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U.S. Department of Health and Human Services

Recognized Consensus Standards

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06/27/2016 Radiology 12-302 IEC 60601-2-44 Edition 3.2: 2016 Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of x-ray equipment for computed tomography
06/27/2016 Radiology 12-301 IEC 60601-2-8 Edition 2.1 b:2015 Medical electrical equipment - Part 2-8: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV
06/27/2016 Radiology 12-300 NEMA PS 3.1 - 3.20 (2016) Digital Imaging and Communications in Medicine (DICOM) Set
06/27/2016 Radiology 12-299 IEC 62563-1 Edition 1.1 2016-03 CONSOLIDATED VERSION Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods
06/27/2016 Radiology 12-298 NEMA MS 10-2010 Determination of Local Specific Absorption Rate (SAR) in Diagnostic Magnetic Resonance Imaging
06/27/2016 Radiology 12-297 ANSI IES RP-27.1-2015 Recommended Practice for Photobiological Safety for Lamps and Lamp Systems - General Requirements
06/27/2016 Radiology 12-295 IEC 60601-2-33 Ed. 3.2 b:2015 Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
06/27/2016 Radiology 12-294 IEC 60601-2-45 Edition 3.1 2015 Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices
06/27/2016 Radiology 12-293 IEC 60601-2-37 Edition 2.1 2015 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
08/14/2015 Radiology 12-292 IEEE Std 3333.2.1-2015 IEEE Recommended Practice for Three-Dimensional (3D) Medical Modeling
08/14/2015 Radiology 12-291 IEC 62127-2 Edition 1.2 2017-03 CONSOLIDATED VERSION Ultrasonics -- Hydrophones -- Part 2: Calibration for ultrasonic fields up to 40 MHz
08/14/2015 Radiology 12-290 IEC 61910-1 Edition 1.0 2014-09 Medical electrical equipment - Radiation dose documentation - Part 1: Radiation dose structured reports for radiography and radioscopy
08/14/2015 Radiology 12-289 IEC 62220-1-1 Edition 1.0 2015-03 Medical electrical equipment-Characteristics of digital X-ray imaging devices Part 1-1: Determination of the detective quantum efficiencyDetectors used in radiographic imaging
04/04/2016 Radiology 12-288 NEMA MS 9-2008 (R2020) Standards Publication Characterization of Phased Array Coils for Diagnostic Magnetic Resonance Images
01/27/2015 Radiology 12-287 NEMA XR 28-2013 Supplemental Requirements for User Information and System Function Related to Dose in CT
01/27/2015 Radiology 12-286 NEMA XR 27 Amendment 1-2013 X-ray equipment for interventional procedures - User Quality Control Mode
01/27/2015 Radiology 12-285 IEC 60601-2-1 Edition 3.1 2014-07 Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV
07/09/2014 Radiology 12-283 ISO 12609-2 First edition 2013-07-15 Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications -- Part 2: Guidance for use
07/09/2014 Radiology 12-282 ISO 12609-1 First edition 2013-07-15 Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications -- Part 1: Specification for products
07/09/2014 Radiology 12-281 IEC 60601-2-62 Edition 1.0 2013-07 Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment
07/09/2014 Radiology 12-280 IEC 62555 Edition 1.0 2013-11 Ultrasonics -- Power measurement -- High intensity therapeutic ultrasound (HITU) transducers and systems
07/09/2014 Radiology 12-279 IEC 62127-03 Edition 1.1 2013-05 Ultrasonics -- Hydrophones -- Part 3: Properties of hydrophones for ultrasonic fields up to 40 MHz
07/09/2014 Radiology 12-277 IEC 62127-1 Edition 1.1 2013-02 Ultrasonics -- Hydrophones -- Part 1: Measurement and characterization of medical ultrasonic fields up to 40 MHz
07/09/2014 Radiology 12-275 IEC 61161 Edition 3.0 2013-01 Ultrasonics -- Power measurement -- Radiation force balances and performance requirements
07/09/2014 Radiology 12-273 IEC 60825-1 Edition 2.0 2007-03 Safety of laser products - Part 1: Equipment classification, and requirements [Including: Technical Corrigendum 1 (2008), Interpretation Sheet 1 (2007), Interpretation Sheet 2 (2007)]
07/09/2014 Radiology 12-272 IEC 60601-2-17 Edition 3.0 2013-11 Medical electrical equipment - Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment
01/30/2014 Radiology 12-270 IEC 61223-3-5 First edition 2004-08 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)]
01/14/2014 Radiology 12-269 IEC 60601-1-3 Edition 2.1 2013-04 Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
01/14/2014 Radiology 12-268 IEC 60601-2-22 Edition 3.1 2012-10 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
01/30/2014 Radiology 12-267 IEC 61217 Edition 2.0 2011-12 Radiotherapy equipment - Coordinates, movements, and scales
01/30/2014 Radiology 12-266 IEC 61689 Edition 3.0 2013-02 Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0.5 MHz to 5 MHz
01/30/2014 Radiology 12-264 NEMA MS 11-2010 Determination of Gradient-Induced Electric Fields in Diagnostic Magnetic Resonance Imaging
01/30/2014 Radiology 12-262 ISO 11670 Second edition 2003-04-01 Lasers and laser-related equipment - Test methods for laser beam parameters - Beam positional stability [Including: Technical Corrigendum 1 (2004)]
01/30/2014 Radiology 12-261 IEC ISO 10918-1 First edition 1994-02-15 Information technology - Digital compression and coding of continuous-tone still images: Requirements and guidelines [Including: Technical Corrigendum 1 (2005)]
01/30/2014 Radiology 12-259 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
08/06/2013 Radiology 12-255 IEC 60601-2-11 Edition 3.0 2013-01 Medical electrical equipment - Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment
08/06/2013 Radiology 12-253 IEC 60976 Edition 2.0 2007-10 Medical electrical equipment - Medical electron accelerators - Functional performance characteristics
08/20/2012 Radiology 12-249 IEC 62471 First edition 2006-07 Photobiological safety of lamps and lamp systems
03/16/2012 Radiology 12-248 ISO 21254-3 First edition 2011-07-15 Lasers and laser-related equipment - Test methods for laser-induced damage threshold - Part 3: Assurance of laser power (energy) handling capabilities
03/16/2012 Radiology 12-246 ISO 21254-2 First edition 2011-07-15 Lasers and laser-related equipment - Test methods for laser-induced damage threshold - Part 2: Threshold determination
03/16/2012 Radiology 12-245 ISO 21254-1 First edition 2011-07-15 Lasers and laser-related equipment - Test methods for laser-induced damage threshold - Part 1: Definitions and general principles
03/16/2012 Radiology 12-242 IEC 60601-2-57 Edition 1.0 2011-01 Medical Electrical Equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
03/16/2012 Radiology 12-241 IEC 62274 First Edition 2005-05 Medical electrical equipment - Safety of radiotherapy record and verify systems
03/16/2012 Radiology 12-232 NEMA MS 4-2010 Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices
01/27/2015 Radiology 12-230 NEMA XR 24-2008 (R2014) Primary user controls for interventional angiography x-ray equipment
01/30/2014 Radiology 12-228 IEC 61391-2 Edition 1.0 2010-01 Ultrasonics - Pulse-echo scanners - Part 2: Measurement of maximum depth of penetration and local dynamic range
03/14/2011 Radiology 12-226 IEC 61223-2-6 Second Edition 2006-11 Evaluation and routine testing in medical imaging departments - Part 2-6: Constancy tests - Imaging performance of computed tomography X-ray equipment
03/14/2011 Radiology 12-221 IEC 61223-3-4 First edition 2000-03 Evaluation and routine testing in medical imaging departments - Part 3-4: Acceptance tests - Imaging performance of dental X-ray
03/14/2011 Radiology 12-217 IEC 62083 Edition 2.0 2009-09 Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems
10/04/2010 Radiology 12-215 IEC 62494-1 Edition 1.0 (2008-08) Medical electrical equipment - Exposure index of digital X-ray imaging systems - Part 1: Definitions and requirements for general radiography
10/04/2010 Radiology 12-214 IEC 62220-1-3 Edition 1.0 2008-06 Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-3: Determination of the detective quantum efficiency - Detectors used in dynamic imaging
10/04/2010 Radiology 12-213 IEC 62220-1-2 Edition 1.0 2007-06 Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-2: Determination of the detective quantum efficiency - Detectors used in mammography
08/06/2013 Radiology 12-211 IEC 60601-2-29 Edition 3.0 2008-06 Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators
08/06/2013 Radiology 12-205 IEC 60601-2-5: Edition 3.0 2009-07 Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment
04/04/2016 Radiology 12-196 NEMA MS 2-2008 (R2020) Determination of Two-Dimensional Geometric Distortion in Diagnostic Magnetic Resonance Images
04/04/2016 Radiology 12-195 NEMA MS 6-2008 (R2014) Determination of Signal-to-Noise Ratio and Image Uniformity for Single-Channel Non-Volume Coils in Diagnostic MR Imaging
07/09/2014 Radiology 12-194 ANSI HPS N43.6-2007 (R2013) Sealed Radioactive Sources - Classification
04/04/2016 Radiology 12-188 NEMA MS-1-2008 (R2020) Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Imaging
04/04/2016 Radiology 12-187 NEMA MS 3-2008 (R2020) Determination of Image Uniformity in Diagnostic Magnetic Resonance Images
03/16/2012 Radiology 12-177 UL 122-2007 (R2011) Standard for Photographic Equipment - Ed. 5.0
12/19/2007 Radiology 12-176 IEC 61223-3-2 Second eidtion 2007-07 Evaluation and routine testing in medical imaging departments - Part 3-2: Acceptance tests - Imaging performance of mammographic X-ray equipment
03/16/2012 Radiology 12-175 ISO 24013 First edition 2006-11-15 Optics and photonics -- Lasers and laser-related equipment - Measurement of phase retardation of optical components for polarized laser radiation
03/16/2012 Radiology 12-174 ISO 13697 First edition 2006-05-15 Optics and photonics -- Lasers and laser-related equipment - Test methods for specular reflectance and regular transmittance of optical laser components
12/19/2007 Radiology 12-173 ISO 14880-4:2006 Optics and photonics -- Microlens arrays -- Part 4: Test methods for geometrical properties
12/19/2007 Radiology 12-172 ISO 14880-3:2006 Optics and photonics -- Microlens arrays -- Part 3: Test methods for optical properties other than wavefront aberrations
12/19/2007 Radiology 12-171 ISO 14880-2:2006 Optics and photonics -- Microlens arrays -- Part 2: Test methods for wavefront aberrations
09/09/2008 Radiology 12-166 NEMA XR 23-2006 (R2020) "Quality Control Manual" Template for Manufacturers of Hardcopy Output Devices Labeled for Final Interpretation in Full-field Digital Mammography
09/09/2008 Radiology 12-165 NEMA XR 22-2006 (R2020) "Quality Control Manual" Template for Manufacturers of Displays and Workstations Labeled for Final Interpretation in Full-field Digital Mammography
03/16/2012 Radiology 12-143 ISO 15367-2 First edition 2005-03-15 Lasers and laser-related equipment - Test methods for determination of the shape of a laser beam wavefront - Part 2: Shack-Hartman sensors
03/16/2012 Radiology 12-142 ISO 11146-2 First edition 2005-02-15 Lasers and laser-related equipment - Test methods for laser beam widths, divergence angles and beam propagation ratios - Part 2: General astigmatic beams
03/31/2006 Radiology 12-141 IEEE N42.13-2004 Calibration and Usage of "Dose Calibrator" Ionization Chambers for the Assay of Radionuclides
03/31/2006 Radiology 12-138 ISO 5799 Second edition 1991-08-01 Photography -- Direct-exposing medical and dental radiographic film/process systems -- Determination of ISO speed and ISO average gradient
03/31/2006 Radiology 12-137 ISO 4090 Third eidition 2001-08-15 Photography - Medical radiographic cassette/screens/films and hard-copy imaging films - Dimensions and specifications
03/31/2006 Radiology 12-136 ISO 9236-1 Second edition 2004-02-01 Photography - Sensitometry of screen/film systems for medical radiography - Part 1: Determination of sensitometric curve shape, speed and average gradient
03/16/2012 Radiology 12-134 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
05/27/2005 Radiology 12-121 IEC 61847: 1998 Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics Ed. 1.0
03/16/2012 Radiology 12-117 ISO 15367-1 First edition 2003-09-15 Lasers and laser-related equipment - Test methods for determination of the shape of a laser beam wavefront - Part 1: Terminology and fundamental aspects
10/04/2004 Radiology 12-116 ISO 13696:2002 Optics and optical instruments -- Test methods for radiation scattered by optical components
03/16/2012 Radiology 12-115 ISO 13695:2004 Optics and photonics - Lasers and laser-related equipment - Test methods for the spectral characteristics of lasers
03/16/2012 Radiology 12-113 ISO 12005 Second edition 2003-04-01 Lasers and laser-related equipment - Test methods for laser beam parameters - Polarization
03/16/2012 Radiology 12-106 ISO 17526 First edition 2003-06-15 Optics and optical instruments - Lasers and laser-related equipment - Lifetime of lasers
03/16/2012 Radiology 12-105 NEMA UD 2-2004 (R2009) Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3
01/14/2019 Radiology 12-102 ANSI IES RP-27.2-00/R17 Recommended Practice for Photobiological Safety for Lamps and Lamp Systems - Measurement Techniques
01/30/2014 Radiology 12-59 IEC 61168:1993 Radiotherapy simulators - Functional performance characteristics
07/12/1999 Radiology 12-51 IEC 61145 (1992-05) Calibration and usage of ionization chamber systems for assay of radionuclides
11/08/2005 Radiology 12-6 IEC 60806 First edition 1984-01 Determination of the maximum symmetrical radiation field from a rotating anode X-Ray tube for medical diagnosis
12/20/2021 Orthopedic 11-393 ASTM F2724-21 Standard Test Method for Evaluating Mobile Bearing Knee Dislocation
12/20/2021 Orthopedic 11-392 ASTM F2723-21 Standard Test Method for Evaluating Mobile Bearing Knee Tibial Baseplate/Bearing Resistance to Dynamic Disassociation
12/20/2021 Orthopedic 11-391 ASTM F2722 - 21 Standard Practice for Evaluating Mobile Bearing Knee Tibial Baseplate Rotational Stops
12/20/2021 Orthopedic 11-390 ISO 23089-2 First edition 2021-05 Implants for surgery - Preclinical mechanical assessment of spinal implants and particular requirements - Part 2: Spinal intervertebral body fusion devices
12/20/2021 Orthopedic 11-389 ISO 7206-10 Second edition 2018-08 Implants for surgery - Partial and total hip-joint prostheses - Part 10: Determination of resistance to static load of modular femoral heads [Including AMENDMENT 1 (2021)]
12/20/2021 Orthopedic 11-388 ASTM F1717-21 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
12/20/2021 Orthopedic 11-387 ASTM F1781-21 Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants
12/20/2021 Orthopedic 11-386 ASTM F2665-21 Standard Specification for Total Ankle Replacement Prosthesis
12/20/2021 Orthopedic 11-385 ASTM F2345-21 Standard Test Methods for Determination of Cyclic Fatigue Strength of Ceramic Modular Femoral Heads
06/07/2021 Orthopedic 11-384 ASTM F3446-20 Standard Test Method for Determination of Frictional Torque and Friction Factor for Hip Implants Using an Anatomical Motion Hip Simulator
06/07/2021 Orthopedic 11-383 ASTM F3143-20 Standard Test Method for Determination of Frictional Torque and Friction Factor for Hip Replacement Bearings under Standard Conditions Using a Reciprocal Friction Simulator
06/07/2021 Orthopedic 11-382 ASTM F3090-20 Standard Test Method for Fatigue Testing of Acetabular Devices for Total Hip Replacement
06/07/2021 Orthopedic 11-381 ASTM F2582-20 Standard Test Method for Dynamic Impingement Between Femoral and Acetabular Hip Components
06/07/2021 Orthopedic 11-380 ASTM F2979-20 Standard Guide for Characterization of Wear from the Articulating Surfaces in Retrieved Metal-on-Metal and other Hard-on-Hard Hip Prostheses
 
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