microscope integrated with a grating interferometer, which simultaneously enables the high spatial resolution imaging and the improved image contrast. Using this theory, several key parameters of phase contrast imaging can be predicted, for instance, the fringe visibility and period, the conversion condition from the differential phase imaging (DPI) to the phase difference imaging (PDI). Additionally, numerical simulations are performed with certain X-ray optical components and imaging geometry. Results demonstrate the accuracy of this developed quantitative analysis method of X-ray phase-sensitive microscope imaging., 8 pages, 3 figures