Section 325.5107. Distribution of devices to persons generally licensed.

(1) The department shall issue a specific license to distribute certain devices of the types enumerated in rule 85 to persons generally licensed under rule 85 if:

(a)     The applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control procedures, labeling, proposed uses and potential hazards of the device to provide reasonable assurance that:

(i)   The radioactive material contained in the device will not be lost.

(ii)   An individual will not receive a radiation dose to a major portion of his body in excess of 0.5 rem in a year under ordinary circumstances of use.

(iii)    The device can be operated safely by individuals not having training in radiological protection.

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

(b)   In describing the label and contents thereon to be affixed to the device, the applicant separately indicates those 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."

(c)    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 tests required in (2)(c), at intervals longer than six months but not exceeding three years, the applicant includes in his 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. In determining the acceptable interval for test of leakage of radioactive material, the department shall consider information on particulars which include:

(i)   Primary containment (source capsule).

(ii)   Protection of primary containment.

(iii)   Method of sealing containment.

(iv)   Containment construction materials.

(v)   Form of contained radioactive material.

(vi)   Maximum temperature withstood during prototype tests.

(vii)   Maximum pressure withstood during prototype tests.

(viii)   Maximum quantity of contained radioactive material.

(ix)   adiotoxicity of contained radioactive material.

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

(2)   A licensee authorized under this rule to distribute certain devices to generally licensed persons:

(a)   Shall report to the department all transfers of such devices to persons generally licensed under rule 85. The report shall identify each general licensee by name and address, the type of device transferred and the quantity and type of radioactive material contained in the device. The report shall be submitted within 30 days after the end of each calendar quarter in which a device is transferred to persons generally licensed.

(b)   Shall furnish to each general licensee in this state to whom he transfers a device a copy of the general license contained in rule 85.

History: 1954 ACS 85, Eff. Dec. 3, 1975.