NEMA XR 28:2013

This standard identifies uniform and standardized manufacturer's information provided to users of a CT scanner. Users include people designated through an Access Control system to operate a CT scanner according to the manufacturer's user instructions, to authorize protocols in the facility where the scanner is housed, and to perform recommended quality control testing on the CT scanner. This user information pertains to perfusion scanning, use of Automatic Exposure Control (AEC), organization of dose-related information, and a requirement for listing reference protocols shipped on the CT system. This user information also requires pre-populating the NEMA XR-25 Dose Check 'Alert' value at a CTDIvol value not to exceed 1 Gy (1000 mGy), as well as system function when switching between a manual mA control mode and automatic exposure control. This standard is established to collect the standardized responses and resolutions to FDA's November 8, 2010 'Letter to the Medical Imaging Technology Alliance Regarding CT Recommendations.' (See Appendix D.) This standard provides supplementary requirements to those already in place for information provided to the user from other normative documents (see Section 1.3, references).