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Part 1020: Performance Standards for Ionizing Radiation Emitting Products
Part 1020: None
21 CFR 1020.30 - Diagnostic x-ray systems and their major components.
21 CFR 1020.30(g) - (g) Information to be provided to assemblers. Manufacturers of components listed in paragraph (a...
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21 CFR 1020.30(e) - (e) Identification of x-ray components. In addition to the identification requirements specified...
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21 CFR 1020.30(k) - (k) Leakage radiation from the diagnostic source assembly. The leakage radiation from the diagno...
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21 CFR 1020.30(j) - (j) Warning label. The control panel containing the main power switch shall bear the warning sta...
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21 CFR 1020.30(c) - (c) Manufacturers' responsibility. Manufacturers of products subject to §§ 1020.30 through 1020....
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21 CFR 1020.30(n) - (n) Aluminum equivalent of material between patient and image receptor. Except when used in a CT...
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21 CFR 1020.30(m) - (m) Beam quality —
21 CFR 1020.30(m)(1) - (1) Half-value layer (HVL). The HVL of the useful beam for a given x-ray tube potential shall no...
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21 CFR 1020.30(d) - (d) Assemblers' responsibility
21 CFR 1020.30(d) - (d) Assemblers' responsibility
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21 CFR 1020.30(d)(1) - (1) Reports of assembly. All assemblers who install certified components shall file a report of ...
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21 CFR 1020.30(h) - (h) Information to be provided to users. Manufacturers of x-ray equipment shall provide to purch...
21 CFR 1020.30(h)(1) - (1) All x-ray equipment. For x-ray equipment to which this section and §§ 1020.31, 1020.32, and ...
21 CFR 1020.30(h)(1)(ii) - (ii) A schedule of the maintenance necessary to keep the equipment in compliance with this sectio...
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21 CFR 1020.30(h)(2) - (2) Tube housing assemblies. For each tube housing assembly, there shall be provided:
21 CFR 1020.30(h)(2)(i) - (i) Statements of the leakage technique factors for all combinations of tube housing assemblies a...
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21 CFR 1020.30(h)(2)(ii) - (ii) Cooling curves for the anode and tube housing; and
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21 CFR 1020.30(h)(3) - (3) X-ray controls and generators. For the x-ray control and associated x-ray high-voltage gener...
21 CFR 1020.30(h)(3)(viii) - (viii) A statement describing the measurement criteria for all technique factors used in paragrap...
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21 CFR 1020.30(h)(3)(i) - (i) A statement of the rated line voltage and the range of line-voltage regulation for operation ...
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21 CFR 1020.30(h)(3)(v) - (v) Generator rating and duty cycle;
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21 CFR 1020.30(h)(3)(ii) - (ii) A statement of the maximum line current of the x-ray system based on the maximum input volta...
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21 CFR 1020.30(h)(3)(vi) - (vi) A statement of the maximum deviation from the preindication given by labeled technique facto...
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21 CFR 1020.30(h)(4) - (4) Beam-limiting device. For each variable-aperture beam-limiting device, there shall be provid...
21 CFR 1020.30(h)(4)(i) - (i) Leakage technique factors for all combinations of tube housing assemblies and beam-limiting d...
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