医疗器械非相干光视网膜蓝光辐射危害研究  

Study on the Biohazard of Incoherent Blue Light from Medical Device on the Retina

作　　者：孟祥峰[1] 李宁[1] 刘艳珍[1] 王浩[1] 任海萍[1] 

机构地区：[1]中国食品药品检定研究院医疗器械检定所,北京102629

出　　处：《中国医疗设备》2017年第9期1-5,共5页China Medical Devices

基　　金：中国食品药品检定研究院中青年基金课题"医用LED设备光辐射危害评价与检测方法研究"(2015C01);人社部留学人员科技活动项目择优资助课题"医疗器械光辐射安全评价研究"资助

摘　　要：目的为了确定不同的测试条件对视网膜蓝光危害辐射量及产品分类的影响。方法本文结合光辐射危害分类标准,分析了视网膜蓝光危害的生物机理,并通过设置不同的实验条件(包括测试距离、视场光阑、孔径光阑),分别对紫外光源和LED光源进行视网膜蓝光危害测试研究。结果无晶状体眼睛(2岁以下婴儿)在含紫外成分光源的视网膜蓝光危害要明显大于正常人眼,且很有可能改变分类结果,而对于紫外成分较低的光源无显著影响;检测设备不会改变光源的亮度,不同的测试条件仅仅改变对测试光源的辐射角度或辐射面积的选取范围,进而导致检测结果的差异。结论通过本文研究可知,测试条件的不同会对辐射量值产生一定影响,但一般不会改变分类结果,但为保证辐射量测试的准确性,必须根据光源的实际情况,按照最不利原则选取合适的实验条件。Objective To determine the impact of different testing conditions on the evaluation of blue light biohazard on the retina and product classifcation. Methods In combination with the classifcation standard of light radiation hazard, the biomechanism of retinal bluelight hazard was analyzed. Blue light hazard on the retina from UV light and LED light was tested under different conditions separately （including distance, aperture stop, feld stop）. Results Blue light containing UV component generated more hazard on aphakic eyes （infants less than 2 years old） than regular eyes, which would probably change classifcation results, while lower UV proportion didn’t show significant impact. The testing device didn’t change the luminance of the light source. The difference of testing condition only changed the selected range of radiant angle and area with different results. Conclusion The difference of testing conditions has impact on radiant exposure, but in general, it doesn’t change classifcation results. To assure the accuracy of radiant exposure measurement, appropriate experimental condition should be selected based on the actual circumstance of light sources following the most unfavorable rule.

关 键 词：医疗器械 非相干光 视网膜 蓝光危害 无晶状体眼 对向角 

分 类 号：R774.1[医药卫生—眼科]