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(1) Procedures would involve techniques not applied routinely during cleanup or maintenance operations; or
(2) Workers would be entering areas not normally occupied where surface contamination and radiation levels are significantly higher than routinely encountered during operation; or
(3) Procedures could result in significantly greater airborne concentrations of radioactive materials than are present during operation; or
(4) Procedures could result in significantly greater releases of radioactive material to the environment than those associated with operation.
(e) Procedures with potential health and safety impacts shall not be carried out prior to approval of the decommissioning plan.
(f) The proposed decommissioning plan, if required by Subsection (d) of this section or by license condition, shall include:
(1) Description of planned decommissioning activities;
(2) Description of methods used to assure protection of workers and the environment against radiation hazards during decommissioning;
(3) A description of the planned final radiation survey;
(4) The information required in (a) (3) and any other information required by (a) that is considered necessary to support the adequacy of the decommissioning plan for approval; and
(5) An updated detailed cost estimate for decommissioning, comparison of that estimate with present funds set aside for decommissioning, and plan for assuring the availability of adequate funds for completion of decommissioning.
(g) The proposed decommissioning plan will be approved by the Department if the Department determines that the decommissioning will be completed as soon as is reasonable and that the health and safety of workers and the public will be adequately protected.
(h) Upon approval of the decommissioning plan by the Department, the licensee shall complete decommissioning in accordance with the approved plan. As a final step in decommissioning, the licensee shall again submit the information required in Subsection (c)(5) and shall certify the disposition of accumulated wastes from decommissioning by completing form RHB 314 (12/95).
(i) If the information submitted under subsection (c)(5) or (h) does not adequately demonstrate that the premises are suitable for release for unrestricted use, the Department shall inform the licensee of the appropriate further actions required for termination of license.
(j) Each specific license continues in effect, beyond the expiration date if necessary, with respect to possession of residual radioactive material present as contamination until the Department notifies the licensee in writing that the license is terminated. During this time, the licensee shall:
(1) Limit actions involving radioactive material to those related to decommissioning; and
(2) Continue to control entry to restricted areas until they are suitable for release for unrestricted use and the Department notifies the licensee in writing that the license is terminated.
(k) Specific licenses shall be terminated by written notice to the licensee when the Department determines that:
(1) Radioactive material has been properly disposed;
(2) Reasonable effort has been made to eliminate residual radioactive contamination, if present; and
(3) A radiation survey has been performed which demonstrates that the premises are suitable for release for unrestricted use; or other information submitted by the licensee is sufficient to demonstrate that the premises are suitable for release for unrestricted use.
Note: Authority cited: Sections 100275, 115000, Health and Safety Code. Reference: Sections 114965, 114970, 115060, 115230 and 115235, Health and Safety Code.
s 30257. Bankruptcy Notification.
(a) Each licensee shall notify the Department in writing immediately following the filing of a voluntary or involuntary petition for bankruptcy under any chapter or title 11 (Bankruptcy) of the United States Code (11 U.S.C.) by or against:
(1) Any licensee;
(2) An entity (as that term is defined in 11 U.S.C. 101 (14)) controlling the licensee or listing the license as property of the estate; or
(3) An affiliate (as that term is defined in 11 U.S.C. 101 (2)) of the license.
(b) This notification must indicate:
(1) The bankruptcy court in which the petition for bankruptcy was filed; and
(2) The date of the filing of the petition.
Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 28501, 28502, 25815, 25860, 25863, 25875 and 25876, Health and Safety Code.
s 30258. General Definitions.
Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.
s 30265. Occupational Dose Limits.
Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811, 25815, 25875 and 25876, Health and Safety Code.
s 30265.1. Determination of Prior Dose.
Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811, 25815, 25875 and 25876, Health and Safety Code.
s 30266. Exposure of Individuals to Concentrations of Radioactive Material in Controlled Areas.
Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811, 25815, 25875 and 25876, Health ad Safety Code.
s 30268. Permissible Levels of Radiation in Uncontrolled Areas.
Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.
s 30269. Concentrations in Effluents to Uncontrolled Areas.
Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811, 25815, 25875 and 25876, Health and Safety Code.
s 30275. Surveys and Tests.
(a) Each user shall make or cause to be made such surveys as are necessary for compliance with all provisions of this regulation.
(b) Upon instruction from the Department or other official agency specifically designated by the Department, each user shall perform or cause to have performed, and shall permit the Department or said agency to perform, such reasonable tests as the Department or said agency deems necessary for the protection of life, health, or property, including, but not limited to, tests of:
(1) Sources of radiation.
(2) Facilities wherein sources of radiation are used or stored.
(3) Radiation detection and monitoring instruments.
(4) Other equipment and devices used in connection with utilization or storage of sources of radiation.
(c) Each sealed source other than sources listed below, shall be tested for contamination prior to initial use and for leakage at least every six months:
(1) Hydrogen-3 or krypton-85 sources.
(2) Sealed sources containing licensed radioactive material in gaseous form.
(3) Source material.
(4) Sources containing radioactive material with a half life of 30 days or less.
(5) Sources of beta- and/or gamma-emitting radioactive material with an activity of 100 microcuries or less.
(6) Sources of alpha and/or neutron-emitting radioactive material with an activity of 10 microcuries or less.
In the absence of a certificate from a transferor indicating that a test has been made prior to the transfer, the sealed source shall not be put into use until tested. If there is reason to suspect that a source might have been damaged, it shall be tested for leakage before further use. Contamination and leak tests shall be capable of determining the presence of 0.005 microcuries of removable contamination. When any contamination or leak test reveals the presence of 0.005 microcuries or more of removable contamination the user shall immediately withdraw the source from use and shall cause it to be decontaminated and repaired or to be disposed of in accordance with applicable provisions of Group 2 of this subchapter. Two copies of a report shall be filed, within 5 days of the test, with the Department or other official agency specifically designated by the Department, describing the source involved, the test results, and the corrective action taken.
(d) The test sample shall be taken from the surface of the source, or source holder, or from the surface of the device in which the source is stored or mounted and on which one might expect contamination to accumulate. Where sealed sources are permanently mounted in devices or equipment, alternate tests for contamination and leakage may be approved by the Department.
(e) Tests for contamination and leakage, decontamination, and repair of sealed sources shall be performed only by persons specifically authorized by the Department to do so in accordance with provisions of Group 2 of this subchapter.
(f) Records of leak tests shall be maintained as specified in United States, title 10, Code of Federal Regulations, part 20, subpart L as incorporated by reference in section 30253..
Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.
s 30276. Personnel Monitoring.
Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.
s 30277. Bio-Assays and Medical Review.
Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.
s 30278. Caution Signs and Labels.
Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.
s 30278.1. Removal of Caution Labels from Empty Containers.
Each user shall, prior to disposal of an empty uncontaminated container to unrestricted areas, remove or deface the radioactive material label or otherwise clearly indicate that the container no longer contains radioactive materials.
Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811, 25815, 25875 and 25876, Health and Safety Code; and 10 CFR 20. 203 (f)(4) (43 FR 22171).
s 30279. Special Requirements for High Radiation Areas and Radiation Machines Capable of Producing High Radiation Areas.
Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.
s 30279.1. Additional Special Requirements for Very High Radiation Areas.
Note: (1) Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811, 25875 and 25876, Health and Safety Code.
s 30280. Notices, Instructions, and Reports to Personnel.
Note: Authority cited: Section 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811, 25815, 25826, 25875 and 25876, Health and Safety Code.
s 30281. Storage and Control of Radioactive Material.
Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811, 25875 and 25876, Health and Safety Code.
s 30282. Procedures for Opening Packages.
Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.
s 30285. General Requirement.
Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811, 25812 and 25815, Health and Safety Code.
s 30287. Disposal by Release into Sanitary Sewerage Systems.
Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.
s 30288. Disposal by Burial in Soil.
s 30289. Treatment or Disposal by Incineration.
Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.
s 30293. Records.
(a) Each user shall keep records showing the receipt, transfer, and disposal of each source of radiation which is subject to licensure or registration pursuant to groups 1.5 and 2 of this subchapter as follows:
(1) The user shall retain each record of receipt of a source of radiation as long as the source of radiation is possessed and for three years following transfer or disposal of the source of radiation.
(2) The user who transferred the source of radiation shall retain each record of transfer for three years after each transfer unless a specific requirement in another part of the regulations in this subchapter dictates otherwise.
(3) The user who disposed of the radioactive material shall retain each record of disposal of the radioactive material until the Department terminates each license that authorizes disposal of the radioactive material.
(b) The user shall retain each record that is required by the regulations in this subchapter or by license condition for the period specified by the appropriate regulation or license condition. If a retention period is not otherwise specified by regulation or license condition, the record shall be retained until the Department terminates each license that authorizes the activity that is subject to the recordkeeping requirement.
(c) Records which shall be maintained pursuant to this subchapter may be the original or a reproduced copy or microform if such reproduced copy or microform is duly authenticated by authorized personnel and the microform is capable of producing a clear and legible copy after storage for the period specified by department regulations. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records such as letters, drawings, specifications, shall include all pertinent information such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records.
(d) If there is a conflict between the Department's regulations in this subchapter, license condition, or other written Department approval or authorization pertaining to the retention period for the same type of record, the retention period specified in the regulations in this subchapter for such records shall apply unless the Department, pursuant to 30104, has granted a specific exemption from the record retention requirements specified in the regulations in this subchapter.
(e) Prior to license termination, each licensee authorized to possess radioactive material with a half-life greater than 120 days, in an unsealed form, shall, if requested by the Department, forward the following records to the Department:
(1) Records of disposal of licensed material made under Title 10, Code of Federal Regulations, sections 20.2002, 20.2003, 20.2004, 20.2005, incorporated by reference in section 30253; and
(2) Records required by Title 10, Code of Federal Regulations section 20.2103(b)(4), incorporated by reference in section 30253.
(f) If licensed activities are transferred or assigned in accordance with section 30194(c), each licensee authorized to possess radioactive material, with a half-life greater than 120 days, in an unsealed form, shall transfer the following records to the new licensee and the new licensee will be responsible for maintaining these records until the license is terminated:
(1) Records of disposal of licensed material made under Title 10, Code of Federal Regulations, sections 20.2002, 20.2003, 20.2004, 20.2005, incorporated by reference in section 30253; and
(2) Records required by Title 10, Code of Federal Regulations, section 20.2103(b)(4), incorporated by reference in section 30243.
(g) Prior to license termination, each licensee shall, if requested by the Department, forward the records required by section 30256(a) to the Department.
Note: Authority cited: Sections 100275 and 115000, Health and Safety Code. Reference: Sections 114965, 114970, 115105, 115110, and 115235, Health and Safety Code.
s 30294. Reports of Theft or Loss of Sources of Radiation.
Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.
s 30295. Notification of Incidents.
(a) Each user shall notify the Department as soon as possible but not later than four hours after the discovery of an event that prevents immediate protective actions necessary to avoid exposures to radiation or radioactive materials that could exceed regulatory limits.
(b) Each user shall notify the Department within 24 hours after the discovery of any of the following events involving radiation or radioactive materials:
(1) An unplanned contamination event involving licensed radioactive material that:
(A) Requires access to the contaminated area by workers or the public, to be restricted for more than 24 hours by imposing additional radiological controls or by prohibiting entry into the area;
(B) Involves a quantity of material greater than five times the lowest annual limit on intake specified in Appendix B of Title 10, Code of Federal Regulations, part 20, incorporated by reference in section 30253 of this regulation for the material; and
(C) Has access to the area restricted for a reason other than to allow isotopes with a half-life of less than 24 hours to decay prior to decontamination.
(2) An event in which equipment is disabled or fails to function as designed when:
(A) The equipment is required by regulation or license condition to prevent releases exceeding regulatory limits, to prevent exposures to radiation and radioactive materials exceeding regulatory limits, or to mitigate the consequences of an accident;
(B) The equipment is required to be available and operable when it is disabled or fails to function; and
(C) No redundant equipment is available and operable to perform the required safety function.
(3) An event that requires unplanned medical treatment at a medical facility of an individual with spreadable radioactive contamination on the individual's clothing or body.
(4) An unplanned fire or explosion damaging any licensed material or any device, container, or equipment containing licensed material when:
(A) The quantity of material involved is greater than five times the lowest annual limit on intake specified in Appendix B of Title 10, Code of Federal Regulations, part 20, incorporated by reference in section 30253 of this regulation for the material; and
(B) The damage affects the integrity of the licensed material or its container.
(C) Reports made by users in response to the requirements of this section shall be made as follows:
(1) Users shall make reports required by subsections (a) and (b) of this section by telephone to the Department. To the extent that the information is available at the time of notification, the information provided in these reports shall include:
(A) The caller's name and call back telephone number;
(B) A description of the event, including date and time;
(C) The exact location of the event;
(D) The isotopes, quantities, and chemical and physical form of the licensed material involved; and
(E) Any personnel radiation exposure data available.
(2) Written report. Each user who makes a report required by subsection (a) or (b) of this section shall submit a written follow-up report within 30 days of the initial report. These written reports shall be sent to the Department. The reports shall include the following:
(A) A description of the event, including the probable cause and the manufacturer and model number (if applicable) of any equipment that failed or malfunctioned;
(B) The exact location of the event;
(C) The isotopes, quantities, and chemical and physical form of the licensed material involved;
(D) Date and time of the event;
(E) Corrective actions taken or planned and the results of any evaluation or assessment; and
(F) The extent of exposure of individuals to radiation or to radioactive materials without identification of individuals by name.
Note: Authority cited: Sections 100275 and 115000, Health and Safety Code. Reference: Sections 114965, 114970, 115105, 115110, and 115235, Health and Safety Code.
s 30297. Reports of Overexposures and Excessive Levels and Concentrations.
Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.
s 30298. Vacating Installations.
Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.
s 30299. Bankruptcy Notification.
Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 28501, 28502, 25815, 25860, 25863, 25875 and 25876, Health and Safety Code.
s 30305. General Provisions.
(a)(1) This article pertains to use of X-rays in medicine, dentistry, osteopathy, chiropractic, podiatry, and veterinary medicine. The provisions of this article are in addition to, and not in substitution for, other applicable provisions of this regulation and of Group 1 of this subchapter.
(2) Any existing machine or installation need not be replaced or substantially modified to conform to the requirements of this regulation provided that the user demonstrates to the Department's satisfaction achievement of equivalent protection through other means.
(3) No person shall make, sell, lease, transfer, lend, or install X-ray or fluoroscopic equipment or the supplies used in connection with such equipment unless such supplies and equipment, when properly placed in operation or properly used, will meet the requirements of this regulation. This includes responsibility for the delivery of cones or collimators, filters, adequate timers and fluoroscopic shutters (where applicable).
(4) For X-ray equipment manufactured after July 31, 1974, the user shall provide sufficient maintenance to keep the equipment in compliance with all applicable radiation protection sections of the Code of Federal Regulations, Title 21, Chapter 1, Subchapter J, Part 1020, Sections 1020.30, 1020.31, and 1020.32.
(5) Each installation shall be provided with such primary barriers and/or secondary barriers as are necessary to ensure compliance with Sections 30265 and 30268. Special requirements are contained in Title 24, California Code of Regulations, Sections 2-9102 through 2-9105.
(b) Use.
(1) The user shall assure that all X-ray equipment under his jurisdiction is operated only by persons adequately instructed in safe operating procedures and competent in safe use of the equipment.
(2) The user shall provide safety rules to each individual operating X-ray equipment under his control, including any restrictions of the operating technique required for the safe operation of the particular X-ray apparatus, and require that the operator demonstrate familiarity with these rules.
(3) No user shall operate or permit the operation of X-ray equipment unless the equipment and installation meet the applicable requirements of these regulations and are appropriate for the procedures to be performed.
(4) Deliberate exposure of an individual to the useful beam for training or demonstration purposes shall not be permitted unless there is also a medical or dental indication for the exposure and the exposure is prescribed by a physician or dentist.
(c) Areas or rooms that contain permanently installed X-ray machines as the only source of radiation shall be posted with a sign or signs
CAUTION X-RAY
in lieu of other signs required by the United States, title 10, Code of Federal Regulations, part 20, section 20.1902 as incorporated by reference in section 30253.
(d) High radiation areas caused by radiographic and fluoroscopic machines used solely in the healing arts and which are in compliance with the access control and signal requirements of title 24, California Code of Regulations, sections 9102 through 9105 shall be exempt from the access control and signal requirements of the United States, title 10, Code of Federal Regulations, part 20, section 20.1601 as incorporated by reference in section 30253.
Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811 and 25815, Health and Safety Code.
s 30306. Definitions.
(a) "Automatic exposure control" means a device which automatically controls one or more technique factors in order to obtain at a preselected location(s) a required quantity of radiation.
(b) "Cineradiography" means the making of a motion picture record of the successive images appearing on a fluorescent screen.
(c) "Contact therapy" means irradiation of accessible lesions usually employing a very short source-skin distance and potentials of 40-50 KV.
(d) "Dead-man switch" means a switch so constructed that a circuit-closing contact can only be maintained by continuous pressure by the operator.
(e) "Diagnostic-type tube housing" means an X-ray tube housing so constructed that the leakage radiation measured at a distance of 1 meter from the source cannot exceed 100 milliroentgens in 1 hour when the tube is operated at its maximum continuous rate of current for the maximum rated tube potential.
(f) "Filter" means material placed in the useful beam to absorb preferentially the less penetrating radiations.
(g) "Interlock" means a device for precluding access to an area of radiation hazard either by preventing entry or by automatically removing the hazard.
(h) "Leakage radiation" means all radiation coming from within the tube housing except the useful beam.
(i) "Protective barrier" means a barrier of attenuating materials used to reduce radiation exposure.
(j) "Primary protective barrier" means a barrier sufficient to attenuate the useful beam to the required degree.
(k) "Scattered radiation" means radiation that, during passage through matter, has been deviated in direction.
( l "Secondary protective barrier" means a barrier sufficient to attenuate stray radiation to the required degree.
(m) "Shutter" means a device, generally of lead, fixed to an X-ray tube housing to intercept the useful beam.
(n) "Stray radiation" means radiation not serving any useful purpose. It includes leakage and scattered radiation.
(o) "Therapeutic-type tube housing" means,
(1) For X-ray therapy equipment not capable of operating at 500 kVp or above, an X-ray tube housing so constructed that the leakage radiation at a distance of 1 meter from the source does not exceed 1 roentgen in an hour when the tube is operated at its maximum rated continuous current for the maximum rated tube potential.
(2) For X-ray therapy equipment capable of operating at 500 kVp or above, an X-ray tube housing so constructed that the leakage radiation at a distance of 1 meter from the source does not exceed either 1 roentgen in an hour or 0.1 percent of the useful beam dose rate at 1 meter from the source, whichever is greater, when the machine is operated at its maximum rated continuous current for the maximum rated accelerating potential.
(3) In either case, small areas of reduced protection are acceptable provided the average reading over any 100 square centimeters area at 1 meter distance from the source does not exceed the values given above.
(p) "Useful beam" means that part of the radiation which passes through the window, aperture, cone, or other collimating device of the tube housing. (T17- 30306-T24).
Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811 and 25815, Health and Safety Code.
s 30307. Fluoroscopic Installations
(a) Equipment.
(1) The tube housing shall be of diagnostic type.
(2) The target-to-panel or target-to-table top distance should not be less than 18 inches and shall not be less than 12 inches.
(3) The total filtration permanently in the useful beam shall not be less than 2.5 millimeters aluminum equivalent. This requirement may be assumed to have been met if the half-value layer is not less than 2.5 millimeters aluminum at normal operating voltages.
(4) The equipment shall be so constructed that the entire cross-section of the useful beam is attenuated by a primary barrier. This barrier is usual ly the viewing device, either a conventional fluoroscopic screen or an image intensification mechanism.
(A) The lead equivalent of the barrier of conventional fluoroscopes shall be at least 1.5 millimeters for equipment capable of operating up to 100 kVp, at least 1.8 millimeters for equipment whose maximum operating potential is greater than 100 kVp and less than 125 kVp, and at least 2.0 millimeters for equipment whose maximum operating potential is 125 kVp or greater. Special attention must be paid to the shielding of image intensifiers so that neither the useful beam nor scattered radiation from the intensifier can produce a radiation hazard to the operator or personnel. With the fluorescent screen 14 inches (35 cm) from the panel or table top, the exposure rate 2 inches 5 cm) beyond the viewing surface of the screen shall not exceed 30 mR/hr for each R per minute at the table top with the screen in the useful beam without a patient and with the fluoroscope operating at the highest potential employed.
(B) Collimators shall be provided to restrict the size of the useful beam to less than the area of the barrier. For conventional fluoroscopes this requirement is met if, when the adjustable diaphragm is opened to its fullest extent, an unilluminated margin is left at all edges of the fluorescent screen with the screen centered in the beam at a distance of 35 cm (14 inches) from the panel or table top.
For image intensified fluoroscopy, shutters shall be provided which can be adjusted to restrict the X-ray field to the visible portion of the image receptor during fluoroscopy. For systems employing rectangular X-ray fields and circular image receptors, this requirement is met if the collimated beam forms a square which circumscribes, and is tangent to, the circular margin of the image receptor.
(C) The tube mounting and the carrier shall be so linked together that the carrier always intercepts the entire useful beam. The X-ray exposure shall automatically terminate when the carrier is removed from the useful beam.
(D) Collimators and adjustable diaphragms or shutters to restrict the size of the useful beam shall provide the same degree of protection as is required of the tube housing.
(5) The exposure switch shall be of the dead-man type.
(6) Each fluoroscopic unit shall be equipped with a manual-reset cumulative timing device, activated by the exposure switch, which will either indicate elapsed exposure time by a signal audible to the fluorocopist or turn off the apparatus when the total exposure exceeds a predetermined limit not exceeding five minutes in one or a series of exposures.
(7) Useful beam exposure rate.
(A) All fluoroscopic equipment. For routine fluoroscopy, the exposure rate measured at the point where the center of the useful beam enters a typical patient shall be as low as is practicable and shall not exceed 5 roentgens per minute under the conditions specified herein. This limit shall not apply during magnification procedures or the recording of fluoroscopic images where higher exposure rates are required. Compliance with this paragraph shall be determined using the measuring specifications of Section 30307(a)(7)(D), plus the following procedures when the automatic exposure rate control is used:
1. The useful beam exposure rate shall be measured with a phantom equivalent to 9 inches of water or 7 7/8 inches of lucite, intercepting the entire useful beam.
2. If the X-ray source is below the table, the X-ray exposure rate shall be measured with the nearest part of the imaging assembly located at 14 inches above the table top.
3. The field size at the point of exposure rate measurement shall be at least 6 1/4 square inches in area in the plane perpendicular to the central ray.
(B) Fluoroscopic equipment manufactured after August 1, 1974, and equipped with automatic exposure rate controls. Fluoroscopic equipment which is provided with automatic exposure rate control shall not be operable at any combination of tube potential and current which will result in an exposure rate in excess of 10 roentgens per minute at the point where the center of the useful beam enters the patient, except during recording of fluoroscopicimages, or when an optional high level control is provided. When so provided, the equipment shall not be operable at any combination of tube potential and current which will result in an exposure rate in excess of 5 roentgens per minute at the point where the center of the useful beam enters the patient unless the high level control is activated. Special means of activation of high level controls shall be required. The high level control shall only be operable when continuous manual activation is provided by the operator. A continuous signal audible to the fluoroscopist shall indicate that the high level control is being employed.
(C) Fluoroscopic equipment manufactured after August 1, 1974, without automatic exposure rate controls. Fluoroscopic equipment which is not provided with automatic exposure rate control shall not be operable at any combination of tube potential and current which will result in an exposure rate in excess of 5 roentgens per minute at the point where the center of the useful beam enters the patient, except during recording of fluoroscopic images, or when an optional high level control is activated. Special means of activation of high level controls shall be required. The high level control shall only be operable when continuous manual activation is provided by the operator. A continuous signal audible to the fluoroscopist shall indicate that the high level control is being employed.
(D) Measuring useful beam exposure rate compliance.
1. If the X-ray tube is below the table, the exposure rate shall be measured 1 centimeter above the tabletop or cradle.
2. If the X-ray tube is above the table, the exposure rate shall be measured at 30 centimeters above the tabletop with the end of the beam-limiting device or spacer positioned as closely as possible to the point of measurement.
3. In a C-arm type of fluoroscope, the exposure rate shall be measured at 30 centimeters from the input surface of the fluoroscopic imaging assembly.
(8) Mobile fluoroscopic equipment shall meet the requirements of this section where applicable, except that:
(A) Inherent provisions shall be made so that the machine is not operated at a source-skin distance of less than 30 cm (12 inches).
(B) Image intensification shall always be provided. Conventional fluoroscopic screens shall not be used.
(C) It shall be impossible to operate a machine when the collimating cone or diaphragm is not in place.
(D) It shall be impossible to energize the useful beam of a mobile fluoroscope unless the entire useful beam is intercepted by the image receptor.
(9) Devices which indicate the X-ray tube potential and current shall be provided, and should be located in such a manner that the operator may monitor the tube potential and current during fluoroscopy.
(10) A shielding device of at least 0.25 millimeters lead equivalent shall be provided for covering the bucky-slot during fluoroscopy.
(11) Whenever practicable, protective drapes, or hinged or sliding panels, of at least 0.25 millimeters lead equivalent shall be provided between the patient and the fluoroscopist to intercept scattered radiation which would otherwise reach the fluoroscopist and others near the machine. Such devices shall not substitute for wearing of a protective apron.
(b) Operating Procedures.
(1) Protective aprons of at least 0.25 mm lead equivalent shall be worn in the fluoroscopy room by each person, except the patient, whose body is likely to be exposed to 5 mR/hr or more.
(2) On fluoroscopes with automatic exposure controls the operator shall monitor the tube current and potential at least once each week to ascertain that they are in their usual ranges for a given set of operating parameters. This requirement may be met by adjusting the controls to usual settings for fluoroscoping an average patient, and using a phantom of any suitable material with attenuation roughly equivalent to six to ten inches of water. Whenever the monitored tube current or potential vary in a way which could increase the patient X-ray exposure rate by more than 25% over the latest exposure rate measurement required by Section 30307(b)(3), the cause(s) for the change shall be determined promptly and the patient exposure rate shall be remeasured. On fluoroscopes with manual exposure control only, the operator shall monitor the tube current and potential at least once each day during use to ascertain that they are within the normal ranges used by the facility. A written log shall be kept of all monitored readings and shall include at least the tube current and potential, the date, identification of the fluoroscope, and name of the person who did the monitoring. Records of all monitored readings shall be preserved at the facility for at least three years.
(3) Measurements of the table top or patient exposure rate shall be made at least once each year for units with automatic exposure control, and at least once each 3 years for units without automatic exposure control, and immediately following alteration or replacement of a major component, such as the X-ray tube, the exposure controls, the imaging assembly, and the power source.
(4) On cineradiography equipment, the exposure rates to which patients are normally subjected shall be determined at least once each year, and immediately following alterations or replacement of a major component, such as the X-ray tube, the exposure controls, the imaging assembly, and the power source.
Note: Authority cited: Sections 102, 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811 and 25815, Health and Safety Code.
s 30308. Radiographic Installations (Other Than Dental and Veterinary Medicine).
(a) Equipment.
(1) The tube housing shall be of diagnostic type.
(2) Suitable devices (diaphragms, cones, adjustable collimators), capable of restricting the useful beam to the area of clinical interest shall be provided to define the beam and shall provide the same degree of attenuation as that required of the tube housing. Such devices shall be calibrated in terms of the size of the projected useful beam at specified source-film distances. For chest photofluorographic equipment, the collimator shall restrict the beam to dimensions no greater than those of the fluorographic screen. The field size indication on adjustable collimators shall be accurate to within 2 percent of the source-film distance. The light field shall be aligned with the X-ray field with the same degree of accuracy.
(3) For equipment manufactured prior to August 1, 1974, the aluminum equivalent of the total filtration in the useful beam shall be not less than that shown in Table 1:
Table 1
Minimum Total Filter
Operating kVp (Inherent plus added)
Below 50 kVp.... 0.5 mm aluminum
50-70 kVp....... 1.5 mm aluminum
Above 70 kVp.... 2.5 mm aluminum
For equipment manufactured on or after August 1, 1974, the half-value layer (HVL) of the useful beam for a given X-ray tube potential shall not be less than the appropriate value specified in Table 2.
Table 2
X-ray tube voltage (kilovolt peak)
_____________________________________
Designed Measured Minimum HVL
Operating Range Minimum HVL (mm of Al)
Below 50 30 0.3
40 0.4
49 0.5
50 to 70 50 1.2
60 1.3
70 1.5
Above 70 70 2.1
80 2.3
90 2.5
100 2.7
110 3.0
120 3.2
130 3.5
140 3.8
150 4.1
(4) A device shall be provided to terminate the exposure after a pre-set time or exposure.
(5) A dead-man type of exposure switch shall be provided and so arranged that it cannot be conveniently operated outside a shielded area, except that exposure switches for "spot film" devices used in conjunction with fluoroscopic tables are excepted from this shielding requirement.
(6) The control panel shall include a device (usually a milliammeter) to give positive indication of the production of X-rays whenever the X-ray tube is energized.
(7) The control panel shall include devices (labeled control settings and/or meters) indicating the physical factors (such as kVp, mA, exposure time, or whether timing is automatic) used for the exposure.
(8) Machines equipped with beryllium window X-ray tubes shall contain keyed filter interlock switches in the tube housing and suitable indication on the control panel of the added filter in the useful beam if the total filtration permanently in the useful beam is less than 0.5 mm aluminum equivalent. The total filtration permanently in the useful beam shall be clearly indicated on the tube housing.
(9) The aluminum equivalent of the table top when a cassette tray is used under the table top, or the aluminum equivalent of the front panel of the vertical cassette holder, shall not be more than 1 mm at 100 kVp.
(b) Operating Procedures.
(1) No individual occupationally exposed to radiation shall be permitted to hold patients during exposures except during emergencies, nor shall any individual be regularly used for this service. If the patient must be held by an individual, that individual shall be protected with appropriate shielding devices such as protective gloves and apron and he shall be so positioned that no part of his body will be struck by the useful beam.
(2) Only individuals required for the radiographic procedure shall be in the radiographic room during exposure; and, except for the patient, all such persons shall be equipped with appropriate protective devices.
(3) The radiographic field shall be restricted to the area of clinical interest.
(4) Gonadal shielding of not less than 0.5 mm lead equivalent shall be used for patients who have not passed the reproductive age during radiographic procedures in which the gonads are in the direct beam, except for cases in which this would interfere with the diagnostic procedure.
(5) The operator shall stand behind the barrier provided for his protection during radiographic exposures.
Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811 and 25815, Health and Safety Code.
s 30309. Special Requirements for Mobile Radiographic Equipment.
(a) Equipment.
(1) All requirements of Section 30308(a) apply except 30308 (a)(5) and 30308 (a)(9).
(2) The exposure control switch shall be of the dead-man type and shall be so arranged that the operator can stand at least 6 feet from the patient and well away from the useful beam.
(3) Inherent provisions shall be made so that the equipment is not operated at source-skin distances of less than 12 inches.
(b) Operating Procedures.
(1) All provisions of Section 30308(b) apply except 30308(b)(5).
(2) The target-to-skin distance shall be not less than 12 inches.
(3) Personnel monitoring shall be required for all individuals operating mobile X-ray equipment.
Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811 and 25815, Health and Safety Code.
s 30310. Special Requirements for Chest Photofluorographic Installations.
(a) Equipment.
(1) All provisions of Section 30308 (a) apply.
(2) A collimator shall restrict the useful beam to the area of the photofluorographic screen.
(3) The incident X-ray exposure where the central ray enters the patient shall not exceed 200 milliroentgens per radiograph for the average patient, and should not exceed 100 milliroentgens per radiograph.
(b) Operating Procedures.
(1) All provisions of Section 30308(b) apply.
Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811 and 25815, Health and Safety Code.
s 30311. Dental Radiographic Installations.
(a) Equipment.
(1) The tube housing shall be of diagnostic type.
(2) Diaphragms or cones shall be used for collimating the useful beam and shall provide the same degree of protection as the housing.
(A) For intra-oral radiography the useful beam shall be restricted to a diameter of not more than 7 cm (2.75 inches) at the surface of the skin.
(3) For intra-oral film exposures a cone or spacer frame shall provide a target-to-skin distance of not less than 18 cm (7 inches) with apparatus operating above 50 kVp or 10 cm (4 inches) with apparatus operating at 50 kVp or below.
(4) The total filtration permanently in the useful beam shall be equivalent to at least 0.5 millimeters of aluminum for equipment operating below 50 kVp, equivalent to at least 1.5 millimeters of aluminum for equipment operating from 50 kVp through 70 kVp, and equivalent to at least 2.5 millimeters of aluminum for equipment operating above 70 kVp.
(5) A device shall be provided to terminate the exposure after a pre-set time or exposure.
(6) The exposure control switch shall be of the dead-man type. If a recycling timer is employed it shall not be possible to make a repeat exposure without release of the exposure switch to reset the timer.
(7) Each installation shall be provided with a protective barrier for the operator or shall be so arranged that the operator can stand at least 6 feet from the patient and well away from the useful beam.
(8) Mechanical support of the tube head and cone shall maintainthe exposure position without drift or vibration.
(9) Panoramic installations. This part applies to those installations which consist of a tube head with a collimator providing a narrow useful beam and an extra oral film carrier which are interlocked in their motion about the patient.
(A) All provisions of Section 30311 (a) apply except 30311 (a)(2)(A), 30311 (a)(3), 30311 (a)(10).
(10) Cephalometric installations.
(A) All provisions of Section 30311 (a) apply except 30311 (a)(2)(A), 30311 (a)(3), and 30311 (a)(9).
(B) The radiographic field shall be restricted to the area of the image receptor.
(11) The X-ray control panel shall include means for indicating X-ray tube voltage (kVp), tube current (mA), and exposure duration. The tube voltage and current shall be indicated by meters or by control settings. A milliammeter, a light or other device shall give clear and distinct visual or audible indication to the operator when X-rays are being produced.
(b) Operating Procedures.
(1) No individual occupationally exposed to radiation shall be permitted to hold patients or films during exposure, nor shall any individual be regularly used for this service.
(2) During each exposure, the operator shall stand at least 6 feet from the patient or behind a protective barrier.
(3) Only the patient shall be in the useful beam.
(4) Neither the tube housing nor the position indicating device (cone, cylinder) shall be hand-held during exposure.
(5) Fluoroscopy shall not be used in dental examinations.
(6) Each patient undergoing dental radiography shall be draped with a protective apron of not less than 0.25 millimeter lead-equivalent to cover the gonadal area.
(7) For intra-oral and cephalometric radiography the X-ray beam and the film shall be aligned very carefully with the area to be radiographed.
(8) Only persons required for the radiographic procedure shall be in the radiographic room during exposures.
Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811 and 25815, Health and Safety Code.
s 30312. Therapeutic X-Ray Installations.
(a) Equipment.
(1) The tube housing shall be of therapeutic type.
(2) For equipment installed on or before August 1, 1979, permanent diaphragms or cones used for collimating the useful beam shall afford the same degree of protection as the housing. Adjustable or removable beam-defining diaphragms or cones shall transmit not more than 5 percent of the useful beam obtained at the maximum kilovoltage and with maximum treatment filter.
(3) For equipment installed after August 1, 1979, permanent beam-defining devices or diaphragms shall afford the same degree of protection as the housing. Adjustable or interchangeable beam-defining devices shall transmit no more than 2 percent of the useful beam for the portion of the useful beam which is to be attenuated by the beam limiting device. Measurements shall be averaged over an area up to but not exceeding 100 square centimeters at the normal treatment distance.
(4) Filters shall be secured in place to prevent them from dropping out during treatment. A filter indication system shall be used on all therapy machines using interchangeable filters. It shall indicate, from the control panel, or from the control station, the presence or absence of any filter except compensating filters, and it shall be designed to permit easy identification of the filter in place. The filter slot shall be so constructed that the radiation escaping through it does not exceed 1 roentgen per hour at 1 meter, or, if the patient is likely to be exposed to radiation escaping from the slot, 30 roentgens per hour at 5 centimeters from the external opening. Each interchangeable filter shall be marked with its thickness and material. (continued)