[Code of Federal Regulations]
[Title 10, Volume 1]
[Revised as of January 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 10CFR35.50]

[Page 562-563]
 
                            TITLE 10--ENERGY
 
                CHAPTER I--NUCLEAR REGULATORY COMMISSION
 
PART 35--MEDICAL USE OF BYPRODUCT MATERIAL--Table of Contents
 
                Subpart C--General Technical Requirements
 
Sec. 35.50  Possession, use, calibration, and check of dose calibrators.


    (a) A licensee shall possess and use a dose calibrator to measure 
the activity of dosages of photon-emitting radionuclides prior to 
administration to each patient or human research subject.
    (b) A licensee shall:
    (1) Check each dose calibrator for constancy with a dedicated check 
source at the beginning of each day of use. To satisfy the requirement 
of this paragraph, the check must be done on a frequently used setting 
with a sealed source of not less than 10 microcuries of radium-226 or 50 
microcuries of any other photon-emitting radionuclide;
    (2) Test each dose calibrator for accuracy upon installation and at 
least annually thereafter by assaying at least two sealed sources 
containing different radionuclides whose activity the manufacturer has 
determined within 5 percent of its stated activity, whose activity is at 
least 10 microcuries for radium-226 and 50 microcuries for any other 
photon-emitting radionuclide, and at least one of which has a principal 
photon energy between 100 keV and 500 keV;
    (3) Test each dose calibrator for linearity upon installation and at 
least quarterly thereafter over a range from the highest dosage that 
will be administered to a patient or human research subject to 1.1 
megabecquerels (30 microcuries); and
    (4) Test each dose calibrator for geometry dependence upon 
installation over the range of volumes and volume configurations for 
which it will be used. The licensee shall keep a record of this test for 
the duration of the use of the dose calibrator.
    (c) A licensee shall also perform appropriate checks and tests 
required by this section following adjustment or repair of the dose 
calibrator.
    (d) A licensee shall mathematically correct dosage readings for any 
geometry or linearity error that exceeds 10 percent if the dosage is 
greater than 10 microcuries and shall repair or replace the dose 
calibrator if the accuracy or constancy error exceeds 10 percent.

[[Page 563]]

    (e) A licensee shall retain a record of each check and test required 
by this section for three years unless directed otherwise. The records 
required in paragraphs (b)(1) through (b)(4) of this section must 
include:
    (1) For paragraph (b)(1) of this section, the model and serial 
number of the dose calibrator, the identity of the radionuclide 
contained in the check source, the date of the check, the activity 
measured, and the initials of the individual who performed the check;
    (2) For paragraph (b)(2) of this section, the model and serial 
number of the dose calibrator, the model and serial number of each 
source used, the identity of the radionuclide contained in the source 
and its activity, the date of the test, the results of the test, and the 
identity of the individual performing the test.
    (3) For paragraph (b)(3) of this section, the model and serial 
number of the dose calibrator, the calculated activities, the measured 
activities, the date of the test, and the identity of the individual 
performing the test.
    (4) For paragraph (b)(4) of this section, the model and serial 
number of the dose calibrator, the configuration of the source measured, 
the activity measured for each volume measured, the date of the test, 
and the identity of the individual performing the test.

[51 FR 36951, Oct. 16, 1986, as amended at 53 FR 19247, May 27, 1988; 59 
FR 61783, Dec. 2, 1994]