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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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07/06/2020 Radiology 12-330 Complete NEMA Standards Publication XR 28-2018 Supplemental Requirements for User Information and System Function Related to Dose in CT
12/23/2019 Radiology 12-329 Complete IEC 60601-2-43 Edition 2.2 2019-10 CONSOLIDATED VERSION Medical electrical equipment - Part 2-43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures
12/23/2019 Radiology 12-328 Complete IEC 61223-3-5 Edition 2.0 2019-09 Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment [Including: Technical Corrigendum 1 (2006)]
12/23/2019 Radiology 12-327 Complete ISO 11551 Third eidtion 2019-10 Optics and optical instruments - Lasers and laser-related equipment - Test method for absorptance of optical laser components
07/15/2019 Radiology 12-326 Complete NEMA NU 2-2018 Performance Measurements of Positron Emission Tomographs
07/06/2020 Radiology 12-325 Complete NEMA Standards Publication XR 25 -2019 Computed Tomography Dose Check
01/14/2019 Radiology 12-324 Complete ISO 13694 Third edition 2018-11 Optics and Photonics - Lasers and laser-related equipment - Test methods for laser beam power (energy) density distribution
01/14/2019 Radiology 12-323 Complete ISO 11990 Third edition 2018-08 Lasers and laser-related equipment - Determination of laser resistance of tracheal tube shaft and tracheal tube cuffs
01/14/2019 Radiology 12-322 Complete NEMA MS 5-2018 Determination of Slice Thickness in Diagnostic Magnetic Resonance Imaging
01/14/2019 Radiology 12-321 Complete ANSI IES RP-27.3-17 Recommended Practice for Photobiological Safety for Lamps - Risk Group Classification and Labeling
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