California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 5 - Sanitation (Environmental) › Subchapter 4 - Radiation › Group 3 - Standards for Protection Against Radiation › Article 4.5 - Requirements for the Use of X-Ray in Mammography › Section 30316 - Mammography System Requirements

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(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.