最不利原则在医疗器械光辐射安全分类测试中的应用研究  

Study on Application of the Most Unfavorable Principle in Classification Testing of Optical Radiation Safety from Medical Devices

作　　者：孟祥峰[1] 王浩[1] 刘艳珍[1] 李宁[1] 任海萍[1] MENG Xiang-feng;WANG Hao;LIU Yan-zhen;LI Ning;REN Hai-ping(Institute for Medical Devices Control,National Institutes for Food and DrugControl, Beijing 100050, China)

机构地区：[1]中国食品药品检定研究院医疗器械检定所,北京100050

出　　处：《中国医疗设备》2017年第7期25-27,83,共4页China Medical Devices

基　　金：国家科技支撑计划项目(2015BAI43H00)

摘　　要：目的为了保证患者在诊断和治疗的同时不受到过多的光辐射危害,对光辐射安全进行评价。方法本文依照最不利原则,对医疗器械领域的不同类型表观光源特性进行分析,对其测试关键技术进行了研究。结果本文研究并通过举例给出了不同表光光源及多个光源的情况下,辐照度和辐亮度最不利分类实验测试条件的选择,并给出了具体的测试方案。结论通过本文的研究,有利于规范光辐射分类的测试方法,保证测试结果的唯一性、准确性。Objective In order to reduce the harm of light radiation in the diagnosis and treatmentprocess of patients,this paper evaluated the safety of optical radiation.Methods This paper analyzedthe characteristics of different types of apparent light source in the field of medical devices,and studiedthe key technologies of the test according to the most unfavorable principle.Results The selection oftest conditions for the most unfavorable classification of irradiance and radiance under different lightsources and multiple light sources was studied in this paper.And the specific test scheme was presentedat the same time.Conclusion This research is helpful to standardize the test methods of optical radiationclassification,so as to ensure the uniqueness and accuracy of the test results.

关 键 词：辐射安全 辐照度 辐亮度 最不利原则 多光源 

分 类 号：R197.39[医药卫生—卫生事业管理]