1. (a) Radiation machines or radiation generating devices that do not meet the radiation machine requirements in Section .0600 of this Chapter or radiation generating devices in Rule .0807 of this Chapter shall not be sold, installed, or used prior to the agency completing a review of information regarding the radiation machine and determining if the use of the radiation machine is allowed. The user or manufacturer of the radiation machine shall submit the following to the agency for review:

   1. (1) an application form in accordance with Rule .0203(d) of this Section;
   2. (2) the manufacturer manual;
   3. (3) description of intended use;
   4. (4) operator training provided to the end user;

   5. (5) an independent equipment survey to include the following:

      1. (A) all equipment settings available to the operator;
      2. (B) output at the highest setting; and
      3. (C) leakage radiation around the radiation machine.

   6. (6) an area survey to include the following:

      1. (A) radiation levels in adjacent areas, the operator location, and annual exposure to an operator;
      2. (B) the survey instrument used; and
      3. (C) the name and legible signature of the person who performed the survey.
   7. (7) the hazard level associated with the use of the radiation machine.
   8. (8) means to achieve radiation protection equivalent to the rules of this Section.
2. (b) After receiving the information in Paragraph (a) of this Rule, the agency will respond to the applicant in writing within 90 calendar days. Upon review, the agency may require additional information to determine if the radiation machine is allowed for use.

History Note: Authority G.S. 104E‑7; 104E-20;
Eff. June 1, 1989;
Amended Eff. June 1, 1993;
Transferred and Recodified from 15A NCAC 11 .0212 Eff. February 1, 2015;
Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public interest Eff. June 22, 2019;
Amended Eff. October 1, 2025.