IS0 10993 is a series of biocompatibility evaluation standards issued by the International Organization for Standardization (IS0) to evaluate the safety of biomaterials for in vivo use. Among them, ISO 109931 is the general principle of this series of standards, which specifies the overall requirements and methods for biocompatibility evaluation.

The ISO 10993 testing items include the following aspects:

1. Biological evaluation: including cytotoxicity testing, cell proliferation testing, gene mutation testing, chromosome abnormality testing, etc., to evaluate the impact of materials on cells and genes,.

2. Biochemical evaluation: including solubility testing, dissolution testing, biodegradability evaluation, etc., to evaluate the chemical stability and biodegradability performance of materials in vivo

3. Immunological evaluation: including immunotoxicity testing, immune stimulation testing, complement activation testing, etc., to evaluate the impact of materials on the immune system.

4. Physical and mechanical evaluation: including surface morphology testing, mechanical performance testing, wear resistance testing, etc., to evaluate the physical and mechanical properties and durability of materials. 5. Tissue compatibility evaluation: including implantation testing, stimulation testing, inflammatory response testing, etc., to evaluate the tissue compatibility and safety of materials in vivo. 6. Non allergenic evaluation: including skin sensitivity testing, allergenicity testing, etc., to evaluate the risk of allergic reactions caused by materials. It should be noted that the specific testing items may vary depending on the material's purpose, usage, and national and regional regulatory requirements. Sometimes it is necessary to consider other factors comprehensively, such as toxicological evaluation of materials and clinical evaluation.

The ISO 10993 standard is an important reference in the field of biomedical materials, which can help material manufacturers and medical device manufacturers evaluate and ensure the biocompatibility and safety of their products.