Fed Regist. 1998 Nov 5;63(214):59750-1.
The Food and Drug Administration (FDA) is proposing to amend its regulations governing mammography that published in a document entitled "Quality Mammography Standards." The purpose of these amendments is to eliminate a conflict between the mammography regulations, which must be followed by all facilities performing mammography, and FDA's Electronic Product Radiation Control (EPRC) performance standards, which establish radiation safety performance requirements for x-ray units, including mammographic systems.
美国食品药品监督管理局(FDA)提议修订其在一份名为《优质乳房X线摄影标准》的文件中公布的乳房X线摄影监管规定。这些修订的目的是消除乳房X线摄影规定(所有进行乳房X线摄影的机构都必须遵守)与FDA的电子产品辐射控制(EPRC)性能标准之间的冲突,EPRC性能标准为包括乳房X线摄影系统在内的X射线设备制定了辐射安全性能要求。