摘要
目的:研究远红外温热治疗仪的安全性和有效性。方法:基于生产企业和临床机构调研,对远红外温热治疗仪的工作原理、治疗机理、预期用途、风险因素和性能要求五个方面进行了文献和标准研究。结论:远红外温热治疗仪的安全性应通过医用电气安全和温度、放射性核素限量等性能指标的加以控制,其有效性应通过临床试验加以验证,其预期用途宜界定在以热疗为理疗手段的适用症,因远红外线的穿透性其热疗效果要优于传统热疗方式。
Objective： This article aim to research the safety and efficacy of far-infrared thermal therapy instrument.Methods： Based on field study at manufacture and hospital,a literature and standards study is carried out on the working principle,treatment mechanism,intended use,risk factors and requirements of the far-infrared thermal therapy instrument.Conclusions： The safety of far-infrared thermal therapy instrument should be assured by electrical safety,temperature control and radionuclide limits.Its efficacy should be validated by clinical research,and its intended use should be defined for application of hyperthermia,because of its far-infrared penetrating effect superior to the traditional methods in terms of hyperthermia.
出处
《中国医疗器械信息》
2010年第5期29-33,共5页
China Medical Device Information
关键词
远红外温热治疗仪
安全性
有效性
热疗
far-infrared thermal therapy instrument
safety
efficacy
hyperthermia
