X-Ray Machine Performance Standards

01. Radiation Output. X-ray machines must have a consistent radiation output within specified limits. (7-1-26) 02. Image Quality. The machines must produce high-quality images with sufficient contrast, resolution, and minimal noise. (7-1-26) 03. Safety Features. X-ray machines must include the following safety features: (7-1-26) a. Beam Lighting Devices: to restrict the X-ray beam to the area of interest and reduce patient exposure; (7-1-26) b. Warning Lights and Signals: to indicate when the machine is in operation; and (7-1-26) c. Interlocks: to prevent accidental exposure by ensuring that the X-ray beam is only activated when the machine is properly configured. (7-1-26) 04. Maintenance and Calibration. Regular maintenance and calibration of X-ray machines are required to ensure they operate within specified performance standards. (7-1-26) 05. Compliance. X-ray machines used for human imaging must comply with (a) or (b) and must comply with (c): (7-1-26) a. U.S. Food and Drug Administration (FDA): FDA regulations on radiation-emitting products. (7-1-26) b. International Electrotechnical Commission (IEC): IEC standards for medical electrical equipment. (7-1-26) c. Documentation of compliance should be maintained for two (2) license renewal periods and be made available for inspection by regulatory authorities. (7-1-26)