[Immunogenic evaluation and test strategy for medical devices]

Chenghu Liu1, Ping Wu, Yanping Shi

  • 1State Food and Drug Administration Jinan Quality Supervision and Inspection Center for Medical Devices, Jinan, 250101. liuchenghu510@163.com

This paper emphasizes on the strategy for immunogenic evaluation of medical devices. expecting to fulfill the scientific procedure for immunogenic evaluation of medical devices and to improve the standard systems for biological evaluation of medical devices in the future.

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