Current through Register Vol. 49, No. 18, September 16, 2024
(1) The
equipment used for mammography shall be specifically designed for mammogra-phy
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 mil-liammeter, 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.
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.
*Original authority
1992.
