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appropriate elements when they are con interposed between the patient and the tained within the tube housing
image receptor during radiography and or Tube rating chart means the set of curves fluoroscopy. This includes, but is not limited which specify the rated limits of operation of to, any stretcher equipped with a radiolucent the tube in terms of the technique factors. panel and any table equipped with a cassette
Useful beam means the radiation which tray (or bucky), cassette tunnel, fluoroscopic passes through the tube housing port and the image receptor, or spot-film device beneath aperture of the beam-limiting device when the tabletop. the exposure switch or timer is activated.
X-ray tube means any electron tube which Variable-aperture beam-limiting device means is designed for the conversion of electrica a beam-limiting device which has the capac energy into x-ray energy. ity for stepless adjustment of the x-ray field (c) Manufacturers' responsibility. Manufacsize at a given SID.
turers of products subject to $$ 1020.30 Visible area means the portion of the input through 1020.33 shall certify that each of surface of the image receptor over which in their products meet all applicable require cident x-ray photons are producing a visible ments when installed into a diagnostic x-ray image.
system according to instructions. This cerX-ray control means a device which con tification shall be made under the format trols input power to the x-ray high-voltage specified in $ 1010.2 of this chapter. Manufacgenerator and/or the x-ray tube. It includes turers may certify a combination of two or equipment such as timers, phototimers, more components if they obtain prior auautomatic brightness stabilizers, and similar thorization in writing from the Director of devices, which control the technique factors the Office of Compliance of the Center for of an x-ray exposure.
Devices and Radiological Health (CDRH.. X-ray equipment means an x-ray system, Manufacturers shall not be held responsible subsystem, or component thereof. Types of for noncompliance of their products if that x-ray equipment are as follows:
noncompliance is due solely to the improper (1) Mobile I-ray equipment means X-ray installation or assembly of that product by equipment mounted on a permanent base another person; however, manufacturers are with wheels and/or casters for moving while responsible for providing assembly instruccompletely assembled;
tions adequate to assure compliance of their (2) Portable X-ray equipment means x-ray components with the applicable provisions of equipment designed to be hand-carried; and $$ 1020.30 through 1020.33.
(3) Stationary x-ray equipment means x-ray (d) Assemblers' responsibility. An assembler equipment which is installed in a fixed loca who installs one or more components certion.
tified as required by paragraph (C) of this X-ray field means that area of the intersec section shall install certified components tion of the useful beam and any one of the that are of the type required by $ 1020.31. set of planes parallel to and including the 1020.32, or 1020.33 and shall assemble, install. plane of the image receptor, whose perimeter adjust, and test the certified components acis the locus of points at which the AKR is cording to the instructions of their respecone-fourth of the maximum in the intersec tive manufacturers. Assemblers shall not be tion.
liable for noncompliance of a certified comX-ray high-voltage generator means a device ponent if the assembly of that component which transforms electrical energy from the was according to the component manufacturpotential supplied by the x-ray control toer's instruction. the tube operating potential. The device may (1) Reports of assembly. All assemblers who also include means for transforming alter- install certified components shall file a re nating current to direct current, filament port of assembly, except as specified in para transformers for the x-ray tube(s), high-volt graph (d)(2) of this section. The report wi! age switches, electrical protective devices, be construed as the assembler's certification and other appropriate elements.
and identification under $8 1010.2 and 1010.3 of X-ray subsystem means any combination of this chapter. The assembler shall affirm in two or more components of an x-ray system the report that the manufacturer's instruc for which there are requirements specified in tions were followed in the assembly or that this section and $S 1020.31 and 1020.32.
the certified components as assembled into X-ray system means an assemblage of com the system meet all applicable requirements ponents for the controlled production of x of $1020.30 through 1020.33. All assembler le rays. It includes minimally an x-ray high ports must be on a form prescribed by the voltage generator, an x-ray control, a tube Director, CDRH. Completed reports must be housing assembly, a beam-limiting device, submitted to the Director, the purchaser. and the necessary supporting structures. Ad and, where applicable, to the State agency ditional components which function with the responsible for radiation protection within 1 system are considered integral parts of the days following completion of the assembly. system.
(2) Erceptions to reporting requirements. Re X-ray table means a patient support device ports of assembly need not be submitted for with its patient support structure (tabletop) any of the following:
Reloaded or replacement tube housing mblies that are reinstalled in or newly mbled into an existing x-ray system; ) Certified accessory components that e been identified as such to CDRH in the rt required under $1002.10 of this chap
i) Repaired components, whether or not oved from the system and reinstalled ng the course of repair, provided the inal installation into the system was reced; or
(A) Components installed temporarily -n X-ray system in place of components oved temporarily for repair, provided the porarily installed component is identiby a tag or label bearing the following rmation: aporarily Installed Component s certified component has been assem1, installed, adjusted, and tested by me ording to the instructions provided by the
ufacturer. nature mpany Name eet Address, P.O. Box y, State, Zip Code ce of Installation B) The replacement of the temporarily inlled component by a component other n the component originally removed for air shall be reported as specified in paraph (d)(1) of this section. e) Identification of r-ray components. In adion to the identification requirements cified in $1010.3 of this chapter, manufacers of components subject to this section
$1020.31, 1020.32, and 1020.33, except hightage generators contained within tube sings and beam-limiting devices that are egral parts of tube housings, shall permaatly inscribe or affix thereon the model mber and serial number of the product so at they are legible and accessible to view. e word "model" or "type" shall appear as rt of the manufacturer's required identiation of certified x-ray components. here the certification of a system or substem, consisting of two or more compoats, has been authorized under paragraph
of this section, a single inscription, tag, label bearing the model number and serial mber may be used to identify the product. 1) Tube housing assemblies. In a similar enner, manufacturers of tube housing asmblies shall also inscribe or affix thereon
name of the manufacturer, model numr, and serial number of the x-ray tube nich the tube housing assembly incorrates. 2) Replacement of tubes. Except as specified
paragraph (e)(3) of this section, the reacement of an x-ray tube in a previously anufactured tube housing assembly ceried under paragraph (c) of this section conitutes manufacture of a new tube housing
assembly, and the manufacturer is subject to the provisions of paragraph (e)(1) of this section. The manufacturer shall remove, cover, or deface any previously affixed inscriptions, tags, or labels that are no longer applicable.
(3) Quick-change x-ray tubes. The requirements of paragraph (e)(2) of this section 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 xray 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.
(g) Information to be provided to assemblers. Manufacturers of components listed in paragraph (a)(1) of this section shall provide to assemblers subject to paragraph (d) of this section 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 $$ 1020.31, 1020.32, and 1020.33, 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 and/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:
(1) A statement of the rated line voltage and the range of line-voltage regulation for operation at maximum line current;
(2) 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);
(3) A statement of the technique factors that constitute the maximum line current condition described in paragraph (g)(2) of this section.
(h) Information to be provided to users. Man- condition described in paragraph (h)(3Xii) a ufacturers of x-ray equipment shall provide this section; to purchasers and, upon request, to others at (iv) In the case of battery-powered genera a cost not to exceed the cost of publication tors, a specification of the minimum state a and distribution, manuals or instruction charge necessary for proper operation; sheets which shall include the following
(v) Generator rating and duty cycle; technical and safety information:
(vi) A statement of the maximum den (1) All X-ray equipment. For X-ray equip
ation from the preindication given by la ment to which this section and SS 1020.31,
beled technique factor control settings or in 1020.32, and 1020.33 are applicable, there shall
dicators during any radiographic or CT expo be provided:
sure where the equipment is connected to a (i) Adequate instructions concerning any
power supply as described in accordance with radiological safety procedures and pre this paragraph. In the case of fixed technique cautions which may be necessary because of
factors, the maximum deviation from the unique features of the equipment; and
nominal fixed value of each factor shall be (ii) A schedule of the maintenance nec
stated; essary to keep the equipment in compliance
(vii) A statement of the maximum deviwith this section and $$ 1020.31, 1020.32, and
ation from the continuous indication of I1020.33.
ray tube potential and current during any (2) Tube housing assemblies. For each tube
fluoroscopic exposure when the equipment is housing assembly, there shall be provided: (i) Statements of the leakage technique
connected to a power supply as described in factors for all combinations of tube housing
accordance with this paragraph; and assemblies and beam-limiting devices for
(viii) A statement describing the measurewhich the tube housing assembly manufac
ment criteria for all technique factors used turer states compatibility, the minimum fil
in paragraphs (h)(3)(iii), (h)(3)(vi), and tration permanently in the useful beam ex
(h)(3)(vii) of this section, for example, the bepressed as millimeters (mm) of aluminum
ginning and endpoints of exposure time equivalent, and the peak tube potential at
measured with respect to a certain percentwhich the aluminum equivalent was ob
age of the voltage waveform. tained;
(4) Beam-limiting device. For each variable (ii) Cooling curves for the anode and tube
aperture beam-limiting device, there shall be housing; and
provided; (iii) Tube rating charts. If the tube is de (i) Leakage technique factors for all consigned to operate from different types of x binations of tube housing assemblies ari ray high-voltage generators (such as single beam-limiting devices for which the bear phase self rectified, single-phase half-wave limiting device manufacturer states compatrectified, single-phase full-wave rectified, 3- ibility; and phase 6-pulse, 3-phase 12-pulse, constant po- (ii) A statement including the minimu
ial. capacitor energy storage) or under aluminum equivalent of that part of the de modes of operation such as alternate focal vice through which the useful beam passes spot sizes or speeds of anode rotation which and including the x-ray tube potential at affect its rating, specific identification of which the aluminum equivalent was obthe difference in ratings shall be noted.
tained. When two or more filters are pro(3) X-ray controls and generators. For the x vided as part of the device, the statement ray control and associated x-ray high-volt shall include the aluminum equivalent of age generator, there shall be provided:
each filter (i) A statement of the rated line voltage (5) Imaging system information. For X-ray and the range of line-voltage regulation for systems manufactured on or after June 10. operation at maximum line current;
2006, that produce images using the (ii) A statement of the maximum line cur fluoroscopic image receptor, the following rent of the x-ray system based on the max information shall be provided in a separate. imum input voltage and output current char- single section of the user's instruction manacteristics of the tube housing assemblyual or in a separate manual devoted to this compatible with rated output voltage and information: rated current characteristics of the x-ray (i) For each mode of operation, a descripcontrol and associated high-voltage gener- tion of the mode and detailed instructions ob ator. If the rated input voltage and current how the mode is engaged and disengaged characteristics of the tube housing assembly The description of the mode shall identify are not known by the manufacturer of the x those technique factors and system controls ray control and associated high-voltage gen that are fixed or automatically adjusted by erator, the manufacturer shall provide nec- selection of the mode of operation, including essary information to allow the purchaser to the manner in which the automatic adjustdetermine the maximum line current for his ment is controlled. This information shail particular tube housing assembly(ies);
include how the operator can recognize (iii) A statement of the technique factors which mode of operation has been selected that constitute the maximum line current prior to initiation of x-ray production.
For each mode of operation, a descripexample(s) of any specific clinical proces) or imaging task(s) for which the is recommended or designed and how mode should be used. Such recendations do not preclude other clinical
Displays of values of AKR and cumulative erma. For fluoroscopic X-ray systems ifactured on or after June 10, 2006, the wing shall be provided: A schedule of maintenance for any sysinstrumentation associated with the disof air kerma information necessary to tain the displays of AKR and cumue air kerma within the limits of allowed rtainty specified by $ 1020.32(k)(6) and, if apability for user calibration of the disis provided, adequate instructions for calibration;
Identification of the distances along leam axis:
From the focal spot to the isocenter,
From the focal spot to the reference loon to which displayed values of AKR and ulative air kerma refer according to D.32(k)(4); i) A rationale for specification of a refce irradiation location alternative to 15 from the isocenter toward the x-ray ce along the beam axis when such alterve specification is made according to 0.32(k)(4)(ii). [Reserved] Warning label. The control panel coning the main power switch shall bear the ning statement, legible and accessible to
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 100 square cm with no linear dimension greater than 20 cm.
(1) Radiation from components other than the diagnostic source assembly. The radiation emitted by a component other than the diagnostic source assembly shall not exceed an air kerma of 18 microGy (vice 2 mR exposure) in 1 hour at 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 100 square cm with no linear dimension greater than 20 cm.
(m) Beam quality-(1) Half-value layer (HVL). The 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 paragraph (m)(1) of 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 xray 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 paragraph (m)(1) of this section, linear interpolation or extrapolation may be made. Positive means 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:
Varning: This x-ray unit may be danus to patient and operator unless safe sure factors, operating instructions and ntenance schedules are observed." :) Leakage radiation from the diagnostic ce assembly. The leakage radiation from diagnostic source assembly measured at stance of 1 meter in any direction from source shall not exceed 0.88 milligray y) air kerma (vice 100 milliroentgen 1) exposure) in 1 hour when the x-ray tube perated at the leakage technique factors. le maximum rated peak tube potential of
tube housing assembly is greater than maximum rated peak tube potential for diagnostic source assembly, positive
2 In the case of a system, which is to be operated with more than one 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.
Dental X-ray systems designed for use with intraoral image receptors and manufactured after December 1, 1980. 2 Dental 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.
3 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.