中国医学装备2023，Vol.20Issue(12)：213-216,4.DOI:10.3969/J.ISSN.1672-8270.2023.12.044
基于GB9706.1-2020的医用电气设备全生命周期质量控制方法研究
Research on full life cycle quality control methods of medical electrical equipment based on GB9706.1-2020
摘要
Abstract
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.关键词
医用电气设备/GB9706.1-2020/质量控制/上市后监管Key words
Medical electrical equipment/GB9706.1-2020/Quality control/Post-market surveillance分类
医药卫生引用本文复制引用
金建,秦丽平,孙正捷,邵茂丰..基于GB9706.1-2020的医用电气设备全生命周期质量控制方法研究[J].中国医学装备,2023,20(12):213-216,4.基金项目
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" （2022C03029）
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" （2020016）
