Analysis of Risk Prevention and Control in Production for Medical X-ray CT System and Some Suggestions for Field Inspection.
10.3969/j.issn.1671-7104.2018.02.009
- VernacularTitle:医用X射线CT生产环节风险防控分析以及对现场体系考核的一些建议
- Author:
Yiqiang YANG
1
Author Information
1. Center for Certification & Evaluation, Shanghai Food and Drug Administration, Shanghai, 200020.
- Publication Type:Journal Article
- Keywords:
CT;
Field Inspection;
GMP;
Risk Prevention and Control
- MeSH:
China;
Equipment Safety;
Tomography, X-Ray Computed;
X-Rays
- From:
Chinese Journal of Medical Instrumentation
2018;42(2):111-114
- CountryChina
- Language:Chinese
-
Abstract:
In recent years, the R&D and production level for Computed Tomography(short for CT) have been greatly improved and developed in China. In fact, it leads to higher requirements for medical device regulators. In order to clear key points in field inspection for regulators, this article analyzes the risk prevention and control points in the production process of CT based on the 5M1E analysis, and combined with medical device good manufacturing practice (short for GMP), presents exploratively some suggestions on the field inspection of CT manufacturers. This article also has important sense for regulators to clear the pertinence and improve the efficiency during the field inspection.
