Analysis of Risk Prevention and Control in Production for Medical X-ray CT System and Some Suggestions for Field Inspection / 中国医疗器械杂志
Chinese Journal of Medical Instrumentation
;
(6): 111-114, 2018.
Article
in Chinese
| WPRIM
| ID: wpr-774496
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.
Full text:
Available
Index:
WPRIM (Western Pacific)
Main subject:
X-Rays
/
Tomography, X-Ray Computed
/
China
/
Equipment Safety
Type of study:
Etiology study
Country/Region as subject:
Asia
Language:
Chinese
Journal:
Chinese Journal of Medical Instrumentation
Year:
2018
Type:
Article
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