Zhu Jiawei, Yang Xuehe, Zheng Chen, Yang Pengfei, Li Yaqiu, Li Qian
The Fifth Electronics Research Institute of Ministry of Industry and Information Technology, Guangzhou 510610, P. R. China.
Key Laboratory of Active Medical Devices Quality & Reliability Management and Assessment, Guangzhou 510610, P. R. China.
Sheng Wu Yi Xue Gong Cheng Xue Za Zhi. 2022 Oct 25;39(5):1050-1058. doi: 10.7507/1001-5515.202202032.
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.
