[Establishment of Evaluation System for Medical Optical Radiation Protective Eyewears]

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.