Section 22-B6913. MEASURING, GAUGING, AND CONTROLLING DEVICES

 

6913.1A specific license to distribute certain devices of the types enumerated in §6803 of chapter 68 of this title to persons generally licensed under that section shall be issued only if the requirements of this section are met.

 

6913.2The applicant shall submit sufficient information relating to the design, manufacture, prototype testing, quality control procedures, labeling, proposed uses, and potential hazards of the device to reasonably ensure the following:

 

(a)The radioactive material contained in the device will not be lost;

 

(b)No individual will receive a radiation exposure to a major portion of his or her body in excess of five-tenths (0.5) rem in a year under ordinary circumstances of use;

 

(c)The device can be safely operated by individuals not having training in radiological protection; and

 

(d)The radioactive material within the device will not be accessible to unauthorized individuals.

 

6913.3In describing the label or labels and the label contents to be affixed to the device, the applicant shall separately indicate instructions and precautions that are necessary to assure safe operation of the device. The instructions and precautions shall be contained on labels bearing the statement, “REMOVAL OF THIS LABEL IS PROHIBITED.”

 

6913.4If the applicant desires that the device be tested for proper operation of the on-off mechanism and indicator, if any, and for leakage of radioactive material, subsequent to the initial test required by §§6803.9 and 6803.10, at intervals longer than six (6) months, but not exceeding three (3) years, the applicant shall include in the application sufficient information to demonstrate that the longer interval is justified by performance characteristics of the device or similar devices, and by design features which have a significant bearing on the probability or consequences of leakage of radioactive material from the device.

 

6913.5In determining the acceptable interval for tests of leakage of radioactive material, the Director shall consider information on particulars which includes, but is not necessarily limited to, the following:

 

(a)Primary containment (source capsule);

 

(b)Protection of primary containment;

 

(c)Method of sealing containment;

 

(d)Containment construction materials;

 

(e)Form of contained radioactive material;

 

(f)Maximum temperature withstood during prototype tests;

 

(g)Maximum pressure withstood during prototype tests;

 

(h)Maximum quantity of contained radioactive material;

 

(i)Radiotoxicity of contained radioactive material; and

 

(j)Operating experience with identical devices or similarly designed and constructed devices.

 

source

Regulation No. 70-33 (July 10, 1970), 17 DCR 39 (July 27, 1970); 6A DCRR § 8-2:1021(f); as amended by Final Rulemaking published at 53 DCR 3721 (May 5, 2006).