Section 410IAC5-6.1-123. Intraoral dental radiographic systems

 

                                (a) In addition to compliance with sections 118 and 119 of this rule, intraoral dental x-ray equipment and associated facilities shall comply with this section. Extraoral dental radiographic systems are exempt from this section, but must comply with section 121 of this rule. Intraoral dental x-ray facilities must be evaluated at intervals not to exceed thirty-six (36) months by a diagnostic imaging physicist or x-ray machine inspector approved by the department.

                                (b) X-ray systems designed for use with an intraoral image receptor shall be provided with means to limit the SSD to no less than eighteen (18) cm if the system is capable of operation above fifty (50) kVp or no less than ten (10) cm, if the system is not capable of operation above fifty (50) kVp.

                                (c) Radiographic systems designed for use with an intraoral image receptor shall be provided with means to limit the x-ray beam such that:

(1) if the minimum SSD is eighteen (18) cm or more, the x-ray field, at the minimum SSD, shall be containable in a circle of diameter seven (7) cm or less; or

(2) if the minimum SSD is less than eighteen (18) cm, the x-ray field, at the minimum SSD, shall be containable in a circle of diameter six (6) cm or less.

                                (d) Means shall be provided to terminate exposure at:

(1) a preset time interval;

(2) a preset product of current and time;

(3) a preset number of pulses; or

(4) a preset radiation exposure to the image receptor.

It shall not be possible to make an exposure when the timer is set to the zero (0) or off position if either is provided. With a timer setting of five-tenths (0.5) seconds or less, the average exposure period (T_avg) shall be no less than five (5) times the maximum exposure period (T_max) minus the minimum exposure period (T_min) when four (4) timer tests are performed. This requirement is expressed mathematically as:

                                                                                                                                                                                       T_avg ≥ 5 (T_max - T_min)

                                (e) An x-ray 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 one-half (1/2) second or less. The x-ray control shall provide visual indication observable at or from the operator's protected position whenever x-rays are produced. In addition, a signal audible to the operator shall indicate that the exposure has terminated. X-ray controls shall be located as follows:

(1) Stationary x-ray systems installed after June 25, 1978, shall have the x-ray control permanently mounted in a protected area so that the operator must remain in that protected area during the entire exposure.

(2) Mobile and portable x-ray systems which are used for greater than one (1) week in the same location, such as a room or suite, shall comply with subdivision (1).

(3) Mobile and portable x-ray systems which are used for greater than one (1) hour and less than one (1) week at the same location, such as a room or a suite, shall comply with subdivision (1) or be provided with a protective barrier six and five-tenths (6.5) feet high placed at least six (6) feet from the tube housing assembly and at least six (6) feet from the patient.

(4) Mobile and portable x-ray systems which are used to make an exposure of a patient at the use location shall comply with subdivision (3) or be provided with a method of x-ray control which will permit the operator to be at least twelve (12) feet from the tube housing assembly during an exposure.

                                (f) The coefficient of variation of exposure shall not exceed ten-hundredths (0.10) when all technique factors are held constant. This requirement shall be deemed to have been met if, when four (4) exposures are made at identical technique factors, the value of the average exposure (E_avg) is no less than five (5) times the maximum exposure (E_max) minus the minimum exposure (E_min). This requirement is expressed mathematically as:

                                                                                                                                                                                       E_avg ≥ 5 (E_max - E_min)

                                (g) Patient and film holding devices shall be used when the techniques permit.

                                (h) The tube housing and the position indicating device shall not be hand held during an exposure.

                                (i) The x-ray system shall be operated in such a manner that the useful beam at the patient's skin complies with subsection (c).

                                (j) Dental fluoroscopy shall be conducted only with image intensification.

                                (k) Diagnostic x-ray systems incorporating one (1) or more certified components shall be required to comply with the following additional requirements which relate to those certified components:

(1) When such equipment is operated on an adequate power supply as specified by the manufacturer in accordance with applicable federal standards, the coefficient of variation of exposure shall be no greater than five-hundredths (0.05) for any specific combination of selected technique factors.

(2) When such equipment allows a choice of x-ray tube current settings and is operated on a power supply specified by the manufacturer in accordance with applicable federal standards, for any tube potential (kVp) within forty percent (40%) to one hundred percent (100%) of the maximum kVp rating, the absolute value of the difference between the ratio of average exposure in mR to the indicated mAs obtained at any two (2) consecutive tube current settings, shall not differ by more than ten-hundredths (0.10) of the absolute value of their sum. A minimum of four (4) measurements per tube current setting are required to determine each average exposure. This requirement is expressed mathematically as:

                                                                                                                                                                                    -X₁ - X₂- ≤ 0.10 -X₁ + X₂-

Where:

X1 and X2

=

The ratios of average exposure to mAs obtained at each of two (2) consecutive tube current settings

(3) Deviation of technique factors from indicated values shall not exceed the limits specified for that system by its manufacturer.

(4) Termination of exposure shall cause automatic resetting of the timer to its initial setting or to the zero (0) position.

(5) All dental x-ray systems manufactured on or after December 1, 1980, shall have a half-value layer of not less than one and five-tenths (1.5) mm aluminum equivalent. Systems operating above seventy (70) kVp are subject to the filtration requirements of section 119(f) of this rule.

(Indiana State Department of Health; 410 IAC 5-6.1-123; filed Oct 29, 1993, 5:00 p.m.: 17 IR 377; readopted filed Jul 11, 2001, 2:23 p.m.: 24 IR 4234; readopted filed May 22, 2007, 1:44 p.m.: 20070613-IR-410070141RFA; readopted filed Sep 11, 2013, 3:19 p.m.: 20131009-IR-410130346RFA)