Challenges and Counter-measures of the Leachable Substances in Medical Devices.
10.3969/j.issn.1671-7104.2021.04.018
- Author:
Chenghong YE
1
;
Li XIAO
1
;
Yongqing WANG
1
Author Information
1. Center for Medical Device Evaluation of NMPA, Beijing, 100081.
- Publication Type:Journal Article
- Keywords:
challenges;
leachable substances;
medical device
- From:
Chinese Journal of Medical Instrumentation
2021;45(4):434-437
- CountryChina
- Language:Chinese
-
Abstract:
The safety of leachable substances in medical devices is an important guarantee of the safety of medical devices, and is also the focus of attention in the review of medical devices in recent years. Combined with the difficult issues in the study of leachable substances, the challenges in the study of leachable substances in medical devices were briefly described, and the counter-measures were briefly described for reference by relevant institutions and researchers.
