T/CSBM 0022-2022 Evaluation method for degradation, osteoconduction, and tissue response of biodegradable magnesium bone implants

Scope

Main Technical Content: 1. **Experimental Design** 1.1 **Overview** This method involves implanting biodegradable magnesium-based metal bone implants into the bone tissue of experimental animals for a certain period of time. At different time points during the experiment, evaluations are conducted through imaging and histological examinations, combined with image quantitative analysis, to assess the degradation performance, osteogenesis ability, and local tissue response of the implants. Note: Before conducting in vivo degradation tests, it is recommended to first perform qualitative and quantitative analyses of the implants in accordance with the requirements of GB/T 16886.15. 1.2 **Sample Preparation** 1.2.1 **Experimental Samples** 1.2.1.1 The physical properties of the experimental samples (e.g., shape, surface roughness) can affect the degradation performance of the materials. 1.2.1.2 Each experimental sample should undergo the same manufacturing, processing, cleaning, sterilization, and packaging procedures as the final product. 1.2.1.3 After sample preparation and sterilization, special attention should be paid to preventing the samples from being scratched, damaged, or contaminated before or during implantation. 1.2.2 **Reference Samples** Reference samples may be selected from currently available materials that are suitable for comparison with biodegradable magnesium-based materials, or from clinically accepted similar materials consistent with the intended use of the biodegradable magnesium-based materials, to evaluate the local histological response after implantation and compare the degradation rates and new bone formation rates of the materials. 1.2.3 **Sample Shape** Implant samples can be processed into cylindrical, screw-shaped, or threaded designs. 1.2.4 **Sample Size** The size of the implant samples should be determined based on the size of the selected animals and their bone tissues. Note: In principle, reference s

Development Information

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