Radiation-Emitting Products

For purposes of AEC testing, are different image receptor sizes considered different “configurations”?

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Different image receptor sizes are considered different configurations and have to be tested separately during the mammography equipment evaluation. With respect to AEC performance testing during the annual physics survey, the medical physicist can limit testing in the contact configuration to one image receptor size (usually the small size). However, FDA does recommend that in addition to this required testing, the medical physicist also measure the optical density (MOD) obtained using the large image receptor and a 4 cm thick homogeneous material and compare it to the mean optical density obtained for the small image receptor. When results across different size image receptors (different equipment configurations) are compared, the physicist should use the action limit of +/- 0.30 OD.

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Page Last Updated: 07/16/2014
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