SO10993, or biocompatibility, refers to the mutual adaptability between medical materials and the tissues and physiological systems of patients. The successful and safe use of medical materials in clinical practice is mainly due to their good biocompatibility. Usually, some medical materials release toxic substances during use, resulting in incompatibility with patients. For the purpose of monitoring biocompatibility, the use of medical materials and their extracts is generally simulated under bad conditions to ensure safety under normal conditions of use. In the ISO 10993, part 1 to part 20 stipulate a series of mandatory standards to evaluate the biocompatibility of medical materials. In the fifth part, the judgment standard is to study the cytotoxicity of medical material extracts on established cell lines (in vitro). In vitro studies are generally less expensive and easier to conduct in areas where animal experimentation is frowned upon.

In order to protect humans from potential biological risks of medical devices. Many international and national standards and guidelines for biological evaluation of medical devices have been compiled. It will serve as a guidance document for the biological evaluation of medical devices, as part of the overall evaluation and development of each device, with a risk management process. This approach integrates existing data and reviews obtained from various sources, and the selection and application of additional tests done when needed, to form a complete biological response assessment of medical devices. It should be noted that medical devices refer to a wide range of materials that may exist in different shapes, and another limit may be a comprehensive device or combination of instruments that include a large number of components made of more than one material.

1. Purpose of the experiment: The objective of this t is to evaluate that biological response of the test article to mammalian fibroblast. The test is designed based on the sample extract 

2. Test basis Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity ISO10993-5: 2009 Biological evaluation of medical devices 

3. Control and sample validation Test sample name, sterilization status, model, specification, batch number, character, liquid color, stability, solubility, sample material, and retention condition 

4. Test system validation The laboratory uses the mouse cell assay because of its sensitivity to the test article extract. Contact of the test article with the test system via the extract (using a carrier compatible with the test system) is considered the best route of administration and is recommended by ISO 10993-5: 2009. 

5. Test Design and Dose Aseptic preparation of test and control samples. The sample crystals were leached with MEM medium containing 10% fetal bovine serum according to (sample: volume of leaching solution), and then leached for 24 hours at 37 ℃ and 60 pm on a constant temperature culture shaker. The extract was immediately used for the experiment. 

6. Evaluation criteria 150% of the sample extract is at least the same as or higher than the cell viability of 100% 

7. The final result was 41009% and cell viability%. 7. Comparison of experimental results: Groups, Blank Control, Negative Control, Positive Control, 100% Sample Extract, 75% Sample Extract, 50% Sample Extraction, 25% Sample Extraction.

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