(a) A radiation machine designed for general purpose radiography or special nonmammography procedures shall not be used for mammography.
(b) Radiation machines used for mammography shall:
(1) Be specifically designed and manufactured for mammography and meet the requirements of section 30305(a)(4).
(2) Provide a tube-image receptor assembly that is capable of being fixed in any operating position where it is designed to operate and once fixed in any such position, does not undergo unintended motion and does not fail in the event of power interruption.
(3) If equipped with screen-film image receptors:
(A) Be able to be operated with image receptors of 18 x 24 centimeters (cm) and 24 x 30 cm;
(B) Have moving grids matched to all image receptor sizes provided; and
(C) Be able to be operated with the grid removed, if the system is used for magnification procedures;
(4) If used to perform noninterventional problem solving procedures, have a radiographic magnification capability with at least one magnification value within the range of 1.4 to 2.0.
(5) When equipped with more than one focal spot, indicate, prior to exposure, which focal spot has been selected.
(6) When equipped with more than one target material, indicate, prior to exposure, the preselected target material.
(7) When equipped such that the target material and/or focal spot are selected by a system algorithm that is based on the exposure or on a test exposure, display, after the exposure, the target material and/or focal spot actually used during the exposure.
(8) Incorporate a compression device that provides:
(A) An initial power-driven compression activated by hands-free controls operable from both sides of the patient; and
(B) Fine adjustment compression controls operable from both sides of the patient.
(C) Provides 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 but shall be exempt from the requirements of paragraph (D);
(D) Except as provided in paragraph (E), provides a compression paddle that is flat and parallel to the image receptor holder assembly and does not deflect from parallel by more than 1.0 cm at any point on the surface of the compression paddle when compression is applied. The chest wall edge of the compression paddle shall be straight and parallel to the edge of the image receptor. The chest wall edge shall not appear on the image;
(E) If the compression paddle is intended by the manufacturer's design to not be flat and parallel to the image receptor holder assembly during compression, the paddle shall meet the manufacturer's design specifications and maintenance requirements; and
(F) If the chest wall edge is bent upward for patient comfort, the edge shall not appear on the image.
(9) Provide manual selection of milliampere-seconds (mAs) or at least one of its component parts (milliamperes (mA) and/or time);
(10) Indicate kVp, mA and time and/or mAs before the exposure begins, or when AEC mode is used, the technique factors that are set prior to the exposure;
(11) When the AEC mode is used, indicate the actual technique factors (kVp and mAs or mA and time) used, after completion of the exposure;
(12) If used with screen-film image receptors, provide an AEC mode that is operable in all combinations of equipment configuration provided on that unit, such as grid, nongrid, magnification, nonmagnification and various target-filter combinations, and:
(A) Provides a positioning or selection of the detector that is flexible in the placement of the detector under the target tissue;
(B) Clearly indicates the size and available positions of the detector at the X-ray input surface of the compression paddle;
(C) Clearly indicates the selected position of the detector; and
(D) Provides a means to vary the selected optical density from the normal or baseline setting.
(13) If equipped with a light beam that passes through the X-ray beam-limiting device, the light provides an average illumination of no less than 160 lux (15 foot candles) at the lesser of 100 centimeters or the maximum source-to-image-distance the machine can obtain.
(c) Mammography using a screen-film mammography system shall not be performed unless:
(1) The X-ray film and intensifying-screens are designated by the film manufacturer and the screen manufacturer as appropriate for mammography and the X-ray film matches the screen's spectral output as specified by the screen manufacturer;
(2) Chemical solutions used for processing mammograms are capable of developing the film so as to meet the minimum requirements specified by the film manufacturer;
(3) Special lights for film illumination, or hot lights, that are capable of producing light levels greater than that provided by the view box are available; and
(4) Film masking devices that can limit the illuminated area to a region equal to or smaller than the exposed portion of the film are available in the facility.
Credits
Note: Authority cited: Sections 114975, 115000, 115060 and 131200, Health and Safety Code. Reference: Sections 115060, 131050 and 131051, Health and Safety Code.
History
1. New section filed 2-10-2003 as an emergency; operative 2-10-2003 (Register 2003, No. 7). A Certificate of Compliance must be transmitted to OAL by 6-10-2003 or emergency language will be repealed by operation of law on the following day.
2. Certificate of Compliance as to 2-10-2003 order, including amendment of subsection (b)(9), transmitted to OAL 6-6-2003 and filed 7-18-2003 (Register 2003, No. 29).
3. Amendment of section and Note filed 12-18-2019; operative 7-1-2020 pursuant to Government Code section 11343.4(b)(2) (Register 2019, No. 51).
This database is current through 4/26/24 Register 2024, No. 17.
