心电类医用电子仪器综合验证评价方案设计的探讨

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

摘要: 该研究介绍了现行的心电类医用电子仪器的检测内容和标准，结合临床实际需求，探讨了心电类医用电子仪器综合验证评价方案，主要包括硬件性能检测、自动诊断功能检测和临床应用评价，强调了综合验证评价方案在临床的实用性和重要性，为方案涉及机构提供参考。

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.