| (H) Radiation machines needing correction or repair.
The correction or repair shall begin within 30 days following the
failure and the registrant shall perform or cause to be performed
the correction or repair according to a designated plan. Correction
or repair shall be completed no longer than 90 days from discovery
unless authorized in writing by the agency.
(I) Records of radiation machine corrections or repairs.
The registrant shall maintain records of corrections or repairs and
any tests, measurements or numerical readings listed in subparagraph
(J) of this paragraph in accordance with subsection (k)(2) of this
section for inspection by the agency.
(J) Equipment performance evaluations (EPE).
(i) For all dental radiation machines, the registrant
shall perform, or cause to be performed, EPE tests for each item specified
in clauses (v) - (xi) of this subparagraph as follows:
(I) within 30 days after initial installation of radiation
machines:
(II) within 30 days after reinstallation of a radiation
machine; and
(III) within 30 days after repair of a radiation machine
component that would affect the radiation output that includes, but
is not limited to, the timer, tube, and power supply.
(ii) Frequency of EPE. For x-ray and CT systems, an
EPE shall be performed at the frequency listed in the following table.
Attached Graphic
(iii) Records of the EPE results shall be available
for inspection by the agency and shall include the following:
(I) measurements and numerical readings;
(II) indication of pass or fail for each test; and
(III) maintenance by the registrant in accordance with
subsection (k)(2) of this section for inspection by the agency.
(iv) Radiation machines needing correction or repair.
If a radiation machine requires correction or repair following an
EPE, the correction or repair shall begin within 30 days following
the failure and the registrant shall perform or cause to be performed
the correction or repair according to a designated plan. Correction
or repair shall be completed no longer than 90 days from discovery
unless authorized in writing by the agency.
(v) Timer.
(I) The accuracy of the timer shall meet the manufacturer's
specifications. If the manufacturer's specifications are not obtainable,
the timer accuracy shall be plus or minus 10% of the indicated time
with testing performed at 0.5 second.
(II) Means shall be provided to terminate the exposure
at a preset time interval, a preset product of current and time, a
preset number of pulses, or a preset radiation exposure to the image
receptor. In addition, it shall not be possible to make an exposure
when the timer is set to a "zero" or "off" position if either position
is provided.
(vi) Exposure reproducibility. When all technique factors
are held constant, including control panel selections associated with
automatic exposure control systems, the coefficient of variation of
exposure for both manual and automatic exposure control systems shall
not exceed 0.05. This requirement applies to clinically used techniques.
(vii) Kilovolt peak. If the registrant possesses documentation
of the appropriate manufacturer's kilovolt peak specifications, the
radiation machine shall meet those specifications. If the registrant
does not possess documentation of the appropriate manufacturer's kilovolt
peak specifications, the indicated kilovolt peak shall be accurate
to within plus or minus 10% of the indicated settings. For radiation
machines with fewer than three fixed kilovolt peak settings, the radiation
machine shall be checked at those settings.
(viii) Tube stability. The x-ray tube shall remain
physically stable during exposures. In cases where tubes are designed
to move during exposure, the registrant shall assure proper and free
movement of the radiation machine.
(ix) Collimation. Field limitation shall meet the requirements
of paragraphs (9) and (10) of this subsection.
(x) Entrance exposure limits (air kerma limits) for
dental facilities. The in-air exposure (entrance air kerma) for an
adult bite wing view shall be determined from the exposure technique
used by the registrant for the average adult patient. The in-air exposure
(entrance air kerma) for intraoral (bite wing) dental radiography
shall not exceed the following entrance exposure limits (air kerma
limits):
Attached Graphic
(xi) Measurements of the radiation output for a radiation
machine. Measurements of the radiation output for a radiation machine
shall be performed with a calibrated dosimetry system in accordance
with the following.
(I) The dosimetry system calibration shall be traceable
to a national standard.
(II) Dosimetry systems shall be calibrated within 24
months from the date of the prior calibration.
(xii) Record of dosimetry system calibration. The registrant
shall verify all dosimetry equipment meets the requirements of clause
(xi) of this subparagraph.
(6) Dental research.
(A) Any research using radiation machines on humans
shall be approved by an Investigational Review Board (IRB) as required
by Title 45, CFR, Part 46, and Title 21, CFR, Part 56. The IRB shall
include at least one licensed dentist to direct any use of radiation
in accordance with this section.
(B) Facilities with radiation machines with investigational
device exemptions that are involved in clinical studies shall comply
with primary regulations that govern the conduct of clinical studies
and that apply to the manufacturers, sponsors, clinical investigators,
institutional review boards, and the medical device. These regulations
include the following:
(i) 21 CFR, Part 812, Investigational Device Exemptions;
(ii) 21 CFR, Part 50, Protection of Human Subjects;
(iii) 21 CFR, Part 56, Institutional Review Boards;
(iv) 21 CFR, Part 54, Financial Disclosure by Clinical
Investigators; and
(v) 21 CFR, Part 820, Subpart C, Design Controls of
the Quality System Regulation.
(7) Educational facilities. Facilities conducting training
using non-humans are held to all the requirements of this section
except for paragraph (5)(J) of this subsection concerning EPE and
for paragraphs (12) and (13) of this subsection concerning image processing.
(8) Certified radiation machines for dental facilities.
The registrant shall not make, nor cause to be made, any modification
of components or installations of components certified in accordance
with the United States Food and Drug Administration Title 21, CFR,
Part 1020, "Performance Standards for Ionizing Radiation Emitting
Products," as amended, in any manner that could cause the installations
or the components to fail to meet the requirements of the applicable
parts of the standards specified in Title 21, CFR, Part 1020, except
where a variance has been granted by the Director, Center for Devices
and Radiological Health, United States Food and Drug Administration.
A copy of the variance shall be maintained by the registrant in accordance
with subsection (k)(2) of this section for inspection by the agency.
All modifications of components or installation of components must
be approved by the manufacturer.
(9) Additional requirements for dental intraoral radiation
machines.
(A) Source-to-skin distance. Radiation machines designed
for use with an intraoral image receptor shall be provided with means
to limit source-to-skin distance to not less than:
(i) 18 centimeters if operable above 50 kilovolt peak;
or
(ii) 10 centimeters if not operable above 50 kilovolt
peak.
(B) Field limitation. Radiation machines designed for
use with an intraoral image receptor shall be provided with means
to limit the x-ray beam such that:
(i) if the minimum source-to-skin distance is 18 centimeters
or more, the x-ray field at the minimum source-to-skin distance shall
be restricted to a dimension of no more than seven centimeters; and
(ii) if the minimum source-to-skin distance is less
than 18 centimeters, the x-ray field at the minimum source-to-skin
distance shall be restricted to a dimension of no more than six centimeters.
(10) Additional requirements for dental extraoral radiation
machines.
(A) Dental panoramic radiation machines shall be provided
with means to restrict the x-ray beam to the following:
(i) the imaging slit in the transverse axis; and
(ii) no more than a total of 0.5 inches larger than
the imaging slit in the vertical axis.
(B) All other dental extraoral radiation machines (e.g.,
cephalometric) shall be provided with means to restrict the x-ray
field to the image receptor. The x-ray field shall not exceed the
image receptor by more than:
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