Section R12-1-605. X-ray Machine Standards

A.      A registrant shall prevent leakage radiation from the diagnos- tic source assembly measured at a distance of 1 meter in any direction from the source assembly from exceeding 25.8 µC/ kg (100 milliroentgens) in one hour when the x-ray tube is operated at its leakage technique factors. The Agency shall determine compliance by obtaining measurements averaged over an area of 100 square centimeters (15.5 square inches) with no linear dimension greater than 20 centimeters (7.9 inches).

B.       The registrant shall prevent radiation emitted by a component other than the diagnostic source assembly from exceeding 516 nC/kg (2 milliroentgens) in one hour at 5 centimeters from any accessible surface of the component when it is operated in an assembled x-ray system under any conditions for which it was designed. The Agency shall determine compliance by obtain- ing measurements averaged over an area of 100 square centi- meters (15.5 square inches) with no linear dimension greater than 20 centimeters (7.9 inches).

C.      Beam quality.

1.        The registrant shall prevent the useful beam half-value layer (HVL) for diagnostic x-ray given x-ray tube poten- tial from falling below the values shown in Table I. If it is necessary to determine the HVL at an x-ray tube potential that is not listed in Table I, the registrant shall use linear interpolation or extrapolation to make the determination.