中国标准化Issue(10)：115-120,6.DOI:10.3969/j.issn.1002-5944.2025.10.018
射频消融治疗设备标准分析与计量初探
Preliminary Analysis and Metrology of Radiofrequency Ablation Therapy Equipment Standards
摘要
Abstract
Radiofrequency ablation(RFA)therapy equipment is widely used in clinical applications,which poses high usage risks.The National Medical Products Administration(NMPA)has promulgated and implemented national standards for medical electrical equipment and sectoral standards for RFA therapy equipment applied in the fields of cardiology,hepatology,gynecology,and otorhinolaryngology.Subsequently,the RFA therapy equipment standards were integrated,and the fundamental mandatory sectoral standard YY 0650-2022,General technical requirements for Radio frequency ablation therapy equipment,was released.Additionally,the standards for cardiology and hepatology were revised and supplemented,with the new standards set to be implemented soon.This paper analyzes the common technical parameters involved in the sectoral standards in different application fields,namely operating frequency,output power,temperature,and time,and explores the connections and differences among these sectoral standards.From a metrological perspective,it provides suggestions for metrological characteristics,calibration conditions,and calibration methods,filling the gap in the metrology of RFA therapy equipment and further improving the traceability system for the measurement values of RFA therapy equipment.关键词
射频消融治疗设备/国家标准/行业标准/计量/校准Key words
radiofrequency ablation therapy equipment/national standard/sectoral standard/metrology/calibration引用本文复制引用
李修宇,丁强,朱文清,于海容,刘洋,任燕楠,赵紫艳..射频消融治疗设备标准分析与计量初探[J].中国标准化,2025,(10):115-120,6.基金项目
本文受2023年度山东省计量科学研究院国家重点研发计划项目"射频治疗设备性能评价与质控关键技术研究"(项目编号:2023YFC2414300)资助. （项目编号:2023YFC2414300）
