脉冲光辐射源安全相关标准与测量方法研究  

Research on Standards and Measurement Methods Related to Photobiological Safety of Pulsed Optical Radiation Sources

作　　者：潘建根 李培培[2] 李倩 曹良才[1] PAN Jiangen;LI Peipei;LI Qian;CAO Liangcai(State Key Laboratory of Precision Measurement Technology and Instrument,Department of Precision Instrument,Tsinghua University,Beijing 100084,China;EVERFINE Corporation,Hangzhou Zhejing 310053,China)

机构地区：[1]清华大学精密仪器系,精密测试技术及仪器国家重点实验室,北京100084 [2]杭州远方光电信息股份有限公司,浙江杭州310053

出　　处：《中国医疗设备》2024年第5期148-154,共7页China Medical Devices

基　　金：国家重点研发计划(2022YFF0705500)。

摘　　要：脉冲光辐射源在医疗美容行业中的应用日益广泛,而与之相伴的光辐射安全问题也备受业界关注。当前多个光生物安全相关标准涉及脉冲光辐射源的测量和评价,其具体条款要求尚未规范和统一,按照不同标准得到的产品安全等级分类也可能会大相径庭。本文基于标准发展的脉络和理论依据,梳理比较了脉冲光辐射源的测量和评价方法,并以典型的脱毛仪产品为例,利用实测数据分析计算了其在不同标准下的危险等级分类。本文的测量分析可持续完善医美产品的评价标准,为进一步规范医疗器械管理提供一定的参考。Pulsed optical radiation sources are widely and rapidly applied in the medical cosmetology,and the associated issue of optical radiation safety has attracted significant attention of consumers as well as practitioners in the industry.Recently,multiple photobiological safety standards involve the measurement and evaluation of pulsed optical radiation sources,but the specific requirements of these standards differ from each other.As a result,the classification of product safety levels obtained according to different standards may vary greatly.In this paper,the measurement and evaluation methods of pulsed optical radiation sources were compared and analyzed based on the development and theoretical basis of the standards.A hair removal machine was taken as an example,measured data were utilized to analyze and calculate its hazard level classification under different standards.The research of the measurement and analysis can provide a reference for continuously improving the evaluation standards of medical cosmetology products and further regulating the management of the related medical devices.

关 键 词：脉冲光辐射源 光生物安全 曝辐限值 危险等级 

分 类 号：R197.39[医药卫生—卫生事业管理]