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Electronic Code of Federal Regulations

e-CFR Data is current as of July 30, 2014

Title 10: Energy
PART 35—MEDICAL USE OF BYPRODUCT MATERIAL
Subpart F—Manual Brachytherapy


§35.432   Calibration measurements of brachytherapy sources.

(a) Before the first medical use of a brachytherapy source on or after October 24, 2002, a licensee shall have—

(1) Determined the source output or activity using a dosimetry system that meets the requirements of §35.630(a);

(2) Determined source positioning accuracy within applicators; and

(3) Used published protocols currently accepted by nationally recognized bodies to meet the requirements of paragraphs (a)(1) and (a)(2) of this section.

(b) Instead of a licensee making its own measurements as required in paragraph (a) of this section, the licensee may use measurements provided by the source manufacturer or by a calibration laboratory accredited by the American Association of Physicists in Medicine that are made in accordance with paragraph (a) of this section.

(c) A licensee shall mathematically correct the outputs or activities determined in paragraph (a) of this section for physical decay at intervals consistent with 1 percent physical decay.

(d) A licensee shall retain a record of each calibration in accordance with §35.2432.

[67 FR 20370, Apr. 24, 2002, as amended at 68 FR 19325, Apr. 21, 2003]



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