Regulation Considerations of Medical Devices with Wireless Technology.
10.3969/j.issn.1671-7104.2020.03.015
- Author:
Xiaoling WANG
1
;
Shuai NIU
1
;
Zhizhen ZHONG
1
Author Information
1. Certification and Evaluation Center of Shanghai Food and Drug Administration, Shanghai, 200003.
- Publication Type:Journal Article
- Keywords:
active health;
medical devices;
wireless communication
- MeSH:
Computer Security;
Wireless Technology
- From:
Chinese Journal of Medical Instrumentation
2020;44(3):258-262
- CountryChina
- Language:Chinese
-
Abstract:
Wireless technology has been widely used in medical devices and has brought convenience to medical care. However, wireless medical devices face risks such as data security and radio frequency interference. This study highlights safety and effectiveness evaluation of wireless medical devices, and discusses technical characteristics and regulation requirements, providing references for industry development and regulation.
