Section R12-1-611.02. Other Use of Electronically-Produced Radiation to Deliver Superficial Therapeutic Radiation Dosage

A person shall not utilize any device which is designed to electri-

cally generate a source of ionizing radiation to deliver superficial therapeutic radiation dosage, and which is not appropriately regu- lated under any existing category of therapeutic radiation machine, until:

1.        The applicant or registrant has, at a minimum, provided the Agency with:

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 autho- rized user physician or physicians and qualified 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 Agency in its review of the application; and

2.        The applicant or registrant has received written approval from the Agency to utilize the device in accordance with the regulations and specific conditions the Agency con- siders necessary for the medical use of the device; and

3.        The applicant or registrant has submitted the application information and forms required by Article 2.

4.        In addition to the requirements of this Section, a regis- trant using a device for x-ray radiation therapy shall meet the requirements of R12-1-611.01(Q), (R), and (S).

Historical Note

New Section R12-1-611.02 made by final rulemaking at 20 A.A.R. 811, effective May 3, 2014 (Supp. 14-1).