Section 180-20-012 - OTHER USES OF ELECTRONICALLY PRODUCED RADIATION TO DELIVER THERAPEUTIC RADIATION DOSAGEA person must not utilize any device which is designed to electrically generate a source of ionizing radiation to deliver therapeutic radiation dosage, and which is not regulated under any existing category of therapeutic radiation machine, until the following requirements have been met.
012.01SUBMISSION REQUIREMENTS. The applicant or registrant must submit: (A) A detailed description of the device and its intended application or applications;(B) Facility design requirements, including shielding and access control;(C) Documentation of appropriate training for users and radiological medical physicist or physicists;(D) Methodology for measurement of dosages to be administered to patients or human research subjects;(E) Documentation regarding calibration, maintenance, and repair of the device, as well as instruments and equipment necessary for radiation safety(F) Radiation safety precautions and instructions; and(G) Other information requested by the Department in its review of the application.012.02WRITTEN APPROVAL. The applicant or registrant must receive written approval from the Department to utilize a device specified in 180 NAC 20-012. The device may be used only as specified in this chapter and specific conditions the Department considers necessary for the medical use of the device.180 Neb. Admin. Code, ch. 20, § 012
Adopted effective 11/21/2020