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随着对生物材料生物相容性研究工作的不断深入,以及医疗器械在临床使用过程中所出现的一些问题,人们开始认识到医疗器械与人体免疫系统之间相互作用的重要性。单独致敏试验不能全面地评价生物材料类医疗器械免疫学的各个方面,不能为生物材料的临床使用提供安全有效的试验资料,不能为管理机构的决策提供可靠的技术数据。本文着重介绍了医疗器械免疫毒性试验原理和方法。
With the continuous research into the biocompatibility of biomaterials and some problems in the clinical use of medical devices, people are beginning to recognize the importance of the interaction between medical devices and the human immune system. Individual sensitization tests can not fully evaluate all aspects of immunology of medical devices of biological materials. They can not provide safe and effective test data for the clinical use of biological materials, and can not provide reliable technical data for the decision of the regulatory agencies. This article focuses on the principles and methods of immunotoxicity testing of medical devices.