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
潘建根 1李培培 2李倩 2曹良才3
作者信息
- 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;杭州远方光电信息股份有限公司,浙江 杭州 310053
- 2. 杭州远方光电信息股份有限公司,浙江 杭州 310053
- 3. 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
- 折叠
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.
Abstract
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Key words
pulsed optical radiation source/photobiological safety/exposure limits/hazard level引用本文复制引用
基金项目
国家重点研发计划(2022YFF0705500)
出版年
2024
国家科技期刊平台
NSTL
维普
万方数据