Radiation-Emitting Products

When performing a physics survey or mammography equipment evaluation on a unit with multiple target/filter combinations, what tests or measurements must be performed for each combination?

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For a unit with multiple target/filter combinations, the following tests must be performed for each clinically used target/filter combination:

  • Focal spot condition (for different target materials (tracks) only) (21 C.F.R. 900.12(e)(5)(iii)(A)(3)

  • X-ray field/light field/image receptor/compression paddle alignment (for different target materials (tracks) only) (21 C.F.R. 900.12(e)(5)(vii))

  • Beam quality and half-value layer (21 C.F.R. 900.12(e)(5)(iv) and (vi))

  • System artifacts (21 C.F.R. 900.12(e)(5)(ix)) Also see Approved Alternative Standards

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