射频消融治疗设备标准分析与计量初探

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Preliminary Analysis and Metrology of Radiofrequency Ablation Therapy Equipment Standards

LI Xiu-yu* DING Qiang ZHU Wen-qing YU Hai-rong LIU Yang REN Yan-nan ZHAO Zi-yan （Shandong Institute of Metrology）

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.

Keywords： radiofrequency ablation therapy equipment， national standard， sectoral standard， metrology， calibration

0 引 言

射频又称为射频电流，是一种高频电磁波，在医疗卫生、无线通信、航空航天等领域应用广泛[1]。（剩余6089字）