§ 221.202. Equipment requirements.

 (a)  Accreditation. All diagnostic CT X-ray systems must be accredited by an accrediting organization recognized by the Department within 1 year from first patient use.

 (b)  Technical and safety information. The technical and safety information relating to the conditions of operation, dose information and imaging performance provided by the CT manufacturer shall be maintained by the facility and readily accessible to the operators.

 (c)  Termination of exposure. The operator shall be able to terminate the X-ray exposure at any time during a scan, or series of scans under X-ray system control, of greater than 0.5 second duration. Termination of the X-ray exposure shall necessitate resetting of the conditions of operation prior to initiation of another scan.

 (d)  Tomographic plane indication and alignment.

   (1)  For any single tomogram system, a means shall be provided to permit visual determination of the tomographic plane or a reference plane offset from the tomographic plane.

   (2)  For any multiple tomogram system, a means shall be provided to permit visual determination of the location of a reference plane. This reference plane may be offset from the location of the tomographic plane.

 (e)  Status indicators and control switches.

   (1)  The CT X-ray control and gantry shall provide visual indication whenever X-rays are produced and, if applicable, whether the shutter is open or closed.

   (2)  The emergency buttons or switches shall be clearly labeled as to their function.

   (3)  Each individual scan or series of scans shall require initiation by the operator.

 (f)  Indication of CT conditions of operation. The CT X-ray system shall be designed so that the CT conditions of operation to be used during a scan or a scan sequence are indicated prior to the initiation of a scan or a scan sequence. On equipment having all or some of these conditions of operation at fixed values, this requirement may be met by permanent markings. Indication of CT conditions of operation shall be visible from any position from which scan initiation is possible.

 (g)  Leakage radiation. The leakage radiation from the diagnostic source assembly measured at a distance of 1 meter in any direction from the source may not exceed 100 milliroentgens (25.8 µC/kg) in 1 hour when the X-ray tube is operated at its leakage technique factors. Compliance shall be determined by measurements averaged over an area of 100 square centimeters with no linear dimension greater than 20 centimeters.

 (h)  Additional requirements applicable to CT X-ray systems containing a gantry manufactured after September 3, 1985.

   (1)  The total error in the indicated location of the tomographic plane or reference plane by the light field or laser indicator may not exceed 5 millimeters.

   (2)  If the X-ray production period is less than 0.5 second, the indication of X-ray production shall be actuated for at least 0.5 second. Beam-on and shutter status indicators at or near the gantry shall be discernible from any point external to the patient opening where insertion of any part of the human body into the primary beam is possible.

   (3)  The CT X-ray system shall be normalized to water.

   (4)  The CT number for water for a region of interest, not exceeding 100 square millimeters, shall be 0 ± 7.0 CT number units. The facility’s performance phantom shall be utilized, with the technique factors specified by the QMP, to confirm compliance. In instances when a CTN of 0 for water is inappropriate, as in 3D treatment planning, the QMP may establish and maintain an equivalent value.

   (5)  With the performance phantom, the mean CT number of water of one group of pixels may not differ from the mean CT number of water of a second group of pixels equal size within the same image by more than the manufacturer’s published specifications, or those established by the QMP.

   (6)  The noise, utilizing the facility’s performance phantom, may not exceed the manufacturer’s published specifications.

   (7)  The total error between the indicated and actual slice thickness may not exceed 2.0 millimeters.

   (8)  A distance of at least 100 millimeters measured in a CT image shall agree with the actual distance to within ± 5%.

   (9)  Premature termination of the X-ray exposure by the operator shall necessitate resetting the CT conditions of operation prior to the initiation of another scan.

Authority

   The provisions of this §  221.202 issued and amended under sections 301 and 302 of the Radiation Protection Act (35 P.S. § §  7110.301 and 7110.302); and section 1920-A of The Administrative Code of 1929 (71 P.S. §  510-20).

Source

   The provisions of this §  221.202 adopted October 2, 1998, effective October 3, 1998, 28 Pa.B. 4894; amended November 16, 2001, effective November 17, 2001, 31 Pa.B. 6282; amended July 16, 2004, effective July 17, 2004, 34 Pa.B. 3823; amended October 26, 2018, effective January 24, 2019, 48 Pa.B. 6791. Immediately preceding text appears at serial pages (333950) and (304519) to (304520).

Cross References

   This section cited in 25 Pa. Code §  221.61 (relating to radiation therapy simulation systems); 25 Pa. Code §  221.64 (relating to CBCT); 25 Pa. Code §  221.65 (relating to X-ray attenuation systems); 25 Pa. Code §  221.201 (relating to definitions); and 25 Pa. Code §  223.31 (relating to registrant responsibilities).



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