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

Production Risk Analysis and Key Points for Field Inspection of Medical Electron Linear Accelerator

医用电子直线加速器具有系统结构复杂、核心部件多、控制精度要求高等特点,对产品质量控制和监管都提出了较高的要求。该研究通过对医用电子直线加速器技术特点及生产环节风险分析,结合医疗器械生产质量管理规范要求,提出了此类产品现场体系检查要点,对企业的质量管理人员和监管部门的检查员具有一定参考意义。

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.