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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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07/09/2014 Radiology 12-280 Complete IEC 62555 Edition 1.0 2013-11 Ultrasonics -- Power measurement -- High intensity therapeutic ultrasound (HITU) transducers and systems
01/30/2014 Radiology 12-259 Complete IEC 61674 Edition 2.0 2012-11 Medical electrical equipment -- Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging
03/16/2012 Radiology 12-177 Complete UL 122-2007 (R2011) Standard for Photographic Equipment - Ed. 5.0
03/16/2012 Radiology 12-134 Complete ISO 11146-1 First edition 2005-01-15 Lasers and laser-related equipment - Test methods for laser beam widths, divergence angles and beam propagation ratios - Part 1: Stigmatic and simple astigmatic beams
07/12/1999 Radiology 12-51 Complete IEC 61145 (1992-05) Calibration and usage of ionization chamber systems for assay of radionuclides
11/08/2005 Radiology 12-6 Complete IEC 60806 First edition 1984-01 Determination of the maximum symmetrical radiation field from a rotating anode X-Ray tube for medical diagnosis
12/18/2023 Orthopedic 11-409 Complete ASTM F3495-23 Standard Test Methods for Determining the Static Failure Load of Ceramic Knee Femoral Components
12/18/2023 Orthopedic 11-408 Complete ASTM F2777-23 Standard Test Method for Evaluating Knee Bearing (Tibial Insert) Endurance and Deformation Under High Flexion
12/18/2023 Orthopedic 11-407 Complete ASTM F3140-23 Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Unicondylar Knee Joint Replacements
12/18/2023 Orthopedic 11-406 Complete ASTM F3141-23 Standard Guide for Total Knee Replacement Loading Profiles
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