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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 12-325 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
09/17/2018 Radiology 12-320 Complete IEC 62667 Edition 1.0 2017-08 Medical electrical equipment - Medical light ion beam equipment - Performance characteristics
09/17/2018 Radiology 12-319 Complete IEC 60601-2-68 Edition 1.0 2014-09 Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment
09/17/2018 Radiology 12-318 Complete IEC 60601-2-64 Edition 1.0 2014-09 Medical electrical equipment - Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment
06/07/2018 Radiology 12-316 Complete IEC 62359 Edition 2.1 2017-09 CONSOLIDATED VERSION Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields
06/07/2018 Radiology 12-315 Complete NEMA MS 8-2016 Characterization of the Specific Absorption Rate (SAR) for Magnetic Resonance Imaging Systems
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