摘要
医用光辐射防护眼镜为Ⅱ类医疗器械,需要符合医疗器械安全有效性的要求。该研究建立了医用光辐射防护眼镜的评价体系。结合医疗器械注册单元划分指导原则,给出了医用光辐射防护眼镜型号规格的划分方法。医用光辐射防护眼镜不仅属于配装眼镜,同时具有特殊光辐射防护性能。该研究给出了医用光辐射防护眼镜性能指标的评价方法和医用光辐射防护眼镜货架有效期评价方法。
As a kind of class II medical device,medical optical radiation protective eyewears should meet the requirements of safety and effectiveness.In this study,the evaluation system of medical optical radiation protective eyewears is established.Combined with the medical device registration unit division guidelines,the classification method of medical optical radiation protective eyewears is given.Medical optical radiation protective eyewears are not only assembled spectacles,but also have special optical radiation protection performance.The performance evaluation method of medical optical radiation protective eyewears and the evaluation method of shelf life for medical optical radiation protective eyewears are given.
作者
骆永洁
王敬涛
彭建华
华鹏彬
LUO Yongjie;WANG Jingtao;PENG Jianhua;HUA Pengbin(Zhejiang Institute of Medical Device Testing,Hangzhou,310019)
出处
《中国医疗器械杂志》
2022年第5期570-573,577,共5页
Chinese Journal of Medical Instrumentation
基金
浙江省医疗器械检验研究院自立项项目(20210001)。
关键词
光辐射
防护性能
有效期
optical radiation
protection performance
shelf life
