Preclinical immunotoxicity evaluation of implantable medical devices
10.7687/j.issn1003-8868.2017.08.117
- VernacularTitle:植入性医疗器械的临床前免疫毒性评价
- Author:
lin Yan WANG
1
;
yuan Yu MA
;
Xiong ZHAO
;
zhu Zhen SUN
;
gang Jin ZHANG
Author Information
1. 军事医学科学院野战输血研究所全军血液安全与保障重点实验室
- Keywords:
implantable medical device;
immunotoxicity;
inflammation;
immunosuppression;
immunostimulation
- From:
Chinese Medical Equipment Journal
2017;38(8):117-121,126
- CountryChina
- Language:Chinese
-
Abstract:
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.
