10853.1The provisions of this section are applicable to:
(a) The following components of diagnostic x-ray systems: (1) Tube housing assemblies, x-ray controls, x-ray high-voltage generators, x-ray tables, cradles, film changers, vertical cassette holders mounted in a fixed location and cassette holders with front panels, and beam-limiting devices manufactured after August 1, 1974;(2) Fluoroscopic imaging assemblies manufactured after August 1, 1974, and before April 26, 1977, or after June 10, 2006;(3) Spot-film devices and image intensifiers manufactured after April 26, 1977;(4) Cephalometric devices manufactured after February 25, 1978;(5) Image receptor support devices for mammographic x-ray systems manufactured after September 5, 1978;(6) Image receptors that are electrically powered or connected with the x-ray system manufactured on or after June 10, 2006; and(7) Fluoroscopic air kerma display devices manufactured on or after June 10, 2006;(b) Diagnostic x-ray systems, except computed tomography x-ray systems, incorporating one (1) or more of such components. However, such x-ray systems shall be required to comply only with those provisions of this section and §§ 10854 and 10855, which relate to the components certified in accordance with § 10853.5 and installed into the systems;(c) Computed tomography (CT) x-ray systems manufactured before November 29, 1984; and(d) CT gantries manufactured after September 3, 1985.10853.2The following provisions of this section are applicable to CT x-ray systems manufactured or remanufactured on or after November 29, 1984:
(b) Subsection 10853.4(r) "CT";(c) Subsection 10853.4(z) "Dose";(d) Subsection 10853.4(jjj) "Scan"; (a) Subsection 10853.4(kkk) "Scan Time";(b) Subsection 10853.4(rrr) "Technique Factors";(c) Subsection 10853.4(sss) "Tomogram"; (h) Subsection 10853.17(f) through (h); and10853.3The provisions of this section, including those provisions in 21 C.F.R. § 1020.33, are applicable to CT x-ray systems manufactured or remanufactured on or after September 3, 1985. The date of manufacture of the CT system is the date of manufacture of the CT gantry.
10853.4As used in this section and §§ 10854 and 10855 the following definitions apply:
(a)Accessible surface - the external surface of the enclosure or housing provided by the manufacturer;(b)Accessory component - (1) A component used with diagnostic x-ray systems, such as a cradle or film changer, that is not necessary for the compliance of the system with applicable provisions of this chapter but which requires an initial determination of compatibility with the system;(2) A component necessary for compliance of the system with applicable provisions of this chapter but which may be interchanged with similar compatible components without affecting the system's compliance, such as one (1) of a set of interchangeable beam-limiting devices; or(3) A component compatible with all x-ray systems with which it may be used and that does not require compatibility or installation instructions, such as a tabletop cassette holder;(c)Air kerma - kerma in air (see definition of Kerma);(d)Air kerma rate (AKR) - the air kerma per unit time;(e)Aluminum equivalent - the thickness of aluminum (type 1100 alloy) n11 affording the same attenuation, under specified conditions, as the material in question;(f)Articulated joint - a joint between two (2) separate sections of a tabletop in which a joint provides the capacity for one (1) of the sections to pivot on the line segment along which the sections join;(g)Assembler - any person engaged in the business of assembling, replacing, or installing one (1) or more components into a diagnostic x-ray system or subsystem. The term includes the owner of an x-ray system or his or her employee or agent who assembles components into an x-ray system that is subsequently used to provide professional or commercial services;(h)Attenuation block - a block or stack of type 1100 aluminum alloy, or aluminum alloy having equivalent attenuation, with dimensions twenty centimeters (20 cm) or larger by twenty centimeters (20 cm) or larger by three and eight tenths centimeters (3.8 cm), that is large enough to intercept the entire x-ray beam;(i)Automatic exposure control (AEC) - a device which automatically controls one or more technique factors in order to obtain at a preselected location(s) a required quantity of radiation;(j)Automatic exposure rate control (AERC) -a device which automatically controls one (1) or more technique factors in order to obtain at a preselected location(s) a required quantity of radiation per unit time;(k)Beam axis -a line from the source through the centers of the x-ray fields;(l)Beam-limiting device -a device which provides a means to restrict the dimensions of the x-ray field;(m)C-arm fluoroscope -a fluoroscopic x-ray system in which the image receptor and the x-ray tube housing assembly are connected or coordinated to maintain a spatial relationship. Such a system allows a change in the direction of the beam axis with respect to the patient without moving the patient;(n)Cantilevered tabletop -a tabletop designed such that the unsupported portion can be extended at least one hundred centimeters (100 cm) beyond the support;(o)Cassette holder -a device, other than a spot-film device, that supports or fixes the position of an x-ray film cassette during an x-ray exposure;(p)Cephalometricdevice -a device intended for the radiographic visualization and measurement of the dimensions of the human head;(q)Coefficient of variation -the ratio of the standard deviation to the mean value of a population of observations. It is estimated using the following equation: Click to view image
where:
s = Estimated standard deviation of the population.
X = Mean value of observations in sample.
X[i] = ith observation sampled.
n = Number of observations sampled.
(r)Computed tomography (CT) -the production of a tomogram by the acquisition and computer processing of x-ray transmission data;(s)Control panel -that part of the x-ray control upon which are mounted the switches, knobs, pushbuttons, and other hardware necessary for manually setting the technique factors;(t)Cooling curve -the graphical relationship between heat units stored and cooling time;(u)Cradle means: (1) A removable device which supports and may restrain a patient above an x-ray table; or(2) A device: (A) Whose patient support structure is interposed between the patient and the image receptor during normal use;(B) Which is equipped with means for patient restraint; and(C) Which is capable of rotation about its long (longitudinal) axis.(v)CT gantry -tube housing assemblies, beam-limiting devices, detectors, and the supporting structures, frames, and covers which hold or enclose these components;(w)Cumulative air kerma -the total air kerma accrued from the beginning of an examination or procedure and includes all contributions from fluoroscopic and radiographic irradiation;(x)Diagnostic source assembly -the tube housing assembly with a beam-limiting device attached;(y)Diagnostic x-ray system -an x-ray system designed for irradiation of any part of the human body for the purpose of diagnosis or visualization;(z)Dose -the absorbed dose as defined by the International Commission on Radiation Units and Measurements. The absorbed dose(D) is the energy deposited per unit mass of medium (D=de/dm), in units of joules per kilogram (J/kg), where the special name for the unit of absorbed dose is gray (Gy);(aa)Equipment -x-ray equipment;(bb)Exposure (X) -the quotient of dQ divided by dm (X=dQ/dm) where dQ is the absolute value of the total charge of the ions of one sign produced in air when all the electrons and positrons liberated or created by photons in air of mass, dm are completely stopped in air in units of coulomb per kilogram (C/kg). A second meaning of exposure is the process or condition during which the x-ray tube produces x-ray radiation;(cc)Field emissionequipment -equipment which uses an x-ray tube in which electron emission from the cathode is due solely to action of an electric field;(dd)Fluoroscopic air kerma display device -a device, subsystem, or component that provides the display of AKR and cumulative air kerma required by § 10855.31. It includes radiation detectors, if any, electronic and computer components, associated software, and data displays;(ee)Fluoroscopic imaging assembly -a subsystem in which x-ray photons produce a set of fluoroscopic images or radiographic images recorded from the fluoroscopic image receptor. It includes the image receptor(s), electrical interlocks, if any, and structural material providing linkage between the image receptor and diagnostic source assembly;(ff)Fluoroscopic irradiation time -the cumulative duration during an examination or procedure of operator-applied continuous pressure to the device, enabling x-ray tube activation in any fluoroscopic mode of operation;(gg)Fluoroscopy -a technique for generating x-ray images and presenting them simultaneously and continuously as visible images. This term has the same meaning as the term "radioscopy" in the standards of the International Electrotechnical Commission;(hh)General purpose radiographic x-ray system -any radiographic x-ray system which, by design, is not limited to radiographic examination of specific anatomical regions;(ii)Half-value layer (HVL) -the thickness of specified material which attenuates the beam of radiation to an extent such that the AKR is reduced to one-half (1/2) of its original value. In this definition the contribution of all scattered radiation, other than any which might be present initially in the beam concerned, is deemed to be excluded;(jj)Image intensifier -a device, installed in its housing, which instantaneously converts an x-ray pattern into a corresponding light image of higher energy density;(kk)Image receptor -any device, such as a fluorescent screen, radiographic film, x-ray image intensifier tube, solid-state detector, or gaseous detector, which transforms incident x-ray photons either into a visible image or into another form which can be made into a visible image by further transformations. In those cases where means are provided to preselect a portion of the image receptor, the term "image receptor" shall mean the preselected portion of the device;(ll)Image receptor support device -for mammography x-ray systems, that part of the system designed to support the image receptor during a mammographic examination and to provide a primary protective barrier;(mm)Isocenter -the center of the smallest sphere through which the beam axis passes when the equipment moves through a full range of rotations about its common center;(nn)Kerma - the quantity as defined by the International Commission on Radiation Units and Measurements. The kerma (K)is the quotient of dE[tr] by dm, where dE[tr] is the sum of the initial kinetic energies of all the charged particles liberated by uncharged particles in a mass dm of material; thus K=dE[tr]/dm, in units of J/kg, where the special name for the unit of kerma is gray (Gy). When the material is air, the quantity is referred to as "air kerma;"(oo)Last-image-hold (LIH) radiograph -an image obtained either by retaining one (1) or more fluoroscopic images, which may be temporally integrated, at the end of a fluoroscopic exposure or by initiating a separate and distinct radiographic exposure automatically and immediately in conjunction with termination of the fluoroscopic exposure;(pp)Lateral fluoroscope -the x-ray tube and image receptor combination in a biplane system dedicated to the lateral projection. It consists of the lateral x-ray tube housing assembly and the lateral image receptor that are fixed in position relative to the table with the x-ray beam axis parallel to the plane of the table;(qq)Leakage radiation -radiation emanating from the diagnostic source assembly except for: (2) Radiation produced when the exposure switch or timer is not activated.(rr)Leakage technique factors -the technique factors associated with the diagnostic source assembly which are used in measuring leakage radiation. They are defined as follows: (1) For diagnostic source assemblies intended for capacitor energy storage equipment, the maximum-rated peak tube potential and the maximum-rated number of exposures in an hour for operation at the maximum-rated peak tube potential with the quantity of charge per exposure being ten millicoulombs (10 mC) or the minimum obtainable from the unit, whichever is larger;(2) For diagnostic source assemblies intended for field emission equipment rated for pulsed operation, the maximum-rated peak tube potential and the maximum-rated number of x-ray pulses in an hour for operation at the maximum-rated peak tube potential; and(3) For all other diagnostic source assemblies, the maximum-rated peak tube potential and the maximum-rated continuous tube current for the maximum-rated peak tube potential;(ss)Light field -that area of the intersection of the light beam from the beam-limiting device and one (1) of the set of planes parallel to and including the plane of the image receptor, whose perimeter is the locus of points at which the illuminance is one-fourth of the maximum in the intersection;(tt)Line-voltage regulation -the difference between the no-load and the load line potentials expressed as a percent of the load line potential; that is, Percent line-voltage regulation = 100(V[n] - V[i])/V[i]
where:
V[n] = No-load line potential and
V[i] = Load line potential.
(uu)Maximum line current -the root mean square current in the supply line of an x-ray machine operating at its maximum rating;(vv)Mode of operation - for fluoroscopic systems, a distinct method of fluoroscopy or radiography provided by the manufacturer and selected with a set of several technique factors or other control settings uniquely associated with the mode. The set of distinct technique factors and control settings for the mode may be selected by the operation of a single control. Examples of distinct modes of operation include normal fluoroscopy (analog or digital), high-level control fluoroscopy, cineradiography (analog or digital), digital subtraction angiography, electronic radiography using the fluoroscopic image receptor, and photospot recording. In a specific mode of operation, certain system variables affecting air kerma, AKR, or image quality, such as image magnification, x-ray field size, pulse rate, pulse duration, number of pulses, source-image receptor distance (SID), or optical aperture, may be adjustable or may vary; their variation per se does not comprise a mode of operation different from the one that has been selected;(ww)Movable tabletop -a tabletop which, when assembled for use, is capable of movement with respect to its supporting structure within the plane of the tabletop;(xx)Non-image-intensified fluoroscopy -fluoroscopy using only a fluorescent screen;(yy)Peak tube potential -the maximum value of the potential difference across the x-ray tube during an exposure;(zz)Primary protective barrier -the material, excluding filters, placed in the useful beam to reduce the radiation exposure for protection purposes;(aaa)Pulsed mode -operation of the x-ray system such that the x-ray tube current is pulsed by the x-ray control to produce one (1) or more exposure intervals of duration less than one-half (1/2) second;(bbb)Quick change x-ray tube -an x-ray tube designed for use in its associated tube housing such that: (1) The tube cannot be inserted in its housing in a manner that would result in noncompliance of the system with the requirements of § 10853.23 and 10853.25;(2) The focal spot position will not cause noncompliance with the provisions of this section or § 10854 or § 10855;(3) The shielding within the tube housing cannot be displaced; and(4) Any removal and subsequent replacement of a beam-limiting device during reloading of the tube in the tube housing will not result in noncompliance of the x-ray system with the applicable field limitation and alignment requirements of §§ 10854 and 10855;(ccc)Radiation therapy simulation system -a radiographic or fluoroscopic x-ray system intended for localizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field;(ddd)Radiography -a technique for generating and recording an x-ray pattern for the purpose of providing the user with an image(s) after termination of the exposure;(eee)Rated line voltage -the range of potentials, in volts, of the supply line specified by the manufacturer at which the x-ray machine is designed to operate;(fff)Rated output current -the maximum allowable load current of the x-ray high-voltage generator;(ggg)Rated output voltage -the allowable peak potential, in volts, at the output terminals of the x-ray high-voltage generator;(hhh)Rating -the operating limits specified by the manufacturer;(iii)Recording -producing a retrievable form of an image resulting from x-ray photons;(jjj)Scan -the complete process of collecting x-ray transmission data for the production of a tomogram. Data may be collected simultaneously during a single scan for the production of one (1) or more tomograms;(kkk)Scan time -the period of time between the beginning and end of x-ray transmission data accumulation for a single scan;(lll)Solid state x-ray imaging device -an assembly, typically in a rectangular panel configuration, that intercepts x-ray photons and converts the photon energy into a modulated electronic signal representative of the x-ray intensity over the area of the imaging device. The electronic signal is then used to create an image for display or storage;(mmm)Source -the focal spot of the x-ray tube;(nnn)Source-image receptor distance (SID) -the distance from the source to the center of the input surface of the image receptor;(ooo)Source-skin distance (SSD) -the distance from the source to the center of the entrant x-ray field in the plane tangent to the patient skin surface;(ppp)Spot-film device -a device intended to transport or position a radiographic image receptor between the x-ray source and fluoroscopic image receptor. It includes a device intended to hold a cassette over the input end of the fluoroscopic image receptor for the purpose of producing a radiograph;(qqq)Stationary tabletop -a tabletop which, when assembled for use, is incapable of movement with respect to its supporting structure within the plane of the tabletop;(rrr)Technique factors -the following conditions of operation: (1) For capacitor energy storage equipment, peak tube potential in kilovolts (kV) and quantity of charge in milliampere-seconds (mAs);(2) For field emission equipment rated for pulsed operation, peak tube potential in kV and number of x-ray pulses;(3) For CT equipment designed for pulsed operation, peak tube potential in kV, scan time in seconds, and either tube current in milliamperes (mA), x-ray pulse width in seconds, and the number of x-ray pulses per scan, or the product of the tube current, x-ray pulse width, and the number of x-ray pulses in mAs;(4) For CT equipment not designed for pulsed operation, peak tube potential in kV, and either tube current in mA and scan time in seconds, or the product of tube current and exposure time in mAs and the scan time when the scan time and exposure time are equivalent; and(5) For all other equipment, peak tube potential in kV, and either tube current in mA and exposure time in seconds, or the product of tube current and exposure time in mAs;(sss)Tomogram -the depiction of the x-ray attenuation properties of a section through a body;(ttt)Tube -an x-ray tube, unless otherwise specified;(uuu)Tube housing assembly -the tube housing with tube installed. It includes high-voltage or filament transformers and other appropriate elements when they are contained within the tube housing;(vvv)Tube rating chart -the set of curves which specify the rated limits of operation of the tube in terms of the technique factors;(www)Useful beam -the radiation which passes through the tube housing port and the aperture of the beam-limiting device when the exposure switch or timer is activated;(xxx)Variable-aperture beam-limiting device -a beam-limiting device which has the capacity for stepless adjustment of the x-ray field size at a given SID;(yyy)Visible area -the portion of the input surface of the image receptor over which incident x-ray photons are producing a visible image;(zzz)X-ray control -a device which controls input power to the x- ray high-voltage generator or the x-ray tube. It includes equipment such as timers, phototimers, automatic brightness stabilizers, and similar devices, which control the technique factors of an x-ray exposure;(aaaa)X-ray equipment -an x-ray system, subsystem, or component thereof which include: (1) Mobile, mounted on a permanent base with wheels or casters for moving while completely assembled;(2) Portable, designed to be hand-carried; and(3) Stationary, which is installed in a fixed location.(bbbb)X-ray field -that area of the intersection of the useful beam and any one (1) of the set of planes parallel to and including the plane of the image receptor, whose perimeter is the locus of points at which the AKR is one-fourth (1/4) of the maximum in the intersection;(cccc)X-ray high-voltage generator -a device which transforms electrical energy from the potential supplied by the x-ray control to the tube operating potential. The device may also include means for transforming alternating current to direct current, filament transformers for the x-ray tube(s), high-voltage switches, electrical protective devices, and other appropriate elements;(dddd)X-ray subsystem -any combination of two (2) or more components of an x-ray system for which there are requirements specified in this section and §§ 10854 and 10855;(eeee)X-ray system -an assemblage of components for the controlled production of x-rays. It includes minimally an x-ray high-voltage generator, an x-ray control, a tube housing assembly, a beam-limiting device, and the necessary supporting structures. Additional components which function with the system are considered integral parts of the system;(ffff)X-ray table -a patient support device with its patient support structure (tabletop) interposed between the patient and the image receptor during radiography or fluoroscopy. This includes, but is not limited to, any stretcher equipped with a radiolucent panel and any table equipped with a cassette tray (or bucky), cassette tunnel, fluoroscopic image receptor, or spot-film device beneath the tabletop; and(gggg)X-ray tube -any electron tube which is designed for the conversion of electrical energy into x-ray energy;10853.5Manufacturers of products subject to §§ 10853, 10854, and 10855 shall certify that each of their products meet all applicable requirements when installed into a diagnostic x-ray system according to instructions. This certification shall be made under the format specified in § 10845. Manufacturers may certify a combination of two (2) or more components if they obtain prior authorization in writing from the Department. Manufacturers shall not be held responsible for noncompliance of their products if that noncompliance is due solely to the improper installation or assembly of that product by another person; however, manufacturers are responsible for providing assembly instructions adequate to assure compliance of their components with the applicable provisions of §§ 10853, 10854, and 10855.
10853.6An assembler who installs one (1) or more components certified as required by § 10853.5 shall install certified components that are of the type required by § 10854 or § 10855 and shall assemble, install, adjust, and test the certified components according to the instructions of their respective manufacturers. Assemblers shall not be liable for noncompliance of a certified component if the assembly of that component was according to the component manufacturer's instruction.
10853.7All assemblers who install certified components shall file a report of assembly, except as specified in § 10853.8(a) through (d). The report will be construed as the assembler's certification and identification under §§ 10845 and 10846. The assembler shall affirm in the report that the manufacturer's instructions were followed in the assembly or that the certified components as assembled into the system meet all applicable requirements of §§ 10853 through 10855. All assembler reports must be on a form that the Department prescribes. Completed reports must be submitted to the Department and the purchaser within fifteen (15) days following completion of the assembly.
10853.8Reports of assembly need not be submitted for any of the following:
(a) Reloaded or replacement tube housing assemblies that are reinstalled in or newly assembled into an existing x-ray system;(b) Certified accessory components that have been identified as such to the Department in the report required under § 10808 of this chapter;(c) Repaired components, whether or not removed from the system and reinstalled during the course of repair, provided the original installation into the system was reported; or(d) Components installed temporarily in an x-ray system in place of components removed temporarily for repair, provided the temporarily installed component is identified by a tag or label bearing the following information: Temporarily Installed Component
This certified component has been assembled, installed, adjusted, and tested by me according to the instructions provided by the manufacturer.
Signature
Company Name
Street Address, P.O. Box
City, State, Zip Code
Date of Installation.
10853.9The replacement of the temporarily installed component by a component other than the component originally removed for repair shall be reported as specified in § 10853.6.
10853.10In addition to the identification requirements specified in § 10846 of this chapter, manufacturers of components subject to this section and §§ 10854 and 10855, except high-voltage generators contained within tube housings and beam-limiting devices that are integral parts of tube housings, shall permanently inscribe or affix thereon the model number and serial number of the product so that they are legible and accessible to view. The word "model" or "type" shall appear as part of the manufacturer's required identification of certified x-ray components. Where the certification of a system or subsystem, consisting of two or more components, has been authorized under § 10853.5, a single inscription, tag, or label bearing the model number and serial number may be used to identify the product.
10853.11In a similar manner, manufacturers of tube housing assemblies shall also inscribe or affix thereon the name of the manufacturer, model number, and serial number of the x-ray tube which the tube housing assembly incorporates.
10853.12Except as specified in § 10853.13, the replacement of an x-ray tube in a previously manufactured tube housing assembly certified under § 10853.5 constitutes manufacture of a new tube housing assembly, and the manufacturer is subject to the provisions of § 10853.10. The manufacturer shall remove, cover, or deface any previously affixed inscriptions, tags, or labels that are no longer applicable.
10853.13The requirements of § 10853.12 shall not apply to tube housing assemblies designed and designated by their original manufacturer to contain quick change x-ray tubes. The manufacturer of quick-change x-ray tubes shall include with each replacement tube a label with the tube manufacturer's name, the model, and serial number of the x-ray tube. The manufacturer of the tube shall instruct the assembler who installs the new tube to attach the label to the tube housing assembly and to remove, cover, or deface the previously affixed inscriptions, tags, or labels that are described by the tube manufacturer as no longer applicable.
10853.14Manufacturers of components listed in § 10853.1 shall provide to assemblers subject to § 10853.6 and, upon request, to others at a cost not to exceed the cost of publication and distribution, instructions for assembly, installation, adjustment, and testing of such components adequate to assure that the products will comply with applicable provisions of this section and §§ 10854 and 10855, when assembled, installed, adjusted, and tested as directed. Such instructions shall include specifications of other components compatible with that to be installed when compliance of the system or subsystem depends on their compatibility. Such specifications may describe pertinent physical characteristics of the components or may list by manufacturer model number the components which are compatible. For x-ray controls and generators manufactured after May 3, 1994, manufacturers shall provide:
(a) A statement of the rated line voltage and the range of line-voltage regulation for operation at maximum line current;(b) A statement of the maximum line current of the x-ray system based on the maximum input voltage and current characteristics of the tube housing assembly compatible with rated output voltage and rated output current characteristics of the x-ray control and associated high-voltage generator. If the rated input voltage and current characteristics of the tube housing assembly are not known by the manufacturer of the x-ray control and associated high-voltage generator, the manufacturer shall provide information necessary to allow the assembler to determine the maximum line current for the particular tube housing assembly(ies); and(c) A statement of the technique factors that constitute the maximum line current condition described in Paragraph (b).10853.15Manufacturers of x-ray equipment shall provide to purchasers and, upon request, to others at a cost not to exceed the cost of publication and distribution, manuals or instruction sheets which shall include the following technical and safety information:
(a) For x-ray equipment to which this section and §§ 10854 and 10855 are applicable, there shall be provided: (1) Adequate instructions concerning any radiological safety procedures and precautions which may be necessary because of unique features of the equipment; and(2) A schedule of the maintenance necessary to keep the equipment in compliance with this section and §§ 10854 and 10855.10853.16For each tube housing assembly, there shall be provided:
(a) Statements of the leakage technique factors for all combinations of tube housing assemblies and beam-limiting devices for which the tube housing assembly manufacturer states compatibility, the minimum filtration permanently in the useful beam expressed as millimeters (mm) of aluminum equivalent, and the peak tube potential at which the aluminum equivalent was obtained;(b) Cooling curves for the anode and tube housing; and(c) If the tube is designed to operate from different types of x-ray high-voltage generators (such as single-phase self-rectified, single-phase half-wave rectified, single-phase full-wave rectified, 3-phase 6-pulse, 3-phase 12-pulse, constant potential, capacitor energy storage) or under modes of operation such as alternate focal spot sizes or speeds of anode rotation which affect its rating, specific identification of the difference in ratings shall be noted.10853.17For the x-ray control and associated x-ray high-voltage generator, there shall be provided:
(a) A statement of the rated line voltage and the range of line-voltage regulation for operation at maximum line current;(b) A statement of the maximum line current of the x-ray system based on the maximum input voltage and output current characteristics of the tube housing assembly compatible with rated output voltage and rated current characteristics of the x-ray control and associated high-voltage generator. If the rated input voltage and current characteristics of the tube housing assembly are not known by the manufacturer of the x-ray control and associated high-voltage generator, the manufacturer shall provide necessary information to allow the purchaser to determine the maximum line current for his particular tube housing assembly(ies);(c) A statement of the technique factors that constitute the maximum line current condition described in § 10853.17(b) of this section;(d) In the case of battery-powered generators, a specification of the minimum stated of charge necessary for proper operation;(e) Generator rating and duty cycle;(f) A statement of the maximum deviation from the pre-indication given by labeled technique factor control settings or indicators during any radiographic or CT exposure where the equipment is connected to a power supply as described in accordance with this paragraph. In the case of fixed technique factors, the maximum deviation from the nominal fixed value of each factor shall be stated;(g) A statement of the maximum deviation from the continuous indication of x-ray tube potential and current during any fluoroscopic exposure when the equipment is connected to a power supply as described in accordance with this paragraph; and(h) A statement describing the measurement criteria for all technique factors used in § 10853.17(c), (f), and (g); for example, the beginning and endpoints of exposure time measured with respect to a certain percentage of the voltage waveform.10853.18For each variable-aperture beam-limiting device, there shall be provided:
(a) Leakage technique factors for all combinations of tube housing assemblies and beam-limiting devices for which the beam-limiting device manufacturer states compatibility; and(b) A statement including the minimum aluminum equivalent of that part of the device through which the useful beam passes and including the x-ray tube potential at which the aluminum equivalent was obtained. When two (2) or more filters are provided as part of the device, the statement shall include the aluminum equivalent of each filter.10853.19For x-ray systems manufactured on or after June 10, 2006, that produce images using the fluoroscopic image receptor, the following information shall be provided in a separate, single section of the user's instruction manual or in a separate manual devoted to this information:
(a) For each mode of operation, a description of the mode and detailed instructions on how the mode is engaged and disengaged. The description of the mode shall identify those technique factors and system controls that are fixed or automatically adjusted by selection of the mode of operation, including the manner in which the automatic adjustment is controlled. This information shall include how the operator can recognize which mode of operation has been selected prior to initiation of x-ray production; and(b) For each mode of operation, a descriptive example(s) of any specific clinical procedure(s) or imaging task(s) for which the mode is recommended or designed and how each mode should be used. Such recommendations do not preclude other clinical uses.10853.20For fluoroscopic x-ray systems manufactured on or after June 10, 2006, the following shall be provided:
(a) A schedule of maintenance for any system instrumentation associated with the display of air kerma information necessary to maintain the displays of AKR and cumulative air kerma within the limits of allowed uncertainty specified by § 10855.35 and, if the capability for user calibration of the display is provided, adequate instructions for such calibration;(b) Identification of the distances along the beam axis: (1) From the focal spot to the isocenter, and(2) From the focal spot to the reference location to which displayed values of AKR and cumulative air kerma refer according to § 10855.31(d).(c) A rationale for specification of a reference irradiation location alternative to fifteen centimeters (15 cm.) from the isocenter toward the x-ray source along the beam axis when such alternative specification is made according to § 10855.33.RESERVED
10853.22The control panel containing the main power switch shall bear the following warning statement, legible and accessible to view:
"Warning: This x-ray unit may be dangerous to patient and operator unless safe exposure factors, operating instructions and maintenance schedules are observed."
10853.23The leakage radiation from the diagnostic source assembly measured at a distance of one meter (1 m) in any direction from the source shall not exceed eighty-eight hundredths milligray (0.88 mGy) air kerma (vice one hundred milliroentgen (100 mR) exposure) in one (1) hour when the x-ray tube is operated at the leakage technique factors. If the maximum rated peak tube potential of the tube housing assembly is greater than the maximum rated peak tube potential for the diagnostic source assembly, positive means shall be provided to limit the maximum x-ray tube potential to that of the diagnostic source assembly. Compliance shall be determined by measurements averaged over an area of one hundred square centimeters (100 cm2) with no linear dimension greater than twenty centimeters (20 cm).
10853.24The radiation emitted by a component other than the diagnostic source assembly shall not exceed an air kerma of eighteen microGy (18 microGy) (vice two milliroentgen (2 mR) exposure) in one (1) hour at five centimeters (5 cm) from any accessible surface of the component when it is operated in an assembled x-ray system under any conditions for which it was designed. Compliance shall be determined by measurements averaged over an area of one hundred square centimeters (100 cm2) with no linear dimension greater than twenty centimeters (20 cm.).
10853.25The HVL of the useful beam for a given x-ray tube potential shall not be less than the appropriate value shown in Table 1 in this section under the heading "Specified Dental Systems," for any dental x-ray system designed for use with intraoral image receptors and manufactured after December 1, 1980; under the heading "I -- Other X-Ray Systems," for any dental x-ray system designed for use with intraoral image receptors and manufactured before December 1, 1980, and all other x-ray systems subject to this section and manufactured before June 10, 2006; and under the heading "II -- Other X-Ray Systems," for all x-ray systems, except dental x-ray systems designed for use with intraoral image receptors, subject to this section and manufactured on or after June 10, 2006. If it is necessary to determine such HVL at an x-ray tube potential which is not listed in table 1 in this subsection, linear interpolation or extrapolation may be made. Positive means2 shall be provided to ensure that at least the minimum filtration needed to achieve the above beam quality requirements is in the useful beam during each exposure. Table 1 follows:
Table 1. |
X-Ray Tube Voltage | Minimum HVL |
(kilovolt peak) | (mm of aluminum) |
Designed | Measured | Specified | I -- Other X- | II -- Other X- |
Operating | Operating | Dental | Ray Systems3 | Ray Systems4 |
Range | Potential | Systems5 |
Below 51 | 30 | 1.5 | 0.3 | 0.3 |
40 | 1.5 | 0.4 | 0.4 |
50 | 1.5 | 0.5 | 0.5 |
51 to 70 | 51 | 1.5 | 1.2 | 1.3 |
60 | 1.5 | 1.3 | 1.5 |
70 | 1.5 | 1.5 | 1.8 |
Above 70 | 71 | 2.1 | 2.1 | 2.5 |
80 | 2.3 | 2.3 | 2.9 |
90 | 2.5 | 2.5 | 3.2 |
100 | 2.7 | 2.7 | 3.6 |
110 | 3.0 | 3.0 | 3.9 |
120 | 3.2 | 3.2 | 4.3 |
130 | 3.5 | 3.5 | 4.7 |
140 | 3.8 | 3.8 | 5.0 |
150 | 4.1 | 4.1 | 5.4 |
10853.26Fluoroscopic systems manufactured on or after June 10, 2006, incorporating an x-ray tube(s) with a continuous output of one kilowatt (1 kW) or more and an anode heat storage capacity of one million (1,000,000) heat units or more shall provide the option of adding x-ray filtration to the diagnostic source assembly in addition to the amount needed to meet the HVL provisions of § 10853.25. The selection of this additional x-ray filtration shall be either at the option of the user or automatic as part of the selected mode of operation. A means of indicating which combination of additional filtration is in the x-ray beam shall be provided.
10853.27For capacitor energy storage equipment, compliance shall be determined with the maximum selectable quantity of charge per exposure.
10853.28Except when used in a CT x-ray system, the aluminum equivalent of each of the items listed in Table 2 in Paragraph (n) of this section, which are used between the patient and image receptor, may not exceed the indicated limits. Compliance shall be determined by x-ray measurements made at a potential of 100 kilovolts peak and with an x-ray beam that has an HVL specified in table 1 in § 10853.25 for the potential. This requirement applies to front panel(s) of cassette holders and film changers provided by the manufacturer for patient support or for prevention of foreign object intrusions. It does not apply to screens and their associated mechanical support panels or grids. Table 2 follows:
Table 2. |
Item | Maximum Aluminum |
Equivalent (millimeters) |
1. Front panel(s) of cassette holders (total of all) | 1.2 |
2. Front panel(s) of film changer (total of all) | 1.2 |
3. Cradle | 2.3 |
4. Tabletop, stationary, without articulated joints | 1.2 |
5. Tabletop, movable, without articulated joint(s) (including stationary subtop) | 1.7 |
6. Tabletop, with radiolucent panel having one articulated joint | 1.7 |
7. Tabletop, with radiolucent panel having two or more articulated joints | 2.3 |
8. Tabletop, cantilevered | 2.3 |
9. Tabletop, radiation therapy simulator | 5.0 |
10853.29On battery-powered generators, visual means shall be provided on the control panel to indicate whether the battery is in a state of charge adequate for proper operation.
10853.31Diagnostic x-ray components and systems certified in accordance with § 10845 of this chapter shall not be modified such that the component or system fails to comply with any applicable provision of this chapter unless a variance in accordance with § 10847 of this chapter or an exemption under 21 U.S.C. §§ 360kk(a)(5) or 360oo(b) of the act, has been granted.
10853.32The owner of a diagnostic x-ray system who uses the system in a professional or commercial capacity may modify the system, provided the modification does not result in the failure of the system or component to comply with the applicable requirements of this section or of §§ 10854 and 10855. The owner who causes such modification need not submit the report, provided the owner records the date and the details of the modification in the system records and maintains this information, and provided the modification of the x-ray system does not result in a failure to comply with §§ 10854 and 10855.
1 n1 The nominal chemical composition of type 1100 aluminum alloy is ninety-nine percent (99 %) minimum aluminum, twelve hundredths percent (0.12%) of copper, as given in "Aluminum Standards and Data" (§ 11069). Copies may be obtained from The Aluminum Association, New York, NY.
2In the case of a system, which is to be operated with more than one (1) thickness of filtration, this requirement can be met by a filter interlocked with the kilovoltage selector which will prevent x ray emissions if the minimum required filtration is not in place.
3Dental x ray systems designed for use with intraoral image receptors and manufactured before or on December 1, 1980, and all other x ray systems subject to this section and manufactured before June 10, 2006.
4All x ray systems, except dental x ray systems designed for use with intraoral image receptors, subject to this section and manufactured on or after June 10, 2006.
5Dental x ray systems designed for use with intraoral image receptors and manufactured after December 1, 1980.
D.C. Mun. Regs. tit. 22, r. 22-B10853
Final Rulemaking published at 60 DCR 10252 (July 12, 2013)Authority: Section 19(a)(3) of the District of Columbia Pharmacist and Pharmacy Regulation Act of 1980, effective September 16, 1980 (D.C. Law 3-98; D.C. Official Code § 47-2885.18(a)(3) (2005 Repl.)); Mayor's Order 98-48, dated April 15, 1998; Section 4902 of the Fiscal Year 2002 Budget Support Act of 2001, effective October 3, 2001 (D.C. Law 14-28; D.C. Official Code § 7-731 (2008 Repl.)); Section 15 of the District of Columbia Medical Device Manufacture and Distribution Licensure Act of 1990, effective June 13, 1990 (D.C. Law 8-137; D.C. Official Code § 48-714(a) (2005 Repl.)); and Mayor's Order 98-88, dated May 29, 1998.