Section 325.5703. Definitions.

(1) As used in this part the definitions in 21 C.F.R. 1020.33, "Computed tomography (CT) equipment" (June 10, 2005), are adopted by reference. Copies of these regulations are available at no cost  from  the Radiation Safety Section, Michigan Department of Community Health, P.O. Box 30664, Lansing, Michigan 48909 or via  the  internet  at website: www.michigan.gov/rss and from the Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993 or via  the internet at website:

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm.

(2)     As used in this part the following definitions apply:

(a)    "Annual" means a period of 12 consecutive months.

(b)     "Computed tomography (CT)" means the production of a tomogram by the acquisition and computer processing of x-ray transmission data. Computed tomography includes the capability of producing axial tomograms.

(c)     "CT medical event" means an unintended event where a physician determines that actual damage has occurred to an organ or a physiological system of an individual due to or suspected  to be due to  exposure to diagnostic radiation from a CT scanner.

(d)     "CT scanner" means a CT machine capable of performing CT scans of the head, other body parts, or full body patient procedures including PET/CT and SPECT/CT scanner hybrids if used for CT only procedures.

(e)       "Medical physicist" means a person trained in evaluating the performance of CT scanners, related equipment, and facility quality assurance programs and who meets the requirements in R 325.5707.

(f)    "Positron emission tomography (PET)" means an imaging technique that uses positron- emitting radionuclides  to  produce 3-dimensional images of functional processes in the body.

(g)         "Radiologic technologist" means an individual specifically trained in the use of radiographic equipment and the positioning of  patients  for radiographic examinations and who meets the requirements in R 325.5705.

(h)    "Single photon emission computed tomography (SPECT)" means an imaging technique that  uses  radionuclides  to   produce  3-dimentional  images  of functional processes in the body.

(i)     "Tomogram" means the depiction of the attenuation properties of a section through a body.

(j)       "Traceable to a national standard" means an instrument is calibrated at either the national institute of standards and technology (NIST) or at a calibration laboratory that participates in a proficiency program with  the NIST at least once every 2 years and the  results of the proficiency  test conducted within 24 months of calibration show agreement within ± 3% of the national standard in the appropriate energy range.

History: 2011 AACS.