What limits are placed on leakage and backscatter radiation?
The applicable performance standard for a diagnostic source assembly, under 21 CFR 1020.30(k), limits radiation leakage from the x-ray source assembly to an air kerma of 0.88 mGy (corresponding to an exposure of 100 mR) in one hour at a distance of one meter from the x-ray source when measured as specified in the standard.
