Radiation-Emitting Products

Dosimetry - Annual Quality Control Test

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900.12(e)(5)(vi): Dosimetry. The average glandular dose delivered during a single craniocaudal view of an FDA-accepted phantom simulating a standard breast shall not exceed 3.0 milligray (mGy) (0.3 rad) per exposure. The dose shall be determined with technique factors and conditions used clinically for a standard breast.

  1. My facility uses two distinct groups of small size cassettes of different speed classes to image the standard breast. Must annual dose measurements be obtained for both groups of cassettes?
  2. We are using an FDA cleared single-use cushion pad when performing mammograms on some of our patients. Do we have to include the pad when performing the phantom and dose QC tests?


Page Last Updated: 07/11/2014
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