N.Y. Comp. Codes R. & Regs. tit. 10 § 16.51

Current through Register Vol. 46, No. 45, November 2, 2024

Section 16.51 - General requirements for and prohibited uses of radiation equipment

(a) General requirements. All radiation equipment shall meet any applicable specific provision of the sections of this Part set forth under the heading "Radiation Equipment" (§§ 16.50 -16.63), and all possession or use thereof shall comply with the requirements of sections of this Part set forth under the heading "General Provisions" (§§ 16.1 -16.20), and any other requirement imposed by the department. Radiation equipment which is not intended to be used, must be made inoperable to the satisfaction of the department by dismantling or sealing with an official New York State Department of Health seal or other suitable method; and shall not be unsealed or restored to operable condition without prior authorization by the department.

(b) Prohibited uses and activities include:

(1) nonimage intensified fluoroscopic equipment which has not been certified in accordance with 21 CFR part 1020 (see section 16.200 of this Part);

(2) shoe-fitting fluoroscopic devices;

(3) intra-oral fluoroscopy used in dental examinations;

(4) photofluorographic equipment;

(5) the sale of gold jewelry which is known by the owner to be contaminated with radioactive materials, except for sale to the department.

(c) Precedence of Federal performance standard. Wherever any requirement of this Part relating to radiation equipment conflicts with the Federal performance standard for diagnostic X- ray systems and their major components ( 21 CFR 1020.30 ), the Federal performance standard, when effective, shall take precedence over and supersede any conflicting requirement of this Part.

N.Y. Comp. Codes R. & Regs. Tit. 10 § 16.51