Abstract：Objective To carry out research on the cyber security of medical devices, combined with daily inspection and standard
research, put forward the solution of quality control, and reduce the risk in the use process of medical devices. Methods According
to the expected use and environment of medical devices, analysis and research were carried out from three aspects of confidentiality,
integrity and availability. Twenty requirements that manufacturers and inspection institutions should follow in the process of product
design and inspection were put forward, which basically covered all the elements of cyber security. Results Around the twenty
requirements of medical device cyber security, specific test methods were proposed to guide practice. The method of writing test
cases, executing test scripts and functional verification was used to establish vulnerability scanning process requirements, execution
elements and related requirements. Conclusion Cyber security should run through the whole life cycle of medical devices. With the
implementation of new technologies and methods, the quality control methods should be dynamically updated.
王晨希，王权，李佳戈. 医疗器械网络安全质量控制探讨[J]. 中国医疗设备, 2021, 36(9): 23-27.
WANG Chenxi, WANG Quan, LI Jiage. Discussion on Quality Control of Medical Devices Cyber Security. China Medical Devices, 2021, 36(9): 23-27.
