射频美容设备的电磁兼容性试验研究  

Research on Electromagnetic Compatibility Test of RF Beauty Equipment

作　　者：邱波[1] 陈婕 赵五芹[1] 索彦彦 QIU Bo;CHEN Jie;ZHAO Wuqin;SUO Yanyan(Shenzhen Institute of Metrology and Quality Testing,Shenzhen 518055,China;Shenzhen Customs Industrial Products Testing Technology Center,Shenzhen 518055,China)

机构地区：[1]深圳市计量质量检测研究院,广东深圳518055 [2]深圳海关工业品检测技术中心,广东深圳518055

出　　处：《电子质量》2024年第7期73-78,共6页Electronics Quality

摘　　要：近年来随着医疗美容行业的兴起,各类医疗美容产品的关注度也随之提高。2023年4月1日,国家药监局器审中心正式发布了《射频美容设备注册审查指导原则》(下称《指导原则》),用于规范射频美容设备的管理。同时,自2024年4月1日起,射频治疗仪(包括射频皮肤治疗仪)类产品未依法取得医疗器械注册证不得生产、进口和销售。首先,对《指导原则》中电磁兼容(EMC)部分进行了详细的研究和剖析;其次,对比射频美容设备与常规医用设备的试验差异;最后,对实际测试中出现的问题进行了分析,并提出了整改建议,对于射频美容设备后续的设计和生产具有一定的指导意义,同时有助于业内人士更好地理解与应用《指导原则》。In recent years,with the rise of medical beauty industry,the attention of all kinds of medical beauty products has also increased.On April 1,2023,the Instrument Examination Center of the State Food and Drug Administration officially issued the“Guiding Principles for the Examination of Equipment Registration in RF beauty”(hereinafter referred to as“the Guiding Principles”)to standardize the management of equipment in RF Beauty.At the same time,since April 1,2024,products such as RF therapeutic devices(including RF skin therapeutic devices)may not be produced,imported or sold without obtaining the medical device registration certificate according to law.Firstly,the EMC part of“the Guiding Principles”is studied and analyzed in detail.Then,the test differences between RF beauty equipment and conventional medical equipment are compared.Finally,the problems in the actual test are analyzed and suggestions for improvement are put forward,which has certain guiding significance for the subsequent design and production of RF beauty equipment,and can help the industry to better understand and apply“the Guiding Principles”.

关 键 词：射频美容设备 医疗器械 电磁兼容 试验 

分 类 号：TN03[电子电信—物理电子学] TB114.37[理学—概率论与数理统计]