Production Risk Analysis and Key Points for Field Inspection of Medical Electron Linear Accelerator
10.12455/j.issn.1671-7104.230405
- VernacularTitle:医用电子直线加速器生产环节风险分析及现场体系核查要点
- Author:
Yiqiang YANG
1
Author Information
1. 上海市医疗器械化妆品审评核查中心,上海市,200020
- Keywords:
medical electron linear accelerator(LINAC);
production risk;
field inspection;
good manufacturing practice
- From:
Chinese Journal of Medical Instrumentation
2024;48(2):212-216
- CountryChina
- Language:Chinese
-
Abstract:
The medical electron linear accelerator(LINAC)has the characteristics of complex system structure,many core components and high precision control requirements,which puts forward higher requirements for product quality control and regulation.This study puts forward the main points of field inspection through the analysis of the technical characteristics and production risk of LINAC,combined with the requirements of the good manufacturing practice of medical devices.It has certain reference significance for quality management personnel and field inspectors.
