title: [Immunogenic evaluation and test strategy for medical devices].
abstract: 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.
authors.affiliation: State Food and Drug Administration Jinan Quality Supervision and Inspection Center for Medical Devices, Jinan, 250101. liuchenghu510@163.com
authors.forename: Chenghu
authors.initials: C
authors.lastname: Liu
authors.forename: Ping
authors.initials: P
authors.lastname: Wu
authors.forename: Yanping
authors.initials: Y
authors.lastname: Shi
authors.forename: Min
authors.initials: M
authors.lastname: Wang
mesh_terms: D004869:Equipment Safety / Q000379:methods*; D014116:Toxicology / Q000379:methods*