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Stationary tabletop means a tabletop has the capacity for stepless adjustwhich, when assembled for use, is in- ment of the X-ray field size at a given capable of movement with respect to
SID. its supporting structure within the Visible area means the portion of the plane of the tabletop.
input surface of the image receptor Technique factors means the following over which incident x-ray photons are conditions of operation:
producing a visible image. (1) For capacitor energy storage X-ray control means a device which equipment, peak tube potential in kilo controls input power to the x-ray highvolts (kV) and quantity of charge in voltage generator and/or the X-ray milliamperes-seconds (mAs);
tube. It includes equipment such as (2) For field emission equipment timers, phototimers, automatic brightrated for pulsed operation, peak tube ness stabilizers, and similar devices. potential in kV and number of x-ray which control the technique factors of pulses;
an x-ray exposure. (3) For CT equipment designed for X-ray equipment means an x-ray syspulsed operation, peak tube potential tem, subsystem, or component thereof. in kV, scan time in seconds, and either Types of x-ray equipment are as foltube current in milliamperes (mA), x- lows: ray pulse width in seconds, and the (1) Mobile x-ray equipment means inumber of x-ray pulses per scan, or the ray equipment mounted on a permaproduct of the tube current, x-ray pulse nent base with wheels and/or casters width, and the number of x-ray pulses for moving while completely assemin mAs;
bled; (4) For CT equipment not designed (2) Portable r-ray equipment means Xfor pulsed operation, peak tube poten- ray equipment designed to be hand-cartial in kV, and either tube current in ried; and mA and scan time in seconds, or the (3) Stationary I-ray equipment means product of tube current and exposure x-ray equipment which is installed in a time in mas and the scan time when 'fixed location. the scan time and exposure time are X-ray field means that area of the equivalent; and
intersection of the useful beam and any (5) For all other equipment, peak one of the set of planes parallel to and tube potential in kV, and either tube including the plane of the image recepcurrent in ma and exposure time in tor, whose perimeter is the locus of seconds, or the product of tube current points at which the exposure rate is and exposure time in mAs.
one-fourth of the maximum in the Tomogram means the depiction of the intersection. X-ray attenuation properties of a sec X-ray high-voltage generator means a tion through a body.
device which transforms electrical enTube means an X-ray tube, unless ergy from the potential supplied by the otherwise specified.
x-ray control to the tube operating poTube housing assembly means the tube tential. The device may also include housing with tube installed. It includes means for transforming alternating high-voltage and/or filament trans- current to direct current, filament formers and other appropriate ele transformers for the X-ray tube(s), ments when they are contained within high-voltage switches, electrical prothe tube housing.
tective devices, and other appropriate Tube rating chart means the set of elements. curves which specify the rated limits of X-ray system means an assemblage of operation of the tube in terms of the components for the controlled productechnique factors.
tion of x-rays. It includes minimally an Useful beam means the radiation X-ray high-voltage generator, an X-ray which passes through the tube housing control, a tube housing assembly, a port and the aperture of the beam-lim- beam-limiting device, and the neciting device when the exposure switch essary supporting structures. Addior timer is activated.
tional components which function with Variable-aperture beam-limiting device the system are considered integral means a beam-limiting device which parts of the system.
X-ray subsystem means any combinaion of two or more components of an (-ray system for which there are requirements specified in this section und $8 1020.31 and 1020.32.
X-ray table means a patient support levice with its patient support strucure (tabletop) interposed between the atient and the image receptor during adiography and/or fluoroscopy. This ncludes, but is not limited to, any tretcher equipped with a radiolucent anel and any table equipped with a assette tray (or bucky), cassette tunel, image intensifier, or spot-film deice beneath the tabletop.
X-ray tube means any electron tube rhich is designed for the conversion of lectrical energy into x-ray energy. (C) Manufacturers' responsibility. Manfacturers of products subject to $ 1020.30 through 1020.33 shall certify hat each of their products meet all aplicable requirements when installed nto a diagnostic x-ray system accordng to instructions. This certification hall be made under the format speciied in $1010.2 of this chapter. Manufacurers may certify a combination of wo or more components if they obtain rior authorization in writing from the Director of the Office of Compliance nd Surveillance of the Center for Deices and Radiological Health. Manuacturers shall not be held responsible or noncompliance of their products if hat noncompliance is due solely to the mproper installation or assembly of hat product by another person; howver, manufacturers are responsible for roviding assembly instructions adeluate to assure compliance of their omponents with the applicable proviions of $$ 1020.30 through 1020.33.
(d) Assemblers' responsibility. An asembler who installs one or more comjonents certified as required by pararaph (c) of this section shall install ertified components that are of the ype required by $$ 1020.31, 1020.32, or 020.33 and shall assemble, install, adust, and test the certified components ccording to the instructions of their espective manufacturers. Assemblers hall not be liable for noncompliance of
certified component if the assembly if that component was according to he component manufacturer's instruc
(1) Reports of assembly. All assemblers who install certified components shall file a report of assembly, except as specified in paragraph (d)(2) of this section. The report will be construed as the assembler's certification and identification under $$ 1010.2 and 1010.3 of this chapter. 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 S$ 1020.30 through 1020.33. All assembler reports must be on a form prescribed by and available from the Director, Center for Devices and Radiological Health, 9200 Corporate Blvd., Rockville, MD 20850. Completed reports must be submitted to the Director, the purchaser, and, where applicable, to the State agency responsible for radiation protection within 15 days following completion of the assembly.
(2) Exceptions to reporting requirements. Reports of assembly need not be submitted for any of the following:
(i) Reloaded or replacement tube housing assemblies that are reinstalled in or newly assembled into an existing X-ray system;
(ii) Certified accessory components that have been identified as such to the Center for Devices and Radiological Health in the report required under $1002.10 of this chapter;
(iii) 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
(iv) 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
The replacement of the temporarily tube a label with the tube manufacturinstalled component by a component er's name, the model, and serial numother than the component originally ber of the x-ray tube. The manufacremoved for repair shall be reported as turer of the tube shall instruct the asspecified in paragraph (d)(1) of this sec- sembler who installs the new tube to tion.
attach the label to the tube housing as(e) Identification of x-ray components. sembly and to remove, cover, or deface In addition to the identification re the previously affixed inscriptions, quirements specified in $1010.3 of this tags, or labels that are described by the chapter, manufacturers of components tube manufacturer as no longer applisubject to this section and $8 1020.31, cable. 1020.32, and 1020.33, except high-voltage
(f) [Reserved] generators contained within tube
(g) Information to be provided to assemhousings and beam-limiting devices
blers. Manufacturers of components that are integral parts of tube
listed in paragraph (a)(1) of this section housings, shall permanently inscribe or
shall provide to assemblers subject to affix thereon the model number and se
paragraph (d) of this section and, upon rial number of the product so that they
request, to others at a cost not to exare legible and accessible to view. The
ceed the cost of publication and disword "model" or "type" shall appear
tribution, instructions for assembly, as part of the manufacturer's required
installation, adjustment, and testing of identification of certified x-ray compo
such components adequate to assure nents. Where the certification of a sys
that the products will comply with aptem or subsystem, consisting of two or
plicable provisions of this section and more components, has been authorized
$$ 1020.31, 1020.32, and 1020.33, when aspursuant to paragraph (c) of this sec
sembled, installed, adjusted, and tested tion, a single inscription, tag, or label
as directed. Such instructions shall inbearing the model number and serial
clude specifications of other componumber may be used to identify the
nents compatible with that to be inproduct.
stalled when compliance of the system (1) Tube housing assemblies. In a similar manner, manufacturers of tube
or subsystem depends on their compat
ibility. Such specifications may dehousing assemblies shall also inscribe or affix thereon the name of the manu
scribe pertinent physical characteris
tics of the components and/or may list facturer, model number, and serial number of the x-ray tube which the
by manufacturer model number the tube housing assembly incorporates.
components which are compatible. For (2) Replacement of tubes. Except as
x-ray controls and generators manufacspecified in paragraph (e)(3) of this sec
tured after May 3, 1994, manufacturers tion, the replacement of an x-ray tube
shall provide: in a previously manufactured tube
(1) A statement of the rated line volthousing assembly certified pursuant to
age and the range of line-voltage reguparagraph (c) of this section con- lation for operation at maximum line stitutes manufacture of a new tube
current; housing assembly, and the manufac (2) A statement of the maximum line turer is subject to the provisions of current of the x-ray system based on paragraph (e)(1) of this section. The the maximum input voltage and curmanufacturer shall remove, cover, or rent characteristics of the tube hous
ace any previously affixed inscrip- ing assembly compatible with rated tions, tags, or labels, that are no output voltage and rated output curlonger applicable.
rent characteristics of the x-ray con(3) Quick-change r-ray tubes. The re- trol and associated high-voltage generquirements of paragraph (e)(2) of this ator. If the rated input voltage and section shall not apply to tube housing current characteristics of the tube assemblies designed and designated by housing assembly are not known by the their original manufacturer to contain manufacturer of the x-ray control and quick change x-ray tubes. The manu- associated high-voltage generator, he facturer of quick-change x-ray tubes shall provide necessary information to shall include with each replacement allow the assembler to determine the
aximum line current for the parcular tube housing assembly(ies); (3) A statement of the technique facrs that constitute the maximum line arrent condition described in para-aph (g)(2) of this section. (h) Information to be provided to users. anufacturers of x-ray equipment all provide to purchasers and, upon quest, to others at a cost not to exred the cost of publication and disibution, manuals or instruction veets which shall include the folwing technical and safety informaon: (1) All I-ray equipment. For X-ray quipment to which this section and 1020.31, 1020.32, and 1020.33 are applible, there shall be provided: (i) Adequate instructions concerning
y radiological safety procedures and recautions which may be necessary ecause of unique features of the equipent; and (ii) A schedule of the maintenance ecessary to keep the equipment in ompliance with this section and 1020.31, 1020.32, and 1020.33. (2) Tube housing assemblies. For each abe housing assembly, there shall be rovided: (i) Statements of the leakage techque factors for all combinations of ibe housing assemblies and beam-liming devices for which the tube housig assembly manufacturer states comitibility, the minimum filtration perLanently in the useful beam expressed 3 millimeters of aluminum equivant, and the peak tube potential at hich the aluminum equivalent was btained; (ii) Cooling curves for the anode and ibe housing; and (iii) Tube rating charts. If the tube is esigned to operate from different ypes of x-ray high-voltage generators uch as single-phase self rectified, sinle-phase half-wave rectified, singlehase full-wave rectified, 3-phase 6alse, 3-phase 12-pulse, constant potenal, capacitor energy storage) or under lodes of operation such as alternate cal spot sizes or speeds of anode rotaon which affect its rating, specific lentification of the difference in ratigs shall be noted.
(3) X-ray controls and generators. For he x-ray control and associated x-ray
high-voltage generator, there shall be provided:
(i) A statement of the rated line voltage and the range of line-voltage regulation for operation at maximum line current;
(ii) 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);
(iii) A statement of the technique factors that constitute the maximum line current condition described in paragraph (h)(3)(ii) of this section;
(iv) In the case of battery-powered generators, a specification of the minimum state of charge necessary for proper operation;
(v) Generator rating and duty cycle;
(vi) A statement of the maximum deviation from the preindication 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;
(vii) 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
(viii) A statement describing the measurement criteria for all technique factors used in paragraphs (h)(3)(iii), (h)(3)(vi), and (h)(3)(vii) of this section; for example, the beginning and endpoints of exposure time measured with respect to a certain percentage of the voltage waveform.
(4) Beam-limiting device. For each averaged over an area of 100 square variable-aperture beam-limiting de- centimeters with no linear dimension vice, there shall be provided;
greater than 20 centimeters. (i) Leakage technique factors for all (m) Beam quality—(1) Half-value layer. combinations of tube housing assem The half-value layer (HVL) of the useblies and beam-limiting devices for ful beam for a given x-ray tube potenwhich the beam-limiting device manu tial shall not be less than the approfacturer states compatibility; and
priate value shown in table I under (ii) A statement including the min “Specified dental systems," for any imum aluminum equivalent of that dental x-ray system designed for use part of the device through which the with intraoral image receptors and useful beam passes and including the x- manufactured after December 1, 1980; ray tube potential at which the alu- and under “Other x-ray systems," for minum equivalent was obtained. When all other x-ray systems subject to this two or more filters are provided as part section. If it is necessary to determine of the device, the statement shall in such HVL at an x-ray tube potential clude the aluminum equivalent of each which is not listed in table I, linear infilter.
terpolation or extrapolation may be (i) [Reserved]
made. Positive means 2 shall be pro(j) Warning label. The control panel vided to insure that at least the mincontaining the main power switch shall imum filtration needed to achieve the bear the warning statement, legible above beam quality requirements is in and accessible to view:
the useful beam during each exposure. “Warning: This x-ray unit may be dan
TABLE gerous to patient and operator unless safe exposure factors and operating instructions
X-ray tube voltage (kilovolt peak) Minimum HVL (mill are observed."
meters of aluminum)
Measured (k) Leakage radiation from the diag Designed operating
Specified Other X operating
range nostic source assembly. The leakage radi
ray sys systems
tems ation from the diagnostic source as
Below 51 ........... sembly measured at a distance of i
04 meter in any direction from the source shall not exceed 2.58x10-5 coulombs per 51 to 70 ......... kilogram (C/kg) (100 milliroentgens (mR)) in 1 hour when the x-ray tube is
Above 70 operated at the leakage technique fac
2.3 tors. If the maximum rated peak tube
2.5 potential of the tube housing assembly
3.0 is greater than the maximum rated
3.2 peak tube potential for the diagnostic
3.51 source assembly, positive means shall
150 be provided to limit the maximum xray tube potential to that of the diag
(2) Measuring compliance. For capacnostic source assembly. Compliance
itor energy storage equipment, complishall be determined by measurements
ance shall be determined with the maxaveraged over an area of 100 square
imum selectable quantity of charge per centimeters with no linear dimension
exposure. greater than 20 centimeters.
(n) Aluminum equivalent of material be(1) Radiation from components other
tween patient and image receptor. Except than the diagnostic source assembly. The
when used in a CT x-ray system, the radiation emitted by a component
aluminum equivalent of each of the other than the diagnostic source as
items listed in table II, which are used sembly shall not exceed 5.16x10 -7 C/kg (2 mR) in 1 hour at 5 centimeters from
2 In the case of a system which is to be opany accessible surface of the compo
erated with more than one thickness of filnent when it is operated in an assem
tration, this requirement can be met by a illbled x-ray system under any conditions ter interlock with the kilovoltage selector for which it was designed. Compliance which will prevent x-ray emission is the minshall be determined by measurements imum required filtration is not in place.