Instruction of clinical testing method for medical devices.
- Author:
Jilun YE
1
;
Siping CHEN
;
Tianfu WANG
;
Yueming CHEN
Author Information
1. School of Medicine, Shenzhen University, Shenzhen, Guangdong, 518060. yejilun@126.com
- Publication Type:Journal Article
- MeSH:
Equipment Failure Analysis;
Equipment Safety;
Equipment and Supplies;
standards;
Humans
- From:
Chinese Journal of Medical Instrumentation
2011;35(5):369-382
- CountryChina
- Language:Chinese
-
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.
