[Discussion on Design of Comprehensive Verification and Evaluation Schemes for Electrocardiogram Medical Electronic Instruments]

Yajun Shi; Jinli Wang; Ling Gao; Zhenshi Liang; Qian Wang; Qing Dan; Ying Dong; Yundai Chen

doi:10.3969/j.issn.1671-7104.2022.02.023

[Discussion on Design of Comprehensive Verification and Evaluation Schemes for Electrocardiogram Medical Electronic Instruments]

Zhongguo Yi Liao Qi Xie Za Zhi. 2022 Mar 30;46(2):225-229. doi: 10.3969/j.issn.1671-7104.2022.02.023.

[Article in Chinese]

Authors

Yajun Shi¹, Jinli Wang¹, Ling Gao¹, Zhenshi Liang², Qian Wang², Qing Dan¹, Ying Dong¹, Yundai Chen³

Affiliations

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.

PMID: 35411756
DOI: 10.3969/j.issn.1671-7104.2022.02.023

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.

Keywords: electrocardiograph; medical instruments; protocol design; verification and evaluation.

MeSH terms

Electrocardiography*
Electronics, Medical*
Reference Standards