Mammography Equipment Requirements

PURPOSE: This rule establishes requirements for mammography equipment, including radiation machines and other components of mammography systems. Editor's Note: The secretary of state has determined that the publication of this rule in its entirety would be unduly cumbersome or expensive. The entire text of the material referenced has been filed with the secretary of state. This material may be found at the Office of the Secretary of State or at the headquarters of the agency and is available to any interested person at a cost established by state law. (1) The equipment used for mammography shall be specifically designed for mammography and shall meet the following requirements: (A) Equipment shall meet the Food and Drug Administration (FDA) performance standards for diagnostic X-ray systems and their major components in 21 CFR 1020.30 and FDA standards for radiographic equipment in 21 CFR 1020.31 upon installation and while in use; (B) The image receptor systems and all their individual components shall be designed specifically for mammography and shall function properly; (C) The equipment shall be limited to providing kilovoltage (kV)-target-filter combinations appropriate to image receptors meeting the requirements of subsection (1)(B); (D) The half value layer (HVL) in millimeters of aluminum of the useful beam for systems operating at X-ray tube potentials of less than thirty-five kilovoltage potential (35 kVp) shall be equal to or greater than the product of the tube potential in kilovolts multiplied by one-hundredth (0.01) and shall not exceed this calculated product by more than plus one-tenth millimeter (+0.1 mm) of aluminum; (E) Devices parallel to the imaging plane shall be available to adequately immobilize and compress the breast; (F) Film-screen units shall have the capability for using anti-scatter grids; (G) Film-screen units shall have the capability of automatic exposure control; (H) The equipment shall have a control panel that includes a device, usually a milliammeter, or a means for an audible signal to give positive indication of the production of X rays whenever the X-ray tube is energized. The control panel shall include appropriate indicators—labeled control settings or meters that show the physical factors, such as kVp, milliamperes (mA), milliampere-seconds (mAs), exposure time or whether timing is automatic—when used for exposure; (I) The developer temperature of the photographic processor shall be maintained as specified by the film manufacturer for the particular film-developer-processor-development time combination; and (J) The focal spot size and source-to-image receptor distances shall be limited to those appropriate for mammography. AUTHORITY: sections 192.762 and 192.766, RSMo Supp. 1992.* This rule was previously filed as 19 CSR 20-11.070. Emergency rule filed Oct. 5, 1992, effective Oct. 15, 1992, expired Feb. 12, 1993. Emergency rule filed Feb. 3, 1993, effective Feb. 13, 1993, expired June 12, 1993. Original rule filed Nov. 4, 1992, effective June 7, 1993. Amended: Filed April 28, 1993, effective Nov. 8, 1993. Changed to 19 CSR 30-11.070 July 30, 1998. *Original authority 1992.