Article

biocompatibility testing

Biocompatibility evaluation can be classified according to the part (such as skin, mucous membrane, tissue, blood, etc.), method (direct, indirect contact or implantation), time (short-term, long-term and long-lasting) and purpose of the medical device contacting the human body. The evaluated biocompatibility test items are as follows.

1. Cytotoxicity test

2. Stimulus and delayed hypersensitivity test

3. Systemic toxicity test

4. Subchronic toxicity (subacute toxicity)

5. Genetic toxicity test

6. Implant test

7. Blood compatibility test

8. Chronic toxicity test

9. Carcinogenicity test

10. Reproductive and developmental toxicity test

11. Biodegradation test

12. Toxicokinetic Research Test

13. Immunotoxicity test

14. EO residue