《在用医用电气设备安全风险评价技术规范》构建研究

Research on Construction of Technical Specifications for Safety Risk Assessment ofIn-use Medical Electrical Equipment

REN Jian1.2.3 LEI Di1.2.3 ZHANG Min-juan1.2.3 SUN Xiao-ning1.2.3 CHEN Yue-rong1.2.3 NIU Wen1.2.3 WANG Chen1.2.3 ZHAO Zhi-jie1.2.3 ZHANG Hong-tao1.2.3 LONG Cun-lin1.2.3* （1.Qinghai Provincial Drug InspectionandTesting Institute; 2.Qinghai Medical Device Testing Enginering Technology Research Center;3.QinghaiProvincialKeyLaboratoryofMedical DeviceQualityControlandRiskAssessment） Abstract：This study systematically establishes a set of technical specifications for safety risk assessment of medical electrical equipment，inviewofthesafetyrisks in theuseof theequipment.Byanalyzing risk sources from multiple aspects，including theequipment，usage environment，operator personnel，and maintenance management， a comprehensive technical framework is proposed，coveringqualifications of evaluation institutions，equipment requirements，evaluationprocesses，risk control，regulatoryresponsibilities，aswellasregularinspectionandtesting. The specifications clarifydiferentiated inspection cycles and testing items for equipment of varying risk levels to strengthen supervision of high-risk devices，and strictly stipulatethe professional qualificationsof evaluationand testing institutions and personnel.This research provides scientific evidence and operational guidelines for medical institutions andregulatory authorities，to enhance safetyof medical electrical equipment，reduce risksof medical accidents，and promote the standardized development of healthcare industry.

Keywords：medicalelectricalipment，setyskssessment，techicalseciatios，riskontrol，egularsption and testing

0 引言

医用电气设备作为现代医疗体系的重要支撑，广泛应用于疾病诊断、治疗和监护等各个环节。（剩余7570字）