10A NCAC 15 .0607         radiation machine requirements

(a)  All radiation machines shall be:

(1)           registered with the agency in accordance with Rule .0203(a) of this Chapter; and

(2)           installed according to the manufacturer's specifications.

(b)  Each diagnostic radiographic and fluoroscopic radiation machine and associated components shall comply with the following provisions of 21 CFR Subchapter J, Diagnostic x-ray systems and their major components, which are hereby incorporated by reference, including subsequent amendments and editions. The following parts of 21 CFR Subchapter J apply:

(1)           Part 1000, "General";

(2)           Subpart A 1000.1, "General Provisions - General";

(3)           Subpart A 1000.3(a) through (1), and (n) through (s), "Definitions";

(4)           Subpart A 1000.15, "Examples of electronic products subject to the Radiation Control for Health and Safety Act of 1968";

(5)           Part 1002, "Records and Reports";

(6)           Subpart A 1002.1(a) and (c)(4), "Applicability";

(7)           Subpart D 1002.31, "Preservation and inspection of records";

(8)           Part 1003, "Notification of Defects of Failures to Comply";

(9)           Subpart A 1003.1, "Applicability";

(10)         Subpart A 1003.2, "Defect in an electronic product";

(11)         Subpart C 1003.21, "Notification by the manufacturer to affected persons";

(12)         Part 1010, "Performance Standards for Electronic Products - General";

(13)         Subpart A 1010.1, "Scope";

(14)         Subpart A 1010.2 (a),(b), and (d), "Certification";

(15)         Subpart A 1010.3, "Identification";

(16)         Subpart A 1010.4(a) and (d), "Variances";

(17)         Part 1020, "Performance Standards for Ionizing Radiation Emitting Products";

(18)         Section 1020.20, "Cold-cathode gas discharge tubes";

(19)         Section 1020.30, "Diagnostic x-ray systems and their main components";

(20)         Section 1020.31, "Radiographic equipment";

(21)         Section 1020.32, "Fluoroscopic equipment"; and

(22)         Section 1020.33, "Computed tomography (CT) equipment".

(c)  The regulations incorporated by reference in Paragraph (b) of this Rule are available free of charge at https://www.ecfr.gov/current/title-21/chapter-I/subchapter-J for Subparagraphs (a)(1) through (a)(22) of this Rule.

(d)  Diagnostic radiation machines and their associated components used on humans and certified in accordance with Paragraph (b)(17) of this Rule shall be maintained to ensure compliance with standards in accordance with Paragraph (b) of this Rule.

(e)  Radiation machines that do not meet the requirements of Paragraph (b)(1) of this Rule shall not be sold, installed, or used in this state prior to the agency completing a review of the radiation machine in accordance with Rule .0212(a) of this Chapter.

(f)  All radiation machines shall meet the following additional requirements:

(1)           The tube housing shall remain stable during radiation exposures unless tube housing movement is a designed function of the radiation machine.

(2)           All position locking, holding, and centering devices on radiation machine components and systems shall function as intended by the manufacturer.

(g)  Veterinary. Radiation machines used in veterinary medicine are exempt from Paragraph (c) of this Rule. The requirements of this paragraph shall apply only to veterinary medicine radiographic installations. Veterinary radiation machine installations shall meet the following requirements:

(1)           The protective tube housing shall be of the diagnostic type.

(2)           Diaphragms or cones shall be provided for collimating the useful beam to the area of the image receptor and shall provide the same degree of protection as is required in the housing.

(3)           The total filtration permanently in the useful beam shall not be less than 0.5 millimeters aluminum equivalent for machines operating up to 50 kVp, 1.5 millimeters aluminum equivalent for machines operating between 50‑70 kVp, and 2.5 millimeters aluminum equivalent for machines operating above 70 kVp.

(4)           A device shall be provided to terminate the exposure after a preset time or exposure.

(5)           A dead‑man type of exposure switch shall be provided, together with an electrical cord of sufficient length, so that the operator can stand out of the useful beam and at least six feet from the animal during all x-ray exposures or behind a protective barrier adequate to assure compliance with dose limit requirements of Rule .1601(a)(8) and .1601(a)(15) of this Chapter.

History Note:        Authority G.S. 104E‑7;

Eff. February 1, 1980;

Amended Eff. January 1, 1994; October 1, 1980;

Transferred and Recodified from 15A NCAC 11 .0607 Eff. February 1, 2015;

Readopted Eff. August 1, 2026.