Federal performance standard for diagnostic x-ray systems and their major components--FDA. Final rule.
The Food and Drug Administration (FDA) is issuing a final rule to amend the Federal performance standard for diagnostic x-ray systems and their major components (the performance standard). The amendments revise the limits established for maximum patient entrance exposure rates for fluoroscopic x-ray systems during high-level control and other modes of operation. The revisions are being made due to concerns regarding excessively large radiation exposure rates on some fluoroscopic x-ray systems. In addition, an inadvertent error is being corrected to improve the accuracy of the regulations.
D006804:Ergonomics; D005471:Fluoroscopy / Q000009:adverse effects / Q000592:standards*; D006801:Humans; D008452:Maximum Allowable Concentration; D010344:Patient Advocacy; D011835:Radiation Protection / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration