Discussion on Design of Comprehensive Verification and Evaluation Schemes for Electrocardiogram Medical Electronic Instruments.
10.3969/j.issn.1671-7104.2022.02.023
- Author:
Yajun SHI
1
;
Jinli WANG
1
;
Ling GAO
1
;
Zhenshi LIANG
2
;
Qian WANG
2
;
Qing DAN
1
;
Ying DONG
1
;
Yundai CHEN
3
Author Information
1. Department of Cardiology, First Medical Center, Chinese PLA General Hospital, Beijing, 100142.
2. Beijing Institute of Medical Device Testing, Beijing, 101111.
3. Senior Department of Cardiology, the Sixth Medical Center of PLA General Hospital, Beijing, 100142.
- Publication Type:Journal Article
- Keywords:
electrocardiograph;
medical instruments;
protocol design;
verification and evaluation
- MeSH:
Electrocardiography;
Electronics, Medical;
Reference Standards
- From:
Chinese Journal of Medical Instrumentation
2022;46(2):225-229
- CountryChina
- Language:Chinese
-
Abstract:
This study introduced the current testing content and standards of ECG medical electronic instruments, combined with actual clinical needs, and discussed the comprehensive verification and evaluation protocol for ECG medical electronic instruments. The protocol mainly includes hardware performance testing, automatic diagnostic function testing and clinical application evaluation. The protocol emphasizes the clinical practicality and importance of the comprehensive verification and evaluation program, and provides a reference for the institutions involved in the program.
