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Performance Standards for Ionizing Radiation Emitting Products

Federal

Performance Standards for Ionizing Radiation Emitting Products

7 provisions · Centers for Medicare & Medicaid Services

Provisions

Citable source units

21 CFR § 1020.10Physical Environment

Television receivers.

This provision establishes manufacturing performance standards and radiation exposure limits for television receivers with cathode ray tubes.

Group

Physical Environment Life Safety

Category

Physical Environment

Domain

Facility Operations

Topics

Radiation safety, Television receiver standards, Ionizing radiation

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21 CFR § 1020.20Physical Environment

Cold-cathode gas discharge tubes.

This provision establishes manufacturing performance standards, radiation exposure limits, and labeling requirements for cold-cathode gas discharge tubes.

Group

Physical Environment Life Safety

Category

Physical Environment

Domain

Facility Operations

Topics

Radiation safety, Gas discharge tube standards, Ionizing radiation

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21 CFR § 1020.30Radiology ImagingEquipment Maintenance

Diagnostic x-ray systems and their major components.

This regulation establishes performance and safety standards for diagnostic x-ray systems, including requirements for manufacturers, assemblers, and equipment maintenance.

Group

Clinical Services

Category

Radiology Imaging

Domain

Radiology

Topics

Diagnostic x Ray standards, X Ray equipment performance, Radiology equipment safety

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21 CFR § 1020.31Radiology ImagingEquipment Maintenance

Radiographic equipment.

The provisions of this section apply to equipment for radiography, except equipment for fluoroscopic imaging or for recording images from the fluoroscopic image receptor, or computed tomography x-ray systems manufactured on or after Nove...

Group

Clinical Services

Category

Radiology Imaging

Domain

Radiology

Topics

Radiographic equipment standards, X Ray performance standards, Radiation safety

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21 CFR § 1020.32Radiology ImagingEquipment Maintenance

Fluoroscopic equipment.

This regulation establishes mandatory performance and safety standards for fluoroscopic imaging equipment, including requirements for protective barriers, field limitation, air kerma rates, and irradiation time displays.

Group

Clinical Services

Category

Radiology Imaging

Domain

Radiology

Topics

Fluoroscopic equipment standards, Radiation safety, Imaging equipment performance

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21 CFR § 1020.33Radiology ImagingEquipment Maintenance

Computed tomography (CT) equipment.

This regulation establishes mandatory performance, safety, and quality assurance standards for manufacturers of computed tomography (CT) x-ray systems used in clinical settings.

Group

Clinical Services

Category

Radiology Imaging

Domain

Radiology

Topics

Computed tomography equipment, Radiology equipment standards, Diagnostic imaging safety

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21 CFR § 1020.40Physical EnvironmentRadiology Imaging

Cabinet x-ray systems.

This regulation establishes mandatory performance and safety standards for cabinet x-ray systems, including requirements for radiation emission limits, safety interlocks, warning indicators, and equipment labeling.

Group

Physical Environment Life Safety

Category

Physical Environment

Domain

Radiology

Topics

Cabinet x Ray safety, Radiation safety standards, X Ray equipment requirements

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