RESUMEN
The preclinical immunotoxicity evaluation of implantable medical devices was described.Firstly,the guidelines and regulations about the immunotoxicity evaluation of medical devices were summarized.These documents directed the immunotoxicity evaluation of implantable medical devices.Secondly,various aspects concerning the design of the immunotoxicity evaluation experiments were discussed here,including the hazardous effect of potential degradation products,the risk management of medical devices,the tests for interactions,the tests for in vitro cytotoxicity,the tests for local effects after implantation,the tests for irritation and delayed-type hypersensitivity,the tests for systemic toxicity.Thirdly,different types of immune responses with regard to immunotoxicity evaluation were listed and introduced here.In the end,the evaluation of implantable medical devices was expected to be more rigorous in the future.
RESUMEN
The preclinical immunotoxicity evaluation of implantable medical devices was described.Firstly,the guidelines and regulations about the immunotoxicity evaluation of medical devices were summarized.These documents directed the immunotoxicity evaluation of implantable medical devices.Secondly,various aspects concerning the design of the immunotoxicity evaluation experiments were discussed here,including the hazardous effect of potential degradation products,the risk management of medical devices,the tests for interactions,the tests for in vitro cytotoxicity,the tests for local effects after implantation,the tests for irritation and delayed-type hypersensitivity,the tests for systemic toxicity.Thirdly,different types of immune responses with regard to immunotoxicity evaluation were listed and introduced here.In the end,the evaluation of implantable medical devices was expected to be more rigorous in the future.