Current through Register Vol. 48, No. 9, September 27, 2024
The equipment requirements of this Part are intended to
ensure that mammography equipment is capable of producing quality mammograms
over the full range of clinical conditions.
5.10.1 Prohibited equipment. Xeromammography
equipment shall not be used for mammography procedures. Radiographic equipment
designed for general purpose or special non-mammography procedures shall not be
used for mammography. This prohibition includes systems that have been modified
or equipped with special attachments for mammography. This requirement
supersedes the implied acceptance of such systems in
21 CFR, Section
1020.31(f)(3).
5.10.2 General. Only special purpose
equipment designed for mammography shall be specifically used for mammography
and shall be certified pursuant to
21 CFR, Section
1010.2 as meeting the applicable requirements
of 21 CFR, Section
1020.30, effective as of April 1,
1997.
5.10.3 Motion of tube-image
receptor assembly.
5.10.3.1 The assembly shall
be capable of being fixed in any position where it is designed to operate. Once
fixed in any such position, it shall not undergo unintended motion.
5.10.3.2 The mechanism ensuring compliance
with RHB
5.10.3.1 shall not fail in the event of power
interruption.
5.10.4
Image receptor sizes.
5.10.4.1 Systems using
screen-film image receptors shall provide, at a minimum, for operation with
image receptors of eighteen by twenty-four centimeters (18 x 24 cm) and
twenty-four by thirty centimeters (24 x 30 cm).
5.10.4.2 Systems using screen-film image
receptors shall be equipped with moving grids matched to all image receptor
sizes provided.
5.10.4.3 Systems
used for magnification procedures shall be capable of operation with the grid
removed from between the source and image receptor.
5.10.5 Beam limitation and light fields.
5.10.5.1 All systems shall have beam-limiting
devices that allow the useful beam to extend to or beyond the chest wall edge
of the image receptor.
5.10.5.2 For
any mammography system with a light beam that passes through the x-ray beam
limiting device, the light shall provide an average illumination of not less
than one hundred sixty lux (160 lx)(15 footcandles) at one hundred centimeters
(100 cm) or the maximum source-image receptor distance (SID), whichever is
less.
5.10.6
Magnification
5.10.6.1 Systems used to
perform noninterventional problem solving procedures shall have radiographic
magnification capability available for use by the operator.
5.10.6.2 Systems used for magnification
procedures shall provide, at a minimum, at least one (1) magnification value
within the range of 1.4 to 2.0.
5.10.7 Focal Spot Selection
5.10.7.1 When more than one (1) focal spot is
provided, the system shall indicate, prior to exposure, which focal spot is
selected.
5.10.7.2 When more than
one (1) target material is provided, the system shall indicate, prior to
exposure, the preselected target material.
5.10.7.3 When the target material and/or
focal spot is selected by a system algorithm that is based on the exposure or
on a test exposure, the system shall display, after the exposure, the target
material and /or focal spot actually used during the exposure.
5.10.8 Compression. All
mammography systems shall incorporate a compression device that shall be used
for all routine projections and for all projections except when necessity
requires imaging without compression.
5.10.8.1 Application of compression.
Effective October 28, 2002, each system shall provide:
5.10.8.1.1 An initial power-driven
compression activated by hands-free controls operable from both sides of the
patient; and
5.10.8.1.2 Fine
adjustment compression controls operable from both sides of the
patient.
5.10.8.2
Compression paddle:
5.10.8.2.1 Systems shall
be equipped with different sized compression paddles that match the sizes of
all full-field image receptors provided for the system. Compression paddles for
special purposes, including those smaller than the full size of the image
receptor (for "spot compression") may be provided. Such compression paddles for
special purposes are not subject to the requirements of subsections
RHB 5.10.8.2.4 and
5.10.8.2.5 of this Section.
5.10.8.2.2 Except as provided in subsection
RHB 5.10.8.2.3 of this
Part, the compression paddle shall be flat and parallel to the breast support
table and shall not deflect from parallel by more than one centimeter (1 cm) at
any point on the surface of the compression paddle when compression is
applied.
5.10.8.2.3 Equipment
intended by the manufacturer's design to not be flat and parallel to the breast
support table during compression shall meet the manufacturer's design
specifications and maintenance requirements.
5.10.8.2.4 The chest wall edge of the
compression paddle shall be straight and parallel to the edge of the image
receptor.
5.10.8.2.5 The chest wall
edge may be bent upward to allow for patient comfort but shall not appear on
the image.
5.10.9 Technique factor selection and
display.
5.10.9.1 Manual selection of
milliAmpere seconds (mAs) or at least one (1) of its component parts
(milliAmpere (mA) and/or time) shall be available.
5.10.9.2 The technique factors (peak tube
potential in kilovolt (kV) and either tube current in mA and exposure time in
seconds or the product of tube current and exposure time in mAs) to be used
during an exposure shall be indicated before the exposure begins, except when
automatic exposure controls (AEC) are used, in which case the technique factors
that are set prior to the exposure shall be indicated.
5.10.9.3 Following AEC mode use, the system
shall indicate the actual kiloVoltage peak (kVp) and mAs used during the
exposure. The mAs may be displayed as mA and time.
5.10.10 Automatic exposure control.
5.10.10.1 Each screen-film system shall
provide an AEC mode that is operable in all combinations of equipment
configuration provided (e.g., grid, nongrid, magnification, nonmagnification
and various target-filter combinations).
5.10.10.2 The positioning or selection of the
detector shall permit flexibility in the placement of the detector under the
target tissue.
5.10.10.2.1 The size and
available positions of the detector shall be clearly indicated at the x-ray
input surface of the breast compression paddle.
5.10.10.2.2 The selected position of the
detector shall be clearly indicated.
5.10.10.3 The system shall provide means for
the operator to vary the selected optical density from the normal (zero (0))
setting.
5.10.11 X-ray
film. The facility shall use x-ray film for mammography that has been
designated by the film manufacturer as appropriate for mammography.
5.10.12 Intensifying screens. The facility
shall use intensifying screens for mammography that have been designated by the
screen manufacturer as appropriate for mammography and shall use film that is
matched to the screen's spectral output as specified by the
manufacturer.
5.10.13 Film
processing solutions. When processing mammography films, the facility shall use
chemical solutions that are capable of developing the film used by the facility
in a manner equivalent to the minimum requirements specified by the film
manufacturer.
5.10.14 Lighting. The
facility shall make special lights for film illumination (i.e., hot-lights),
capable of producing light levels greater than that provided by the view box,
available to the interpreting physicians.
5.10.15 Film masking devices. Facilities
shall ensure that filmmasking devices that can limit the illumination area to a
region equal to or smaller than the exposed portion of the film are available
to all interpreting physicians.
