10 centimeters if not
operable above 50 kVp.
b. An open ended PID (position indicating
device) shall be used on new dental x-ray equipment purchased after the
effective date of these regulations.
3 Radiation Exposure Control for Certified and
Noncertified Systems.
a Exposure Initiation.
i. Means shall be provided to initiate the
radiation exposure by a deliberate action on the part of the operator, such as
the depression of a switch. Radiation exposure shall not be initiated without
such an action; and
ii. 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.
b Exposure Termination.
i. Means shall be provided to terminate the
exposure at a preset time interval, preset product of current and time, a
preset number of pulses, or a preset radiation exposure to the image
receptor.
ii. An x-ray exposure
control shall be incorporated into each x-ray system such that an exposure can
be terminated by the operator at any time, except for exposures of 1/2 second
or less.
iii. Termination of an
exposure shall cause automatic resetting of the timer to its initial setting or
to "zero".
d. Exposure Duration
(Timer) Reproducibility. With a timer setting of 0.5 seconds or less, the
difference between the maximum exposure time
(
Tmax) and the minimum exposure time
(
Tmin) shall be less than or equal to
10% of the average exposure time (
T), when four timer test
are performed:
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e Exposure Control Location and Operation
Protection.
i. Stationary x-ray
systems shall be required to have the x-ray exposure control permanently
mounted in a protected area, so that the operator is required to remain in that
protected area during the entire exposure; and
ii. Mobile and portable x-ray systems which
are:
i. used for greater than one week in the
same location, i.e., a room or suite, shall meet the requirements of
1.6.7(3)(e)(i); and
ii. used for
less than one week in the same location, shall be provided with either a
protective barrier at least 6.5 feet (2m) high for operator protection, or
means to allow the operator to be at least 12 feet (3.7 m) from the tube
housing assembly while making exposures.
4. Exposure Reproducibility. The coefficient
of variation shall not exceed 0.05 when all technique factors are held
constant. This requirement shall be deemed to have been met if, when 4
exposures are made within a period of one hour at identical technique factors,
the difference between the maximum exposure value
(
Emax) and the minimum exposure value
(
Emin) shall be less than or equal to
10% of the average exposure (
E):
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5.
Linearity. When the equipment allows a choice of x-ray tube current settings
and is operated on a power supply as specified by the manufacturer in
accordance with any fixed x-ray tube potential within the range of 40 to 100
percent of the maximum rating, the average ratios of exposure to the indicated
millampere-seconds product obtained at any 2 consecutive tube current settings
shall not differ by more than 0.10 times their sum:
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where
X1 and
X2 are the average mR/mAs (C/kg/mAs)
values obtained at each of 2 consecutive tube current settings.
6. Accuracy. Deviation of
technique factors from indicated values shall not exceed the limits specified
for that system by its manufacturer. In the absence of manufacturer's
specifications, the deviation shall not exceed 10% of the indicated
value.
7. kVp Limitations. Dental
x-ray machines with a nominal fixed kVp of less than 50 kVp shall not be used
to make diagnostic dental radiographs of humans.
8 Administrative Controls.
a. Patient and film holding devices shall be
used when the techniques permit.
b.
The tube housing and the PID shall not be hand held during an
exposure.
c. The x-ray system shall
be operated in such a manner that the useful beam at the patient's skin does
not exceed the requirements of 1.6.7(2).
d. Dental fluoroscopy without image
intensification shall not be used.