[Code of Federal Regulations]
[Title 10, Volume 1]
[Revised as of January 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 10CFR35.52]

[Page 564]
 
                            TITLE 10--ENERGY
 
                CHAPTER I--NUCLEAR REGULATORY COMMISSION
 
PART 35--MEDICAL USE OF BYPRODUCT MATERIAL--Table of Contents
 
                Subpart C--General Technical Requirements
 
Sec. 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.

[59 FR 61783, Dec. 2, 1994]