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.
Artículo
en Chino
| 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.
Texto completo:
Disponible
Índice:
WPRIM (Pacífico Occidental)
Asunto principal:
Rayos X
/
Tomografía Computarizada por Rayos X
/
China
/
Seguridad de Equipos
Tipo de estudio:
Estudio de etiología
País/Región como asunto:
Asia
Idioma:
Chino
Revista:
Chinese Journal of Medical Instrumentation
Año:
2018
Tipo del documento:
Artículo
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