Analysis and Some Thoughts on Safety Evaluation of Hearing Aids.
10.3969/j.issn.1671-7104.2019.02.015
- Author:
Shuai NIU
1
;
Na TA
2
;
Xiaoling WANG
1
Author Information
1. Center for Certification and Evaluation, Shanghai Food and Drug Administration, Shanghai, 200020.
2. Center for Medical Device Evaluation, National Medical Products Administration, Beijing, 100044.
- Publication Type:Journal Article
- Keywords:
electric safety;
electromagnetic compatibility;
hearing aids;
safety evaluation
- MeSH:
Equipment Safety;
Hearing Aids;
adverse effects
- From:Chinese Journal of Medical Instrumentation
2019;43(2):129-131
- CountryChina
- Language:Chinese
-
Abstract:
Based on analysis of the domestic and foreign laws and regulations for hearing aids,some suggestions of safety evaluation about standards,premarket technical review and regulation are presented in this article.It is hoped to be helpful for registration and regulation of hearing aids.
