Extraction methods that simulate those used in the clinic are recommended for obtaining extraction solutions. For polyvinyl chloride (PVC) medical devices that have contact with human blood, an alternative medium (ethanol/water mixture) is suggested as an extraction screening vehicle to evaluate the di(2-ethylhexyl)phthalate (DEHP) released. A test comparing the extraction ability between the alternative medium and whole blood from three healthy volunteers has been conducted. An experimental method is provided outlining the chemical analysis of the DEHP released from medical devices made with polyvinyl chloride (PVC). Gas chromatography-mass spectrometry (GC-MS) in the selective ion monitoring (SIM) mode was used to analyze and quantify the extracted DEHP. The linear range of the SIM method was 0.1-200 μg/mL, and the recoveries were 89.6-101.5% and 91.0-98.9% when using the ethanol/water mixture and whole blood as the extraction media, respectively. The validated method demonstrates that it is suitable for the determination of the DEHP released from PVC medical devices that have contact with blood. The results from the determination of the DEHP released will be compared with the limits derived from toxicological data for the parenteral exposure route and certain population groups, and the results will be used in the risk assessment of medical devices.

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To analyze the vibration characteristic differences of a gear transmission system with gear and shaft cracks, an improved computational method for deriving the shaft stiffness matrix with breathing cracks is developed. Also, the three-dimensional contact model of spur gear with a crack is established via the finite element method (FEM), and its meshing stiffness is calculated. Simultaneously, considering bearing stiffness and shaft flexibility, the finite element dynamic models of two-stage gear transmission system with gear and shaft cracks are established. Based on this, different source fault vibration responses are compared and the influencing factors are explored. In addition, a novel signal processing method based on the particle swarm optimization, maximum correlated kurtosis deconvolution, variational, mode decomposition and fast spectral kurtosis (PSO-MCKD-VMD-FSK) is utilized to extract fault characteristics for the signal-to-noise ratio and uneven energy distribution problems. Results show that a system with gear cracks mainly presents periodic impact in the time domain, while in the frequency domain it impacts rotation frequency modulation near the meshing frequency and its multiple frequencies. However, the shaft crack breathing effect meant that the time domain mainly presents "simple harmonic" modulation, and the rotation frequency and its faulty shaft multiplication occurs in the low-frequency region of the frequency domain. The PSO-MCKD-VMD-FSK method extracts fault features in a strong noise environment and has good robustness. Results identify different source faults and provide a theoretical basis.