[34 Pa.B. 3823]
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DIAGNOSTIC INSTALLATIONS GENERAL REQUIREMENTS § 221.25. Beam quality.
(a) Diagnostic X-ray systems shall have filtration that satisfies the requirements of Table I. The requirements of this section shall be considered to have been met if it can be demonstrated that the half value layer of the primary beam is not less than that shown in Table II.
TABLE I
Filtration Required vs. Operating Voltage
Operating Voltage (kVp) Total Filtration
(inherent plus added)
(millimeters aluminum equivalent)Below 50 .5 millimeters 50--70 1.5 millimeters Above 70 2.5 millimeters
TABLE II
Design operating range (Kilovolts peak) Measured potential
(Kilovolts peak)Minimum half-value layer
(millimeters of aluminum)Specified dental systems* All other X-ray systems Below 51 30 1.5 0.3 40 1.5 0.4 50 1.5 0.5 51 to 70 51 1.5 1.2 60 1.5 1.3 70 1.5 1.5 Above 70 71 2.1 2.1 80 2.3 2.3 90 2.5 2.5 100 2.7 2.7 110 3.0 3.0 120 3.2 3.2 130 3.5 3.5 140 3.8 3.8 150 4.1 4.1 Note: Half-value layers for kilovoltages not listed in Table II may be determined by interpolation or extrapolation.
* Dental systems manufactured after December 1, 1980, designed for use with intraoral image receptors.
(b) Beryllium window tubes shall have a minimum of 0.5 millimeter aluminum equivalent filtration permanently installed in the useful beam.
(c) For capacitor energy storage equipment, compliance with this section shall be determined with the maximum quantity of charge per exposure.
(d) The required minimal aluminum equivalent filtration shall include the filtration contributed by materials which are always present between the source and the patient.
(e) For X-ray systems having variable filtration in the useful beam, a means shall be provided to prohibit exposure unless the filtration requirements of subsection (a) are met for the kVp selected.
§ 221.29. Kilovoltage (kV) accuracy.
(a) For variable kV units, the kV output may not vary from the set-indicated value by more than 10% over the range of technique factors normally used. Discrepancies of more than 10% between set-indicated and measured kV values shall be investigated by a qualified expert or service agent and appropriate action taken.
(b) For fixed kV units, the kV output may not vary from the set-indicated value by more than 20% over the range of technique factors normally used. Discrepancies of more than 20% between set-indicated and measured kV values shall be investigated by a qualified expert or service agent and appropriate action taken.
§ 221.36a. Limitation of useful beam of fluoroscopic equipment.
(a) The fluoroscopic imaging assembly shall be provided with a primary protective barrier which intercepts the entire cross section of the useful beam at any source-to-image receptor distance.
(b) The X-ray tube used for fluoroscopy may not produce X-rays unless a barrier is in position to intercept the useful beam and the imaging device is in place and operable.
(c) A means shall be provided for stepless (continuous) adjustment of the field size.
(d) The minimum field size at the greatest source to image receptor distance shall be containable in a square of 5 centimeters by 5 centimeters unless otherwise provided in 21 CFR 1020.32(b) (relating to fluoroscopic equipment).
(e) Equipment may not be operated at a source to skin distance less than 30 centimeters or as required under 21 CFR 1020.32(g).
(f) The width of the X-ray field in the plane of the image receptor may not exceed that of the visible area of the image receptor by more than 3% of the source to image receptor distance. The sum of the excess length and the excess width may not be greater than 4% of the source to image receptor distance.
(g) For rectangular X-ray fields used with a circular image receptor, the error in alignment shall be determined along the length and width dimensions of the X-ray field which passes through the center of the visible area of the image receptor.
(h) Compliance with subsections (a)--(g) shall be determined with the beam axis perpendicular to the plane of the image receptor.
(i) Spot-film devices shall meet the following additional requirements:
(1) A means shall be provided between the source and the patient for adjustment of the X-ray field size to the size of the portion of film which has been selected on the spot-film selector.
(2) The adjustments shall be automatically accomplished except when the X-ray field size in the plane of the film is smaller than that of the film.
(3) The total misalignment of the edges of the X-ray field with the respective edges of the selected portion of the image receptor along the length or width dimensions of the X-ray field in the plane of the image receptor may not exceed 3% of the source-to image receptor when adjusted for full coverage of the selected portion of the image receptor.
(4) The sum, without regard to sign, of the misalignment along any two orthogonal dimensions, may not exceed 4% of the source to image receptor distance.
(5) The center of the X-ray field in the plane of the film shall be aligned with the center of the film within 2% of the source to image receptor distance.
§ 221.38a. Entrance exposure rate.
(a) Fluoroscopic systems without high level control. The exposure rate may not exceed 10 roentgens (2.58 mC/kg) per minute except during recording of fluoroscopic images.
(b) Fluoroscopic systems with high level control.
(1) When the high level control is activated, the maximum exposure rate shall be 20 roentgens (5.16 mC/kg) per minute.
(2) When the high level control is not activated, the maximum exposure rate shall be 10 roentgens (2.58 mC/kg) per minute.
(3) Special means of activation of high level controls are required. The high level control shall only be operable when continuous manual activation is provided by the operator.
(4) There shall be an indication to the fluoroscopist that the high level control is being used.
(c) Frequency of output measurements. Output measurements to show compliance with this section shall be made at least annually and after maintenance that could affect the output of the machine.
(d) Compliance requirements. Compliance with subsections (a)--(c) shall be determined as follows:
(1) If the source is below the table, the exposure rate shall be expressed for the center of the useful beam 1 centimeter above the tabletop or cradle with the image intensifier 30 centimeters above the tabletop or cradle.
(2) If the source 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 with the source at its closest possible position of operation.
(4) The tube potential and current shall be set to give the maximum exposure possible from the X-ray system. For systems with automatic exposure control, at least 3 millimeters of lead shall be placed between the measuring device and image receptor.
(5) The measurement shall be made at the center of the useful beam.
OTHER SYSTEMS § 221.61. Radiation therapy simulation systems.
(a) Fluoroscopic systems used solely for radiation therapy simulations shall comply with §§ 221.35a, 221.37a, 221.40a and 221.41a. The requirements in § 221.41a (relating to fluoroscopic timer) may also be satisfied if a means is provided to indicate the cumulative time that an individual patient has been exposed to X-rays. In this case, procedures shall require that the timer be reset between examinations.
(b) CT units used solely for therapy simulations shall comply with §§ 221.202(f)(1), (7) and (8) and 221.203 (relating to equipment requirements; and facility design requirements).
THERAPEUTIC X-RAY SYSTEMS WITH ENERGIES LESS THAN 1 MEV § 221.73. Surveys.
(a) A facility shall have a survey made by, or under the direction of, a qualified expert. The survey shall also be done after a change in the facility or equipment which might cause a change in radiation levels.
(b) The qualified expert or radiological physicist shall report the survey results in writing to the individual in charge of the facility and a copy of the report shall be maintained by the registrant for inspection by the Department. The facility shall be operated in compliance with limitations indicated by the survey.
§ 221.74. Calibration.
(a) The calibration of an X-ray system shall be performed at intervals not to exceed 1 year and after a change of replacement of components which could cause a change in the radiation output.
(b) The calibration of the radiation output of the X-ray system shall be performed by or under the direction of a qualified expert for radiation therapy calibration who is physically present at the facility during the calibration.
(c) The calibration of the radiation output of an X-ray system shall be performed with a calibrated instrument. The calibration of the instrument shall be traceable to a National standard. The instrument shall have been calibrated within the preceding 2 years.
(d) Calibrations made under this section shall be made so that the dose at a reference point in soft tissue may be calculated as accurately as possible but with an uncertainty of no greater than 5%.
(e) The calibration of the X-ray system shall include, but is not limited to, the following determinations:
(1) The exposure rates for each combination of field size, technique factors, filter and treatment distance used.
(2) The degree of congruence between the radiation field and the field indicated by the localizing device if a device is present.
(3) An evaluation of the uniformity of the largest radiation field used.
(f) Records of calibration performed under this section shall be maintained by the registrant for at least 5 years after completion of the calibration.
(g) A copy of the most recent X-ray system calibration shall be available at the control panel.
§ 221.75. Spot checks.
Spot checks shall be performed on X-ray systems capable of operation at greater than 150 kVp. The spot checks shall meet the following requirements:
(1) The procedures shall be in writing and shall have been developed by a qualified expert for radiation therapy calibration.
(2) If a radiological physicist does not perform the spot check measurements, the results of the spot check measurements shall be reviewed by a radiological physicist within 15 days.
(3) The measurements taken during the spot checks shall demonstrate the degree of consistency of the operating characteristics which can affect the radiation output of the X-ray system.
(4) The spot-check procedure shall specify the frequency at which tests or measurements are to be performed and the acceptable tolerance for each parameter measured in the spot check when compared to the value for that parameter determined in the calibration specified in § 221.74 (relating to calibration).
(5) The procedure shall also note conditions which require that the system be recalibrated under § 221.74.
(6) Records of spot-check measurements performed under this section shall be maintained by the registrant for 5 years following the measurement.
(7) Spot check measurements shall be performed using a dosimetry system that has been calibrated under § 221.74(c). Alternatively, a dosimetry system used solely for spot check measurements may be calibrated by direct intercomparison with a system that has been calibrated under § 221.74(c). The alternative calibration method shall have been performed within the previous year and after each servicing that may have affected the system calibration.
COMPUTED TOMOGRAPHY X-RAY SYSTEMS § 221.202. Equipment requirements.
(a) Termination of exposure. The operator shall be able to terminate the X-ray exposure at any time during a scan, or series of scans under X-ray system control, of greater than 0.5 second duration. Termination of the X-ray exposure shall necessitate resetting of the conditions of operation prior to initiation of another scan.
(b) Tomographic plane indication and alignment.
(1) For any single tomogram system, a means shall be provided to permit visual determination of the tomographic plane or a reference plane offset from the tomographic plane.
(2) For any multiple tomogram system, a means shall be provided to permit visual determination of the location of a reference plane. This reference plane may be offset from the location of the tomographic plane.
(c) Status indicators and control switches.
(1) The CT X-ray control and gantry shall provide visual indication whenever X-rays are produced and, if applicable, whether the shutter is open or closed.
(2) The emergency buttons or switches shall be clearly labeled as to their function.
(3) Each individual scan or series of scans shall require initiation by the operator.
(d) Indication of CT conditions of operation. The CT X-ray system shall be designed so that the CT conditions of operation to be used during a scan or a scan sequence are indicated prior to the initiation of a scan or a scan sequence. On equipment having all or some of these conditions of operation at fixed values, this requirement may be met by permanent markings. Indication of CT conditions of operation shall be visible from any position from which scan initiation is possible.
(e) Leakage radiation. The leakage radiation from the diagnostic source assembly measured at a distance of 1 meter in any direction from the source may not exceed 100 milliroentgens (25.8 µC/kg) in 1 hour when the X-ray tube is operated at its leakage technique factors. Compliance shall be determined by measurements averaged over an area of 100 square centimeters with no linear dimension greater than 20 centimeters.
(f) Additional requirements applicable to CT X-ray systems containing a gantry manufactured after September 3, 1985.
(1) The total error in the indicated location of the tomographic plane or reference plane by the light field or laser indicator may not exceed 5 millimeters.
(2) If the X-ray production period is less than 0.5 second, the indication of X-ray production shall be actuated for at least 0.5 second. Beam-on and shutter status indicators at or near the gantry shall be discernible from any point external to the patient opening where insertion of any part of the human body into the primary beam is possible.
(3) The CT X-ray system shall be normalized to water.
(4) The CT number for water for a region of interest, not exceeding 100 square millimeters, shall be 0 ± 10.0 CT number units. The facility's performance phantom shall be utilized, with the technique factors specified by the qualified expert, to confirm compliance. In instances when a CTN of 0 for water is inappropriate, as in 3D treatment planning, the qualified expert may establish and maintain an equivalent value.
(5) With the performance phantom, the mean CT number of water of one group of pixels may not differ from the mean CT number of water of a second group of pixels equal size within the same image by more than the manufacturer's published specifications.
(6) The noise, utilizing the facility's performance phantom, may not exceed the manufacturer's published specifications.
(7) The total error between the indicated and actual slice thickness may not exceed 2.0 millimeters.
(8) A distance of at least 100 millimeters measured in a CT image shall agree with the actual distance to within ± 5%.
(9) Premature termination of the X-ray exposure by the operator shall necessitate resetting the CT conditions of operation prior to the initiation of another scan.
§ 221.204. Radiation measurements and performance evaluations.
(a) Radiation measurements.
(1) The CTDI or MSAD along the two axes specified in paragraph (2)(ii) shall be measured. The CT dosimetry phantom shall be oriented so that the measurement point 1.0 centimeter from the outer surface and within the phantom is in the same angular position within the gantry at the point of maximum surface exposure identified. The CT conditions of operation shall be reproducible and correspond to typical values used by the registrant. If the point of maximum surface exposure constantly changes due to system design, then measurements shall be taken at four different locations-top left, top right, bottom left, bottom right--1 centimeter from the outer surface of the phantom.
(2) CT dosimetry phantoms shall be used in determining the radiation output of a CT X-ray system. The phantoms shall meet the definition for a CT dosimetry phantom under 21 CFR 1020.33(b)(6) (relating to computed tomography (CT) equipment).
(i) The phantoms shall be specifically designed for CT dosimetry and deemed appropriate by the facility's qualified expert and the Department.
(ii) CT dosimetry phantoms shall provide a means for the placement of dosimeters along the axis of rotation and along a line parallel to the axis of rotation 1.0 centimeter from the outer surface and within the phantom. The means for the placement of dosimeters or alignment devices at other locations may be provided.
(iii) Any effects on the doses measured due to the removal of phantom material to accommodate dosimeters shall be accounted for through appropriate corrections to the reported data or included in the statement of maximum deviation for the values obtained using the phantom.
(iv) Dose measurements shall be performed with the CT dosimetry phantom placed on the patient couch or support device without additional attenuation materials present.
(3) In addition to the items in subsection (b), the following items shall be evaluated annually or after any component repair or change which in the opinion of the qualified expert may effect the performance of the CT unit:
(i) HVL (half value layer) determination at the most commonly used kVp or 120 kVp.
(ii) CTDI or MSAD as specified in § 221.201 (relating to definitions) for commonly used techniques.
(iii) Tomographic plane indication (light/laser alignment).
(iv) Slice thickness as specified in § 221.202(g)(7) (relating to equipment requirements).
(v) Distance readout calibration.
(4) The measurement of the radiation output of a CT X-ray system shall be performed with a dosimetry system that has calibration traceable to National Institute of Standards and Technology. The calibration of the system shall be in accordance with an established calibration protocol. The calibration protocol published by the AAPM is accepted as an established protocol. Other protocols which are equivalent will be accepted, but the user shall submit that protocol to the Department for concurrence that the protocol is equivalent.
(5) An mR/mAs value shall be determined at least annually for the head and body.
(6) Procedures and results shall be maintained for 5 years and be available for review by the Department.
(b) Performance evaluations.
(1) Written performance evaluation procedures shall be developed by a qualified expert. These procedures shall be available for review by the Department.
(2) The performance evaluation procedures shall include at least the following using the facility's performance phantom:
(i) Noise.
(ii) Contrast scale.
(iii) Spatial resolution (low and high contrast).
(iv) Mean CT number for water.
(v) Acceptable tolerances.
(3) The performance evaluation shall be performed at intervals not to exceed 3 months by the qualified expert or an individual designated by the qualified expert.
(4) The qualified expert need not be present during the performance evaluation, but shall be informed within 48 hours of any problems or unacceptable deviations.
(5) Performance evaluations shall include acquisition of images obtained with the performance phantom using the same processing mode and CT conditions of operation as are used to perform the measurements required by subsection (a).
(6) Records of the performance evaluations shall be maintained for inspection by the Department for at least 4 years.
§ 221.205. Operating procedures.
(a) Information shall be available at the control panel regarding the operation and performance evaluations of the system. The information shall include the following:
(1) The dates of the latest radiation measurements and performance evaluation and the location within the facility where the results of those tests may be obtained.
(2) Instructions on the use of the CT phantoms including a schedule of performance evaluations appropriate for the system, allowable variations for the indicated parameters and the results of at least the most recent performance evaluation conducted on the system.
(3) A current technique chart available at the control panel which specifies for each routine examination the CT conditions of operation and the number of scans per examination.
(b) If the radiation measurements and performance evaluation of the CT X-ray system indicates that a system operating parameter has exceeded a tolerance established by the qualified expert, the use of the CT X-ray system on patients shall be limited to those uses permitted by established written instructions of the qualified expert.
APPENDIX A
DETERMINATION OF COMPETENCEThe registrant shall ensure that individuals who operate diagnostic X-ray equipment have received training on the subjects listed in this appendix. The individual shall be trained and competent in the general operation of the X-ray equipment, and in the following subject areas, as applicable to the procedures performed and the specific equipment utilized:
(1) Basic properties of radiation.
(2) Units of measurement.
(3) Sources of radiation exposure.
(4) Methods of radiation protection.
(5) Biological effects of radiation exposure.
(6) X-ray equipment.
(7) Image recording and processing.
(8) Patient exposure and positioning.
(9) Procedures.
(10) Quality assurance.
(11) Regulations.
CHAPTER 223. VETERINARY MEDICINE
RADIOACTIVE MATERIAL § 223.21. In vitro testing.
A veterinarian who uses radioactive material for in vitro testing shall comply with 10 CFR 31.11 (relating to general license for use of by-product material for certain in vitro clinical or laboratory testing) but is exempt from 10 CFR Part 20 Subpart K (relating to waste disposal).
§ 223.22. Sealed sources.
A veterinarian who uses sealed sources for therapeutic treatment of animals shall comply with 10 CFR Part 35, Subparts F, G, H and K but is exempt from 10 CFR 35.632--35.645 and 35.2632--35.2645.
CHAPTER 224. MEDICAL USE OF RADIOACTIVE MATERIAL
Subchapter A. GENERAL § 224.10. Incorporation by reference.
(a) Except as provided in this chapter, the requirements of 10 CFR Part 35 (relating to medical use of byproduct material) are incorporated by reference.
(b) Notwithstanding the requirements incorporated by reference, 10 CFR 35.8, 35.4001 and 35.4002 (relating to information collection requirements: OMB approval; violations; and criminal penalties) are not incorporated by reference.
Subchapter B. OTHER REQUIREMENTS § 224.21. (Reserved).
§ 224.22. Authorization for calibration, transmission and reference sources.
Notwithstanding the incorporation by reference of 10 CFR 35.65 (relating to authorization for calibration, transmission, and reference sources), a licensee authorized for medical use radioactive materials may not receive, possess or use radium in total quantity of 3.7 MBq (100 µci) or more for check, calibration, transmission and reference use except as specifically authorized by the Department.
§ 224.23. Decay-in-storage.
Notwithstanding the incorporation by reference of 10 CFR Part 35 (relating to medical use of byproduct material), a licensee may hold sealed sources of radioactive material with a physical half-life of up to 300 days for decay-in-storage before disposal in ordinary trash.
CHAPTER 225. RADIATION SAFETY REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC OPERATIONS
Subchapter A. GENERAL PROVISIONS § 225.1. Purpose and scope.
(a) This chapter establishes radiation safety requirements for persons utilizing radiation sources for industrial radiography. Licensees and registrants who use radiation sources for industrial radiography shall comply with this chapter. The requirements of this chapter are in addition to and not in substitution for other applicable requirements in this article, in particular, the requirements and provisions of Chapters 215, 217--220, 228 and 230.
(b) Persons using only radiation-producing machines for industrial radiographic operations need not comply with § 225.2a (relating to incorporation by reference) unless otherwise specified in Subchapter B (relating to radiation-producing machines).
(c) This chapter does not apply to the use of radiation sources for medical diagnosis or therapy.
§ 225.4a. Radiation safety program.
(a) A person who intends to use radiation-producing machines for industrial radiography shall have a program for training personnel, written operating procedures and emergency procedures, an internal review system and an organizational structure for radiographic operations which includes specified delegations of authority and responsibility for operation of the program. This program shall be approved by the Department before commencing industrial radiographic operations.
(b) The registrant shall notify the Department of intended changes to the registrant's radiation safety program and obtain Departmental approval.
Subchapter B. RADIATION-PRODUCING MACHINES
GENERAL ADMINISTRATIVE REQUIREMENTS § 225.71. Definitions.
The following words and terms, when used this subchapter, have the following meanings, unless the context clearly indicates otherwise:
Cabinet radiography--Industrial radiography conducted in an enclosure or cabinet (not a room) so shielded that doses to individual members of the public at every location on the exterior meet the limitations specified in 10 CFR 20.1301 (relating to dose limits for individual members of the public).
Cabinet X-ray system--An X-ray system with the X-ray tube installed in an interlocked enclosure or cabinet, designed to exclude personnel from its interior during operation.
(i) Included are all X-ray systems designed primarily for the inspection of baggage or packages.
(ii) An X-ray tube used within a shielded part of a building or X-ray equipment which may temporarily or occasionally incorporate portable shielding is not considered a cabinet X-ray system.
Certified cabinet X-ray system--An X-ray system which has been certified under 21 CFR 1010.2 (relating to certification) as being manufactured and assembled under 21 CFR 1020.40 (relating to cabinet x-ray systems).
DRD--Direct reading dosimeter--
(i) As used in this subchapter, means an ''individual monitoring device'' (see 10 CFR 20.1003 (relating to definitions)) that does not require additional processing to measure an individual's dose.
(ii) The term also includes the direct reading personnel (individual) monitoring devices known as pocket dosimeter, pocket ionization chamber and electronic personal dosimeter (EPD).
Field radiography--A location where radiographic operations are conducted (onsite or offsite) other than those designated as a permanent radiographic facility.
Industrial radiography--An examination of the structure of materials by nondestructive methods, including fluoroscopy, which utilizes radiation producing machines to make radiographic images.
NVLAP--National Voluntary Laboratory Accreditation Program.
Permanent radiographic installation--A shielded installation or structure designed or intended for radiography in which radiography is regularly performed.
Personal supervision--The provision of guidance and instruction to a radiographer's assistant given by a radiographer who is:
(i) Physically present at the site.
(ii) In visual contact with the radiographer's assistant while the assistant is using radiation sources.
(iii) In proximity so that immediate assistance can be given if required.
Personnel dosimeter--As used in this subchapter, means any of the ''individual monitoring devices'' (see 10 CFR 20.1003) that shall be processed and evaluated to generate a permanent record of an individual's dose, for example, a film badge, thermoluminescent dosimeter (TLD) or optically stimulated luminescent dosimeter (OSLD).
RSO--radiation safety officer--An individual who ensures that, in the daily operation of the registrant's or licensee's radiation safety program, activities are being performed in accordance with approved procedures and are in compliance with Department requirements.
Radiographer--An individual who performs radiographic operations or an individual in attendance at a site where radiation producing machines are being used who personally supervises industrial radiographic operations.
Radiographer's assistant--An individual who, under the personal supervision of a radiographer, uses radiation producing machines or radiation survey instrumentation.
Radiographer trainee--An individual who is in the process of becoming a radiographer's assistant or a radiographer.
Radiographic operations--The activities associated with a radiation producing machine during use of the machine, to include surveys to confirm adequacy of boundaries, setting up equipment and any activity inside restricted area boundaries.
Safety device--As applied to radiation-producing machines in this subchapter, a device or component that causes the unit to de-energize or interrupt the beam.
Shielded room radiography--Industrial radiography that is conducted in an enclosed room, the interior of which is not occupied during radiographic operations.
§ 225.73. Training of personnel.
(a) A registrant may not allow an individual to act as a radiographer or radiographer's assistant unless that individual meets the requirements of § 225.74 (relating to training and testing).
(b) Persons performing field radiography shall comply with the training requirements in Appendix A (relating to subjects to be covered during the instruction of radiographers).
GENERAL TECHNICAL REQUIREMENTS § 225.82. Operating requirements.
(a) When radiographic operations are performed at a location other than a permanent radiographic installation, a minimum of two radiographic personnel shall be present to operate the X-ray device. At least one of the radiographic personnel shall be qualified as a radiographer. The other individual may be either a radiographer, a radiographer's assistant or a radiographer trainee.
(b) Other than a radiographer, or a radiographer's assistant who is under the personal supervision of a radiographer, an individual may not manipulate the controls or operate the equipment used in industrial radiographic operations.
(c) At each job site, the following shall be supplied by the registrant or licensee:
(1) The appropriate barrier ropes and warning signs.
(2) At least one operable, calibrated radiation survey instrument.
(3) For each worker requiring monitoring, an individual personnel dosimeter that is processed and evaluated by an NVLAP processor.
(4) An operable, calibrated direct reading dosimeter with a range of zero to 51.6 µC/kg (200 milliroentgen) for each worker requiring monitoring.
(d) An industrial radiographic operation may not be performed if any of the items in subsection (c) is not available at the job site or is inoperable.
§ 225.83. Records required at field radiography sites.
Each registrant or licensee conducting radiographic operations at a field radiography site shall maintain and have available for inspection by the Department at that job site, the following records or documents:
(1) The certificate of registration, license or equivalent document which authorizes radiographic operations, and radiographic personnel certifications.
(2) Operating and emergency procedures.
(3) Relevant regulations of the Department.
(4) Survey records required under this chapter for the period of operation at the site.
(5) Daily direct reading dosimeter records for the period of operation at the site.
(6) The current radiation survey meter calibration records for meters in use at the site. Acceptable records include tags or labels that are affixed to the survey meter.
RADIATION-PRODUCING MACHINE REQUIREMENTS § 225.101. Cabinet X-ray systems and baggage/package X-ray systems.
(a) Cabinet and baggage/package X-ray systems that are certified under 21 CFR Chapter I, Subchapter J (relating to radiological health) shall also meet the requirement of 21 CFR 1020.40 (relating to cabinet X-ray systems).
(b) A cabinet X-ray system may not be energized unless all openings are securely closed and exposure to radiation from the system does not exceed the limits in 10 CFR 20.1301 (relating to dose limits for individual members of the public). Each access door to the cabinet shall have an interlock that terminates the exposure whenever the door is opened. The enclosure shall be shielded so that every location on the exterior meets the conditions for an unrestricted area.
(c) A registrant may not permit an individual to operate a cabinet X-ray system until the individual has received a copy of, and instruction in, the operating procedures for the X-ray system and has demonstrated competency in the use of the cabinet X-ray system and an understanding of the operating procedures.
(d) The registrant shall perform radiation surveys to demonstrate compliance with 10 CFR 20.1301 and maintain records of these surveys for inspection by the Department for 3 years:
(1) Upon installation of the equipment.
(2) Following a change in the initial arrangement, relocation of the unit, or following any maintenance requiring the disassembly or removal of any shielding component.
(3) When a visual inspection reveals an abnormal condition.
(e) The registrant shall test on-off switches, interlocks and safety devices at intervals not exceeding 1 year, and make repairs as necessary to maintain all safety features including warning labels. Records of these tests shall be maintained for inspection by the Department for 3 years.
(f) Cabinet X-ray systems and baggage/package X-ray systems are exempt from all other provisions of this chapter.
§ 225.102. Shielded room X-ray radiography.
(a) A room used for shielded room X-ray radiography shall be shielded so that every location on the exterior meets conditions for an unrestricted area and the only access to the room is through openings which are interlocked so that the radiation source will not operate unless all openings are securely closed and meet the requirements of 10 CFR 20.1601 (relating to control of access to high radiation areas).
(b) The operator shall conduct a physical radiation survey to determine that the radiation source is deenergized prior to each entry into the radiographic exposure area.
(c) As an alternative to subsection (b), the registrant may use an independent radiation monitoring system that displays the radiation intensity or displays when radiation levels have returned to their pre-irradiation levels.
(d) With the exception of the provisions of §§ 225.4a and 225.84 (relating to radiation safety program; and operating and emergency procedures), shielded room radiography is exempt from all other provisions of this chapter.
§ 225.103. Field site radiography.
(a) The operator shall conduct a physical radiation survey to determine that the radiation source is de-energized prior to each entry into the radiographic exposure area. Survey results and records of the boundary location shall be maintained and kept available for inspection by the Department for 3 years.
(b) Mobile or portable radiation producing machines shall be physically secured to prevent tampering or removal by unauthorized personnel.
CHAPTER 226. LICENSES AND RADIATION SAFETY REQUIREMENTS FOR WELL LOGGING
GENERAL § 226.3a. Abandonment of a sealed source.
In addition to incorporation by reference of 10 CFR 39.15 and 39.77 (relating to agreement with well owner or operator; and notification of incidents and lost sources; abandonment procedures for irretrievable sources), the requirements of § 78.111 (relating to abandonment) shall also be met.
CHAPTER 227. RADIATION SAFETY REQUIREMENTS FOR ANALYTICAL X-RAY EQUIPMENT, X-RAY GAUGING EQUIPMENT, ELECTRON MICROSCOPES AND X-RAY CALIBRATION SYSTEMS
ANALYTICAL X-RAY EQUIPMENT § 227.11a. Equipment requirements.
(a) Open-beam configurations shall have a safety device which either prevents the entry of any portion of an individual's body into the primary X-ray beam path, or causes the beam to be terminated or interrupted upon entry into the path. A registrant may apply to the Department for an exemption from the requirement of a safety device. The application for an exemption shall include the following:
(1) A description of the various safety devices that have been evaluated.
(2) The reason each of these safety devices cannot be used.
(3) A description of the alternative methods that will be employed to minimize the possibility of an accidental exposure, including procedures to assure that operators and others in the area will be informed of the absence of safety devices.
(b) Open-beam configurations shall be provided with a readily discernible indication of one or both of the following:
(1) X-ray tube status (on-off) located near the radiation source housing, if the primary beam is controlled in this manner.
(2) Shutter status (open-closed) located near each port on the radiation source housing, if the primary beam is controlled in this manner.
(c) Warning devices shall be labeled so that their purpose is easily identified. In addition, equipment manufactured after December 17, 1987, shall have fail-safe characteristics.
(d) An easily visible warning light located immediately adjacent to the tube head or port and labeled with the words ''X-ray on,'' or words containing a similar warning, shall be provided and shall be illuminated when the X-ray tube is energized.
(e) Unused ports on radiation source housings shall be secured in the closed position in a manner which will prevent casual opening.
(f) Analytical X-ray equipment shall be labeled with a readily discernible sign bearing the radiation symbol and both of the following:
(1) ''CAUTION--HIGH INTENSITY X-RAY BEAM'' or words having a similar intent on the X-ray source housing.
(2) ''CAUTION RADIATION--THIS EQUIPMENT PRODUCES RADIATION WHEN ENERGIZED,'' or words having a similar intent, near any switch that energizes an X-ray tube.
(g) On equipment with an open-beam configuration manufactured and installed after December 19, 1987, each port on the radiation source housing shall be equipped with a shutter that cannot be opened unless a collimator or coupling has been connected to the port.
(h) Equipment exclusively designed and exclusively used for vacuum spectroscopy where the tube housing and sample chamber is located behind all external surfaces of the unit shall be exempt from the requirements of this section, §§ 227.12a and 227.13a (relating to area requirements; and operating requirements), but shall meet the requirements of § 227.14 (relating to personnel procedures) and the following:
(1) The unit shall be designed so that when the unit is operating at the maximum kilovoltage and current ratings, the leakage radiation will not be in excess of 0.5 milliroentgens (.129 µC/kg) per hour at a distance of 4 centimeters from any external surface.
(2) Radiation surveys using appropriate radiation survey equipment shall be performed on the analytical X-ray unit upon installation, after moving the unit to a new location, and after maintenance or repair requiring the disassembly or removal of a local component or radiation shielding.
(3) Safety and warning devices shall be tested for proper operation at least annually. If the test reveals that a safety or warning device is not working properly, the unit may not be operated until the warning device is repaired or replaced.
(4) Records of all tests and surveys sufficient to show compliance with subsection (h) shall be maintained and kept available for inspection by the Department for 4 years.
(5) A sign bearing the radiation symbol and the words ''CAUTION RADIATION--THIS EQUIPMENT PRODUCES RADIATION WHEN ENERGIZED,'' or words of similar intent shall be placed next to any switch or device that activates the X-ray tube.
(6) A sign bearing the radiation symbol and the words ''CAUTION--RADIATION,'' or words of similar intent shall be placed next to the opening of the sample chamber.
§ 227.12a. Area requirements.
(a) The source housing construction shall be of a type that when all the shutters are closed and the source is in any possible operating mode, the leakage radiation will not be in excess of 2.5 milliroentgens (.645 µC/kg) per hour at a distance of 5 centimeters from the housing surface.
(b) The X-ray generator shall have a protective cabinet constructed so that the leakage radiation will not be in excess of 0.5 milliroentgen (.129 µC/kg) per hour at a distance of 5 centimeters from the housing surface.
(c) The local components of an analytical X-ray system shall be located and arranged and shall include sufficient shielding or access control so that no radiation levels exist in any area surrounding the local component group which could result in a dose to an individual present therein in excess of the limits given in 10 CFR 20.1301 (relating to dose limits for individual members of the public). For systems utilizing X-ray tubes, these requirements shall be met at any specified tube rating.
(d) To show compliance with subsections (a)--(c), the registrant shall perform radiation surveys:
(1) Upon installation of the equipment and at least every 12 months thereafter.
(2) Following a change in the initial arrangement, number or type of local components in the system.
(3) Following maintenance requiring the disassembly or removal of a local component in the system.
(4) During the performance of maintenance and alignment procedures if the procedures require the presence of a primary X-ray beam when a local component in the system is disassembled or removed.
(5) When a visual inspection of the local components in the system reveals an abnormal condition.
(6) When personnel monitoring devices show a significant increase in radiation exposure over the previous monitoring period or the readings are approaching the radiation dose limits.
(7) When the machine is operated in a manner other than the routine manner specified in § 227.13a (relating to operating requirements).
(e) The registrant shall test and inspect all safety and warning devices at least annually to insure their proper operation. If a safety or warning device is found to be malfunctioning, the machine shall be removed from service until repairs to the malfunctioning device are completed.
(f) Records of surveys and tests sufficient to show compliance with this chapter shall be maintained for 4 years and kept available for inspection by the Department.
(g) The equipment used to conduct the surveys and tests required in this chapter shall be adequate to measure the radiation produced by the radiation source.
§ 227.13a. Operating requirements.
(a) Operating procedures shall be written and available to the analytical X-ray equipment operators. These procedures shall include instructions for sample insertion and manipulation, equipment alignment, routine maintenance and data recording procedures which are related to radiation safety. An individual may not operate analytical X-ray equipment in a manner other than that specified in the operating procedures unless the individual has obtained written approval from the radiation safety officer.
(b) An individual may not bypass or otherwise circumvent a safety device unless the individual has obtained the prior written approval of the radiation safety officer. The radiation safety officer may grant the permission only if the following conditions are met:
(1) The radiation safety officer establishes administrative controls and procedures to assure the radiation safety of individuals working around the system.
(2) The period for the bypass of the safety device is not more than 30 days unless written permission is obtained from the Department for a longer period.
(3) A readily discernible sign bearing the words ''SAFETY DEVICE NOT WORKING,'' or words containing a similar warning, is placed on the radiation source housing.
(c) Except as specified in subsection (b), an operation involving removal of covers, shielding materials or tube housings or modifications to shutters, collimators or beam stops may not be performed without ascertaining that the tube is off and will remain off until safe conditions have been restored. The main switch, rather than interlocks, shall be used for routine shutdown in preparation for repairs.
(d) Emergency procedures shall be written and posted near the equipment and shall list the names and telephone numbers of personnel to contact. The emergency procedures shall also provide information necessary to de-energize the equipment, such as location and operation of the power supply or circuit breakers.
§ 227.14. Personnel requirements.
(a) An individual may not operate or maintain analytical X-ray equipment unless the individual has received instruction in and demonstrated competence as to:
(1) Identification of radiation hazards associated with the use of the equipment.
(2) Significance of the various radiation warning and safety devices incorporated into the equipment, or the reasons they have not been installed on certain pieces of equipment, and the extra precautions necessary if the devices are absent or bypassed.
(3) Written operating and emergency procedures for the equipment.
(4) Symptoms of an acute localized radiation exposure.
(5) Procedures for reporting an actual or suspected exposure.
(6) Use of survey and personnel monitoring equipment.
(7) The applicable regulations of this article and those incorporated by reference.
(b) Finger or wrist personnel monitoring devices shall be provided to and shall be used by:
(1) Analytical X-ray equipment workers using systems having an open-beam configuration and not equipped with a safety device as described in § 227.12a(c) (relating to area requirements).
(2) Personnel maintaining analytical X-ray equipment if the maintenance procedures require the presence of a primary X-ray beam when a local component in the analytical X-ray system is disassembled or removed or when safety devices are bypassed.
(c) Reported dose values may not be used for the purpose of determining compliance with 10 CFR 20.1201 (relating to occupational dose limits for adults) unless they are evaluated by a qualified expert.
(d) The registrant or licensee shall notify the Department within 5 days of a suspected radiation overexposure to an individual from analytical X-ray machines. This notification is required even if subsequent investigation reveals no actual over-exposure actually occurred.
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