§ 35.52 - Possession, use, calibration, and check of instruments to measure dosages of alpha- or beta-emitting radionuclides.

(a) This section does not apply to unit dosages of alpha- or beta- emitting radionuclides that are obtained from a manufacturer or preparer licensed pursuant to 10 CFR 32.72 or equivalent Agreement State requirements.

(b) For other than unit dosages obtained pursuant to paragraph (a) of this section, a licensee shall possess and use instrumentation to measure the radioactivity of alpha- or beta-emitting radionuclides. The licensee shall have procedures for use of the instrumentation. The licensee shall measure, by direct measurement or by combination of measurements and calculations, the amount of radioactivity in dosages of alpha- or beta-emitting radionuclides prior to administration to each patient or human research subject. In addition, the licensee shall:

(1) Perform tests before initial use, periodically, and following repair, on each instrument for accuracy, linearity, and geometry dependence, as appropriate for the use of the instrument; and make adjustments when necessary; and

(2) Check each instrument for constancy and proper operation at the beginning of each day of use.