医用光辐射防护眼镜评价体系的建立

      Establishment of Evaluation System for Medical Optical Radiation Protective Eyewears

      • 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。

         

        Abstract: 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.

         

      /

      返回文章
      返回