醫用材料的生物相容性測試－細胞毒性(ISO 10993-5) - 立雍科技實業有限公司｜膠合棧板｜紙棧板｜木棧板｜護角紙

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Biocompatibility testing of medical materials – cytotoxicity (ISO 10993-5)

2008-08-17

Biocompatibility testing of medical materials – cytotoxicity (ISO 10993-5)

Biocompatibility refers to the compatibility between medical materials and the patient's tissues and physiological systems. The success and safe use of medical materials in clinical practice are primarily due to their good biocompatibility. However, some medical materials release toxic substances during use, leading to incompatibility with patients. To monitor biocompatibility, worst-case scenario simulations of the use of medical materials and their extracts are typically conducted to ensure safety under normal use conditions. ISO 10993, in parts 1 to 20, specifies a series of mandatory standards for evaluating the biocompatibility of medical materials. Part 5 of this standard assesses the cytotoxicity of extracts of medical materials against established cell lines (studies conducted in vitro). In vitro studies are generally less expensive and easier to conduct in regions where animal testing is discouraged.

Cell culture experiments are used in biocompatibility studies of medical materials. Generally, there are three methods for studying the cytotoxicity of medical materials. The first method is the direct contact method, suitable for low-density materials, such as contact lenses. The test material is placed directly on a cell line and then heated at an appropriate temperature. During heating, some soluble chemicals diffuse into the culture medium and come into direct contact with the cells. If the cell lines surrounding the material show abnormalities, degeneration, or decomposition, the material can be considered cytotoxic.

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