Ariz. Admin. Code § 9-7-611.02

Current through Register Vol. 30, No. 45, November 8, 2024

Section R9-7-611.02 - Other Use of Electronically-Produced Radiation to Deliver Superficial Therapeutic Radiation Dosage

A person shall not utilize any device which is designed to electrically generate a source of ionizing radiation to deliver superficial therapeutic radiation dosage, and which is not appropriately regulated under any existing category of therapeutic radiation machine, until:

1. The applicant or registrant has, at a minimum, provided the Department 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 authorized 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 Department in its review of the application; and

2. The applicant or registrant has received written approval from the Department to utilize the device in accordance with the regulations and specific conditions the Department considers 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 registrant using a device for x-ray radiation therapy shall meet the requirements of R9-7-611.01(Q), (R), and (S).

Ariz. Admin. Code § R9-7-611.02

New Section R9-7-611.02 recodified from R12-1-611.02 at 24 A.A.R. 813, effective March 22, 2018 (Supp. 18-1).