Research on the current situations of reliability and evaluation in Chinese active medical device industry.
10.7507/1001-5515.202202032
- Author:
Jiawei ZHU
1
;
Xuehe YANG
1
;
Chen ZHENG
2
;
Pengfei YANG
2
;
Yaqiu LI
1
;
Qian LI
1
Author Information
1. The Fifth Electronics Research Institute of Ministry of Industry and Information Technology, Guangzhou 510610, P. R. China.
2. Center for Medical Device Evaluation, National Medical Products Administration, Beijing 100081, P. R. China.
- Publication Type:Journal Article
- Keywords:
Active medical devices;
Current situations;
Evaluation;
Reliability
- MeSH:
Reproducibility of Results;
Industry;
China
- From:
Journal of Biomedical Engineering
2022;39(5):1050-1058
- CountryChina
- Language:Chinese
-
Abstract:
Active medical device is a kind of medical device which is widely used. In order to realize the goal of high-quality development, product with high reliability is a necessary requirement for the domestic active medical device industry. By means of literature research, data collection, field research, materials comprehensive combing and analysis, this paper systematically analyzes and studies the current situations and the existing problems of reliability and evaluation from the dimensions of Chinese active medical device industry policy, enterprise situation and evaluation method. In addition, by considering the technical characteristics of reliability work, concrete suggestions for solving the problems are given from the directions of standard and guiding principle, so as to provide reference for active medical device industry to develop scientific and objective reliability technical standard system and guiding principle, which are in accord with the current characteristics of Chinese active medical device industry and supervision.
