3701:1-67-11. Other uses of electronic radiation-generating equipment for therapeutic purposes

A person shall not utilize, for therapeutic purposes, any electronic radiation-generating equipment that is not appropriately regulated under any existing category of therapy equipment, until:

(A) The handler has, at a minimum, provided the department with:

(1) A detailed description of the therapy equipment and its intended application(s);

(2) Facility design requirements, including shielding and access control;

(3) Documentation of appropriate training for authorized physicians, veterinarians and qualified medical physicists;

(4) Methodology for measurement of dosages to be administered to patients or human research subjects;

(5) Documentation regarding calibration, maintenance, and repair of the therapy equipment, as well as instruments and equipment necessary for radiation safety;

(6) Radiation safety precautions and instructions; and

(7) Other information requested by the department in its review of the application; and

(B) The handler has received written approval from the department to utilize the therapy equipment in accordance with the rules and specific conditions the department considers necessary to assure safe operation and to provide adequate radiation protection.

Effective: 3/1/2016
Five Year Review (FYR) Dates: 11/10/2015 and 11/15/2020
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.01, 3748.02, 3748.04 , 3748.05, 3748.06, 3748.07, 3748.12, 3748.121, 3748.13, 3748.14, 3748.15, 3748.17, 3748.18, 3748.19, 3748.20, 3748.22, 3748.99
Prior Effective Dates: 8/1/2011