Discussion on Technical Evaluation of Magnetocardiography.
10.3969/j.issn.1671-7104.2019.04.016
- Author:
Lujie JIANG
1
;
Hong QIAN
1
Author Information
1. Center for Certification & Evaluation, SHFDA, Shanghai, 200020.
- Publication Type:Journal Article
- Keywords:
SQUID;
magnetocardiograph;
registration documents;
technical evaluation
- MeSH:
Industry;
trends;
Magnetocardiography;
standards
- From:
Chinese Journal of Medical Instrumentation
2019;43(4):294-296
- CountryChina
- Language:Chinese
-
Abstract:
There is no corresponding product standard and industry standard for the search and development of magnetocardiograph at home and abroad. In this paper, based on the working principle and clinical application function of magnetocardiograph, and on the basis of relevant regulations and normative documents of medical device registration, some thoughts and concerns about the technical review of this kind of product are put forward.
