CFR section

21 CFR 1020.31(c)(1): Radiographic equipment

PART 1020-PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING PRODUCTS

Key facts

Citation 21 CFR 1020.31(c)(1)
Section Radiographic equipment
Part PART 1020-PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING PRODUCTS
Subchapter 21 CFR J Radiological
Product types cited Devices
Regulation text (excerpt) (1) Equipment having independent selection of x-ray tube current (mA). The average ratios of air kerma to the indicated milliampere-seconds product (mGy/mAs) obtained at any two consecutive tube current settings shall not differ by more than 0.10 times their sum. This is: |X1 - X2| ≤0.10(X1 + X2); where X1 and X2 are the average mGy/mAs values obtained at each of two consecutive mAs selector settings or at two settings differing by no more than a factor of 2 where the mAs selector provides…

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