title: [Instruction of clinical testing method for medical devices].
abstract: The article introduces the clinical testing method for the product of patient monitor, the definition of direct measurement and indirect measurement method, and the different testing methods. The clinical testing methods for none invasive blood pressure, pulse oxygen saturation and ECG analysis have significant value, which are important solutions to test the safety and effectiveness of medical devices by using the equivalent analysis method. These methods above are also provided as reference for other medical devices' clinical testing.
authors.affiliation: School of Medicine, Shenzhen University, Shenzhen, Guangdong, 518060. yejilun@126.com
authors.forename: Jilun
authors.initials: J
authors.lastname: Ye
authors.forename: Siping
authors.initials: S
authors.lastname: Chen
authors.forename: Tianfu
authors.initials: T
authors.lastname: Wang
authors.forename: Yueming
authors.initials: Y
authors.lastname: Chen
mesh_terms: D019544:Equipment Failure Analysis; D004869:Equipment Safety; D004864:Equipment and Supplies / Q000592:standards; D006801:Humans