[Normalize product registration standard of digital mammography system].
This paper aims to discuss the issues needed to be considered during the process of defining the registered product standards and industry standards of digital mammographic X-ray camera system. Meanwhile, for the future reference of establishment of standards, it adds the additional technical requirements not only from the features of device's structure, but also from the risk of clinical use.
Biomedical Engineering Institute, Capital Medical University, Beijing 100069.
Yujing
Y
Zhang
Zhicheng
Z
Liu
Zhiyong
Z
Sun
D008327:Mammography / Q000295:instrumentation* / Q000592:standards*; D011856:Radiographic Image Enhancement / Q000295:instrumentation