Research on full life cycle quality control methods of medical electrical equipment based on GB9706.1-2020 / 中国医学装备

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.