Current through all regulations passed and filed through March 18, 2024
(A) Dental equipment
shall meet the following
equipment standards:
(1)
For dental
intraoral equipment, a means shall be provided to limit the source-
to-skin distance (SSD) to not less than eighteen
centimeters;
(2)
For dental
intraoral equipment, the x-ray field at the minimum SSD shall be
containable in a circle having a diameter of no more than seven
centimeters;
(3) A
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;
(4) The exposure control switch shall meet
the following requirements:
(a) The switch
shall be of the "dead-man" type;
(b) The
operator shall be able to terminate the exposure at any time during an exposure
of greater than one-half second. Except during panoramic radiography,
termination of the exposure shall cause automatic resetting of the timer to its
initial setting or to zero; and
(c) It shall not be possible to make an
exposure when the timer is set to "zero" or "off" position if either position
is provided;
(5) The kVp accuracy shall be within plus or
minus ten per cent of the indicated value;
(6) For manual exposures, the accuracy of the
timing device shall be within plus or minus ten per cent of the indicated
setting. The timing device shall be tested at a minimum of two settings within
the operative range of fifty milliseconds to one thousand milliseconds;
(7) Visual indication shall be provided
whenever x-rays are produced. Certified equipment also shall provide audible
indication to the operator while x-rays are produced or on termination of the
exposure;
and
(8) The coefficient of
variation for reproducibility of kVp, timing, and radiation exposure shall not
exceed 0.05 for four consecutive exposures.
(B) In addition to other structural shielding
requirements in rule
3701:1-66-02
of the Administrative Code, handlers of dental equipment shall comply with the
following:
(1) Intraoral and panoral units
shall be provided with primary barriers at all areas struck by the useful beam.
Consideration may be given to the attenuation provided by the patient as a
result of direct interaction with the useful beam;
(2) When intraoral or panoral units are in
adjacent human patient occupied rooms or areas,
protective barriers shall be provided between the rooms or areas, unless safety
procedures are documented and implemented to require that no
human patients shall be present in the adjacent
rooms or areas while exposures are being made;
(3) Intraoral and panoral units shall be
provided with a protective barrier for the operator or shall be so arranged
that the operator is located at a minimum distance of six feet from the patient
and out of the useful beam. The operator's position shall be arranged so that
the operator views the patient during the entire exposure; and
(4) When the operator is behind a protective
barrier, a viewing system shall be provided large enough and so placed that the
operator can see the patient without having to leave the protected area during
exposure.
(C) In
addition to the radiation safety requirements listed in rule
3701:1-66-02
of the Administrative Code, handlers of dental equipment shall not permit any
individual to hold any part of the x-ray tube housing, cone, or mechanical
support of the x-ray tube during exposure.
(D)
In addition to the quality
assurance requirements of rules
3701:1-66-02
and
3701:1-66-04
of the Administrative Code, handlers of dental
radiation-generating equipment shall conduct annual evaluations of x-ray
operators to include the following:
(1)
Positioning of
the x-ray tube;
(2)
Image processing;
(3)
Operator location
during x-ray exposure;
(4)
Appropriate radiologic protocol; and
(5)
applicable
regulatory requirements.
(E) Handlers of dental panoral equipment
shall comply with all requirements of paragraphs (A) to (D) of this rule,
except for paragraphs (A)(1) and (A)(2) of this rule, and must comply with the
following:
(1) Dental panoral x-ray machines
shall be certified pursuant to 21 C.F.R. part 1020 (as
effective on the effective date of
this rule);
and
(2) The x-ray field shall
be limited to the dimensions of the slit in the image receptor holder or
limited to the dimensions of the active portion of the image receptor.
(F) Except for dental
equipment used for panoral use, handlers of radiographic equipment used for
extraoral dental procedures shall comply with the requirements of paragraphs
(A) and (B) of rule
3701:1-66-05
of the Administrative Code.
(G)
Fluoroscopy without image intensification shall not be used for dental
examinations. Handlers of image intensified fluoroscopic equipment shall comply
with the applicable requirements of rule
3701:1-66-07
of the Administrative Code .
(H) Handlers of dental cone-beam CT
radiation-generating equipment shall
comply with the applicable requirements of rule
3701:1-66-10
of the Administrative Code .
(I) Handlers of hand-held
radiation-generating equipment used for dental procedures shall meet the
requirements of paragraphs (A), (B), and (D) of this rule, and shall develop
and implement safe operating procedures as part of the quality assurance
program specified in rule
3701:1-66-04
of the Administrative Code, which shall address at least the following:
(1) Hand-held radiation-generating equipment
shall be used for intraoral purposes only;
(2) Operators of the hand-held
radiation-generating equipment shall wear a full lead apron of not less than
0.25 millimeter lead equivalent;
(3)
Hand-held radiation-generating
equipment shall be equipped with
a backscatter shield of not less than 0.25 millimeters lead equivalent and 15.2
centimeters in diameter that is positioned as close as practicable to the
distal end of the device;
(4)
Storage and security procedures shall be developed and implemented to assure
hand-held radiation-generating equipment is secured against unauthorized use or
removal when not under the control and constant surveillance of the
registrant;
(5) Operator
training, as required in paragraph (B)(5) of rule
3701:1-66-04
of the Administrative Code, shall include documented specific instruction to
the x-ray operator regarding the prohibition on placing any part of their body
into the useful beam and ensuring there are no bystanders within a radius of at
least six feet from the patient being examined during exposure; and
(6)
Hand-held
radiation-generating equipment shall not be used in hallways or waiting
rooms.
(J) Dental
equipment shall not be operated at
less than a measured fifty-one kVp.
(K) Dental equipment used by veterinarians
shall comply with all requirements of this rule except paragraphs (A)(1),
(D), (E), (I) and
(J) of this rule. Additionally, the useful beam shall be limited to the area of
clinical interest.
(L) Extraoral
dental equipment used by veterinarians shall follow the requirements of
paragraph (F) of rule
3701:1-66-05
of the Administrative Code.