X-ray Safety

The U.S. Food and Drug Administration (FDA) have responsibility for assuring manufacturers produce cabinet x-ray systems that do not pose a radiation safety hazard. For most electronic products that emit radiation, safety regulation is divided between FDA and state regulatory agencies. Typically, FDA regulates the manufacture of the products and the states regulate the use of the products. For further information on FDA regulations that apply to manufacturers of electronic products that emit radiation (such as a cabinet x-ray system) see the FDA web site (http://www.fda.gov/cdrh/comp/eprc.html).

Manufacturers are required to certify that their products meet the Federal Radiation Safety Performance Standard for cabinet x-ray systems. Specifically, the standard requires that the radiation emitted from a cabinet x-ray system not exceed an exposure of 0.5 milliroentgens in one hour at any point five centimeters from the external surface. Most cabinet x-ray systems emit less than this limit. In addition, the standard also requires safety features that include warning lights, warning labels and interlocks.
For comparison, the average person in the United States receives a dose of about 360 millirem of radiation per year from background radiation. (Note: 1 milliroentgen of exposure to x-rays will result in approximately 1 millirem of dose. These terms are defined later in this document.) Background radiation is radiation that is always present in the environment. Eighty percent of that exposure comes from natural sources: radon gas, the human body, outer space, rocks, and soil. The remaining 20 percent comes from man-made radiation sources, primarily medical x rays.