摘要
研究医用电气设备的基本安全与基本性能,形成其在设计、研发、验证、流通、应用及维护多个环节的质量控制,促进医疗器械安全有效监管。对比分析国家标准GB9706.1-2007与GB9706.1-2020标准的差异,结合产品设计文档、可用性文档、风险管理文档,更新产品的安全与要求。提出了医用电气设备的全生命周期质量控制流程,完善新标准下的符合性论证。增强生产企业的风险管理措施,明确质量责任主体意识,建立医用电气设备的全生命周期质量控制方法,满足产品注册及上市后的监管要求。
To study the basic safety and basic performance of medical electrical equipment,to form quality control in multiple aspects of design,research and development,verification,circulation,application and maintenance,and to promote effective supervision of medical equipment safety.The differences between national standards GB9706.1-2007 and GB9706.1-2020 were compared and analyzed,and the product safety and requirements were updated by combining product design documents,usability documents and risk management documents.A full life cycle quality control process for medical electrical equipment was proposed to improve the demonstration of compliance under the new standard.Manufacturers should strengthen the risk management strategies,clarify the awareness of quality responsibility,establish the full life cycle quality control methods for medical electrical equipment,and meet the requirements for product registration and post-market supervision.
作者
金建
秦丽平
孙正捷
邵茂丰
JIN Jian;QIN Li-ping;SUN Zheng-jie(Zhejiang Institute of Medical Device Supervision and Testing,NMPA Key Laboratory forBiomedical Optics,Key Laboratory of Safety Evaluation of Medical Devices of Zhejiang Province,Hangzhou 310018,China;不详)
出处
《中国医学装备》
2023年第12期213-216,共4页
China Medical Equipment
基金
浙江省科技计划(2022C03029)“医用机器人产品及导航系统研发—神经反馈引导的交互式外骨骼康复机器人产品研发及应用”
浙江省药品监督系统科技计划(2020016)“医用电气设备关键性能安全评价方法研究”。
