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Song J.,Jinan Quality Supervision and Inspection Center for Medical Devices
Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation | Year: 2011

Through five experiments, such as "Circle", "square", "side that does not shake", "burning edge", "filter", this paper discussed the effect of different experimental methods of polypropylene fiber liquid filtration membrane particles shedding. The results show that: the particles falling off the edge of the polypropylene fiber Double-sided liquid filtration membrane are very important and must be considered off the evaluation of particle pollution. Source


Xu H.,Jinan Quality Supervision and Inspection Center for Medical Devices
Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation | Year: 2010

Compare and analyze the standards related to centrifuge apparatus and make corresponding suggestions in allusion to the problems existed in the test method and physical performance during product standard drafting process. Source


Sun L.,Jinan Quality Supervision and Inspection Center for Medical Devices
Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation | Year: 2011

A series of new replacement methods of skin irritation test such as EpiSkin, EpiDermSIT (updated) and SkinEthicRHE have been validated by ECVAM. Due to it, animals are protected to the full extent. These provide more methods for biological evaluation of medical devices. Source


Zeng D.,Jinan Quality Supervision and Inspection Center for Medical Devices | Hou L.,Jinan Quality Supervision and Inspection Center for Medical Devices | Shi Y.,Jinan Quality Supervision and Inspection Center for Medical Devices
Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation | Year: 2012

The overseas and domestic application status and research progress of genotoxicity evaluation of medical devices is briefly introduced. The trend of future development is analyzed. Source


Sun X.-X.,Jinan Quality Supervision and Inspection Center for Medical Devices | Gai X.-X.,Jinan Quality Supervision and Inspection Center for Medical Devices | Sun L.-K.,Jinan Quality Supervision and Inspection Center for Medical Devices | Wang X.-M.,Jinan Quality Supervision and Inspection Center for Medical Devices | And 2 more authors.
Journal of Xi'an Jiaotong University (Medical Sciences) | Year: 2016

Objective: To make a dynamic evaluation of the immunotoxicology caused by heterogeneous bone implantation and reveal its immunological mechanisms. Methods: Heterogeneous bone was provided by Guangdong Grandhope Biotech Co., Ltd. Immunology of Balb/c mice by blood biochemical analysis, ELISA and flow cytometry after the test of lymphocyte transformation in vitro. We dynamically monitored the immunological changes Balb/c mice after 1 week, 2 weeks and 4 weeks of muscle implantation to evaluate the immunological effect of the heterogeneous bone on the body. Results: Our experiments showed that the heterogeneous bone did not cause immune stimulation of lymphocytes in vitro, and there were no differences between implantation of heterogeneous bone and the sham operation in the levels of C3, IgG, IgM, inflammatory factors (TNF-α and IL-6) in serum and ALP in implantation site. Moreover, heterogeneous bone implantation did not affect the proportion or activation of peripheral blood mononuclear cells (PBMCs) and lymphocytes in the lymph node. Conclusion: The heterogeneous bone cannot mediate immunotoxicology in vivo, which may provide experimental data and theoretical basis for clinical application of heterogeneous bone. © 2016, Editorial Board of Journal of Xi'an Jiaotong University (Medical Sciences). All right reserved. Source

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