About FDA
Standards and Guidance Documents Impacted by the Laboratory of Imaging Physics
IEC 62127-1: “Ultrasonics - Hydrophones - Part 1: Measurement and characterization of medical ultrasonic fields up to 40 MHz.”
IEC 61391-2: “Ultrasonics - Pulse-echo scanners, Part 2: Measurement of maximum depth of penetration and local dynamic range.”
IEC 62563-1: "Medical image display systems-Part 1: Evaluation methods"
IEC 62563-2: "Medical image display systems: maintenance cycle and addition of measurement methods for color"
IEC 60601-44: "Medical electrical equipment - Part 2-44: Particular requirements for basic safety and essential performance of X-ray equipment for computed tomography"
IEC 61223-3-5: "Evaluation and routine testing in medical imaging departments –Part 3-5: Acceptance tests –Imaging performance of computed tomography X-ray equipment"
IEC 61223-3-6: "Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment"
IEC 110/215/NP (future IEC 62629-x-x): "3D display devices"
AIUM TSC draft standard: “Methods for specifying acoustic properties of tissue-mimicking phantoms and objects.”
AAPM CTSC: "Computed Tomography Subcommittee"
AAPM TG111: "The future of CT dosimetry"
AAPM TG200: "CT Dosimetry Phantoms and the implementation of AAPM Report Number 111"
AAPM TG196: "Monte Carlo reference datasets for imaging research"
AAPM TG195: "Requirements and methods for color displays in medicine"
AAPM TG171: "Tomosynthesis"
AAPM TG169: "Measurements of the 3D Image Noise-Power Spectrum in Computed Tomography"
Class II Special Controls Guidance Document: Bone Sonometers (July 17, 2008)
Class II Special Controls Guidance Document: Full-Field Digital Mammography System







